(69 days)
Not Found
No
The document describes a laser system for treating varicose veins and does not mention any AI or ML components or functionalities.
Yes
The device is used for the treatment of a medical condition (reflux of the small saphenous vein associated with varicose veins and varicosities), which falls under the definition of a therapeutic device.
No
The device is used for treatment of a medical condition (reflux of the small saphenous vein), not for diagnosis. It's a therapeutic laser system.
No
The device description explicitly states it consists of hardware components: a cabinet housing power supply, cooling system, microcontroller, and laser, as well as a fiber optic and/or handpiece. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of a medical condition (reflux of the small saphenous vein). IVDs are used for the diagnosis or monitoring of diseases or conditions by examining samples taken from the human body (like blood, urine, tissue).
- Device Description: The device is a laser system used to deliver energy for treatment. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, using reagents, or providing diagnostic information.
Therefore, the CoolTouch CTEV and CT3S Nd:YAG Laser Systems are therapeutic devices, not IVDs.
N/A
Intended Use / Indications for Use
In addition to already cleared indications, the intended use of the CoolTouch CTEV and CT3S Nd:YAG Laser Systems is: for treatment of reflux of the small saphenous vein associated with varicose veins and varicosities.
Product codes
GEX
Device Description
The CoolTouch Nd:YAG Laser Systems are Nd:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optic, and/or the handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small saphenous vein
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical results were submitted that indicate that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of reflux of the small saphenous vein associated with varicose veins and varicosities.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CoolTouch Inc. Model NS-160 (CTEV).and CT3S Nd:YAG Laser Systems
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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AUG 9 - 2005
CoolTouch Incorporated Model CTEV and CT3S Nd:YAG Laser Systems 510(k) Premarket Notification 510(k) SUMMARY
| Submitter: | CoolTouch Incorporated |
|---|---|
| Address: | 9085 Foothills Boulevard |
| Roseville, CA 95747 | |
| Contact Person: | Donald V. Johnson |
| Vice-President of Operations | |
| Telephone: | (916) 677-1912 |
| Facsimile: | (916) 677-1901 |
| Date Prepared: | May 31, 2005 |
| Device Trade Name: | CoolTouch Corporation Models CTEV and CT3S |
| Nd:YAG Laser Systems | |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Laser Surgical Instrument. |
| 21 C.F.R. § 878.4810 | |
| Legally Marketed Predicate | |
| Devices: | CoolTouch Inc. Model NS-160 (CTEV).and CT3S |
| Nd:YAG Laser Systems | |
| Description of the CoolTouch | |
| Nd:YAG Laser Systems: | The CoolTouch Nd:YAG Laser Systems are Nd:YAG |
| lasers producing laser emission at 1320 nm. The lasers | |
| consist of three interconnected sections: The cabinet, | |
| which houses the power supply, cooling system, | |
| microcontroller and the laser, the fiber optic, and/or the | |
| handpiece. | |
| Intended use of CoolTouch | |
| Nd:YAG Laser Systems: | In addition to already cleared indications, the intended |
| use of the CoolTouch CTEV and CT3S Nd:YAG Laser | |
| Systems is: | |
| for treatment of reflux of the small saphenous vein | |
| associated with varicose veins and varicosities. | |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | Clinical results were submitted that indicate that the |
| CoolTouch Nd:YAG Laser Systems are effective in the | |
| treatment of reflux of the small saphenous vein | |
| associated with varicose veins and varicosities. | |
| Conclusion: | In addition to previously cleared indications, the |
| CoolTouch CTEV and CT3S Nd:YAG Laser Systems | |
| are indicated: | |
| for treatment of reflux of the small saphenous vein | |
| associated with varicose veins and varicosities. | |
| Additional Information: | None requested at this time |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 9 - 2005
Mr. Donald V. Johnson Vice-President, Operations CoolTouch Corporation 9085 Foothills Boulevard Roseville, California 95747
Re: K051434 Trade/Device Name: CoolTouch NS-160 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: May 31, 2005 Received: June 1, 2005
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & no rowe 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) This iciter with anow you to ought mading of substantial equivalence of your device to a legally prematication. The PDF miaing of castification 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 11 you desire specific acrioliance at (240) 276-0115. Also, please note the regulation entitled, Comacs the Office of Comphanes an (21 t notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour response 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 vo
Barbara Barchus
for
Mark N. Melkerson Acting 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
K 051434 510(k) Number:
Device Name: CoolTouch NS-160 Nd: YAG Laser System
Indications for Use:
In addition to previously cleared indications for use, the CoolTouch CTEV and CT3S Nd:YAG Laser Systems are indicated for the treatment of reflux of the small saphenous vein associated with varicose veins and varicosities.
(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)
OR Over-the-Counter Use __
Sharbara mnhus
(Division Sign-Off)
Sivision of General, Restorative and Neurological Devices
510(k) Number K051434