The W.O.M. Laser U100plus is intended for use in endoscopic surgical procedures to fragment stones. The W.O.M. Laser U100plus is indicated for use to fragment urinary stones (kidney, ureter and bladder) and biliary stones in the contact mode during closed surgical procedures.

Device Description

The W.O.M. Laser U100plus is an intracorporal laser lithotripter in Urology and Gastroenterology. It transmits 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 device incorporates an internal water cooling cycle with a water-air heat exchanger system. It provides safety features and displays parameters on the operator panel. Differences from the predicate W.O.M. Laser U100 include a minor increase in pulse energy and pulse frequency, and the option of a double pulse setting.

AI/ML Overview

The provided text describes a 510(k) submission for the W.O.M. Laser U100plus, a device intended for stone fragmentation. However, it does not explicitly state acceptance criteria in a table format with specific performance metrics (e.g., success rates, fragmentation times) that the device must meet.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technical characteristics, and safety/effectiveness data. The "study" mentioned isn't a performance study with defined quantitative acceptance criteria and results against those criteria, but rather a general statement about supporting data.

Here's a breakdown of the requested information based on the provided text, with explanations where information is not available:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Safety: Device complies with IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility).	The device complies with IEC 60601-1 and IEC 60601-1-2. Additionally, it meets UL 2601-1 and bears the CE mark.
Effectiveness: Safe and effective for the fragmentation of biliary stones in closed surgical procedures.	In vitro, in vivo, and clinical data provided demonstrate that the W.O.M. Laser U100plus is safe and effective for the fragmentation of biliary stones in closed surgical procedures.
Effectiveness: Improved stone fragmentation efficiency compared to predicate (W.O.M. Laser U100).	The differences to the predicate W.O.M. Laser U100 result in an improvement of the stone fragmentation efficiency.
Safety: Non-thermal and non-cutting properties compared to Holmium:YAG laser (Dornier Medilas H/2) representing a substantial improvement in safety by avoiding tissue injury.	The laser effect is non-thermal, unlike the Dornier Medilas H/2, and does not lead to critical heating, representing a substantial improvement in safety by avoiding the risk of tissue injury.
Substantial Equivalence: Same intended use, similar design features, and identical principles of operation as predicate W.O.M. Laser U100; same intended use and indication for use as Dornier Medilas H/2. Minor differences to W.O.M. Laser U100 raise no new questions of safety and effectiveness. Differences to Dornier Medilas H/2 do not raise concerns regarding safety and effectiveness.	The device has the same intended use, similar design features, and identical principles of operation as W.O.M. Laser U100. It has the same intended use and indication for use as Dornier Medilas H/2. Minor differences to W.O.M. Laser U100 are stated to raise no new questions of safety and effectiveness. Differences to Dornier Medilas H/2 are stated to not raise concerns regarding safety and effectiveness.

Note on Acceptance Criteria: The document describes compliance with standards and comparative statements regarding predicates, which function as "acceptance criteria" within the context of a 510(k) summary focused on substantial equivalence. It does not provide specific quantitative benchmarks or thresholds for performance (e.g., "95% stone clearance rate").

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document broadly states "In vitro, in vivo and clinical data has been provided." No specific number of cases or samples for these studies is mentioned.
- Data Provenance: Not specified (e.g., country of origin). The document does not indicate whether data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the establishment of a "ground truth" using experts for a test set, as would be common in an AI evaluation. Instead, the studies referred to are to demonstrate safety and efficacy of a medical device.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to studies involving human readers and interpretation of data (e.g., imaging studies) where adjudicated ground truth is established. The document describes studies on a laser lithotripter, not an interpretive AI system.
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 is not an AI device or an imaging interpretation system. The device is a surgical laser, and the studies described are related to its direct physical performance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI system. The device itself is a standalone medical instrument. The "study" refers to the performance of the device itself in in vitro, in vivo, and clinical settings.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The concept of "ground truth" in the AI sense is not directly applicable here. The "truth" being established in the in vitro, in vivo, and clinical studies would likely relate to objective measurements of stone fragmentation, safety parameters (e.g., tissue damage), and clinical outcomes relevant to the device's intended use. Specific details on how effectiveness (e.g., successful fragmentation) was measured or validated are not provided in this summary.
The sample size for the training set:
- Not applicable. This is a medical device, not an AI/machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.

Summary

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OCT = 1 2003

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

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

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

Contact Person:	Susanne Raab320 North Columbus StreetAlexandria, VA 22314
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Phone number: 703-299-0523

Date Prepared: June 25, 2003

Name of Device and Name/Adress of Sponsor:

W.O.M. Laser U100plus

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

Classification Name:

Laser instrument, surgical, powered

Common or Usual Name:

Intracorporal Laser Lithotripter in Urology and Gastroenterology

Predicate Device:

W.O.M. Laser U100 (K023041)
Dornier Medilas H/2 (K984591) .

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

Intended Use and Indication for Use:

The W.O.M. Laser U100plus is intended for use in endoscopic surgical ◆ procedures to fragment stones.
The W.O.M. Laser U100plus is indicated for use to fragment urinary stones . (kidney, ureter and bladder) and biliary stones in the contact mode during closed surgical procedures.

Technical Characteristics and Substantial Equivalence:

The W.O.M. Laser U100plus and the predicate devices are intended for use in endoscopic surgical procedures to fragment stones. All three devices are indicated for use to fragment urinary and biliary stones in the contact mode during closed surgical procedures. However, the Dornier Medilas H/2 (K984591) is also indicated for use in cutting, vaporization, ablation and coagulation of soft tissue.

The W.O.M. Laser U100plus and the predicate device W.O.M. Laser U100 (K023041) have identical principles of operation and similar technological characteristics. Both devices use the same physical processes to generate the laser beams and method of transmission to the stone. The W.O.M. Laser U100plus and the predicate device 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 proposed device and the predicate device W.O.M. Laser U100 devices incorporate an internal water cooling cycle with a water-air heat exchanger system. In addition. both devices provide the same safety features and similar parameters are displayed on the operator panel of the devices. The differences between the two laser devices are a minor increasement of the pulse energy and pulse frequency and the option of a double pulse setting

The W.O.M. Laser U100plus and the predicate device Dornier Medilas H/2 (K984591) generate their respective laser beam through different physical processes. The predicate device Dornier Medilas H/2 is a Holmium: Y AG laser, that operates with a thermal decomposition of the stone material. Unlike the Dornier Medilas H/2. the laser effect of the W.O.M. Laser U100plus is nonthermal and does not lead to a critical heating of the operating area. This represents a substantial improvement in the safety of laser lithotripsy by avoiding the risk of tissue injury that may result from the use of an Holmimum: Y AG laser to fragment stones in the urinary tract.

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

The differences of the W.O.M. Laser U100plus to the predicate device W.O.M. Laser U100 (K023041) are minor and raise no new questions of safety and effectiveness. Moreover the differences between both devices result in an improvement of the stone fragmentation efficiency. In addition, W.O.M. believes that the differences of the W.O.M. Laser U100plus and the Dornier Medilas H/2 (K984591) do not raise any concerns regarding the safety and effectiveness. Moreover, the non-thermal and non-cutting properties of the W.O.M. Laser U100plus represent a substantial improvement in the safety of laser lithotripsy.

Safety and Effectiveness Information:

In vitro, in vivo and clinical data has been provided to demonstrate that the W.O.M. Laser U100plus 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.

Conclusion:

The W.O.M. Laser U100plus has the same intended use, similiar design features and identical principles of operation as the predicate device W.O.M. Laser U100 (K023041). Moreover, the W.O.M. Laser U100plus has the same intended use and indication for use as the Dornier Medilas H/2 (K984591). The differences of the W.O.M. Laser U100plus to the predicate device W.O.M. Laser U100 (K023041) are minor and raise no new questions of safety and effectiveness. Finally, in vitro, in vivo and clinical study results demonstrate that the W.O.M. Laser U100plus is safe and effective for the fragmentation of urinary and biliary stones in closed surgical procedures.

Accordingly, W.O.M. WORLD OF MEDICINE AG believes that the W.O.M. Laser U100plus is substantially equivalent to the W.O.M. Laser U100 (K023041) and the Dornier Medilas H/2 (K984591).

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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 features a stylized image of an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT = 1 2003

W.O.M. World of Medicine AG c/o Ms. Susanne Raab 320 North Columbus Street Alexandria, Virginia 22314

Re: K032023

Trade/Device Name: W.O.M. Laser U100plus 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: June 25, 2003

Received: July 17, 2003

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.

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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). please contact the Office of Compliance at (301) 594-4659. 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 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

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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INDICATION FOR USE STATEMENT

510(k) Number (if known): K 032023

Device Name: W.O.M. Laser U100plus

Indications for Use:

The W.O.M. Laser U100plus is indicated for use in the contact mode to fragment urinary stones (kidney, ureter and bladder) and biliary stones in closed surgical procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use (Per 21 C.F.R. 801.109)

Over-The-Counter

Muriam C. Provost

(Optional Format 3-10-98)

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

510(k) Number Kv32423

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.