Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation.

Excision of intrauterine myomas -
Excision of intrauterine polyps -
Lysis of intrauterine adhesions -
Incision of uterine septa
Endometrial ablation

Device Description

The telescopic clip is a component of the VRS resectoscopic electrodes, and is designed to secure the distal portion of the electrode within the resectoscope. The telescopic clip is currently manufactured with Polypropylene (PP). It is proposed to change the material to Polybutyleneterephthalate (PBT).

AI/ML Overview

This document describes a 510(k) premarket notification for a modified medical device, the VERSAPOINT* Resectoscopic System. The modification involves changing the material of a component, the telescopic clip, from Polypropylene (PP) to Polybutyleneterephthalate (PBT).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Performance Requirements	Not explicitly stated in terms of quantitative metrics or thresholds. The general requirement is for the modified device to meet the "performance requirements described" for the predicate device.	"Biocompatibility and bench testing have been performed to verify that the product meets the performance requirements described."
Biocompatibility	Implicitly, that the new material (PBT) is biocompatible and safe for its intended use within the human body.	"Biocompatibility and bench testing have been performed..."
Material Equivalence	The new material (PBT) must perform functionally equivalently to the original material (PP) for the telescopic clip within the resectoscope. This would include mechanical strength, durability, resistance to sterilization, and electrical insulation properties (if applicable).	"...bench testing have been performed to verify that the product meets the performance requirements described."

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

Test Set Sample Size: Not specified. The document only mentions "Biocompatibility and bench testing" were performed. There is no information on the number of units tested or the specific conditions of these tests.
Data Provenance: Not specified. Given this is a 510(k) submission to the FDA, it is expected that the testing was conducted under controlled conditions, likely in a laboratory setting, in compliance with relevant standards. However, the country of origin of the data or whether it was retrospective or prospective is not mentioned.

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

Number of Experts: Not applicable. The "ground truth" in this context refers to the device meeting its performance requirements, which is established through technical testing (biocompatibility and bench testing), not through expert consensus on observational data.
Qualifications of Experts: Not applicable for establishing ground truth in this type of submission. The performance testing would be conducted by qualified engineers and technicians.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical or imaging data. For bench and biocompatibility testing, the results are typically evaluated against pre-defined specifications and standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI-assisted diagnostic tool on human reader performance, typically in imaging. This submission focuses on a material change to a surgical instrument, not an AI-based diagnostic tool.

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

Standalone Performance Study: No, a standalone performance study was not done. This concept is also specific to AI algorithms. The device in question is a surgical instrument.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device modification is the established performance requirements for the predicate device and relevant industry standards concerning material properties, biocompatibility, and functional integrity for surgical instruments. The testing aims to demonstrate that the modified device, despite the material change, continues to meet these pre-defined engineering and safety standards.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This submission is for a physical device with a material change, not a machine learning model that requires a training set.

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

Ground Truth for Training Set: Not applicable. As there is no machine learning model, there is no training set or associated ground truth to establish.

Summary

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MAR - 9 2004

Attachment IV - 510(k) Summary

Statement:

Information supporting claims of substantial equivalence, as defined under the Federal Informanon supporting claims of substantial equivaness is summarized below.
Food, Drug, and Cosmetic Act, respecting safety and effectiveness with the Food, Drug, and Cosment Ass, respecting on mary is formatted in accordance with the Agency's final rule.

Modified Device Name: VERSAPOINT* Resectoscopic System

Predicate Device Name: VERSAPOINT* Electrosurgery System (SCUBA)

Device Description:

The telescopic clip is a component of the VRS resectoscopic electrodes, and is designed The telescopie cup is a component stal portion of the electrode within the resectoscope. The telescopic clip is currently manufactured with Polypropylene (PP). It is proposed to change the material to Polybutyleneterephthalate (PBT).

Indications for Use:

Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, frysteroscopic crocroourgeral prd benign conditions requiring endometrial ablation.

Excision of intrauterine myomas -
Excision of intrauterine polyps -
Lysis of intrauterine adhesions -
Incision of uterine septa -
Endometrial ablation t

Technological Characteristics:

The modified device has the same technological characteristics as the predicate device. The only change to the device is to the material of the telescopic clip. The telescopic clip The only change to the ad with Polypropylene (PP). It is proposed to change the material to Polybutyleneterephthalate (PBT).

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Performance Data:

Biocompatibility and bench testing have been performed to verify that the product meets the performance requirements described.

Conclusion:

Based upon the 510(k) summaries and 510(k) statements and the information provided Dascu upon the stocky outliners device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.

Contact:

Patricia M. Hojnoski Sr. Project Manager Regulatory Affairs Gynecare, A Division of Ethicon, Inc. P.O. Box 151, Route 22 West Somerville, NJ 08876

Date:

February 6, 2004

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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 features a stylized depiction of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2004

Ms. Patricia M. Hojnoski Sr. Project Manager Regulatory Affairs Gynecare Worldwide A Division of ETHICON, Inc. U.S. Route 22 West P.O. Box 151 SOMERVILLE NJ 08876

Re: K040302 Trade/Device Name: VERSAPOINT* Resectoscope System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulation Number: 21 CFR 884.4160 Regulation Name: Unipolar endoscopic coagulatorcutter and accessories Regulatory Class: II Product Code: 85 HIH and HFI Dated: February 6, 2004 Received: February 10, 2004

Dear Ms. Hojnoski:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 Section 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brygdon

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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Indications for Use

510(k) Number (if known): K040302 _VERSAPOINT* Resectoscopic System __ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Excision of intrauterine myomas -
Excision of intrauterine polyps -
Lysis of intrauterine adhesions -
Incision of uterine septa
Endometrial ablation

Prescription Use
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadlon

Page 1 of 1

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number .

000003

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.