RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612

K122660 · Boston Scientific Corporation · PKL · Dec 3, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K122660
• Device Name: RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612
• Applicant: Boston Scientific Corporation
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Dec 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Resolution™ Hemostasis Clipping Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic Marking 2. Hemostasis for: Mucosal/sub-mucosal defects < 3cm Bleeding ulcers . Arteries < 2cm . Polyps < 1.5cm in diameter . Diverticula in the colon . 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel 4. As a supplemental closure method of luminal perforations 20mm that can be treated conservatively.

Device Story

Sterile, single-use endoscopic clipping device; consists of delivery system (handle, catheter) and clip. Delivery system materials: thermoplastic elastomers, stainless steel, polyethylene, polyester. Clip components: stainless steel capsule/jaws, Cobalt Chrome Yoke, styrene tension breaker. Used by physicians during endoscopic procedures. Clip jaws allow up to five opening/closing cycles for repositioning at lesion site. Device provides mechanical closure of tissue defects or vessel bleeding; aids in marking or tube anchoring. Subject of 510(k) is MR Conditional labeling for 1.5T and 3.0T MRI environments.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: thermoplastic elastomers, stainless steel, polyethylene, polyester, Cobalt Chrome, styrene. Form factor: endoscopic delivery catheter (155cm and 235cm lengths). Mechanical actuation: manual handle-operated clip deployment with repositioning capability (up to 5 cycles). MR Conditional (1.5T and 3.0T).

Indications for Use

Indicated for patients requiring endoscopic clip placement in the gastrointestinal tract for marking, hemostasis (mucosal/sub-mucosal defects <3cm, bleeding ulcers, arteries <2cm, polyps <1.5cm, colonic diverticula), anchoring jejunal feeding tubes, or 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 (K040148)

Submission Summary (Full Text)

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K122660 `Page 1/2

#### SECTION 5 510(k) SUMMARY

#### 1. Submitter

DEC 03 2012

Boston Scientific Corporation . 100 Boston Scientific Way Marlborough. MA 01752 Telephone: [phone] Fax: [phone]

Contact: Thomas Hirte Senior Manager Regulatory Affairs Date Propared: August 30, 2012

#### 2. Device

Trade Name: Common Name: Classification Name: Regulation Number: Product Code: Classification:

Resolution™ Hemostasis Clipping Device Endoscopic Clipping Device Hemorrhoidal Ligator 876.4400 FHN and MND Class II

#### 3. Predicate Devices

The Boston Scientific Corporation, Resolution™ Hemostasis Clipping Device (K040148).

#### 4. Device Description

The Resolution™ Hemostasis Clipping Device is a sterile, single-use, endoscopic clipping device consisting of two main components; the delivery system, and the clip.

The delivery system is made up of a handle and delivery catheter. The delivery system is constructed using thermoplastic elastomers, stainless steel, polyethylone, and polyester materials. The Resolution™ Hemostasis Clipping Device delivery system is offered in 155cm and 235cm working lengths.

The clip consists of a stainless steel capsule, and clip anns, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The Resolution clip jaws are engineered such that they can be opened and closed up to five times, aiding in repositioning of the clip at the lesion site. Opening and closing capability may be limited by clinical circumstances and patient anatomy, among other factors.

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122660 Page 2/2

#### 5. Indication for Use:

The Resolution™ Hemostasis Clipping Device is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

- 1. Endoscopic Marking
- 2. Hemostasis for:
- Mucosal/sub-mucosal defects < 3cm
- Bleeding ulcers .
- Arteries < 2cm .
- Polyps < 1.5cm in diameter .
- Diverticula in the colon .
- 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel
- 4. As a supplemental closure method of luminal perforations 20mm that can be treated conservatively.

#### 6. Technological Characteristics:

There are no differences in the technological characteristics between the proposed and predicate devices. The purpose of this Traditional 510(k) is to request a labeling claim that the proposed Resolution™ Hemostasis Clips are Magnetic Resonance (MR) Conditional and may be used for both 1.5 and 3.0 Tesla Magnetic Resonance Imaging (MRI) devices.

#### 7. Performance Data:

Non-clinical bench testing was conducted to support the MR Conditional labeling claim.

#### 8. Conclusion:

Boston Scientific has demonstrated that the proposed Resolution™ Hemostasis Clipping Device is substantially equivalent to currently marketed Resolution™ Hemostasis Clipping Device (K040148).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with outstretched wings. The bird is enclosed in a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference of the circle.

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

March 25, 2015

Boston Scientific Corporation Thomas Hirte Senior Manager, Regulatory Affairs 100 Boston Scientific Way Marlborough, MA 01752

K122660 Re:

Trade/Device Name: Resolution™ Hemostasis Clipping Device Regulation Number: 21 CFR8 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE ltr): November 26, 2012 Received (Date on orig SE ltr): November 27, 2012

Dear Thomas Hirte,

This letter corrects our substantially equivalent letter of December 14, 2012.

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

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Page 2 -

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 (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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Joyce M. Whang -S

for Benjamin 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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K122660

### SECTION 4 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

Indications for Use:

K122660
To Be Determined

**To Be Determined**

Resolution™ Hemostasis Clipping Device

The Resolution™ Hemostasis Clipping Device is indicated for use endoscopic clip placement within the gastrointestinal tract for the purpose of:

1. Endoscopic Marking

- 2. Hemostasis for;
- Mucosal/sub-mucosal defects < 3cm .
- Bleeding ulcers .
- Aneries < 2cm .
- Polyps < 1.5cm in diameter ●
- Diverticula in the colon l
- 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel
- 4. As a supplemental closure method of luminal perforations <20mm that can be treated conservatively.

Prescription Use X (Part 21 CFR 801 Part D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Herbert P. Lerner

Division Sign-Off ision of Reproductive. Gastro-Renal, ological Devic

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