RESOLUTION HEMOSTASIS CLIPPING DEVICE

K040148 · Boston Scientific Corp · MCH · Apr 22, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040148
• Device Name: RESOLUTION HEMOSTASIS CLIPPING DEVICE
• Applicant: Boston Scientific Corp
• Product Code: MCH · General, Plastic Surgery
• Decision Date: Apr 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Resolution™ Hemostasis Clipping Device is intended for the treatment of peptic ulcer bleeding, post polypectomy bleeds, wound closures, and general endoscopic closure that can be deployed through a standard flexible gastroscope and colonoscope.

Device Story

Resolution™ Hemostasis Clipping Device is a single-use, pre-loaded mechanical clip and delivery system. Used during endoscopic procedures via standard flexible gastroscope or colonoscope. Operated by physicians to place clips for hemostasis, tissue marking, anchoring feeding tubes, or closing luminal perforations. Device functions as a mechanical fastener to approximate tissue or secure devices within the GI tract. Provides immediate mechanical closure or marking, aiding in hemorrhage control and defect management. Benefits include reduced need for surgical intervention for minor perforations and effective management of GI bleeding/defects.

Clinical Evidence

Bench testing only. Substantial equivalence supported by functional testing and comparison of technological characteristics against the predicate device.

Technological Characteristics

Single-use, pre-loaded mechanical clip and delivery system. Designed for use through standard flexible endoscopes. Mechanical actuation principle. No electronic components or software.

Indications for Use

Indicated for endoscopic clip placement within the gastrointestinal tract for: endoscopic marking; hemostasis for mucosal/submucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, and colon diverticula; anchoring jejunal feeding tubes to small bowel wall; and supplemental closure of luminal perforations <20mm treatable conservatively.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Olympus Clip Fixing Device (K013066)
• Olympus Clip Fixing Device (K990687)
• Olympus Clip Fixing Device (K963160)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Boston Scientific Corporation, Endoscopy Mr. James D. McMahon Senior Regulatory Affairs Specialist One Boston Scientific Place Natick. MA 01760-1537

K040148 Re:

> Trade/Device Name: Resolution™ Hemostasis Clipping Device Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: FHN, MND, MCH Dated (Date on orig SE Itr): January 22, 2004 Received (Date on orig SE Itr): January 23, 2004

Dear Mr. McMahon,

This letter corrects our substantially equivalent letter of April 22, 2004.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have 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 device, subject to the general controls provisions 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

JUL 2 7 2015

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Benjamin R. Fisher -S

Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

| 510(k) Number | To be determined K040148 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Resolution™ Hemostasis Clipping Device |
| Indications For Use | Indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: <ul><li>endoscopic marking</li><li>hemostasis for mucosal/submucosal defects &lt;3cm, bleeding ulcers, arteries &lt;2mm, polyps &lt;1.5cm in diameter, diverticula in the colon</li><li>anchoring to affix jejunal feeding tubes to the wall of the small bowel</li><li>as a supplemental closure method of luminal perforations &lt;20mm that can be treated conservatively.</li></ul> |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODI3)

| Prescription Use | |
|----------------------|--|
| (Per 21 CFR 801.109) | |

WinnOR

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

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(Division Sign-Off) Proprietary and Confidential Information of Boston Scientific Corporation 8 Division of Reproductive, Abdominal, and Radiological Device 510(k) Number .

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K040148

Traditional 510(k) Premarket Notification Resolution™ Hemostasis Clipping Device

and the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of the states o

.

APR 2 2 2004

Boston Scientific Corporation March 29, 2004

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## 510 (k) SUMMARY

| SPONSOR: | Boston Scientific Corporation<br>One Boston Scientific Place<br>Natick, MA 01760 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | James D. McMahon<br>Senior Regulatory Affairs Specialist |
| DEVICE: | |
| Trade Name:<br>Common Name:<br>Classification: | ResolutionTM Hemostasis Clipping Device<br>Endoscopic Clipping Device<br>Class II, per 21 CFR Part 876.4400 |
| PREDICATE DEVICE: | Olympus Clip Fixing Device (K013066, K990687, K963160) |
| DESCRIPTION: | The ResolutionTM Hemostasis Clipping Device is a single-use<br>pre-loaded mechanical clip and delivery system used for<br>endoscopic clipping. |
| INTENDED USE: | The ResolutionTM Hemostasis Clipping Device is intended for<br>the treatment of peptic ulcer bleeding, post polypectomy bleeds,<br>wound closures, and general endoscopic closure that can be<br>deployed through a standard flexible gastroscope and<br>colonoscope. |
| COMPARISON OF<br>CHARACTERISTICS: | The ResolutionTM Hemostasis Clipping Device is substantially<br>equivalent to the predicate Olympus Clip Fixing devices, as they<br>have similar technological characteristics. The results of<br>performance testing shows no new issues of safety or<br>effectiveness. |
| PERFORMANCE DATA: | FDA's "Guidance for the Content of Premarket Notifications",<br>and the results of technological characteristics and functional<br>testing support a determination of substantial equivalence for the<br>new device when compared to the predicate device. The<br>ResolutionTM Hemostasis Clipping Device is substantially<br>equivalent to the currently marketed Olympus Rotatable Clip<br>Fixing Device (K013066). |

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Proprietary and Confidential Information of Boston Scientific Corporation