Anchoring to affix jejunal feeding tubes to the wall of the small bowel
As a supplemental closure method of luminal perforations <20mm 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, 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.

AI/ML Overview

The provided text describes the Resolution™ Hemostasis Clipping Device and its indications for use, but it does not contain specific acceptance criteria or details of a study that proves the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.

Instead, the document focuses on regulatory approval (510(k) submission) for a medical device and mentions non-clinical bench testing to support an MR Conditional labeling claim.

Therefore, I cannot provide the requested information based on the input document.

However, I can extract what limited information is available and explain why other requested details are not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific study. The "performance data" section only mentions "Non-clinical bench testing was conducted to support the MR Conditional labeling claim."
Reported Device Performance: Not provided beyond the statement that bench testing was done to support MR Conditional labeling. No specific metrics (e.g., sensitivity, specificity, accuracy, or other performance measures typically associated with AI/diagnostic devices) are given.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. The document refers to "non-clinical bench testing," which implies physical device testing rather than testing on patient data. There is no mention of a "test set" in the context of patient data, data provenance, or study design (retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. This information pertains to studies involving human interpretation of data for ground truth, which is not described in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. This is relevant for expert-adjudicated ground truth in studies, which is not mentioned here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study was not done. The device is an endoscopic clipping device, not an AI or diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided for a clinical "ground truth." For the "MR Conditional" claim, the "ground truth" would be established by specific MR safety testing standards and measurements of magnetic field interactions (e.g., heating, artifact, force, torque). The document does not detail these specific measurements or the standards used.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. This device is not an AI algorithm that requires a training set.

Summary of what is present:

Device Name: Resolution™ Hemostasis Clipping Device
Indications for Use: Endoscopic marking, hemostasis for various defects/bleeding, anchoring feeding tubes, supplemental closure for luminal perforations.
Purpose of 510(k): To request a labeling claim that the proposed Resolution™ Hemostasis Clips are Magnetic Resonance (MR) Conditional for both 1.5 and 3.0 Tesla MRI devices.
Performance Data Mentioned: "Non-clinical bench testing was conducted to support the MR Conditional labeling claim." (No details provided on the criteria or specific results of this testing).

Summary

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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: 508-683-4454 Fax: 508-683-5939

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.

0000014

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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
1. Hemostasis for:
- Mucosal/sub-mucosal defects < 3cm
- Bleeding ulcers .
- Arteries < 2cm .
- Polyps < 1.5cm in diameter .
- Diverticula in the colon .
1. Anchoring to affix jejunal feeding tubes to the wall of the small bowel
1. 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 (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 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:

Endoscopic Marking

1. Hemostasis for;
- Mucosal/sub-mucosal defects < 3cm .
- Bleeding ulcers .
- Aneries < 2cm .
- Polyps < 1.5cm in diameter ●
- Diverticula in the colon l
1. Anchoring to affix jejunal feeding tubes to the wall of the small bowel
1. 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

(・・・ 13

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.