(173 days)
The CoolTouch NS-160 Nd: YAG Laser System is indicated for the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.
The CoolTouch NS-160 Nd:YAG Laser System is an ND:YAG laser producing laser emission at 1320 nm. The laser consists of two sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, and the fiber optic.
The provided text describes a 510(k) premarket notification for the CoolTouch NS-160 Nd:YAG Laser System. It states that "Clinical data produced results that indicate that the CoolTouch Nd:YAG Laser System is effective in the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities." However, it does not provide specific quantitative acceptance criteria or detailed results to fill out the table requested. It also lacks detailed methodology for the clinical study.
Therefore, many sections of your request cannot be fulfilled from the provided text.
Here's what can be extracted based on the given information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not specified in text | Not specified in text |
| Qualitative Acceptance: Efficacy in treating reflux of greater saphenous vein associated with varicose veins and varicosities. | Reported Performance: Clinical data indicates effectiveness in treating reflux of the greater saphenous vein associated with varicose veins and varicosities. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country, retrospective/prospective). The document only states "Clinical data produced results."
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 specified. The document does not mention the use of experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 is a laser system, not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The text implies an evaluation of clinical outcomes ("effective in the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities"). However, the precise method of determining "ground truth" or clinical success (e.g., specific imaging follow-up, patient reported outcomes, physician assessment criteria) is not detailed.
8. The sample size for the training set
- Not applicable. This is a medical device (laser system), not a machine learning algorithm requiring a "training set."
9. How the ground truth for the training set was established
- Not applicable. (See answer to #8).
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SEP 2 8 2004
CoolTouch Inc. CoolTouch NS-160 Nd:YAG Laser System 510(k) Premarket Notification 510(k) SUMMARY
KO4 0421
This 510(k) summary of safety and effectiveness for the CoolTouch NS-160 Nd:YAG Laser System is submitted in accordance with the requirements of SMDA of 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | CoolTouch Inc. |
|---|---|
| Address: | 9085 Foothills BoulevardRoseville, CA 95747 |
| Contact Person: | Donald V. JohnsonVice-President of Operations |
| Telephone: | (916) 677-1912 |
| Facsimile: | (916) 677-1901 |
| Date Prepared: | April 6. 2004 |
| Device Trade Name: | CoolTouch Model NS-160 Nd:YAG Laser System |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Laser Surgical Instrument.21 C.F.R. § 878.4810 |
| Legally Marketed Predicate Device: | Diomed 810nm Surgical Laser, K023543, K012398Biolitec Ceralas D10-60 810nm Diode Laser, K030700Biolitec Ceralas D 980nm Diode Laser, K024088 |
| Description of the CoolTouchNd:YAG Laser Systems: | The CoolTouch NS-160 Nd:YAG Laser System is anND:YAG laser producing laser emission at 1320 nm.The laser consists of two sections: The cabinet, whichhouses the power supply, cooling system,microcontroller and the laser, and the fiber optic. |
| Intended use of CoolTouchNd:YAG Laser Systems: | The CoolTouch NS-160 Nd: Y AG Laser System isindicated for the treatment of reflux of the greatersaphenous vein associated with varicose veins andvaricosities. |
| Nonclinical Performance Data: | None |
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| Clinical Performance Data: | Clinical data produced results that indicate that theCoolTouch Nd:YAG Laser System is effective in thetreatment of reflux of the greater saphenous veinassociated with varicose veins and varicosities. |
|---|---|
| Conclusion: | The CoolTouch NS-160 Laser System is indicated forthe treatment of reflux of the greater saphenous veinassociated with varicose veins and varicosities. TheCoolTouch NS-160 is substantially equivalent to thepredicate devices with the same intended use. |
| Additional Information: | None requested at this time |
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 8 2004
Mr. Donald V. Johnson Vice President of Operations CoolTouch, Inc. 9085 Foothills Boulevard Roseville, California 95747
Re: K040921
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: August 16, 2004 Received: August 19, 2004
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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
K040921 510(k) Number:
Device Name: CoolTouch NS-160 Nd: YAG Laser System
Indications for Use:
The CoolTouch NS-160 Nd: YAG Laser System is indicated for the treatment of reflux of the greater 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)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Prescription Use 510(k) Number OR K640921 Over-the-Counter Use
(per 21 CFR 801.109)
§ 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.