[Product description]

The Disposable Pulmonary Nodules Localization Needle is composed of a protective sleeve, an anti-releasing buckle, an anti-backout buckle, an introducer needle, a propelling part and a localization string with a localization hook. The protective sleeve is composed of a protective sleeve tubing and a protective sleeve tap. The introducer needle is composed of a needle tube, which has only one tip shape, and an introducer needle handle. The propelling part is composed of a propelling tube and a propelling handle. The localization string with localization hook is composed of a localization string with scale marks and a localization hook.

[Intended Use]

The Disposable Pulmonary Nodules Localization Needle is used for the CT-guided percutaneous assisted preoperative localization and intraoperative marking of pulmonary nodule.

[Intended User]

This product may only be used by radiologist or thorax surgeon before surgical operation and by thorax surgeon during the surgical operation.

[Intended Environment]

Computed tomography suite and operating room.

[Indications for Use]

Pulmonary nodules or small pulmonary nodules.

[Patient Population]

Adults.

[Intended Benefits]

The localization success rate is 71.4%-100%, which ensures the complete removal of the pulmonary nodule, while preserving more normal lung parenchyma to the maximum extent.

[Contraindications]

Absolute contraindications: 1. increased bleeding propensity;

                                            2. no suitable puncture site localizable;

                                            3. not suitable candidates for segmentectomy or wedge resection.

Relative contraindications: 1. intake of anticoagulants;

2. insufficient lung reserve;

3. cardiac insufficiency;

4. pulmonary hypertension;

5. pronounced emphysema;

6. chronic respiratory insufficiency;

7. severe dyspnoea;

8. severe pleural adhesions;

9. preoperative CT findings suggestive of possible distant metastasis;

10. pulmonary nodules for which thoracic surgeons deem unsuitable for puncture and localization.

[Potential Risks]

Bleeding, hemoptysis, dislodgement/shedding, hemorrhage, migration, pain, pneumothorax, pulmonary hemorrhage, unplanned thoracotomy.

[Specification]

Table 1 Specification of Disposable Pulmonary Nodules Localization Needle (Unit: mm)

[Warnings]

1. This product was expressly manufactured for single use and may not be reused after its initial use. The manufacturer declines any responsibility in the case of product resterilization or reuse. The product is not designed for the essential cleaning and sterilization processes. Sterility of the reprocessed single-use product is therefore not guaranteed. In addition, the quality of the material may be impaired, with safe use no longer be guaranteed. The risk of unintended injuries and infection, particularly cross-infection in patients and medical personnel, increases disproportionately in this case.

2. The localization string and localization hook are meant to be guides only. DO NOT use them as retractors.

3. If the buckle of the introducer needle is dislodged before surgery, the localization hook may not be released in the expected position during the operation.

4. The localization hook can only be released after the introducer needle reaches the edge of the pulmonary nodule, and it is strictly prohibited to release it in advance.

5. The localization hook and localization string should only be retained in the body less than 24h.

6.This device is not intended for use except as indicated in the Intended Use.

7. After use, the product may be a potential biohazard. Handle and dispose of in accordance with acceptable medical practice and applicable local, state, and federal laws and regulations related to product contamination by blood.

[Precautions]

1. The intended users shall be experienced in percutaneous lung puncture and receive product training before operation.

2. To reduce the possibility of unwanted complications (pain, pneumothorax, hook dislocation) the period of time up to resection of the lesion should be minimized.

3. The depth of the pulmonary nodule shall not be more than the maximum insertion depth of the product.

4. The patient shall be instructed to inhale and hold his/her breath while the needle is inserted.

5. If a lobectomy or pneumonectomy is being considered by the surgeon, preoperative localization using this product is not required; therefore, no restriction is placed on the depth of the nodule.

6. Once deployed, the localization hook of this product cannot be retracted and is intended for single use only.

[Steps Prior to Use]

1. Ensure that the packaging is unopened and/or undamaged and check the expiration date. In the case of damaged packaging, the product may not be used.

Note: If the components are damaged or bent, do not use.

2. Open the packaging.

3. The first principle of CT-guided localization is to obtain the shortest needle insertion route. The insertion of the introducer needle should be vertical from the outside chest into the pleural surface. For certain lesions sheltered from bone structure, oblique needling insertion may be considered.

Note: Depending on the location of the nodule, feasible positions include the prone, supine, and lateral decubitus positions, among others. Wherever possible a needle entry site immediately cephalad to a rib should be chosen to avoid intercostal vessel puncture. Care should be taken to avoid the internal mammary vessels if the puncture is performed adjacent to the costal cartilages and sternum. The needle tip should preferably be placed at the periphery of the lesion within 1cm.

4. To achieve acceptable clinical CT scans of the thorax, a CT scanner should meet or exceed the following capabilities:

Acquired slice thickness: =5 mm, with intervals equal to or less than the slice thickness

Capable of performing a low-dose lung CT of CTDIvol =3 mGy for a standard size patient.

[Directions for Use]

1. Local disinfection and administration of local anaesthetic at the puncture site.

2. Remove the Protective Sleeve Tubing and move the Protective Sleeve Tap to the corresponding position of the Needle Tube, whose distance from the needle tip shall be equal to puncture depth.(Figure 3)

3. Insert the Introducer Needle - guide the Introducer Needle to the target area under imaging guidance (Figure 4).

Note: The correct positioning of the needle tube tip is to be verified by CT imaging.

4. Unplug the Anti-releasing Buckle; push the Anti-backout Buckle forward to the end to release the Localization Hook (Figure 5).

5. Completely pull out the Introducer Needle with Anti-backout Buckle and the Propelling Part from the body (Figure 6).

6. A CT shall be taken to verified that the localization hook is in the projected position. If the localization fails, re-localize with another product.

7. Completely cover the exposed Localization String with gauze, and then secure the gauze with medical tape (Figure 7).

Note: Do not glue the medical tape directly to the localization string.

[Note to the surgeon]

The colored scale marks on the string offer visual and palable reference to the location of the localization hook and lesion. The “marked” lesion can be carefully verified endoscopically and resected from the tissue with appropriate instruments. Be careful to avoid cutting the localization string during the resection surgery. Use the specimen pouch to remove the resected tissue, along with the intrathoracic portion of the localization hook and localizaion string, through the appropriate trocar puncture site.

It is recommended to mark the location of the pulmonary nodule in the resected specimen, preferably using a suture tag for precise pathological correlation.