Endoscopic marking
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
Anchoring to affix jejunal feeding tubes to the wall bowel; and Anchoring to affix iully covered esophageal self-expanding metal stents to the wall of the esophagus
As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively

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, polyethylene, 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 arms, 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. There are no associated accessories included with this device.

AI/ML Overview

This document describes the Acceptance Criteria and the studies that prove the Resolution™ Hemostasis Clipping Device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Clinical Effectiveness: Stent Anchoring	Resolution Clips should significantly reduce stent migration compared to non-clipped stents when affixing fully covered esophageal self-expanding metal stents (SEMSs).	Study by Vanbiervliet G et al. (2012): - Stent migration was significantly less (p=0.003) when Resolution Clips were used to anchor stents (13%) compared to non-anchored stents (57%). - This met the acceptance criteria, demonstrating the effectiveness of the device in reducing stent migration.
Clinical Effectiveness: Hemostasis (Prophylactic Clipping)	Prophylactic clip closure for post-polypectomy defects should significantly reduce the risk of delayed bleeding.	Study by Liaquat, H et al. (2013): - Multivariate analysis indicated that non-clipped lesions were 6 times more likely to have a delayed bleed (95% CI, 2.0-18.5; p=0.002) than fully clipped lesions. - Partially clipped lesions were not significantly (p=0.17) more likely to have delayed bleeding compared with fully clipped lesions. - Fisher Exact test comparing prophylactically clipped (complete and partial) to non-clipped defects showed a statistically lower rate of delayed bleeding in the Resolution Clip group (2.5%) compared to the non-clip group (9.7%) (p=0.006). - These results met the acceptance criteria, supporting the safety and effectiveness of prophylactic clipping in reducing delayed post-polypectomy hemorrhage.
Safety (General)	Absence of complications in clinical use.	Study by Vanbiervliet G et al. (2012): - No complications were observed in either the clipped or non-clipped groups for stent anchoring. Study by Liaquat, H et al. (2013): - The study's findings regarding reduced delayed bleeding also implicitly support the safety of the device for this indication. - These findings support the safety profile of the device in clinical use.
Biocompatibility	The device must meet the requirements of ISO 10993 for biological evaluation.	The proposed device meets the requirements of ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing". This was asserted because the design and materials remain unchanged from the predicate device (K122660). No new performance data was required for this submission specifically for biocompatibility because of the substantial equivalence assertion.
Sterilization Efficacy	The device must meet the requirements of ISO 11135-1 for ethylene oxide sterilization.	The proposed device meets the requirements of 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". This was asserted because the design and materials remain unchanged from the predicate device (K122660). No new performance data was required for this submission.
Sterilization Residuals	The device must meet the requirements of ISO 10993-7 for ethylene oxide sterilization residuals.	The proposed device meets the requirements of ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals". This was asserted because the design and materials remain unchanged from the predicate device (K122660). No new performance data was required for this submission.

2. Sample Sizes Used for the Test Set and Data Provenance

Study by Vanbiervliet G, Filippi J, Karimdjee BS, et al. (2012):
- Sample Size: The document does not explicitly state the total number of patients or stents included. It references a "pilot comparative study," suggesting a smaller sample size typical of pilot studies. The percentages of migration (13% vs. 57%) are given, implying a comparison between two groups (clipped vs. non-clipped SEMSs).
- Data Provenance: Prospective study. The country of origin is not specified in the provided text.
Study by Liaquat, H, Rohn E, Rex DK (2013):
- Sample Size:
  - Clipped lesions: 277 large sessile or flat colorectal lesions were prophylactically clipped.
  - Control lesions: 247 control lesions (non-clipped).
- Data Provenance: Experience from the specified authors, implying a retrospective analysis of clinical records. The country of origin is not specified in the provided text.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The provided text does not contain information about the number or qualifications of experts used to establish ground truth for the test sets. The studies referenced are clinical studies reporting outcomes (stent migration, delayed bleeding) rather than evaluations of device performance against expert-derived ground truth.

4. Adjudication Method for the Test Set

The provided text does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test sets. The clinical studies likely rely on objective clinical observations and outcomes as reported by treating physicians.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described in the provided text. The studies are clinical outcome studies comparing device use to non-use, not studies evaluating human readers' diagnostic performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (i.e., algorithm only without human-in-the-loop performance) study was not conducted or described. The Resolution™ Hemostasis Clipping Device is a physical medical device, not an AI algorithm. Its performance is directly tied to its use by a clinician.

7. Type of Ground Truth Used

Clinical Outcomes/Events:
- For the Vanbiervliet G et al. study: The ground truth was the objective occurrence of stent migration.
- For the Liaquat, H et al. study: The ground truth was the objective occurrence of delayed post-polypectomy hemorrhage.

8. Sample Size for the Training Set

The provided text does not mention any training set. Since this is a physical medical device and not an AI algorithm, the concept of a "training set" for an algorithm is not applicable here. The device itself was developed and validated through engineering design and possibly pre-clinical testing, but not typically through "training" on a specific dataset like an AI model.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set" described for this physical device.

Summary

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SECTION 5 510(k) SUMMARY

510(k) SUMMARY

1. SUBMITTER:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4347 Fax: 508-683-5939

Contact: Elena Nieves Principal, Regulatory Affairs Specialist Date Prepared: November 24, 2014

2. DEVICE:

Name of Device:	Resolution™ Hemostasis Clipping Device
Common Name:	Hemostasis Clipping Device
Classification Name:	Hemorrhoidal Ligator
Regulation Number:	876.4400
Product Code:	FHN and MND
Classification:	Class II

3. PREDICATE DEVICE:

Resolution™ Hemostasis Clipping Device Name of Device: 510(k) Number: K122660 Classification Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: FHN and MND Classification: Class II

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, polyethylene, and polyester materials. The Resolution™ Hemostasis Clipping Device delivery system is offered in 155cm and 235cm working lengths.

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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 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.

There are no associated accessories included with this device.

5. INDICATIONS FOR USE:

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

1. Endoscopic marking
1. 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
1. 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
1. As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 6. PREDICATE DEVICE:

There are no differences in the technological characteristics between the proposed device and the predicate Resolution Hemostasis Clipping Device (K 122660). The purpose of this Traditional 510(k) is to request an expanded indication for the proposed Resolution™ Hemostasis Clipping Device. The physical device will remain unchanged from the predicate K122660, but the expanded indication requires a change to the product labeling. All other design specifications remain unchanged.

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7. PERFORMANCE DATA:

Non-Clinical Testing:

No performance data was required for this submission. 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", as the design and materials remain unchanged from that of the predict Resolution Hemostasis Clipping Device (K122660).

Clinical Data:

Boston Scientific used published clinical results on the Resolution Hemostasis Clipping Devices used for clipping fully covered esophageal self-expanding metal stents; and delayed bleeding rates with prophylactic clipping.

Vanbiervliet G, Filippi J, Karimdjee BS, et al. "The role of clips in preventing migration of fully covered metallic esophageal stents: a pilot comparative study", Surg Endosc, 2012, 26: p. 53-59, prospectively compared SEMSs that were anchored (affixed) to the wall of the esophagus with the Resolution Clip device to non-clipped SEMSs. Statistical analysis via Fisher Exact test indicated that stent migration was significantly (p=0.003) less when Resolution Clips were used to anchor stents in place (13%) as compared to stents that were not anchored with clips (57%). Furthermore, there were no complications observed in either group.

The report by Liaquat, H, Rohn E, Rex DK, Gastrointest Endosc, 2013. 77(3): p. 401-407, entitled "Prophylactic clip closure reduces risk of delayed postpolypectomy hemorrhage: experience in 277 clipped large sessile or flat colorectal lesions and 247 control lesions", compared rates of delayed bleeding for non-clipped versus prophylactically clipped defects postpolypectomy. The clipped lesions were treated with the Resolution Clip and had a mean size of 31 mm (range 20-100 mm).

A multivariate analysis indicated that the lesions that were not clipped were 6 times more likely to have a delayed bleed (95% CI, 2.0-18.5; p=0.002) than a fully clipped lesion. Furthermore. lesions that were partially clipped were not significantly (p=0.17) more likely to have delayed bleeding compared with fully clipped lesion. A Fisher Exact test comparing prophylactically clipped, complete and partial, to non-clipped defects indicated that the rate of delayed bleeding in the Resolution Clip group, 2.5%, was statistically less than that of the non-clip group 9.7% (p=0.006).

The results indicate that prophylactic polypectomy site closure with Resolution Clips is associated with a reduced the risk of delayed post polypectomy hemorrhage. These results strongly support the safety and effectiveness of the prophylactic use of the Resolution Clip in reducing the risk of delayed bleeding.

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The clinical results demonstrate that the Resolution Hemostasis Clipping Device can be safely and effectively used within the gastrointestinal (GI) tract for the purpose of hemostasis for prophylactic clipping to reduce the risk of delayed bleeding post lesion resection; and anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus.

8. CONCLUSION:

Boston Scientific Corporation has demonstrated that the proposed Hemostasis™ Clipping Device can be safely and effectively used for its proposed expanded indication.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

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

March 25, 2015

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

Re: K142973

Trade/Device Name: Resolution™ Hemostasis Clipping Device Regulation Number: 21 CFR& 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE ltr): October 15, 2014 Received (Date on orig SE ltr): October 16, 2014

Dear Elena Nieves,

This letter corrects our substantially equivalent letter of December 1, 2014.

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142973

Device Name

Resolution™ Hemostasis Clipping Device

Indications for Use (Describe)

The Resolution Hemostasis Clipping Device is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of:

Endoscopic marking
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

Anchoring to affix jejunal feeding tubes to the wall bowel; and Anchoring to affix iully covered esophageal self-expanding metal stents to the wall of the esophagus
As a supplemental closure method of luminal perforations < 20 mm that can be treated conservatively

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
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.(b)
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.