(69 days)
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.
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.
The provided 510(k) summary for the CoolTouch Incorporated Model CTEV and CT3S Nd:YAG Laser Systems describes the device and its intended use, but it does not provide explicit acceptance criteria for a clinical study with specific quantitative metrics. It states broadly that "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."
Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance with numerical values, nor can I provide detailed information about the study design elements you requested (sample size, data provenance, ground truth details, etc.). The summary is very high-level regarding the clinical data.
Here's what can be extracted and what is missing, based only on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What was measured & desired outcome) | Reported Device Performance (What was observed) |
|---|---|
| Explicit acceptance criteria are not stated in the provided text. The document only broadly states "effectiveness" in treatment. | Clinical results "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." (No specific metrics or success rates are provided in this summary) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only states "Clinical results were submitted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe how "effectiveness" was measured or adjudicated.
4. Adjudication method 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:
- This device is a laser system, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable to this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a medical device (laser system) for treatment, not an algorithm.
7. The type of ground truth used:
- The document implies that the ground truth was related to the "treatment of reflux of the small saphenous vein associated with varicose veins and varicosities," and its "effectiveness." However, the specific methodology for establishing this ground truth (e.g., direct observation, post-operative imaging, patient outcomes, expert consensus on clinical signs) is not described.
8. The sample size for the training set:
- Not applicable. This is a medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided 510(k) summary is a regulatory filing that confirms substantial equivalence for a medical device (laser system). It does not contain the detailed clinical study information (like specific acceptance criteria, sample sizes, ground truth methodologies, or reader studies) that would typically be found in a clinical trial report or a summary for an AI/diagnostic device.
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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 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 Models CTEV and CT3SNd:YAG Laser Systems |
| Common Name: | Nd: YAG Surgical Laser |
| Classification Name: | Laser Surgical Instrument.21 C.F.R. § 878.4810 |
| Legally Marketed PredicateDevices: | CoolTouch Inc. Model NS-160 (CTEV).and CT3SNd:YAG Laser Systems |
| 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 three interconnected sections: The cabinet,which houses the power supply, cooling system,microcontroller and the laser, the fiber optic, and/or thehandpiece. |
| Intended use of CoolTouchNd:YAG Laser Systems: | In addition to already cleared indications, the intendeduse of the CoolTouch CTEV and CT3S Nd:YAG LaserSystems is:for treatment of reflux of the small saphenous veinassociated with varicose veins and varicosities. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | Clinical results were submitted that indicate that theCoolTouch Nd:YAG Laser Systems are effective in thetreatment of reflux of the small saphenous veinassociated with varicose veins and varicosities. |
| Conclusion: | In addition to previously cleared indications, theCoolTouch CTEV and CT3S Nd:YAG Laser Systemsare indicated:for treatment of reflux of the small saphenous veinassociated 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
§ 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.