The primary indication for hot biopsy forceps is simultaneous biopsy and coagulation of diminutive polyps. Hot biopsy forceps are intended for use in conjunction with an electrocautery unit.

Device Description

Not Found

AI/ML Overview

The provided text describes the LSVP International Hot Biopsy Forceps and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically seen in performance studies for AI/ML devices.

This document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a separate performance study against predefined acceptance criteria for a novel technology. The "study" here is implicitly the comparison to predicate devices and adherence to general controls.

Therefore, many of the requested fields cannot be directly answered from the provided text.

Here's a breakdown of what can and cannot be answered:

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

Cannot be provided directly. The document doesn't define explicit acceptance criteria or report specific device performance metrics (e.g., accuracy, sensitivity, specificity) in the way an AI/ML device study would. The acceptance is based on the device being "substantially equivalent" to predicate devices.

2. Sample size used for the test set and the data provenance

Cannot be provided. No specific test set or data provenance is mentioned. The substantial equivalence is based on design, function, and intended use comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Cannot be provided. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method for the test set

Cannot be provided. No test set or adjudication method is described.

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

Cannot be provided. This is not an AI/ML device, and no MRMC study is mentioned.

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

Cannot be provided. This is a physical medical device (forceps), not an algorithm.

7. The type of ground truth used

Cannot be provided. No specific ground truth is referenced for performance testing. Substantial equivalence relies on comparison to existing devices.

8. The sample size for the training set

Cannot be provided. This is not an AI/ML device, and no training set is relevant.

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

Cannot be provided. Not applicable.

Summary based on available information:

The document describes a 510(k) premarket notification for the LSVP International Hot Biopsy Forceps. The "study" in this context refers to the demonstration of substantial equivalence to predicate devices already on the market.

Acceptance Criteria (Implicit): The primary acceptance criterion for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise different questions of safety and effectiveness. This is achieved by showing similarities in design, function, and intended use.
Reported Device Performance (Implicit): The reported "performance" is that the LSVP International Hot Biopsy Forceps are "similar in design, function, and intended use to the currently marketed reusable Olympus hot biopsy forceps." This implies that its safety and effectiveness are comparable to the predicate devices.
Predicate Devices: Reusable Hot Biopsy Forceps manufactured by Olympus, Microvasive Corp., Fujinon, Inc., and Mill-Rose Labs.

The device's review and marketing approval explicitly state: "We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This is the core "proof" in this type of submission.

Summary

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K971204
171 3

Summary of Safety and Effectiveness

MAY 27 1997

LSVP International Hot Biopsy Forceps

Device Name:	LSVP International Hot Biopsy Forceps
Common/Usual Name:	Hot Biopsy Forceps
Classification Name:	Gastroenterology urology biopsy instruments (Class II, Tier 2)
Predicate Devices:	Reusable Hot Biopsy Forceps manufactured by Olympus, byMicrovasive Corp., by Fujinon, Inc., and by Mill-Rose Labs.
Submitted by:(contact person)	Ms. Sophia PesotchinskyLSVP International, Inc.12755 Alto Verde LaneLos Altos Hills,Telephone: (415) 917-8100FAX: (415) 948-7822
Summary Preparation Date:	March 27, 1997
Statement of Intended Use:	The LSVP International, Inc. Hot Biopsy Forceps are intendedfor simultaneous biopsy and coagulation of diminutive polyps.Hot biopsy forceps are intended for use in conjunction with anelectrocautery unit.
Comparison to Predicate Devices:	The LSVP International, Inc., Reusable Hot Biopsy Forceps are

similar in design, function, and intended use to the currently marketed reusable Olympus hot biopsy forceps.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. In the center of the seal is a stylized image of an eagle, with its wings spread and its head turned to the right. The eagle is composed of three curved lines, and it appears to be in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 1997

Ms. Sophia Pesotchinsky Vice President, Regulatory Affairs LSVP International, Inc. 12755 Alto Verde Lane Los Altos Hills, California 94022 Re: K971204 LSVP International Hot Biopsy Forceps Dated: April 14, 1997 Received: April 18, 1997 Regulatory class: II 21 CFR §876.4300/Product code: 78 KGE

Dear Ms. Pesotchinsky:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat/ and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2. Indication for use statement

510(k) number K971204

Device name: LSVP International Hot Biopsy Forceps

INDICATION FOR USE:

The primary indication for hot biopsy forceps is simultaneous biopsy and coagulation of diminutive polyps.

Hot biopsy forceps are intended for use in conjunction with an electrocautery unit.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1204

Robert R. Selling/
(Division Sign-Off)

Division of Reproductive, Accioninal, ENT, and Radiological Devices

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).