(18 days)
Not Found
No
The description focuses on the electro-surgical mechanism and hardware components, with no mention of AI or ML capabilities for treatment parameter selection, image analysis, or other functions.
Yes.
The device is intended for treatment of various dermatological conditions, including wrinkles, lesions, and scars, and operates by heating the skin to induce therapeutic changes.
No
The device is described as an "electro-surgical device for use in dermatological applications" that treats various dermatological conditions by heating the skin. Its intended use is for treatment, not diagnosis.
No
The device description clearly outlines multiple hardware components including a generator, footswitch, handpiece, cable assembly, treatment pack (with disposable nozzle and electronic key), and a nitrogen gas cylinder. It is an electro-surgical device that physically interacts with the skin.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Portrait® PSR3 System Function: The Portrait® PSR3 System is an electro-surgical device that directly treats dermatological conditions by applying energy to the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states treatment of various skin conditions, not diagnosis or analysis of biological samples.
- Device Description: The description details a system that delivers energy to the skin, not a system for analyzing biological specimens.
Therefore, based on the provided information, the Portrait® PSR3 System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 .
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (dermatological conditions)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Tests were conducted using a calorimeter to measure the energy delivered. The modified mode provides 4 Joules within the product specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K073111 Portrait® PSR3 System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 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.
1
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.
2
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.
3
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
4
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