(143 days)
No
The description focuses on the electro-surgical mechanism and clinical outcomes, with no mention of AI/ML terms, image processing, or data sets typically associated with AI/ML development.
Yes
The device is described as an "electro-surgical device for use in dermatological applications" and is intended for the "treatment of the following dermatological conditions". It causes "controlled damage" to tissue for therapeutic effect, which clearly indicates it is a therapeutic device.
No
The device is described as an electro-surgical device for treatment of various dermatological conditions, not for diagnosis.
No
The device description explicitly lists hardware components such as a generator, footswitch, handpiece, treatment pack, and nitrogen gas cylinder, indicating it is a hardware-based medical device with potential software control.
Based on the provided information, the Portrait® PSR3 System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of various dermatological conditions by directly acting on the skin tissue. IVD devices are used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details an electro-surgical device that heats the skin to cause biological changes. This is a therapeutic action, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
The Portrait® PSR3 System is a therapeutic device used for dermatological procedures.
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
GEI
Device Description
The Portrait® PSR 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 dermatological surgical and skin resurfacing technologies.
The system includes:
- Portrait® PSR3 Generator-a mobile unit powered from 110/230 VAC standard wall socket . comprising a trolley and lift-out section referred to as a "generator section". Treatment parameters are displayed on the control panel.
- Footswitch-a single pedal unit for activation ♥
- . Handpiece and Cable Assembly-this 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 product supplier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
Clinical studies demonstrated that the Portrait® PSR3 is capable of producing tissue effects similar to that seen with carbon dioxide laser treatment. Clinical studies to support clinical performance of the Portrait® PSR3 to improve acne scarring were conducted as Non-Significant Risk studies and undertaken in compliance with the Code of Federal Regulations, as specified in 21 CFR 812. These studies conclude that the Portrait® PSR³ is safe and effective for treating acne scars.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K071786, K963339, K030453, K053047
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the words "MAR 27 2008 RHYTEC TRUE REGENERATIVE SCIENCE". The date is March 27, 2008. The word "RHYTEC" is in bold, and the words "TRUE REGENERATIVE SCIENCE" are stacked on top of each other to the right of the word "RHYTEC".
KO 73111
510(k) Summary
Page 1 of 3
For the Rhytec, Inc. Portrait® PSR3
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: March 24, 2008
Names
Trade Name: Common Name: Classification Name: Product Code:
Portrait® PSR3 System (None) Electrosurgical cutting and coagulation device GEI
Legally Market Predicate Devices
K071786 Portrait® PSR³ K963339 Coherent UltraPulse K030453 CoolTouch ND:YAG K053047 Fraxel ISR Laser System
Device Description
The Portrait® PSR 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 dermatological surgical and skin resurfacing technologies.
1
SCIENCE
Page 2 of 3
The system includes:
- Portrait® PSR3 Generator-a mobile unit powered from 110/230 VAC standard wall socket . comprising a trolley and lift-out section referred to as a "generator section". Treatment parameters are displayed on the control panel.
- Footswitch-a single pedal unit for activation ♥
- . Handpiece and Cable Assembly-this 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 product supplier.
Indications for Use Statement
The Portrail® 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 4
- . Acne Scars
Technological Characteristics
The technology involved in the Portrait® PSR3 System is not changed from previous Portraille PSR3 submissions.
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, individual plasma pulses are produced that will give predictable tissue effects.
The Portrait® PSR3 uses Nitrogen plasma as compared to laser light used by UltraPulse, CoolTouch ND:YAG and Fraxel ISR Laser System.
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RHYTEC TRUE REGENERATIVE SCIENCE
Page 3 of 3
Substantial Equivalence Comparison
Portrait® PSR3 utilizes the same technology as previously cleared for Portrait® PSR3. There have been no changes to the device design. The substantial equivalence of this device is supported by the prior approval of this device and the clinical data submitted. Other devices used to treat acne scars include the 1320-nmNd:YAG (K030453), Fraxel SR 1500 (K070284) and CO2 Laser (K963339).
Clinical and Non-Clinical Data
Clinical studies demonstrated that the Portrait® PSR3 is capable of producing tissue effects similar to that seen with carbon dioxide laser treatment. Clinical studies to support clinical performance of the Portrait® PSR3 to improve acne scarring were conducted as Non-Significant Risk studies and undertaken in compliance with the Code of Federal Regulations, as specified in 21 CFR 812. These studies conclude that the Portrait® PSR³ is safe and effective for treating acne scars.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle faces right and is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 7 2008
Rhytec Incorporated % Mr. Robert Zoletti Director RA 130 Turner Street Building Two Waltham, Massachusetts 02543
K073111 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: February 29, 2008 Received: March 04, 2008
Dear Mr. Zoletti:
Re:
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.
4
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 the reporting 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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number: K073111
Device Name: Portrait® PSR³
Indications for use:
The Portrait® PSR3 is intended for treatment of the following dermatological conductions:
- Treatment of wrinkles and rhytides 1.
- Superficial skin lesions 2.
- Actinic keratosis 3.
- Viral papillomata 4.
- Seborrhoeic keratosis 5.
- Acne Scars 6.
Prescription Use X
And/Or
Over the Counter Use
(21 CFR Part 801 Subpart D) Subpart C)
(21 CFR Part 801
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Outta
S. Sign Off
Division of General, Restorative, and Neurological Devices
510(k) Number K073111
Rhytec, Inc. November 2007
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