(108 days)
The CoolTouch CTEV Nd:YAG Laser System is indicated for the treatment of superficial incompetent tributary 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.
Here's an analysis of the provided text regarding the CoolTouch Incorporated Model CTEV Nd:YAG Laser Systems, focusing on the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific, quantifiable acceptance criteria for the device's performance (e.g., a certain percentage of vein closure, a specific reduction in symptoms). Instead, the assessment focuses on demonstrating the device's effectiveness in treating the indicated conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device is effective in the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities. | "Clinical results were submitted that indicate that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of vein reflux associated with varicose veins and varicosities." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only mentions "Clinical results were submitted."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the lack of detail on experts and ground truth establishment, it's highly probable no formal adjudication method like '2+1' or '3+1' was used in the assessment described.
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
- MRMC Study: No, this does not appear to be an AI/CAD-based device. The device is a laser system for medical treatment. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This is a medical device (laser system), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated, however, the "clinical results" would likely refer to objective measures of vein closure (e.g., ultrasound findings of successfully treated veins) and/or improvement in patient symptoms, established through clinical follow-up by medical professionals. It's implied this ground truth was based on clinical outcomes as observed by treating physicians, rather than expert consensus on image interpretation or pathology.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable (see point 8).
Summary of Study Details from the Provided Text:
The provided 510(k) summary is very limited in its description of the clinical study. It merely states that "Clinical results were submitted that indicate that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of vein reflux associated with varicose veins and varicosities." There is no detailed information about the study design, number of patients, specifics of the outcomes measured, or the methodology used to establish effectiveness. This brevity is common in 510(k) summaries where the device demonstrates substantial equivalence to a predicate, and extensive new clinical trials might not be required if technological characteristics and intended use are similar, and safety/effectiveness can be argued from existing data and principles. The focus here seems to be on a direct clinical outcome (effectiveness in treatment) rather than diagnostic performance metrics.
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K 061618
CoolTouch Incorporated Model CTEV Nd:YAG Laser Systems 510(k) Premarket Notification 510(k) SUMMARY
SEP 2 5 2006
| 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: | May 31, 2005 |
| Device Trade Name: | CoolTouch Corporation Model CTEV Nd:YAG LaserSystems |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Laser Surgical Instrument.21 C.F.R. § 878.4810 |
| Legally Marketed PredicateDevices: | CoolTouch Inc. Model CTEV (NS-160) Nd:YAG LaserSystems |
| 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. |
| Intended use of CoolTouchNd: YAG Laser Systems: | The CoolTouch CTEV Nd:YAG Laser System isindicated for the treatment of superficial incompetenttributary veins associated with varicose veins andvaricosities. |
| SEP 25 2 |
. . . . .
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| Nonclinical Performance Data: | None |
|---|---|
| Clinical Performance Data: | Clinical results were submitted that indicate that theCoolTouch Nd:YAG Laser Systems are effective in thetreatment of vein reflux associated with varicose veinsand varicosities. |
| Conclusion: | The CoolTouch CTEV Nd:YAG Laser System isindicated for the treatment of superficial incompetenttributary veins associated with varicose veins andvaricosities. |
| Additional Information: | None requested at this time |
020
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. 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
SEP 2 5 2006
New Star Lasers, Inc. % Mr. Donald V. Johnson Vice-President of Operations 9085 Foothills Boulevard Roseville, California 95747
Re: K061618
Trade/Device Name: CoolTouch CTEV 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: Class II Product Code: GEX Dated: August 16, 2006 Received: August 17, 2006
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 for associated or to May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimered prices 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 r ou may, ateres 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 or any I 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) I ma lotter witification. The FDA finding of substantial equivalence of your device to a legally promated 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 If you attire 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 other general 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,
Barbara Buchner
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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INDICATION FOR USE STATEMENT
K061618 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: CoolTouch CTEV Nd: YAG Laser System
Indications for Use:
The CoolTouch CTEV Nd:YAG Laser System is indicated for the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities.
Prescription Use
(per 21 CFR 801.109)
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Over-the-Counter Use_
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
barbare Bnchum
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K0611618
0004
§ 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.