The Laser Fiber GF500 is intended to be used as a fiber optic delivery system in conjunction with the W.O.M. Laser U100 during lithotripsy procedures in the contact mode.

Device Description

The Laser Fiber GF500 is a disposable fiberoptic which is designed to deliver energy from the W.O.M. Laser U100 to the stone in lithotripsy. The fiber which is provided non-sterile is available in 3,5 and 5 meter in length.

AI/ML Overview

The provided text describes a 510(k) summary for the Laser Fiber GF500. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a detailed clinical study with acceptance criteria.

Therefore, many of the requested categories for a study proving device performance (such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training sets) are not applicable or available in this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Intended Use Equivalence: To be used as a fiber optic delivery system in conjunction with the W.O.M. Laser U100 during lithotripsy procedures in the contact mode.	The Laser Fiber GF500 is similar in design, material, and technological characteristics to the predicate devices (Laser Fiber GF100 and InnovaQuartz General Shape Laser Fiber), which have the same intended use. Specifically, it's designed for use with the W.O.M. Laser U100 in lithotripsy in contact mode, just like the GF100.
Design, Material, and Technological Characteristics Equivalence: Similar to predicate devices.	The Laser Fiber GF500 is presented as similar to the Laser Fiber GF100 and InnovaQuartz General Shape Laser Fiber in these aspects. Differences are stated as "minor" and raising "no new questions of safety and effectiveness."
Safety and Effectiveness: No new questions of safety and effectiveness compared to predicate devices.	The submission asserts that the minor differences between the proposed device and predicate devices do not raise new questions of safety and effectiveness, implying it meets the same safety and effectiveness profile as already marketed devices.
Compliance with Standards:	The device has been tested in accordance with the European Standard EN 554 and EN 1174. It bears the CE mark in accordance with the Medical Device Directive 93/42/EEC.

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. This 510(k) submission relies on demonstrating substantial equivalence to existing devices, not on a new clinical study with a test set of patient data. The "performance data" mentioned refers to compliance with European standards, not clinical performance data from a patient sample.

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

Not applicable/Not provided. No clinical test set with expert-established ground truth was part of this submission.

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

Not applicable/Not provided. No clinical test set.

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:

Not applicable/Not provided. This is a physical medical device (laser fiber), not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable/Not provided. This is a physical medical device, not an algorithm.

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

Not applicable/Not provided. The "truth" in this submission relates to the functional and safety characteristics of the device being equivalent to predicate devices, and its compliance with relevant engineering and quality standards (EN 554, EN 1174, and CE marking).

8. The sample size for the training set:

Not applicable/Not provided. No training set for an algorithm was used.

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

Not applicable/Not provided. No training set.

Summary of the K021686 Submission's Approach:

The K021686 submission for the Laser Fiber GF500 is a 510(k) substantial equivalence submission. It aims to demonstrate that the new device is as safe and effective as a legally marketed predicate device, thereby avoiding the need for a full Premarket Approval (PMA), which would involve extensive clinical trials. The core argument for acceptance is:

Similarity in Intended Use: The device performs the same function (fiber optic delivery for lithotripsy with W.O.M. Laser U100) as a predicate device (Laser Fiber GF100).
Similarity in Technological Characteristics: The design, materials, and overall technology are comparable to the identified predicate devices (Laser Fiber GF100 and InnovaQuartz General Shape Laser Fiber).
No New Questions of Safety or Effectiveness: The manufacturer asserts that any differences are minor and do not introduce new risks or effectiveness concerns.
Compliance with Recognized Standards: The device has undergone testing and certification against European standards (EN 554, EN 1174) and holds a CE mark, indicating adherence to certain quality and safety requirements.

This type of submission typically relies on bench testing, engineering analysis, and performance data relative to established standards, rather than de novo clinical trial data with patient samples or expert adjudication as would be seen in a more complex device or an AI/software algorithm submission.

Summary

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K021686

1 of 2

AUG 2 0 2002

510(K) SUMMARY Laser Fiber GF500

I. Submitter:

W.O.M. WORLD OF MEDICINE AG Kaiserin-Augusta-Allee 113 10553 Berlin Germany

II. Device Names:

1. Classification Name:
1. Common or Usual Name:
1. Proprietary Name:

Accessory to Laser Surgical Instrument Fiber Optic Delivery System Laser Fiber GF500

III. Classification:

Class II in accordance with 21 C.F.R. § 878.4810. The product code for the device is GEX.

IV. Predicate Devices:

Laser Fiber GF100 (K011175), W.O.M. WORLD OF MEDICINE AG .
InnovaQuartz General Shape Laser Fiber (K994010) manufactured by ● InnovaQuartz, Inc.

V. Intended Use:

The Laser Fiber GF500 is intended to be used as a fiber optic delivery system in conjunction with the W.O.M. Laser U100 during lithotripsy procedures in the contact mode.

VI. Device Description:

VII. Substantial Equivalence:

The Laser Fiber GF500 described in this notification is similar in design, material and technological characteristics to the Laser Fiber GF100 (K011175) of W.O.M. WORLD OF MEDICINE AG and the InnovaQuartz General Shape Laser Fiber (K994010) manufactured by InnovaQuartz, Inc.

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510(K) SUMMARY Page -2- / -2-

All three devices are intended to be used as a fiber optic delivery system for ND: Yag laser systems. In addition, both the Laser Fiber GF500 and the predicate device Laser Fiber GF100 are designed for use in conjunction with the W.O.M. Laser U100 during lithotripsy procedures in the contact mode. Finally, both the proposed device and the InnovaQuartz General Shape Laser Fiber are approved for reuse.

The differences between the Laser Faser GF500 and predicate devices are minor and raise no new questions of safety and effectiveness. Accordingly, W.O.M. WORLD OF MEDICINE AG believes that the Laser Fiber GF500 is substantially equivalent to the predicate devices currently on the market.

VIII. Performance Data:

The device has been tested in accordance with the European Standard EN 554 and EN 1174. The Laser Fiber GF500 bears the CE mark in accordance with the Medical Device Directive 93/42/EEC.

Signed:

S. Reals

Susanne Raab Official Correspondent

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2002

W.O.M. World of Medicine c/o Šusanne Raab 91 Trowbridge Street Cambridge, Massachusetts 02138

Re: K021686 Trade/Device Name: Laser Fiber GF500 Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in

dermatology Regulatory Class: Class II Product Code: GEX Dated: May 14, 2002 Received: May 22, 2002

Dear Ms. Raab:

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 (OS) 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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Page 2 – Ms. Susanne Raab

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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,

fo Mark N. Millerson

Celia M. Witten, Ph.D., M.D Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

WORLD OF MEDICINE Lemke GmbH

510(K) NUMBER (if known):

DEVICE NAME:

Laser Fiber GF500

INDICATIONS FOR USE:

The Laser Fiber GF500 is intended to be used as a fiber optic delivery system in conjunction with the W.O.M. Laser U100 during lithotripsy procedures in the contact mode.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 C.F.R. § 801.109)

(Optional Format 1-2-96)

Prescription Use

Over-the Counter Ut

Mark N. Milliken

510(k) Number

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. 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 § 878.9.