The Theravant TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all skin types (Fitzpatrick types I-VI).

Device Description

The Theravant System is comprised of the following main components: Main console, Treatment Handpiece(s). The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment.

AI/ML Overview

The provided text is a 510(k) summary for the Theravant TheraClear System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance data for the Theravant system itself.

Therefore, many of the requested items (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance) are not explicitly present in this type of regulatory submission.

Here's an analysis based on the information provided:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This document does NOT present a study with specific acceptance criteria and performance data for the Theravant TheraClear System.

Instead, the submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Aesthera Isolaz System, K083730). The rationale for substantial equivalence is based on:

Identical Indications for Use: The TheraClear System has the same stated indications for use as the predicate device.
Same or Similar Device Operation: The device functions in a comparable manner to the predicate.
Overall Technical and Functional Capabilities: The technical specifications and functional performance are considered similar enough to the predicate.

Since this is a substantial equivalence claim, the "acceptance criteria" are implicitly met if the device is found to be substantially equivalent to the predicate, which has already established its safety and effectiveness. There are no direct performance metrics for the Theravant TheraClear System presented as part of this 510(k) summary to be compared against specific acceptance criteria.

Additional Requested Information (Based on the document):

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

Not Applicable. As explained above, this 510(k) summary does not provide specific acceptance criteria or reported device performance data for the Theravant TheraClear System. It relies on demonstrating substantial equivalence to a predicate device.

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. The document does not describe a clinical trial or test set with a specific sample size for the Theravant TheraClear System. The information provided is for regulatory submission focused on substantial equivalence.

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. No test set or ground truth establishment process is described for the Theravant TheraClear System in this document.

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

Not Applicable. No test set or related adjudication method 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 surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical medical device (laser system), not an algorithm or software-only device. Performance would inherently involve a human operator.

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

Not Applicable. No specific ground truth for performance evaluation of the Theravant TheraClear System is described in this document. The "ground truth" for the regulatory approval relies on the predicate device having already demonstrated safety and effectiveness for its indications.

8. The sample size for the training set

Not Applicable. This document describes a physical medical device, not a machine learning model that would require a "training set."

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

Not Applicable. As above, no training set is relevant to this type of device and submission.

Summary

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K101415

pg 1 of 2

8 2010

Section 1- 510(k) Summary or 510(k) Statement

I. General Information

Submitter:

ﺗﻘ

Theravant Corporation 201 Lindberg Ave Livermore, CA 94551 USA

Contact Person:

Marcy Moore Regulatory Consultant for Theravant Corporation 131 Kelekent Lane Cary, NC 27518 919-363-2432 ph 919-363-0085 fax marcymoore@nc.rr.com

May 14, 2010 Summary Preparation Date:

Names II.

Trade Name:	TheraClear System
Classification:	Class II
	21 CFR 878.4810
Product Code:	ONF
Primary Classification Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology

III. Predicate Device(s)

Aesthera Isolaz System (K083730); .

IV. Product Description

The Theravant System is comprised of the following main components:

Main console .
Treatment Handpiece(s) .

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The Theravant System is a portable tabletop system used to deliver intense pulsed light to the patient treatment site via a delivery handpiece utilizing vacuum technology. Intense pulsed light is emitted through the tip only when the tip is sealed against the selected patient treatment site. All emitted light is contained within the tip during treatment.

PB 2 of

10/ 415

V. Indications for Use

The Theravant TheraClear System is intended for:

The treatment of benign vascular and pigmented lesions; ●
Permanent hair reduction;
The treatment of mild to moderate acne, including pustular acne, comedonal acne, and mild . to moderate inflammatory acne (acne vulgaris).

The TheraClear System is intended for use on all skin types (Fitzpatrick types I-VI).

Rationale for Substantial Equivalence VI.

The TheraClear System shares the identical indications for use as the named predicate(s), and same or similar device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

Safety and Effectiveness Information VII.

The review of the indications for use and technical characteristics demonstrates that the TheraClear System is substantially equivalent to the predicate devices.

VIII. Conclusion

The Theravant System was found to be substantially equivalent to the predicate devices.

The Theravant System shares the identical indications for use as the named predicate(s), and same or similar device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings and body represented by a series of curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Theravant Corporation % Ms. Marcy Moore Regulatory Consultant 131 Kelekent Lane Cary, North Carolina 27518

JUL - 8 2010

Re: K101415

Trade/Device Name: TheraClear 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: ONF Dated: May 19, 2010 Received: May 20, 2010

Dear Ms. Moore:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Marcy Moore

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K10 | 4

Device Name: TheraClear

Indications for Use:

The Theravant TheraClear System is intended for the treatment of benign vascular and pigmented lesions; permanent hair reduction; and the treatment of mild to moderate acne, including gunsular acne, comedonal acne, and mild to moderate inflammatory acne (acne vulgaris), in all e knowner (Fitzpatrick I-VI).

Prescription Use · > (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)

(Division Sign-Oli) Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number: K014115

Page 1 of 1

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.