The Portrait® PSR3 System is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis. Similar biological changes are produced as with established laser-based and RF-based dermatological surgical and skin resurfacing technologies.
The system includes:

Portrait PSR3 Generator a mobile unit comprising a trolley and lift-out section referenced to as a "generator section". Treatment parameters are displayed on the control panel. The unit is powered by a 110/230 VAC standard wall socket.
Footswitch - single pedal unit for activation
Handpiece and Cable Assembly carries RF power and Nitrogen gas to the Nozzle.
Treatment Pack comprising a disposable Nozzle that is connected to the Handpiece and an electronic "treatment pack key" that is used by the generator to ensure the Nozzle is not used beyond its validated operational life. The instrument does not touch the skin during treatment.
Nitrogen Gas Cylinder -- the gas is provided in a cylinder housed in the generator enclosure. Refill cylinders containing the required purity of Nitrogen are obtained by the user from a commercial gas supplier.

AI/ML Overview

The document provided is a 510(k) summary for the Portrait® PSR3 System. It details a modification to an already cleared device (K073111). The primary goal of this submission is to demonstrate substantial equivalence to the predicate device, not necessarily to establish new clinical efficacy or safety from scratch. Therefore, the study described is a non-clinical test focused on the specific modification.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Deliver 4 Joules within product specification (Modified Mode)	"The modified mode provides 4 Joules within the product specification."
No change in indications for use	"The indications have not been changed from the cleared submission, K073111."
No change in technological characteristics	"The technology involved in the Portrait® PSR3 System has not been changed."
Achieve predictable tissue effects (overall system)	Covered by previous clearances, and the modification maintains this characteristic by delivering specified energy.

Note: The acceptance criteria are implicit as the submission focuses on demonstrating substantial equivalence of a modification to a previously cleared device. The "product specification" for 4 Joules is not explicitly defined in the provided text (e.g., a specific tolerance range), but the reported performance states it was met.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated as a number of cycles or measurements, but it was a "Tests" (plural) conducted.
Data Provenance: Not specified, but likely an in-house laboratory test conducted by Rhytec, Inc. ("Tests were conducted using a calorimeter..."). It is a non-clinical test, not involving human subjects or patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for this non-clinical test (energy delivery) was established by direct measurement using a calorimeter, a standard scientific instrument for measuring energy. No human experts were required to establish "ground truth" for the energy output.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical, objective measurement using a calorimeter. There was no need for adjudication as the outcome was directly measured by an instrument.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This submission is for a modification to an existing device and focuses on non-clinical performance (energy delivery).

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

Yes, a standalone test was done, but it was a non-clinical test of the device itself, specifically its ability to deliver the specified energy output. The device (the Portrait® PSR3 System with the modified software/hardware) was tested in isolation using a calorimeter. There is no AI component or algorithm being evaluated for human-in-the-loop performance in this submission.

7. The Type of Ground Truth Used

The ground truth used was objective physical measurement of energy delivery by a calorimeter.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" in the context of this 510(k) submission. This is a modification to a medical device's functionality (delivery of 4 Joules as two consecutive pulses), not an AI/ML algorithm that requires training data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there was no training set.

Summary

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K082197

AUG 2 2 2008

510(k) Summary: K082197

Page 1 of 2

For the Portrait® PSR3 System

General Information

Submitter:

Rhytec, Inc. 130 Turner Street Building Two Waltham, MA 02453

Contact Person:

Robert Zoletti Rhytec, Inc. 130 Turner Street Building Two Waltham, MA 02543 Telephone: 781-419-9482 Email: rzoletti@rhytec.com

Summary Preparation Date:

August 20, 2008

Names

Portrait® PSR3 System Trade Name: Classification Name: Electrosurgical cutting and coagulation device Product Code: GEI

Legally Market Predicate Devices

K073111 Portrait® PSR3 System

Device Description

The system includes:

Portrait PSR3 Generator a mobile unit comprising a trolley and lift-out . section referenced to as a "generator section". Treatment parameters are displayed on the control panel. The unit is powered by a 110/230 VAC standard wall socket.
. Footswitch - single pedal unit for activation
Handpiece and Cable Assembly carries RF power and Nitrogen gas to the . Nozzle.

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K 082197

Page 2 of 2

Treatment Pack comprising a disposable Nozzle that is connected to the . Handpiece and an electronic "treatment pack key" that is used by the generator to ensure the Nozzle is not used beyond its validated operational life. The instrument does not touch the skin during treatment.
Nitrogen Gas Cylinder -- the gas is provided in a cylinder housed in the . generator enclosure. Refill cylinders containing the required purity of Nitrogen are obtained by the user from a commercial gas supplier.

Indications for Use Statement

The Portrait® PSR3 System is intended for treatment of the following dermatological conditions:

. Treatment of wrinkles and rhytides
Superficial skin lesions .
Actinic Keratosis .
Viral Papillomata ●
Seborrhoeic Keratosis .
Acne Scars .

The indications have not been changed from the cleared submission, K073111.

Technological Characteristics

The technology involved in the Portrait® PSR3 System has not been changed.

UHF energy from the generator converts Nitrogen gas into plasma within the Handpiece. The plasma emerges from the Nozzle at the distal end of the Handpiece and is directed onto the skin to be treated. Rapid heating of the skin occurs as the excited gas gives up energy to the skin. Through the combination within the Handpiece of precisely controlled energy and Nitrogen gas, plasma pulses are produced that will give predictable tissue effects.

The Portrait® PSR³ System with the modified software and hardware provides a 4 Joule treatment as two consecutive pulses within 40 milliseconds. This is an additional menu selection that supplements the current mode of supplying 4 Joules as one continuous pulse in 15.4 milliseconds.

Substantial Equivalence Comparison

The Portrait® PSR3 System with the modification is equivalent to the Portrait® PSR3 System cleared in K073111. The modified software and hardware provide an alternative method of delivering a 4 Joule treatment pulse.

Clinical and Non-Clinical Data

Tests were conducted using a calorimeter to measure the energy delivered. The modified mode provides 4 Joules within the product specification.

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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 eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2008

Rhytec Incorporated % Mr. Robert Zoletti Director, Regulatory Affairs and Quality 130 Turner Street, Building 2 Waltham, Massachusetts 02453

Re: K082197

Trade/Device Name: Portrait® PSR3 System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 31, 2008 Received: August 04, 2008

Dear Mr. Zoletti:

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 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. Robert Zoletti

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 (240) 276-0115. 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 Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Wilkerson

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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Indications for Use

510(k) Number: K082197

Device Name: Portrait® PSR3 System

The Portrait® PSR³ System is indicated for treatment of the following dermatological conditions:

Treatment of wrinkles and rhytides .
Superficial skin lesions .
Actinic keratosis ●
Viral papillomata
Seborrhoeic keratosis
Acne scars .

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Melkersen

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

510(k) Number K082197

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.