(55 days)
The CoolTouch LC160 CTEV Nd:YAG Laser System with the JouleTraker accessory is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities.
The CoolTouch Nd:YAG Laser Systems are Nd:YAG lasers producing laser emission at 1320 nm. The lasers consist of a cabinet, which houses the power supply, cooling system, microcontroller and the laser, and the fiber optic. Accessories include a footswitch and a fiber optic pull-back device, the JouleTraker.
The provided text is for a 510(k) Premarket Notification for a laser system and explicitly states that no clinical performance data was submitted. Therefore, the device has not been "proven to meet acceptance criteria" through a study in this submission.
Based on the information provided in K062210:
1. Table of acceptance criteria and the reported device performance:
Since "No clinical performance data was submitted," there is no table of acceptance criteria and reported device performance to present. The submission relies solely on substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance:
Not applicable. No clinical performance data was submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No clinical performance data was submitted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No clinical performance data was submitted.
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. No clinical performance data was submitted. This device is a laser system, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. No clinical performance data was submitted. This device is a laser system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No clinical performance data was submitted.
8. The sample size for the training set:
Not applicable. No clinical performance data was submitted. This device is a laser system, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. No clinical performance data was submitted.
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K06 2210
CoolTouch Incorporated Model LC160 CTEV Nd:YAG Laser Systems 510(k) Premarket Notification 510(k) SUMMARY
| Submitter: | CoolTouch Incorporated |
|---|---|
| Address: | 9085 Foothills BoulevardRoseville, CA 95747 |
| Contact Person: | Donald V. JohnsonVice-President of Operations |
| Telephone: | (916) 677-1912 |
| Facsimile: | (916) 677-1901 |
| Date Prepared: | July 31, 2006 |
| Device Trade Name: | CoolTouch Corporation Model LC160 CTEV Nd:YAGLaser Systems with JouleTraker Accessory |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Laser Surgical Instrument.21 C.F.R. § 878.4810 |
| Legally Marketed PredicateDevices: | CoolTouch Inc. Model CTEV (NS160) Nd:YAG LaserSystems with Trac Back accessory |
| Description of the CoolTouchNd:YAG Laser Systems: | The CoolTouch Nd:YAG Laser Systems are Nd:YAGlasers producing laser emission at 1320 nm. The lasersconsist of a cabinet, which houses the power supply,cooling system, microcontroller and the laser, and thefiber optic. Accessories include a footswitch and a fiberoptic pull-back device, the JouleTraker. |
| Intended use of CoolTouchNd:YAG Laser Systems: | The CoolTouch LC160 CTEV Nd:YAG Laser System isfor treatment of reflux of the great and small saphenousveins associated with varicose veins and varicosities. |
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| Nonclinical Performance Data: | None |
|---|---|
| Clinical Performance Data: | No clinical performance data was submitted. |
| Conclusion: | The CoolTouch LC160 CTEV Nd:YAG Laser Systemsare indicated for treatment of reflux of the great andsmall saphenous veins associated with varicose veinsand varicosities. |
| Additional Information: | None requested at this time |
(_)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 25 2006
New Star Lasers, Inc., dba CoolTouch, Inc. % Mr. Donald V. Johnson Vice President of Operations 9085 Foothills Boulevard Roseville, California 95747
Re: K062210
Trade/Device Name: CoolTouch LC160 CTEV Nd:YAG Laser System with Joule Traker Accessory 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: July 31, 2006 Received: August 1, 2006
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf have and have 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 arior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that provise that the provisions 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 merere, maintens 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 I·DA'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
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Page 2 - Mr. Donald V. Johnson
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. This letter will allow you to begin marketing your device as described in your Section 510(k) rmarket 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
I'd. Pato V.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name: CoolTouch LC160 CTEV Nd: YAG Laser System
Indications for Use:
The CoolTouch LC160 CTEV Nd:YAG Laser System with the JouleTraker accessory is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities.
Prescription Use ﻟﻤﺴﺮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign (IT) Division of General, Restorative and Neurological Devices
510(k) Number (L o 62210
§ 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.