[Product description]

The Endoscopic Anastomosis Clip consists of an anastomosis clip preloaded onto an applicator cap, a releaser (depending on model), wire hooks (depending on model) and a protector cap (depending on model). The anastomosis clip consists of the occlusion jaws and the binding wires. The applicator cap consists of the transparent cap, the fixed sleeve and the threads. The releaser consists of the reel frame, the reel, the lock handle, the entrance sleeve, the inserting tube, the sealing cap and the Velcro tape. There are silicone sleeves on either end of the wire hook.

[Intended Use]

The Endoscopic Anastomosis Clip is an instrument for flexible endoscopy. It can be used for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions, and for endoscopic marking of lesions prior to gastrointestinal surgery.

[Intended User]

Clinicians trained in techniques necessary for the associated endoscopic therapeutic use of an over the scope clip and its potential adverse events.

[Intended Environment]

Endoscopy room or operating room.

[Indications for Use]

The Endoscopic Anastomosis Clip is an instrument for flexible endoscopy. It can be used for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions, and for endoscopic marking of lesions prior to gastrointestinal surgery.

The anastomosis clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

- Endoscopic marking

- Hemostasis for:

- Mucosal/submucosal defects<3 cm

- Bleeding ulcers

- Arteries < 2 mm

- Polyps < 1.5 cm in diameter

- Diverticula in the colon

- Closure of GI tract luminal perforations < 20 mm that can be treated conservatively

[Patient Population]

Adults.

[Intended Clinical Benefits]

Clinical Success Rate- Hemostasis: 66.7-100%

Clinical Success Rate- Closure : 68.4-100%

[Contraindications]

1) Use of the clip device is contraindicated in any patient for whom flexible endoscopy is contraindicated;

2) Treatment of esophageal varices;

3) Patients with a known nickel allergy.

[Complications]

Perforation, tear, and mucosal / tissue Injury

Re-bleeding / hemorrhage

Failure, leakage, infection & inflammation

Device migration & procedure/placement issues

Pain and discomfort

[Specification]

The SI241 series products contain the releaser, the applicator cap, the anastomosis clip, the wire hook and the protector cap.

The SI244 series products are supplementary package for extra applicator cap with anastomosis clip.

Table 1 Specifications and Basic Sizes of Applicator Cap with Anastomosis Clip (Unit: mm)

Table 2 Specifications of the Anastomosis Clips (Unit: mm)

Table 3 Components of the SI241 Series Products

Table 4 Components of the SI244 Series Products

Table 5 Compatibility Chart

[MRI Safety Information]

The Endoscopic Anastomosis Clip has not been evaluated for safety in the MR environment. It has not been tested for heating or unwanted movement in the MR environment. The safety of Endoscopic Anastomosis Clip in the MR environment is unknown. Performing an MR exam on a person who has this medical device may result in injury or device malfunction. Since the anastomosis clip shall be removed from the body within 30 days, a patient can safely undergo an MRI examination once the anastomosis clip has been removed from the body.

[Warnings]

1. Please carefully read all instructions prior to use. Do not exceed the product indications to use.

2. Please carefully examine the integrity of the sterile package prior to use. Do not use the product if the sterile package is damaged.

3. The validity of the product is three years, prohibit using the expired product.

4. This product is disposable and single use only.

5. 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. It is recommended to apply some lubricants to the applicator cap outer surface before deploy it into patients.

2. Mount the protector cap to capture the separated clip to avoid tissue scratch.

3. Based on clinical trials, 8.8% (9/102) of the clips can spontaneously fall off within 30 days.

4. Endoscopic follow-up is mandatory within 30 days. If the clip cannot spontaneously fall off within 30 days, it need to be removed from the body by endoscopic method.