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
Anchoring to affix jejunal feeding tubes to the wall of the small bowel
As a supplementary method for closure of GI tract luminal perforations <20mm that can be treated conservatively

Device Description

The Resolution II Clip consists of a pre-loaded, radiopaque, single-use clip on a flexible delivery system. The Resolution II Clip is designed to be compatible with Gastroscopes with working channels ≥2.8, and/or Duodenoscopes and Colonoscopes with working channels ≥3.2mm. The Resolution II Clip jaws are engineered to open and close no more than 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. The Resolution II Clip will be offered in 155cm and 235cm lengths. The deployed clip is constructed of stainless steel while the delivery system is constructed of stainless steel, polyethylene, and polyester materials.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Resolution II Clip, based on the provided documents:

Acceptance Criteria and Device Performance for Resolution II Clip

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided documents do not explicitly list quantitative acceptance criteria in a pass/fail format with specific thresholds. Instead, they state that "All device bench test results were acceptable" and "All biocompatibility tests... passed." The table below reflects the types of tests performed and the general findings.

Test Category	Specific Tests Performed	Acceptance Criteria (Implicit)	Reported Device Performance
Biocompatibility	Cytotoxicity, Sensitization, Intracutaneous Reactivity, Subacute (Subchronic) Toxicity (Intraperitoneal and Intravenous), Genotoxicity (Ames Assay and Mouse Lymphoma), Implantation, USP Physicochemical	Device materials must not cause adverse biological reactions or toxicity as per EN ISO 10993-1:2009.	All biocompatibility tests passed; device considered biocompatible for intended use.
Mechanical/Physical	Forces, Tensile Strengths, Corrosion Resistance, Dimensional, Endoscope Compatibility	Device must meet design specifications for mechanical integrity, material properties, and compatibility with specified endoscopes as per ISO 14630:2008.	All device bench test results were acceptable; sufficiently meets design specifications.

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

The provided document describes bench testing and biocompatibility testing rather than a clinical study with a "test set" in the context of human data. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable in this context. The tests were performed on the device itself and its components.

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

This information is not applicable as the evaluation was based on bench testing and biocompatibility testing of the device, not on diagnostic accuracy requiring human expert review of clinical cases.

4. Adjudication Method for the Test Set

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission primarily focuses on demonstrating substantial equivalence to a predicate device through:

Same intended use.
Similar technological characteristics (though with fewer deployment steps).
Bench testing and biocompatibility testing.

The document does not describe any human reader studies or evaluate the improvement of human readers with or without AI assistance, as AI is not a component of this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study was not done. The Resolution II Clip is a medical device (endoscopic clipping device), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm does not apply. The device's performance was evaluated through bench testing and biocompatibility assessments.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance was established by engineering design specifications, industry standards (EN ISO 10993-1:2009, ISO 14630:2008), and material properties. The tests were designed to confirm that the device met these predefined physical, mechanical, and biocompatibility requirements.

8. The Sample Size for the Training Set

This information is not applicable. The Resolution II Clip is a physical medical device, not an AI or machine learning model that requires a "training set" of data.

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

This information is not applicable as there is no training set for this device.

Summary

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K102764
Page 1 of 2

SECTION 6 510(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 Sr. Regulatory Affairs Specialist Date Prepared: August 30, 2010

2. Device

Trade Name: Resolution II Clip Common Name: Endoscopic Clipping Device Classification Name: Hemorrhoidal Ligator Regulation Number: 876.4400 Product Code: FIN and MND Classification: Class II

3. Predicate Devices

Boston Scientific Corporation, Resolution Hemostasis Clipping Device (K040148)

4. Device Description

The Resolution II Clip consists of a pre-loaded, radiopaque, single-use clip on u flexible delivery system.

The Resolution II Clip is designed to be compatible with Gastroscopes with working channels ≥2.8, and/or Duodenoscopes and Colonoscopes with working channels ≥3.2mm.

The Resolution II Clip jaws are engineered to open and close no more than five times, aiding in repositioning of the clip at the lesion site. Opening and closing capability may be linited by clinical circumstances and patient anatomy, among other factors.

The Resolution II Clip will be offered in 155cm and 235cm lengths. The deployed clip is constructed of stainless steel while the delivery system is constructed of stainless steel, polyethylene, and polyester materials.

000018

DEC 2 2 2010

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K102764
Page 2 of 2

5. Indication for Use:

The Resolution II Clip is indicated for clip placement within the Gastrointestinal Tract for the purpose ol:

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

6. Technological Characteristics:

The proposed Resolution™ II Clip has the same technological characteristics as the predicate Resolution" M Hemostasis Clipping Device (K040148).

The proposed device has the same intended use and is placed using the same methodology as the predicate device via a flexible delivery system. However, the proposed device functions in a different manner by allowing for clip placement within the gastrointestinal tract with fewer deployment steps.

The materials of the proposed Resolution II Clip can be found above in part 4 of this 510(k) summary.

7. Performance Data:

The proposed Resolution II Clip deployed clip was evaluated in accordinge with EN ISO 10993-1:2009. The following tests were performed on the deployed clip: Cytotoxicity. Sensitization. Intracutaneous Reactivity, Subacute (Subchronic) Toxicity -Intraperitoncal and Intravenous. Genotoxicity - Ames Assay and Mouse Lymphoma, Implantation, and USP Physicochemical.

The delivery system was evaluated in accordance with EN ISO 10993-1:2009. The following tests were performed on the delivery system: Cytotoxicity, Sensitization, and Intracutaneous Reactivity.

The proposed Resolution II Clip was evaluated in accordance with ISO 14630:2008. The following tests were conducted on the Resolution II Clip: Forces, Tensile Strengths, Corrosion Resistance, Dimensional, and Endoscope Compatibility.

8. Conclusion:

All biocompatibility tests conducted on the Resolution II Clip passed. Therefore, the Resolution II Clip is considered biocompatible for its intended use.

All device bench test results were acceptable. The data demonstrate that the Resolution II Clip sufficiently mects the design specifications and is suitable for the intended use.

Boston Scientific has demonstrated that the proposed Resolution II Clip is substantially equivalent to Boston Scientific Corporations currently marketed Resolution Clip (K040148).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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 Sr. Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K102764 Trade/Device Name: Resolution II Clip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated (Date on orig SE ltr): September 23, 2010 Received (Date on orig SE ltr): September 24, 2010

Dear Elena Nieves,

This letter corrects our substantially equivalent letter of December 22, 2010.

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 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:

K102764

510(k) Number (if known):4

Device Name: Resolution II Clip

Indications for Use:

The Resolution II Clip is indicated for clip placement within the Gastrointestinal Tract for the purpose of:

Endoscopic Marking ﻨﺴﺘ
ni Hemostasis for:
- . Mucosal/sub-mucosal defects < 3 cm
- Bleeding ulcers
- . Arteries < 2 mm
- Polyps < 1.5 cm in diameter
- Diverticula in the colon .
Anchoring to affix jejunal feeding tubes to the wall of the small bowel నే...
సా
1. As a supplementary method for closure of GI tract huminal perforations <20mm that can be tranted conservatively

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

Over-The-Counter Usc (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)

Haleen

Page 1 of |
000017

Premarket Notification, Resolution II Clip

DEC 2 2 2 2010

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.