The W.O.M. Laser U100 is intended for use in endoscopic surgical procedures . to fragment stones.
The W.O.M. Laser U100 is indicated for use to fragment urinary stones ● (kidney, ureter and bladder) and biliary stones in the contact mode during closed surgical procedures.
The W.O.M. Laser U100 is indicated for use in the contact mode to fragment urinary stones (kidney, ureter, bladder) and biliary stones in closed surgical procedures.

Device Description

The W.O.M. Laser U100 has the same intended use, identical design features and principles of operation as the predicate device W.O.M. Laser U100 (K011175). Differently to the predicate device the W.O.M. Laser U100 described in this premarket notification is not only indicated for use to fragment urinary stones but also biliary stones. In addition, the W.O.M. Laser U100 has the same intended use and indication for use, similar design features and similar principles of operation as the Candela MDL 2000 LaserTripter (K901723).
All three devices are intended for use in endoscopic surgical procedures to fragment stones. Both the W.O.M. Laser U100 and the Candela MDL 2000 LaserTripter are indicated for use to fragment urinary and biliary stones in the contact mode during closed surgical procedures.
The W.O.M. Laser U100 and the predicate device W.O.M. Laser U100 (K011175) use identical physical processes to generate the laser beams and method of transmission to the stone. Although the W.O.M. Laser U100 and the Candela MDL 2000 LaserTripter (K901723) generate their respective laser beams through different physical processes, the characteristics of the treatment beams (wavelength, pulse energy, pulse duration and pulse frequency) are similar. Moreover, the method of transmission to the stone (laser fiber) is similar and both devices provide aiming beams to allow visual indication of the stone location.
All three devices incorporate an internal water cooling cycle with a water-air heat exchanger system. In addition, all three devices provide identical or similar safety features and identical or similar parameters are displayed on the operator panel of the devices.
Finally, the W.O.M. Laser U100 and the predicate devices transmit pulses of laser energy by a quartz fiber to the stone (contact mode). The laser pulses are transformed into an ultrasonic wave (acoustic impact waves) which mechanically crush the stone.

AI/ML Overview

The provided text describes a 510(k) summary for the W.O.M. Laser U100, a medical device for fragmneting kidney, ureter, bladder and biliary stones. The document focuses on demonstrating substantial equivalence to predicate devices, rather than an AI/ML product. Therefore, many of the requested categories related to algorithm performance, training sets, and expert evaluations are not applicable or cannot be extracted from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or performance metrics in the way one would for an AI/ML device (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards.

Criterion	Reported Performance/Evidence
Intended Use	- Same as predicate W.O.M. Laser U100 (K011175): endoscopic surgical procedures to fragment stones.
	- Same as predicate Candela MDL-2000 (K901723): endoscopic surgical procedures to fragment stones.
Indications for Use	- Extends predicate W.O.M. Laser U100 (K011175) indications to include biliary stones (in addition to urinary stones: kidney, ureter, bladder).
	- Same as predicate Candela MDL-2000 (K901723): urinary and biliary stones in contact mode during closed surgical procedures.
Design Features & Principles of Operation	- Identical to predicate W.O.M. Laser U100 (K011175) for generation of laser beams and method of transmission.
	- Similar to predicate Candela MDL-2000 (K901723) in design features and principles of operation. Both use laser fiber for transmission and provide aiming beams.
Treatment Beam Characteristics	- Identical to predicate W.O.M. Laser U100 (K011175).
	- Similar to Candela MDL-2000 (K901723) in wavelength, pulse energy, pulse duration, and pulse frequency, despite different physical processes for laser generation.
Cooling System	- Identical or similar to both predicate devices (internal water cooling cycle with water-air heat exchanger).
Safety Features & Parameters Displayed	- Identical or similar to both predicate devices.
Mechanism of Action	- All three devices transmit laser energy to mechanically crush stones via acoustic impact waves.
Safety and Effectiveness	- Complies with IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (EMC).
	- Meets UL Standard 2601-1.
	- Bears CE mark (Medical Device Directive 93/42/EEC).
	- In vitro, in vivo and clinical data provided to demonstrate safety and effectiveness for fragmentation of biliary stones in closed surgical procedures. (Specific results not detailed in this summary).
New Questions of Safety & Effectiveness	- "Differences of the W.O.M. Laser U100 to the predicate device W.O.M. Laser U100 (K011175) are minor and raise no new questions of safety and effectiveness." (Most modifications made for UL 2601 compliance).

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

The summary states that "In vitro, in vivo and clinical data has been provided to demonstrate that the W.O.M. Laser U100 is safe and effective for the fragmentation of biliary stones in closed surgical procedures."
Sample size: Not specified in the provided text.
Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

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

Not applicable as this is a medical device approval based on substantial equivalence and clinical data, not an AI/ML algorithm requiring expert-established ground truth for a test set. There's no mention of a human-in-the-loop diagnostic process being evaluated.

4. Adjudication Method

Not applicable. This concept pertains to resolving discrepancies in expert interpretations for AI/ML algorithm evaluation, which is not described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not performed or reported in the provided text. This type of study is relevant for AI-assisted diagnostic tools, not for a laser lithotripter directly.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The W.O.M. Laser U100 is a physical device, not a standalone algorithm. The "in vitro, in vivo and clinical data" refers to direct performance of the device.

7. Type of Ground Truth Used

The document implies that clinical outcomes (fragmentation of biliary stones) and potentially pathology/imaging evidence of stone fragmentation served as the ultimate ground truth in the "in vitro, in vivo and clinical data." However, the exact nature of this "ground truth" (e.g., complete fragmentation, certain size reduction, clinical success rates) is not detailed in this summary.

8. Sample Size for the Training Set

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

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

Not applicable. This device is not an AI/ML algorithm.

Summary

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02 3041 1/3

510(K) SUMMARY W.O.M. Laser U100

DEC 1 1 2002

I. Submitter:

W.O.M. WORLD OF MEDICINE AG Alte Poststraße 11 96337 Ludwigsstadt Germany

II. Device Names:

1.	Classification Name:	Laser surgical instrument for use in generaland plastic surgery and in dermatology, andElectrohydraulic Lithothripter
2.	Common or Usual Name:	Intracorporal Laser Lithotripter in Urologyand Gastroenterology
3.	Proprietary Name:	W.O.M. Laser U100

III. Classification:

Class II. This device is described in 21 CFR. §§ 878.4810 and 876.4480. The product code for the device is GEX, FFK.

IV. Predicate Devices:

W.O.M. Laser U100 (K011175) manufactured by W.O.M. WORLD OF . MEDICINE AG
Candela MDL-2000 Laser LithoTripter (K901723) manufactured by ● Candela Laser Corporation.

Intended Use and Indication for Use: V.

The W.O.M. Laser U100 is intended for use in endoscopic surgical procedures . to fragment stones.
The W.O.M. Laser U100 is indicated for use to fragment urinary stones ● (kidney, ureter and bladder) and biliary stones in the contact mode during closed surgical procedures.

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023041 2/3

510(K) SUMMARY Page -2- / -3-

Technical Characteristics and Substantial Equivalence: VI.

All three devices are intended for use in endoscopic surgical procedures to fragment stones. Both the W.O.M. Laser U100 and the Candela MDL 2000 LaserTripter are indicated for use to fragment urinary and biliary stones in the contact mode during closed surgical procedures.

The W.O.M. Laser U100 and the predicate device W.O.M. Laser U100 (K011175) use identical physical processes to generate the laser beams and method of transmission to the stone. Although the W.O.M. Laser U100 and the Candela MDL 2000 LaserTripter (K901723) generate their respective laser beams through different physical processes, the characteristics of the treatment beams (wavelength, pulse energy, pulse duration and pulse frequency) are similar. Moreover, the method of transmission to the stone (laser fiber) is similar and both devices provide aiming beams to allow visual indication of the stone location.

All three devices incorporate an internal water cooling cycle with a water-air heat exchanger system. In addition, all three devices provide identical or similar safety features and identical or similar parameters are displayed on the operator panel of the devices.

Finally, the W.O.M. Laser U100 and the predicate devices transmit pulses of laser energy by a quartz fiber to the stone (contact mode). The laser pulses are transformed into an ultrasonic wave (acoustic impact waves) which mechanically crush the stone.

The differences of the W.O.M. Laser U100 to the predicate device W.O.M. Laser U100 (K011175) are minor and raise no new questions of safety and effectiveness. Most of the modifications rather have been made to fulfill the UL Standard 2601.

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K0L3041 7/3

510(K) SUMMARY Page -2- / -3-

Safety and Effectiveness Information: VII.

In vitro, in vivo and clinical data has been provided to demonstrate that the W.O.M. Laser U100 is safe and effective for the fragmentation of biliary stones in closed surgical procedures.

The device complies with the International Standard IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). In addition, the device meets the requirements of the Underwriter Laboratories Standard UL 2601-1 and bears the CE mark in accordance with the Medical Device Directive 93/42/EEC.

VIII. Conclusion:

The W.O.M. Laser U100 has the same intended use, identical design features and principles of operation as the predicate device W.O.M. Laser U100 (K011175). Moreover, the W.O.M. Laser U100 has the same intended use and indication for use, similar design features and similar principles of operation as the Candela MDL 2000 Laser Tripter (K901723). The differences of the W.O.M. Laser U100 to the predicate device W.O.M. Laser U100 (K011175) are minor and raise no new questions of safety and effectiveness. Finally, in vivo and clinical study results demonstrate that the W.O.M. Laser U100 is safe and effective for the fragmentation of biliary stones in closed surgical procedures.

Accordingly, W.O.M. WORLD OF MEDICINE AG believes that the W.O.M. Laser U100 is substantially equivalent to the W.O.M. Laser U100 (K011175) and the Candela MDL 200 LaserTripter (K901723).

Signed:

S. Raab

Susanne Raab Official Correspondent

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

ood and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

World of Medicine 1 c/o Ms. Susanne Raab 91 Towbridge Street, #21 Cambridge, Massachusetts 02138

Re: K023041

Trade/Device Name: W.O.M. Laser U100 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II

Product Code: GEX Dated: August 30, 2002 Received: September 12, 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 (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. 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.

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Page 2 - Ms. Susanne Raab

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21CFR 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,

Muriam C. Provost

for 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

APPLICANT:

W.O.M. WORLD OF MEDICINE AG

510(K) NUMBER (if known):

KO2304

DEVICE NAME:

W.O.M. Laser U100

INDICATIONS FOR USE:

The W.O.M. Laser U100 is indicated for use in the contact mode to fragment urinary stones (kidney, ureter, bladder) and biliary stones in closed surgical procedures.

(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)

Miriam C. Provost

Ivision Sign-Off) Division of General, Restorative and Neurological Devices

K023041

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.