DERMACOOL

• K Number: K990417
• Device Name: DERMACOOL
• Manufacturer: OPTOMED CORP.
• Date Cleared: 1999-04-14 ( 63 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K974381 , K951033
• Predicate For: K014253

Intended Use

DermaCool is intended for use with a laser or light source utilized for photo-coagulation of dermatological lesions and is a cooling device indicated for:

1. The reduction of pain,
2. Less discomfort,
3. Cooling of the skin prior, during and after laser or light treatment.

Device Description

DermaCool™ is a skin-cooling device designed for lasers or light sources, which are used for skin treatment applications such as vascular lesions or hair removal. A piece of cooled sapphire window, or lens, which comes in contact with skin, performs skin cooling.

AI/ML Overview

This document provides minimal information about the device, DermaCool™, a skin-cooling accessory for laser systems. It is primarily a 510(k) summary for regulatory clearance and does not contain data from a study demonstrating the device's performance against specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated:

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

No acceptance criteria or reported device performance data are provided in the document. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined criteria through a study.

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

Not applicable. No study is described that would involve a test set.

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. No study is described that would involve establishing ground truth by experts.

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

Not applicable. No study is described that would involve adjudication.

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 skin-cooling accessory, not an AI-based diagnostic tool, and therefore an MRMC study is not relevant to its function.

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

Not applicable. This device is a physical accessory, not an algorithm.

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

Not applicable. No study is described that would involve ground truth data.

8. The sample size for the training set

Not applicable. No study is described that would involve a training set.

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

Not applicable. No study is described that would involve training data with ground truth.

Summary of available information:

The document is a US FDA 510(k) premarket notification summary for the DermaCool™ skin-cooling device. It establishes substantial equivalence to existing legally marketed predicate devices (Candela laser accessories K974381 and K951033, and Cool Laser Optics, Inc. products). The indications for use are:

• Reduction of pain
• Less discomfort
• Cooling of the skin prior, during, and after laser or light treatment.

The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical trials with acceptance criteria and performance metrics. Therefore, the information typically found in a study proving device performance against acceptance criteria is not present in this regulatory document.

Summary

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APPENDIX VII

510(k) summary of Safety and Effectiveness

Submitter: OptoMed, Inc.

13091 Pond Springs Road Austin, TX 78729

• I. Classification: Class II
• II. Common or usual name: Accessory to laser system
• III. Proprietary Name: DermaCool™
• IV. Registration No.: 1645461
• V. Classification Name: Accessory to laser system, powered, 79GEX, CFR 878-4810, Class II.
• VI. Performance standards: None established (as a medical device) under section 514.
• DermaCool™ is a skin-cooling device designed for lasers or VII. Description: light sources, which are used for skin treatment applications such as vascular lesions or hair removal. A piece of cooled sapphire window, or lens, which comes in contact with skin, performs skin cooling.
• VIII. Labels and Labeling: Labels and Instructions for Use are provided. Competitive labels and labeling are provided and the products are compared.
• IX. Indications for Use: DermaCool™ is intended for use with a laser or light source utilized for photo-coagulation of dermatological lesions and is a cooling device indicated for:
  • 1. The reduction of pain,
  • 2. Less discomfort,
  • 3. Cooling of the skin prior, during and after laser or light treatment.
• The DermaCoolTM is substanially equilvalent to X. Substantial Equivalence: laser accessories cleared by Candela under K974381 as a laser accessory, and under K951033 as a pack, hot or cold. It is also equivalent to Cool Laser Optics, Inc. CLO Cool Wand, Cool Bag, and CLO Recirculating Slim Pack which do not appear to have 510(k) clearance.

The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 1399

Shahriar Ghaffari, Ph.D. President OptoMed. Inc. 13091 Pond Spring Road Austin, Texas 78729

K990417 Re: Trade Name: DermaCool™ System and Handpiece Regulatory Class: II Product Code: GEX Dated: February 3, 1999 Received: February 10, 1999

Dear Dr. Ghaffari:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you 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.

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Page 2 - Shahriar Ghaffari, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_44of_61

990417 510(k) Number (if known):__

Device Name: DermaCoo1 System and Handpieces

Indications For Use: DermaCool is intended for use with a laser or light source utilized for photo-coagulation of dermatological lesions and is a cooling device indicated for: '

• 1. The reduction of pain,
• 2. . Less discomfort,
• 3. Cooling of the skin prior, during and after laser or light treatment.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tacoella

(Division Sign-Off)
Division of General Restorative Devices K990417
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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.