LASER SYSTEM MEDIOSTAR H (WITH AND WITHOUT SKIN COOLING SYSTEM) by AESCULAP-MEDITEC NORTH AMERICA

The provided text does not contain specific acceptance criteria or a study proving the device meets those criteria. Instead, it is a 510(k) summary for the AESCULAP-MEDITEC GMBH Laser System MeDioStar H, asserting substantial equivalence to predicate devices rather than presenting performance data.

Here's a breakdown of why the requested information cannot be fully provided based on the input:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in the document. For 510(k) submissions, acceptance criteria often relate to demonstrating substantial equivalence in terms of technological characteristics and intended use compared to legally marketed predicate devices, rather than specific performance metrics against pre-defined thresholds.
Reported Device Performance: The document explicitly states: "Performance data: None. The specifications and intended uses of the laser system MeDioStar H are the same or very similar to those of claimed predicate devices. Because of this, performance data were not required."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

No test set or performance data is mentioned, therefore no sample size or data provenance is available.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable as no test set or ground truth establishment process is described.

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

Not applicable as no test set 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:

No such study was mentioned. The device is a laser system, not an AI-powered diagnostic tool, so an MRMC study involving human readers and AI assistance is not relevant to this submission.

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

Not applicable, as this is a physical medical device (laser system), not a standalone algorithm.

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

Not applicable as no performance data or ground truth establishment process is described. The basis for clearance is substantial equivalence to predicate devices.

8. The sample size for the training set:

Not applicable as no training set or algorithm development is mentioned.

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

Not applicable as no training set is described.

Summary based on the provided text:

The 510(k) submission for the AESCULAP-MEDITEC GMBH Laser System MeDioStar H relies on substantial equivalence to predicate devices rather than presenting novel performance data against specific acceptance criteria. The document explicitly states that "performance data were not required" because the device specifications and intended uses are "the same or very similar" to those of legally marketed lasers (Conerent / Palomar - LightSheer (K982940), LASERSCOPE - Lyra (K990903), and Candela - CANDELA GENTLELASE II DERMATOLOGICAL LASER (K984601)).

Therefore, the "acceptance criteria" in this context are primarily met by demonstrating that the device is as safe and effective as its predicate devices, based on their established performance and the fundamental principles of laser technology for hair removal and vascular lesions. No specific clinical study results or detailed performance metrics are provided in this summary.

Summary

{0}------------------------------------------------

JUN - 1 2000

K994116

510(k) SUMMARY AESCULAP-MEDITEC GMBH LASER SYSTEM MeDioStar H WITH AND WITHOUT COOLING SYSTEM FOR SKIN

This 510(k) summary of safety and effectiveness for the AESCULAP-MEDITEC GMBH Laser System MeDioStar H with and without skin cooling system is submitted in accordance with the requirements of SDMA 1990 and follows Office of Device Evaluation Guidance concerning the organization and content of a 510(k) summary.

Applicant: AESCULAP-MEDITEC GMBH

Address: Prussingstrasse 41 07739 Jena, Germany
Contact Person: Dr. Dirk Colditz Quality Management Representative
+49 3641 65 3453 Phone: Fax: +49 3641 65 3815 e-mail: ctz@aesculap.meditec.com
Preparation date: March 1999

Device name: Laser System MeDioStar H (with and without skin cooling system)

Common Name: MeDioStar H ( without skin cooling system ) MeDioStar HC ( with skin cooling system )
Classification
Name: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810) Product code: GEX - Laser instrument, surgical, powered Panel: 79
Coherent / Palomar LightSheer ( K982940 ) Legally marketed: LASERSCOPE - Lyra ( K990903 ) Candela - CANDELA GENTLELASE II DERMATOLOGICAL LASER ( K984601 )
Description: The laser system MeDioStar H operates as a pulsed diode laser which emits a beam of coherent light at 808 nanometers.
Intended Use: The laser system MeDioStar H is intended to remove unwanted body hair and vascular lesions.
Comparison to: The specifications of the MeDioStar are the same as or

{1}------------------------------------------------

very similar to those of legally marketed lasers such as the Conerent / Palomar - LightSheer ( K982940 ), the LASERSCOPE - Lyra ( K990903 ) and the Candela - CANDELA GENTLELASE II DERMATOLOGICAL LASER ( K984601 )

Performance data: None. The specifications and intended uses of the laser system MeDioStar H are the same or very similar to those of claimed predicate devices. Because of this , performance data were not required.
The MeDioStar H is substantially equivalent to legally marketed CONCLUSION: devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2000

Mr. William Kelley Aesculap-Meditec North American 2525 McGaw Avenue Irvine, California 92623

K994116 Re:

R 77+110
Trade Name: Laser System MeDioStar H With and Without Skin Cooling System Laser System MeDioStar With and Without Skin Cooling System

Regulatory Class: II Product Code: GEX Dated: February 21, 2000 Received: March 7, 2000

Dear Mr. Kelley:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your boomer be device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to ase suted in the enactment date of the Medical Device Amendments, or to devices that May 20, 1970, the cities accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Fel (110). "The general controls provisions of the Act include requirements for provisions of and From 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 (Premarket Approval), it may be subject to such additional controls. Existing major ( remailed in provide), with device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the I urrent Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify and assumptions. Failure to comply with the GMP regulation may result in regulatory Such assumptions: "Farma vos vour of Federal Register. Please note: this response to your premarket notification submission does r cochar regions. Tour might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Mr. William Kelley

This letter will allow you to begin marketing your device as described in your 10(k) This letter will anow you to begin maineting , but antial equivalence of your device to a premarket nothleation. The PDA miding of substance of the results 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 If you desire specific advice 10- 75-diagnostic devices), please contact the Office of and additionally 607.10 for in 1150 and the promotions on the promotion and Compliance at (301) 594-4575. Atuationally, 1993 of Compliance at (301) 594-4639. advertising of your device, produs titled, "Misbranding by reference to premarket Also, prease flote the regulation entition, "Information on your responsibilities under the nothication (21 CPX 607.97). Other general Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dana R. Kirchner

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

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K994116

Device Name: _Laser System MeDioStar H with and without skin cooling system

Indication For USE Statement:

The laser system MeDioStar H (with and without skin cooling system) is intended to remove unwanted body hair and vascular lesions.

The laser system MeDioStar H is restricted to sale to or use by licensed professionals in the United States.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _

Dena R. bochner.

Division Sign-Off) Division of General Restorative Devices 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.