Treatment of mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

Device Description

The Isolaz® 2 System delivers non-coherent 400-1200 nm and 550-1200 nm intense pulsed light via a delivery handpiece utilizing photopneumatic technology. The system consists of a main console and a treatment handpiece. The desired power and delivery time are set by the operator. The modifications made to the device were to reduce and simplify device settings.

AI/ML Overview

The provided text describes a 510(k) summary for the Isolaz® 2 Intense Pulsed Light System, which is a medical device intended for the treatment of mild to moderate acne. However, the text does not contain specific acceptance criteria or a detailed study plan with performance data in the way you've outlined in your request.

Medical device 510(k) submissions typically focus on demonstrating "substantial equivalence" to a predicate device. This often means showing that the new device has similar technological characteristics and is as safe and effective as a legally marketed device, rather than presenting a novel study against predefined quantitative performance criteria.

Therefore, many of the requested data points (e.g., specific acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) are not available in the provided document.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as quantitative metrics. The overall acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device in terms of safety and effectiveness.
Reported Device Performance: The document states:
- "Verification and validation data show that the device meets all product specifications."
- "Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."
- No specific clinical outcome percentages (e.g., X% reduction in acne lesions) are provided in this summary.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies mentioned ("Laboratory and performance tests") were likely internal engineering and safety tests rather than patient-based clinical trials for performance efficacy in the way a pharmaceutical trial might be.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. The summary focuses on engineering and safety compliance rather than clinical validation against expert judgment of acne condition.

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

Not applicable/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:

No MRMC study was mentioned. This device is not an AI diagnostic tool that requires human interpretation.

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

Not applicable. This is a light-based therapy device, not a diagnostic algorithm. Performance would relate to its physical output and biological effect, not an algorithmic output requiring standalone evaluation.

7. The type of ground truth used:

Not applicable in the conventional sense of diagnostic device ground truth. The "ground truth" for this device would be its ability to consistently produce the specified light parameters and its safety in use, rather than a clinical outcome measured against an external standard like pathology. The summary mentions compliance with safety standards (IEC 60601-1, 60601-1-4, 60601-1-2) and biocompatibility (ISO 10993-1).

8. The sample size for the training set:

Not applicable. This device does not use machine learning algorithms that require a "training set."

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

Not applicable.

Summary of Device Rationale from the Document:

The Isolaz® 2 Intense Pulsed Light System is seeking 510(k) clearance by demonstrating substantial equivalence to its predicate device, the Isolaz® Intense Pulsed Light System (K083730).

Key claims for substantial equivalence:

Similar Design and Technology: Delivers non-coherent 400-1200 nm and 550-1200 nm intense pulsed light via photopneumatic technology, similar to the predicate.
Similar Intended Use: Treatment of mild to moderate acne (pustular, comedonal, inflammatory) in all skin types (Fitzpatrick I-VI), identical to the predicate.
Similar Technological Characteristics: Similar in design specification, output energy, and delivery system.
Minor Modifications: Modifications to the system console and handpiece hardware and circuitry do "not significantly affect the safety or effectiveness of the device."
Compliance with Standards: Evaluated and found compliant with IEC 60601-1 and 60601-1-4 for electrical safety, IEC 60601-1-2 for EMI/EMC, and ISO 10993-1 for biocompatibility of treatment tips.
Performance Data (General Statement): "Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."

In essence, the "acceptance criteria" here are that the new Isolaz 2 system has not introduced new safety or effectiveness concerns compared to its predicate and that its modifications are minor, as demonstrated by engineering and safety testing, which allows it to leverage the predicate's established safety and efficacy profile.

Summary

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K121515

SECTION 5: 510(k) SUMMARY *****

JUN - 5 2012

This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, 21 CFR 807.92

1. General Information

Date of Submission: May 17, 2012

Submitted By:

Solta Medical, Inc. 25881 Industrial Blvd Hayward, CA 94545

Contact Person:

Kristine Foss V.P., Regulatory, Clinical & Quality 510-780-4657 (Direct Phone) 510-780-4857 Fax kfoss@solta.com

2. Trade/Proprietary Name of Device:

Isolaz® 2 Intense Pulsed Light System Trade Name: Powered Light Non-laser Surgical Instrument Common Name: C Regulation Number 878.4810 Product Code: ONF General Surgery/Restorative Devices Device Panel: Device Classification: Class II

1. Legally Marketed Predicate Device for Claimed Equivalence: Name: Isolaz® Intense Pulsed Light System 510(k) #: K083730

4. Device Description

5. Intended Use:

The Isolaz® 2 System is intended for treatment of mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

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6. Technological Characteristics:

The Isolaz® 2 System is similar to the predicate device in design specification, output energy, and delivery system. They are both intense pulsed light instruments designed to produce light energy for treatment of mild to moderate acne including pustular acne, comedonal acne and inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI). The modifications to the system console and handpiece hardware and circuitry do not significantly affect the safety or effectiveness of the device. The system was evaluated and found compliant with IEC 60601-1 and 60601-1-4 for electrical safety, IEC 60601-1-2 for EMI/EMC, and ISO 10993-1 for biocompatibility of the treatment tips. Verification and validation data show that the device meets all product specifications.

7. Performance Data:

Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.

8. Conclusion:

By virtue of the design, materials, function and intended use, the Isolaz® 2 Intense Pulsed Light System is as safe, as effective and performs as well as or better than the predicate device. In establishing substantial equivalence to the predicate device. Solta Medical evaluated the indications for use, product specifications, and energy requirements of the device.

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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 and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

Solta Medical % Ms. Kristine Foss Vice President, Regulatory , Clinical & Quality 25881 Industrial Boulevard Hayward, California, 94545

JUN - 5 2012

Re: K121515

Trade/Device Name: Isolaz 2 Intense Pulsed Light 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 17, 2012 Received: May 22, 2012

Dear Ms. Foss:

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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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 (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.

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.

for. Rpt. De curson
Mark N. Melkerson

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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SECTION 4:

Indications for Use

510(k) Number (if known): K121515

Device Name: Isolaz® 2 Intense Pulsed Light System

Indications For Use:

Treatment of mild to moderate acne, including pustular acne, comedonal acne and mild to moderate inflammatory acne (acne vulgaris) in all skin types (Fitzpatrick I-VI).

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)

K121515
510(k) Number

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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.