The Endoscopic Multi-fire Clip Applier was designed to be used with an endoscope to place clips in the gastrointestinal (GI) tract for the purpose of endoscopic marking, hemostasis of mucosal and submucosal defects < 3 cm, bleeding ulcers, arteries < 2 mm, polyps < 1.5 cm in diameter, and anchoring to affix jejunal feeding tubes to the wall of the small bowel. The device is not intended for repair of gastrointestinal tract lumenal perforations.

Device Description

The InScope Endoscopic Multi-Fire Clip Applier is designed for gastrointestinal endoscopic clipping for marking and hemostasis. It consists of a control handle, an insertion tube, jaws at the distal end for gripping the tissue, and up to 5 clips that can be attached to the tissue individually with each actuation of the device handle. The device is provided sterile and is for one time use only.

AI/ML Overview

The provided document, K013889, is a 510(k) premarket notification for the InScope Endoscopic Multi-Fire Clip Applier. The document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than reporting on a clinical study where acceptance criteria are typically detailed.

Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria is not explicitly available in the provided text. The document describes a comparison to a predicate device, but does not provide a table for acceptance criteria and device performance based on a human-centric or AI-centric study.

However, I can extract the information that is present and indicate what is missing based on your request:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined as quantitative acceptance criteria in the document for a performance study. Instead, the document focuses on compliance with standards and technological similarity to a predicate device.	The InScope Endoscopic Multi-Fire Clip Applier was found to be "substantially equivalent to the legally marketed Olympus HX-5/6-1 Endoscopic Clipping Device." This was demonstrated through "bench testing and comparative analysis of features." Bench tests included "scope passage, rotation, clip deliverability, vessel sealing, and minimum and average clip removal force." Specific numerical performance data from these bench tests is not provided.

Acceptance Criteria

Reported Device Performance

Not explicitly defined as quantitative acceptance criteria in the document for a performance study. Instead, the document focuses on compliance with standards and technological similarity to a predicate device.

The InScope Endoscopic Multi-Fire Clip Applier was found to be "substantially equivalent to the legally marketed Olympus HX-5/6-1 Endoscopic Clipping Device." This was demonstrated through "bench testing and comparative analysis of features." Bench tests included "scope passage, rotation, clip deliverability, vessel sealing, and minimum and average clip removal force." Specific numerical performance data from these bench tests is not provided.

Study Details (Based on available information and acknowledging missing data)

Since this is a 510(k) for a medical device cleared via substantial equivalence, the "study" described is primarily bench testing comparing the device to a predicate, not a clinical trial or AI performance study with the specific metrics requested.

Sample size used for the test set and the data provenance: Not applicable in the context of the provided document. The document refers to "bench testing" which implies in-vitro or simulated use, but does not provide details on sample sizes or data provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical or image-based test set involving expert review is not mentioned, as the reported "study" is bench testing for mechanical equivalence.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to the bench testing described.
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: Not applicable. This document is for a mechanical medical device (clip applier), not an AI diagnostic or assistive device, so MRMC studies or AI improvement metrics are irrelevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the bench testing, the "ground truth" would be the engineered specifications and performance characteristics of the predicate device, against which the InScope device's mechanical performance was compared.
The sample size for the training set: Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.
How the ground truth for the training set was established: Not applicable.

Summary of Performance Data and Substantial Equivalence Basis

The document states that the InScope Endoscopic Multi-Fire Clip Applier is "substantially equivalent to the legally marketed Olympus HX-5/6-1 Endoscopic Clipping Device" based on:

Compliance with various standards, practices, and guidances: These include standards for sterilization (AAMI TIR 27, ANSI/AAMI/ISO 11137-1994, ISO 10993-7), biological evaluation (ISO 10993-1), and material specifications (ASTM F67-00, ASTM F136-98, ASTM F138-97, ASTM F899-95, ASTM F3063-00).
Bench testing: This testing assessed "scope passage, rotation, clip deliverability, vessel sealing, and minimum and average clip removal force."
Comparative analysis of features: Between the InScope device and the predicate Olympus device.
Material safety: The tissue contact materials have "a long history of safe usage in medical devices."

The conclusion drawn is that "the device is safe and effective and performs as well as or better than the predicate device."

Summary

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FEB 0 7 2002

K013889
Page 1 of 3

Summary of Safety and Effectiveness for the InScope Endoscopic Multi-Fire Clip Applier

submitted by

InScope, LLC 8210 NW 27th Street Miami. Fl 33122 Phone: (305) 716-7000 Facsimile: (305) 716-7020

Identification of a Legally Marketed Predicate Device

Device Description

Intended Use

Summary of Technological Characteristics

Technological characteristics of the InScope Endoscopic Multi-Fire Clip Applier were compared with the Olympus HX-5/6-1 Endoscopic Clipping Device manufactured and

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K013889
Page 2 of 3
It was de-

marketed by the Olympus Optical Company, Ltd pursuant to 510(k) K963160. I termined that the compared devices are technologically similar.

Summary of Performance Data

The InScope Endoscopic Multi-Fire Clip Applier complies with the following standards, practices, and guidances:

Sterilization of health care products-Radiation sterilization-Substantiation . of 25 kGy for radiation sterilization as a sterilization Does, AAMI TIR 27 -Method VDmax: 1996, Approved 9 May 1996
Sterilization of health care products-- Requirements for validation and routine . control-Radiation sterilization, ANSI/AAMI/ISO 11137-1994, Approved 25 May 1994 by Association for the Advancement of Medical Instrumentation, Approved 11 July 1994 by American National Standards Institute, Inc.
ISO 10993-7, Biological Evaluation of Medical Devices-Part 7: Ethylene ● oxide. Second Edition 1996-08
ISO 10993-1, Biological evaluation of medical devices-Part 1: Guidance on . the selection of tests: International Standards Organization
ASTM F67-00, Standard Specification for Unalloyed Titanium, for Surgical ● Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700)
ASTM F136-98. Specification for Wrought Titanium-6 Aluminum-4 Vanadium . ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications:
ASTM F138-97, Standard Specification for Wrought 18 Chromium-14 Nickel-● 2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
ASTM F899-95, Standard Specification for Stainless Steel Billet, Bar, and Wire . for Surgical Instruments
ASTM F3063-00, Standard Specification for Wrought Nickel-Titanium Shape ● Memory Alloys for Medical Devices and Surgical Implants

The InScope Endoscopic Multi-Fire Clip Applier is substantially equivalent to the legally marketed Olympus HX-5/6-1 Endoscopic Clipping Device manufactured and marketed by the Olympus Optical Company, Ltd pursuant to 510(k) K963160. This has been demonstrated through bench testing and comparative analysis of features. Bench tests included

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R013889
Page 3 of

num and average clip

scope passage, rotation, clip deliverability, vessel sealing, and minimum and average clip removal force.

The tissue contact materials used to fabricate the InScope Endoscopic Multi-Fire Clip Appliers have a long history of safe usage in medical devices. Since the InScope Endoscopic Multi-Fire Clip Applier meets the requirements of the stated standards and embodies technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The In-Scope Endoscopic Multi-Fire Clip Applier will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized design of an eagle with three stripes above it and two wavy lines below it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 7 2002

Mr. Bruce Weber Vice President, Product Assurance Syntheon, LLC 8210 NW 27th Street MIAMI FL 33122

Re: K013889 Trade/Device Name: Endoscopic Multi-Fire Clip Applier Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: 78 FHN, MND Dated: November 21, 2001 Received: November 23, 2001

Dear Mr. Weber:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass black in the 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.

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. 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); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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8013889

Indications for Use

Page_1_of_1

8013889 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: InScope Endoscopic Multi-Fire Clip Applier

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

Nancy Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number: K013889

InScope, LLC

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.