PITANGA by SYNERON MEDICAL LTD. | FDA 510(k) Summary

The Pitanga is indicated for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superfícial benign pigmented lesions.

Device Description

The Pitanga is a device that is used for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions. The Pitanga treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage pigmented and vascular lesions without damaging the surrounding tissues.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Pitanga device.

Key Observation: The provided document is a 510(k) summary (and the FDA's acceptance letter) for the Pitanga device, not a detailed study report. As such, it does not contain the specific acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes, ground truth establishment methods, or expert qualifications that would typically be found in a clinical study report.

The document's primary purpose is to establish "substantial equivalence" to predicate devices, meaning it does not pose new safety or effectiveness concerns. This regulatory pathway often relies on demonstrating that the new device has similar technological characteristics and performs comparably to existing, legally marketed devices, rather than a full de novo clinical effectiveness study with quantitative performance metrics.

Therefore, many of the requested details cannot be extracted from this document.

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be provided from this document. The 510(k) summary states that "Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit." This is a general statement of equivalence, not a presentation of specific acceptance criteria (e.g., "sensitivity > 90%") or detailed performance results (e.g., "sensitivity = 92%").

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

Cannot be provided from this document. The document does not mention any specific test set, its sample size, or its provenance (e.g., country of origin, retrospective/prospective nature).

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

Cannot be provided from this document. There is no mention of a test set, ground truth establishment, or experts involved in such a process.

4. Adjudication method

Cannot be provided from this document. There is no mention of an adjudication method, as no specific test set or expert evaluation 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

No, an MRMC comparative effectiveness study was not done (or at least not reported here). This device is an aesthetic medical device (hair removal, skin lesion treatment), not an AI-powered diagnostic tool, so an MRMC study related to AI assistance for human readers is not relevant to its regulatory submission.

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

Not applicable. This is a physical medical device, not an algorithm. Its "performance" refers to its efficacy in treating patients, not the performance of a standalone algorithm.

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

Cannot be provided from this document. The term "ground truth" is not used, and no specific method for validating clinical outcomes or performance against a gold standard is detailed. The submission relies on substantial equivalence to predicate devices, implying that their established safety and effectiveness serve as the basis.

8. The sample size for the training set

Not applicable / Cannot be provided from this document. This device is hardware-based, not an AI model, so there is no "training set" in the context of machine learning.

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

Not applicable / Cannot be provided from this document. As there is no AI training set, this question is not relevant.

Summary of what the document does provide:

The document primarily provides:

Device Name: Pitanga family of products
Indications for Use: Hair removal on all skin types; treatment of superficial benign vascular lesions (Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma); treatment of superficial benign pigmented lesions.
Predicate Devices: Aurora DS (K021149), Aurora SR (K022266) by Syneron Medical Ltd.; Lumenis family of IPL and IPL/Nd:YAG laser systems (K020839) by Lumenis Inc.
Regulatory Pathway: 510(k) Pre-market Notification, establishing "substantial equivalence" to predicate devices.
Conclusion: The manufacturer believes "no significant differences exist" and "the Pitanga should raise no new issues of safety or effectiveness" when compared to predicate devices.

In conclusion, this 510(k) summary is not a clinical study report and therefore does not contain the detailed quantitative performance metrics, sample sizes, and ground truth information typically associated with establishing acceptance criteria and proving performance through a clinical trial. Its purpose is to demonstrate substantial equivalence to already approved devices.

Summary

{0}------------------------------------------------

AUG 1 9 2003

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS SYNERON MEDICAL Ltd. PITANGA K031489

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Submitter: Syneron Medical Ltd., Sultam Industrial park, P.O.B. 550, Yokneam Elite 20692, Israel. Tel. +972-4-909-7424 ext. 7604, Fax +972-4-909-7417

Name of the Device: Pitanga family of products

The Pitanga is substantially equivalent to a combination of the Predicate Devices: following devices: the Aurora DS, manufactured by Syneron Medical Ltd. and subject of K021149 ; the Aurora SR, manufactured by Syneron Medical Ltd. and subject of K022266. Lumenis family of intense pulse light (IPL) and IPL/Nd:YAG laser systems manufactured by Lumenis Inc. and subject of K020839.
Device Description: The Pitanga is a device that is used for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions. The Pitanga treatment is based on the principle of selective (electromagnetic) thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen and optimized to selectively damage pigmented and vascular lesions without damaging the surrounding tissues.

The Pitanga is intended for hair removal on all skin types and for treatment of superficial benign vascular lesions such as Facial and leg Telangiectasias, Rosacea, Poikiloderma, Angioma and superficial benign pigmented lesions.

Based upon an analysis of the overall performance characteristic for the device, Syneron Medical Ltd. believes that no significant differences exit. Therefore the Pitanga should raise no new issues of safety or effectiveness.

May 8, 2003

Avis Waldum

Dr. Amir Waldman, Director regulatory affairs Syneron medical Ltd.

Date

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 2003

Dr. Amir Waldman Director, Regulatory Affairs Syneron Medical, Inc. Sultam Industrial Park P.O.B 550 Yokneam Elite 20692. Israel

Re: K031489 Trade/Device Name: Pitanga family of products 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 8, 2003 Received: May 21, 2003

Dear Dr. Waldman:

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 mav 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 (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.

{2}------------------------------------------------

Page 2 - Dr. Amir Waldman

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 Office of Compliance at (301) 594-4659. 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 Manufacturers, International and Consumer 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 yours,

Mark A. Millican

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) Number (if known)______________________________________________________________________________________________________________________________________________________

Device Name

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V (Per 21 CFR 801.109)

Over The Counter Use_

(Optional Format 1-2-96)

f. Merle A. Mullener

1, Restorative

510 Number K031489

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.