COOLTOUCH ND: YAG LASER SYSTEM by NEW STAR LASERS, INC.

The CoolTouch® Nd:YAG Laser Systems are ND:YAG lasers producing laser emission at 1320nm. The lasers consist of three interconnected section: The cabinet which houses the power supply, cooling system, microcontroller and the laser, the fiber optics and the handpiece.

AI/ML Overview

The provided text is a 510(k) summary for the CoolTouch® Nd:YAG Laser System. It explicitly states under the "Performance Data" section: "None".

This means that the submission does not include any performance data from a specific study to demonstrate that the device meets acceptance criteria. Instead, the conclusion is based on substantial equivalence to legally marketed predicate devices.

Therefore, many of the requested details regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document as no such study was presented.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Acceptance Criteria: Not explicitly stated as no performance study was conducted. Acceptance was based on substantial equivalence.
Reported Device Performance: Not reported as no performance study was conducted.

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, as no performance test set was used for this 510(k) submission.

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 ground truth for a test set was established for this 510(k) submission.

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

Not applicable, as no test set requiring adjudication was used for this 510(k) submission.

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-assisted diagnostic tool, and no comparative effectiveness study of this nature was conducted or submitted.

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

Not applicable. This device is a laser system, not an algorithm.

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

Not applicable, as no ground truth from a performance study was established for this 510(k) submission.

8. The sample size for the training set

Not applicable, as no training set for an algorithm was used for this 510(k) submission (this is a physical device).

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

Not applicable, as no training set was used for this 510(k) submission.

Summary based on the provided text:

The device's acceptance was based on its substantial equivalence to legally marketed predicate devices (Candela Smoothbeam™ Laser System, K014128 and K022884) for the treatment of back acne and atrophic acne scars. The document explicitly states "Performance Data: None," indicating that no clinical or performance study was submitted to demonstrate effectiveness or safety against predefined acceptance criteria.

Summary

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0 304153

Section 4 510(K) Summary CoolTouch® Nd:YAG Laser System

MAY 1 2 2003

Applicant:	New Star Lasers, Inc.
Address:	9085 Foothills BoulevardRoseville, CA 95747
Contact Person:	Donald V. Johnson
Telephone / Fax / Email	916-677-1900 - Phone916-677-1901 - Fax
Preparation Date:	February 5, 2003
Device Trade Name:	CoolTouch® Nd:YAG Laser SystemCoolTouch® II Nd:YAG Laser System
Common Name:	Nd:YAG Pulsed Surgical Laser
Classification Name:	Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878-4810
Legally Marketed Predicate Device:	Candela Smoothbeam™ Laser SystemK014128 for treatment of back acneK022884 for treatment of atrophic acne scars
Description of the CoolTouch® Nd:YAGLaser Systems	The CoolTouch® Nd:YAG Laser Systems are ND:YAGlasers producing laser emission at 1320nm. The lasersconsist of three interconnected section: The cabinet whichhouses the power supply, cooling system, microcontrollerand the laser, the fiber optics and the handpiece.
Intended use of the CoolTouch® Nd:YAGLaser Systems	The CoolTouch® Nd:YAG Laser System are indicated forthe treatment of back acne and the treatment of atrophicacne scars.
Performance Data:	None
Conclusion:	The CoolTouch® Nd:YAG Laser System is substantiallyequivalent to other existing laser systems in commercialdistribution for treatment of back acne and treatment ofatrophic acne scars.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked one behind the other. The profiles are simple and abstract, with flowing lines suggesting hair or movement.

MAY 1 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Donald V. Johnson Vice President, Operations New Star Lasers, Inc. 9085 Foothills Boulevard Roseville, California 95747

Re: K030453 Trade/Device Name: CoolTouch Nd:YAG Laser System CoolTouch II Nd: YAG Laser System 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: February 11, 2003 Received: February 11, 2003

Dear Mr. Johnson:

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 - Mr. Donald V. Johnson

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. 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) you may obtain. 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 vours.

Sincerely yours,

Marki 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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INDICATION FOR USE STATEMENT

Ka30413 Pending 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: CoolTouch® ND:YAG Laser System

Indications for Use:

The CoolTouch® ND:YAG Laser System is indicated for:

1. treatment of back acne
1. treatment of atrophic acne scars

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use and the prescription use is selected.

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.