The Uropulse is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Uropulse is indicated for use in medicine and surgery, in the following medical specialties:

Arthroscopy .
Urology .
Lithotripsv
Pulmonology
Gastroenterology
Gynecology
ENT
General Surgery

Device Description

The Dornier Medilas D Uropulse Laser is a solid-state Holmium YAG Laser. The laser emits laser radiation in the invisible wavelength range of 2080 nm in either a continuous-wave or pulsed mode, which is absorbed primarily by water, with an average penetration depth of approximately 400μm (0.4mm). Due to the application-dependent optimization of the pulse time of 350 microseconds, the Uropulse can be used in various medical applications including breaking up stones, cutting tissue, tissue ablation, coagulation and vaporization.
The laser is microprocessor-controlled utilizing a watchdog-monitored microprocessor and operates with an internal cooling system and a heat exchanger. The bottom of the housing serves as a tank for cooling water and, at the same time, a base for the laser unit. A cooling circuit conducts away heat that is generated by the laser pump lamp. Water heated by the laser pump is conducted out of the cavity and into the stainless steel cooler. Following cooling, it is returned to the tanks.
A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the User. The control panel consists of a display with integrated touch screen panel applications to control the functions of the laser.
The laser light emission is transmitted to the application site by a sterile fiber optic delivery system (fiber cable) with a SMA 905 connector. Laser energy is transmitted through the fiber to the application site by depressing a foot pedal. The foot pedals, both the wired and wireless, are water- proof and explosion-proof. Various fiber sizes can be utilized depending on the application.
The laser pulse energy at the distal end of the fiber lies within the range of 200-3500mJ. The pulse frequency can be adjusted in 0.2Hz increments between 3 and 20 HZ. The Uropulse contains an aiming beam at a wavelength of 532nm at the maximum power aperture of 1mW. The device employs a Class IV (4) laser pursuant to 21 CFR 1040 and IEC/EN 60825-1.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Medilas H Uropulse," a Holmium: Yttrium Aluminum Garnet (HO:YAG) Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study.

Therefore, many of the requested categories related to acceptance criteria and specific study results (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth for training/test sets) are not applicable or available in this type of submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness (implicit for substantial equivalence)	The submission argues that the Uropulse and its predicate devices are substantially equivalent and have the same intended use. The minor differences are stated to "not raise any concerns regarding the overall safety or effectiveness."
Technical Specifications (e.g., wavelength, power, pulse frequency)	Wavelength: 2080 nm (invisible) Penetration Depth: ~400μm (0.4mm) Pulse Time: 350 microseconds Laser Pulse Energy (distal end): 200-3500mJ Pulse Frequency: 3-20 Hz (adjustable in 0.2Hz increments) Aiming Beam: 532nm at 1mW (Class IV (4) laser)

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

Not Applicable: This submission is for a Special 510(k) based on device modifications and substantial equivalence, not a clinical trial proving performance against a specific test set. The submission does not describe a test set or data provenance in the way clinical studies would.

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

Not Applicable: No test set or ground truth establishment by experts is described in this regulatory submission.

4. Adjudication method for the test set

Not Applicable: 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

Not Applicable: This device is a laser system, not an AI diagnostic tool. MRMC studies are irrelevant here.

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

Not Applicable: This is a laser surgical instrument, not an algorithm. Its performance is inherent in its physical operation, not an algorithmic output.

7. The type of ground truth used

Not Applicable: For this type of device and submission, "ground truth" as it pertains to diagnostic accuracy (like pathology or outcomes data for AI) is not relevant. The "truth" being established is that the modified device performs safely and effectively similarly to its predicates. This is typically supported by engineering testing, bench testing, and comparison of specifications rather than
clinical ground truth derived from expert consensus or pathology on a patient cohort.

8. The sample size for the training set

Not Applicable: This is a hardware laser system, not a machine learning algorithm that requires a "training set."

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

Not Applicable: As above, this is not an AI device and does not have a "training set" with associated "ground truth" in that context.

Summary

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K 130344

MAR 2 1 2013

510(k) SUMMARY Medilas H Uropulse

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

Dornier MedTech America	Phone: 770-514-6163
1155 Roberts Blvd.	Fax: 770-514-6291
Kennesaw, GA 30144	Date Prepared: February 21, 2013

Contact Person: John Hoffer

Phone: 770-514-6163

Name of Device and Name/Address of Sponsor

Medilas H Uropulse 1155 Roberts Blvd. Kennesaw, GA 30144

Common or Usual Name

Holmium: Yttrium Aluminum Garnet (HO:YAG) Laser System

Classification Name

The General and Plastic Surgery Branch has classified Surgical Powered Laser Instruments (Product Code GEX) as a Class II device pursuant to 21 C.F.R. § 878.4810.

Predicate Devices

Dornier Medilas H Solvo K122159 Dornier Medilas H20 Laser K061455 Versa Pulse P20 (K100228)

Purpose of the Special 510(k) Notice

The Uropulse is a modification to the Dornier Medilas H Solvo Laser (K122159).

Device Description

The laser is microprocessor-controlled utilizing a watchdog-monitored microprocessor and operates with an internal cooling system and a heat exchanger. The bottom of the housing serves as a tank for cooling water and, at the same time, a base for the laser unit. A cooling circuit conducts away heat that is generated by the laser pump lamp. Water heated by the laser pump is conducted out of the cavity and into the stainless steel cooler. Following cooling, it is returned to the tanks.

A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the User. The control panel consists of a display with integrated touch screen panel applications to control the functions of the laser.

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The laser light emission is transmitted to the application site by a sterile fiber optic delivery system (fiber cable) with a SMA 905 connector. Laser energy is transmitted through the fiber to the application site by depressing a foot pedal. The foot pedals, both the wired and wireless, are water- proof and explosion-proof. Various fiber sizes can be utilized depending on the application.

The laser pulse energy at the distal end of the fiber lies within the range of 200-3500mJ. The pulse frequency can be adjusted in 0.2Hz increments between 3 and 20 HZ. The Uropulse contains an aiming beam at a wavelength of 532nm at the maximum power aperture of 1mW. The device employs a Class IV (4) laser pursuant to 21 CFR 1040 and IEC/EN 60825-1.

Intended Use

Arthroscopy
Urology
Lithotripsy
Pulmonology
Gastroenterology
Gynecology
ENT
General Surgery

Substantial Equivalence

From a clinical perspective and comparing design specifications, the Uropulse and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics, design and overall performance of the devices. Dornier MedTech America believes that no significant differences exist between the Uropulse and the Domier Medilas H Solvo Laser (K122159).

Dornier MedTech America, Inc. believes the minor differences do not raise any concerns regarding the overall safety or effectiveness. Thus, the Uropulse is substantially equivalent to its predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Dornier Medtech America, Incorporated % Mr. John Hoffer Vice President of Quality, Regulatory and Clinical 1155 Roberts Boulevard Kennesaw, Georgia 30144

March 21, 2013

Re: K130344 Trade/Device Name: Medilas H Uropulse Regulation Number: 21 CFR 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: February 21, 2013 Received: February 25, 2013

Dear Mr. Hoffer:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Mr. John Hoffer

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

FOR Sincerely yours,

Peter Daggmm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K130344 510(k) Number (if known):

Device Name: Medilas H Uropulse

Indications for Use:

Arthroscopy .
Urology .
Lithotripsv
Pulmonology
Gastroenterology
Gynecology
ENT
General Surgery

Prescription Use × (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.03.21 09:30:10=04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130344

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.