INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321

K051950 · Ethicon Endo-Surgery, Inc. · MND · Oct 7, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051950
• Device Name: INSCOPE MULTI-CLIP APPLIER, MODELS IN22321, IN23321
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: MND · Gastroenterology, Urology
• Decision Date: Oct 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of: - Endoscopic marking, . - Hemostasis for: ● - o Mucosal and submucosal defects < 3 cm - Bleeding ulcers o - o Arteries < 2 mm - o Polyps < 1.5 cm in diameter - o Diverticula in the colon - Anchoring to affix jejunal feeding tubes to the wall of the small bowel, . - Closure of GI tract luminal perforations < 20 mm in patients where an alternative . to surgery is required.

Device Story

InScope Multi-Clip Applier is a sterile, single-use, disposable endoscopic instrument; designed for use with flexible endoscopes (min 3.2 mm working channel). Device features two opposing jaws controlled by a proximal handle lever; manual firing mechanism deploys preloaded titanium clips. Used by physicians in clinical settings to achieve hemostasis, mark tissue, anchor feeding tubes, or close GI perforations. Device provides mechanical tissue approximation; benefits include minimally invasive alternative to surgery for specific GI defects.

Clinical Evidence

Bench and preclinical testing only. Results demonstrate performance equivalence to predicates in hemostasis, clip retention, and tissue viability. Literature review supports use for perforation closure, fistulas, anastomotic leaks, and diverticula bleeding without increased safety risks.

Technological Characteristics

Sterile, single-use, disposable endoscopic instrument. Materials include titanium clips. Sensing/actuation: manual lever-actuated mechanical grasping and firing mechanism. Dimensions: compatible with flexible endoscopes having minimum 3.2 mm working channel. No electronic components or software.

Indications for Use

Indicated for patients requiring endoscopic marking, hemostasis (mucosal/submucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula), jejunal feeding tube anchoring, or closure of GI luminal perforations <20mm where surgery is not an option.

Regulatory Classification

Identification

A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

Special Controls

*Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Syntheon, LLC: Endoscopic Multi-Fire Clip Applier
• Olympus Optical Co., Ltd.: Rotatable Clip Fixing Device HX-5/6-1

Submission Summary (Full Text)

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K051950

OCT 7 - 2005

# InScope™ Multi-Clip Applier 510(k) Summary of Safety and Effectiveness

### Company

INSCOPE A Division of Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

### Contact

Kimberly Shoemaker, RAC Manager, Regulatory Affairs

### Date Prepared:

July 15, 2005

### Name of Device

Trade Name: InScope™ Multi-Clip Applier Classification Name: Clip Applier/Endoscopic Clipping Device

### Predicate Devices:

Trade Name: Syntheon, LLC: Endoscopic Multi-Fire Clip Applier Olympus Optical Co., Ltd .: Rotatable Clip Fixing Device HX-5/6-1

### Device Description

The InScope™ Mult-Clip Applier is a sterile, single patient use, disposable instrument capable of attaching clips to the mucosal lining of the gastrointestinal (GI) tract. The clips are used to create hemostasis and/or tissue approximation. The distal, flexible portion of the applier is designed to work with a flexible endoscope having a minimum working channel diameter of 3.2 mm. Two opposing jaws grasp tissue via a manually activated lever on a proximal handle. Once the closure lever is latched, a firing mechanism is manually activated, which deploys a titanium clip over the target tissue. The device is supplied preloaded with four (4) titanium clips.

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K051950

pg 2 of 2

### Indications for Use

The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of:

- Endoscopic marking, .
- Hemostasis for: ●
- o Mucosal and submucosal defects < 3 cm
- Bleeding ulcers o
- o Arteries < 2 mm
- o Polyps < 1.5 cm in diameter
- o Diverticula in the colon
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel, .
- Closure of GI tract luminal perforations < 20 mm in patients where an alternative . to surgery is required.

### Technological Characteristics

The InScope™ Multi-Clip Applier does not have the identical indication statements as the predicate devices, but the differences noted do not alter the intended therapeutic/diagnostic effect.

#### Performance Data

Results of bench and preclinical testing demonstrate that performance of the InScope Multi-Fire Clip Applier is substantially equivalent to the predicate devices in regards to hemostasis, clip retention and lack of tissue damage upon clip placement (tissue remains viable).

A literature review in combination with the preclinical data demonstrates the use of the InScope Multi-Clip Applier for closure of gastrointestinal perforations, fistulas, anastomotic leaks and for control of bleeding diverticula is not likely to raise any new or increased risks to safety and effectiveness compared to risks experienced with similar marketed devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2005

Kimberly Shoemaker, RAC Manager, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road CINCINNATI OH 45242-2839

Re: K051950

Trade/Device Name: InScope™ Multi-Clip Applier Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Product Codes: MND and FHN Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Code: KOG Regulatory Class: II Dated: September 23, 2005 Received: September 26, 2005

Dear Ms. Shoemaker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and bave determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your Apple can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good nanufacturing practice requirements as set forth in the quality systems (QS) (2) CFR Par 801 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): 5051950 Device Name: InScope™ Multi-Clip Applier Indications for Use:

The InScope Multi-Clip Applier is indicated for use with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of:

- Endoscopic marking, .
- Hemostasis for: .
- Mucosal and submucosal defects < 3 cm O
- o Bleeding ulcers
- Arteries < 2 mm o
- Polyps < 1.5 cm in diameter o
- Diverticula in the colon ্ত
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel, ●
- Closure of GI tract luminal perforations < 20 mm in patients where an alternative . to surgery is required.

× Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart (21 CFR 801 Subpart C) D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Byrom

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_6,65195

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