Resolution Clip

K151802 · Boston Scientific Corporation · PKL · Aug 6, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K151802
• Device Name: Resolution Clip
• Applicant: Boston Scientific Corporation
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Aug 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Resolution 360 Clip is indicated for placement in the Gastrointestinal tract for: 1. Endoscopic Marking 2. Hemostasis for: • Mucosal/sub-mucosal defects < 3 cm • Bleeding ulcers • Arteries < 2 mm • Polyps < 1.5 cm in diameter • Diverticula in the colon • Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus 4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively

Device Story

Resolution 360 Clip is a sterile, single-use endoscopic device for GI tract applications. System comprises a delivery catheter with handle and a pre-loaded metal clip. Physician operates device through an endoscope; control knob allows 360° rotation of clip jaws at distal end to facilitate precise positioning at lesion site. Jaws allow up to five open/close cycles for repositioning prior to final deployment. Device provides mechanical tissue approximation for hemostasis, marking, anchoring of tubes/stents, or closure of small perforations. Benefits include improved maneuverability and placement accuracy compared to non-rotating clips, aiding in management of GI bleeding and lesion sites.

Clinical Evidence

Bench testing only. Tests included clip assembly repeated open/close, retention force, torque, rotation, deployment force, scope compatibility, and tensile strength of components. Compliance with ISO 10993 (biocompatibility) and ISO 11135-1 (ethylene oxide sterilization) was demonstrated.

Technological Characteristics

Materials: stainless steel, polyester, Cobalt Chrome, styrene. Components: delivery catheter, handle, clip, tension breaker. Features: 360° rotation control knob, 155cm/235cm working lengths. Sterilization: Ethylene Oxide. Standards: ISO 10993, ISO 11135-1, ISO 10993-7.

Indications for Use

Indicated for patients requiring endoscopic marking, hemostasis of GI defects (mucosal/sub-mucosal <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula), prophylactic clipping post-resection, anchoring of jejunal feeding tubes or esophageal stents, and supplemental closure of luminal perforations <20mm.

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

• Resolution Hemostasis Clipping Device (K142973)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.

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

August 6, 2015

Boston Scientific Corporation Elena Nieves Principal, Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K151802 Trade/Device Name: Resolution 360 Clip Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated: June 30, 2015 Received: July 2, 2015

Dear Elena Nieves,

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.

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 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.

{1}------------------------------------------------

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 (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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

**Indications for Use**

| Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|---------------------------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------------------------|

| 510(k) Number (if known) | K151802 |
|--------------------------|---------------------|
| Device Name | Resolution 360 Clip |

**Indications for Use (Describe)**
The Resolution 360 Clip is indicated for placement in the Gastrointestinal tract for:
1. Endoscopic Marking
2. Hemostasis for:
• Mucosal/sub-mucosal defects < 3 cm
• Bleeding ulcers
• Arteries < 2 mm
• Polyps < 1.5 cm in diameter
• Diverticula in the colon
• Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection
3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus
4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively

| Type of Use (Select one or both, as applicable) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|-------------------------------------------------|------------------------------------------------|
| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

| FORM FDA 3881 (8/14) | Page 1 of 1 |
|----------------------|-------------|
|----------------------|-------------|

PSC Publishing Services [phone] EF

运

.

:

{3}------------------------------------------------

## SECTION 5 510(K) SUMMARY

### 510(k) SUMMARY

#### 1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Elena Nieves Principal Regulatory Affairs Specialist Tel: [phone] Fax: [phone] Date Prepared: August 3, 2015

#### 2. Proposed Device:

Trade Name: Resolution 360™ Clip Device Common Name: Hemostatic Metal Clip for the GI Tract Classification Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: PKL Classification: Class II

### 3. Predicate Device:

Trade Name: Resolution™ Hemostasis Clipping Device Device Common Name: Hemostatic Metal Clip for the GI Tract Classification Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: PKL Classification: Class II 510(k) Clearance Number: K142973

### 4. Device Description:

The Resolution 360™ Clip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip.

The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The Resolution 360™ Clip delivery system is offered in 155cm and 235cm working lengths.

{4}------------------------------------------------

The clip consists of a stainless steel capsule, and clip arms, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The Resolution™ 360 Clip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.

# 5. Indications for Use:

The Resolution 360 Clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

- 1. Endoscopic marking
- 2. Hemostasis for:
- Mucosal/sub-mucosal defects < 3 cm ●
- . Bleeding ulcers
- Arteries < 2 mm ●
- Polyps < 1.5 cm in diameter ●
- Diverticula in the colon ●
- Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection
- 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel; and Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus
- 4. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively

## 6. Technological Characteristics:

The proposed Resolution™ 360 Clip has similar technological characteristic as the predict Resolution™ Hemostasis Clipping Device (K142973).

The proposed device has the identical intended use and is placed using the identical methodology as the predicate device. However, the proposed device functions in a different manner by allowing for the user to rotate the clip jaws 360° via a control knob prior to deployment.

The materials of the proposed Resolution 360 Clip are identical to the predicate device.

## 7. Performance Data:

The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products -Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals",

{5}------------------------------------------------

The following bench tests were performed on the Resolution™ 360 Clip: Clip Assembly Repeated Open/Close; Retention Force; Clip Approach; Torque; Rotation; Clip Opening and Close Force; Clip Deployment; Force; Scope Compatibility/Usability; Working Length; Endoscope Damage; Biopsy Valve Compatibility; Coil to Handle tensile; and Push/Pull wire to Handle Spool Slider tensile.

The testing performed demonstrated that the proposed and predicate delivery systems are equivalent.

## 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Resolution 360 Clip is substantially equivalent to the currently cleared Resolution Hemostatis Clipping Device (K142973).