COOLTOUCH MODELS NS 160 AND LC215 COOLIPO

• K Number: K072751
• Device Name: COOLTOUCH MODELS NS 160 AND LC215 COOLIPO
• Manufacturer: NEW STAR LASERS, INC.
• Date Cleared: 2008-01-02 ( 97 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K062321
• Predicate For: K080163 , K080567 , K081352 , K082721

Intended Use

In addition to previously cleared indications for use, the CoolTouch Model NS160 CoolLipo Nd: Y AG Surgical Laser is indicated for laser-assisted lipolysis.

Device Description

CoolTouch CoolLipo The NS160 Nd: YAG Surgical Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with microcannula setup.

AI/ML Overview

The provided document K072751 is a 510(k) Premarket Notification and primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study for a novel device. As such, it does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner you've outlined for performance studies.

The "study" mentioned is a "Nonclinical performance data" that produced results indicating the device is "effective for laser-assisted lipolysis." However, no specific metrics, acceptance criteria, or detailed study design are provided.

Here's an analysis based on the information available and why most of your requested points cannot be filled:

1. A table of acceptance criteria and the reported device performance:

   • No specific acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc.) are provided in this 510(k) summary. The document establishes substantial equivalence based on the same indication for use, principle of operation, and similar wavelength/pulse energy rate to a predicate device (Cynosure SmartLipo Nd:YAG laser system K062321).
   • The "reported device performance" is simply a general statement: "Nonclinical performance data produced results that indicate the Cooltouch NS160 CoolLipo laser system is effective for laser-assisted lipolysis." No quantitative data is offered.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable. No clinical test set data or sample size is mentioned. The submission relies on "Nonclinical performance data."

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 applicable. There is no mention of an expert panel or ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. No clinical test set or adjudication process is 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:

   • Not applicable. 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. This device is a laser system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable. No specific "ground truth" for clinical efficacy or performance is detailed, as the submission focuses on substantial equivalence based on known technology and "Nonclinical performance data."

8. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" of data, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

   • Not applicable. As above, no training set is discussed.

Summary based on the provided text:

The submission K072751 for the CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser system is a substantial equivalence determination based on comparison to a predicate device (Cynosure SmartLipo Nd:YAG laser system K062321). The core argument is that the device has the "same indication for use, the same principle of operation, and essentially the same wavelength and pulse energy rate" as the predicate device.

The only "study" referenced is "Nonclinical performance data" that "produced results that indicate the Cooltouch NS160 CoolLipo laser system is effective for laser-assisted lipolysis." However, this is a general statement and lacks any specific data, metrics, or detailed methodology typically found in a clinical study report. The document does not provide acceptance criteria or detailed evidence of meeting them.

Summary

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Premarket Notification 510(k) Summary K072751 (As Required by 21 CFR 807.93)

This 510(k) Summary of safety and effectiveness for the New Star Model CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) summary.

Submitter: New Star Lasers, Inc. d.b.a. CoolTouch, Inc. Address: 9085 Foothills Boulevard Roseville, CA 95747 !JAN 0 2 2007 Contact Person: Natalie Vollrath Quality Assurance Manager Telephone/Fax/Email: [phone] - Phone [phone] - Fax [e-mail] - Email Date prepared: October 26, 2007 Device Trade Name: CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser Common Name: Nd: YAG Surgical Laser Classification Name: Instrument, surgical, powered, laser 79-GEX 21 CFR §878.4810 Legally Marketed Predicate Cynosure SmartLipo Nd:YAG laser system Devices: K062321 Device Description: CoolTouch CoolLipo The NS160 Nd: YAG Surgical Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser,

foot switch, and the fiber optic for delivery of the

The Cooltouch NS160 Cool Lipo is indicated for

laser energy with microcannula setup.

laser-assisted lipolysis.

Intended Use:

intended Use:

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Comparison: The Cooltouch NS160 CoolLipo has the same indication for use, the same principle of operation, and essentially the same wavelength and pulse energy rate as the predicate device.

None

Nonclinical performance data produced results that indicate the Cooltouch NS160 CoolLipo laser system is effective for laser-assisted lipolysis.

Clinical Performance Data:

Nonclinical Perfomance Data

Conclusion:

The CoolTouch NC160 CoolLipo Nd:YAG Surgical Laser System is substantially equivalent to the predicate device and is indicated for laserassisted lipolysis.

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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

JAN 0 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

New Star Lasers, Inc. % Ms. Natalie R. Vollrath Quality Assurance Manager 9085 Foothills Boulevard Roseville, California 95747

Re: K072751

Trade/Device Name: CoolTouch NS160 CoolLipo 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: September 26, 2007 Received: September 27, 2007

Dear Ms. Vollrath:

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

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Page 2 - Ms. Natalie R. Vollrath

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Protmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Milliman

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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510(k) Number

Pending 人07 27 51

Device Name

CoolTouch NS160 CoolLipo Nd:YAG Laser System

Indications for Use

In addition to previously cleared indications for use, the CoolTouch Model NS160 CoolLipo Nd: Y AG Surgical Laser is indicated for laser-assisted lipolysis.

FOR M. MELKERSON

(Division Sign-Off)> Division of General, Restorative, and Neurological Devices

1072751 510(k) Number_

Prescription Use X (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)

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Regulation Number and Section

§ 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.