(24 days)
The Portrait® PSR³ is indicated for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides
- Superficial skin lesions
- Actinic Keratosis
- Viral Papillomata
- Seborrhoeic Keratosis
The Portrait® PSR³ is an electro-surgical device for use in dermatological applications. 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 Nittrogen gas, individual plasma pulses are produced that will give predictable tissue effects.
The provided 510(k) summary for the Rhytec, Inc. Portrait® PSR3 indicates that no new performance data or clinical studies were required or performed for this specific submission (K071786).
The statement "The device modifications did not raise new questions of safety or efficacy, no performance data is required" directly addresses this. This implies that the device is considered substantially equivalent to a previously cleared predicate device (K060948 - Portrait® PSR3), and therefore, the acceptance criteria and supporting studies would have been established during the clearance of that predicate device.
Therefore, it is not possible to provide the requested information based solely on the provided document for this specific 510(k) submission.
If information about the acceptance criteria and studies were available, it would have been from the original 510(k) submission for the Portrait® PSR3 (K060948).
However, based on the principle that the current device is substantially equivalent to a predicate, we can infer that the predicate device likely met certain performance criteria for the indicated dermatological conditions.
Without access to the K060948 submission, I cannot populate the table or answer the specific questions comprehensively. The provided document explicitly states that for this 510(k) (K071786), no new performance data was required.
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510(k) Summary for the Rhytec, Inc. Portrait® PSR3
0 71 786
JUL 26 2007
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | Rhytec, Inc.130 Turner StreetBuilding TwoWaltham, MA 02453 |
|---|---|
| Contact Person: | Robert ZolettiDirector, Regulatory Affairs and QualityRhytec, Inc.Telephone: 781-419-9482Fax: 781-419-9401 |
| Summary Preparation Date: | June 22, 2007 |
| Names | |
| Device Name: | Portrait® PSR3 |
| Classification Name: | Electrosurgical cutting and coagulationdevice |
3. Predicate Devices
K060948 - Portrait® PSR3 Rhytec, Inc. Portrait® PSR3
4. Device Description
The Portrait® PSR³ is an electro-surgical device for use in dermatological applications. 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 Nittrogen gas, individual plasma pulses are produced that will give predictable tissue effects.
Product Code: GEI
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0717-86
Page 2 of ②
510(k) Summary for the Rhytec, Inc. Portrait® PSR3
5. Indications for Use
The Portrait® PSR³ is indicated for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides ●
- Superficial skin lesions .
- . Actinic Keratosis
- . Viral Papillomata
- Seborrhoeic Keratosis .
6. Technological Characteristics
Modifications include:
- Revised the allowable plasma pulse repetition rate from 1 to 4.0 Hz to 1 to . 2.5 Hz as recommended in the treatment parameters in K060948.
- Removal of the 12 hour nozzle use life. Nozzle life will continue to be . monitored by the number of pulses used.
- Decreased the number of continuous pulses with the foot switch pressed . from 120 to 50.
- Added the number of pulses per patient treatment to the display. .
7. Clinical and Non-Clinical Data
The device modifications did not raise new questions of safety or efficacy, no performance data is required.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of human figures, with three overlapping profiles. The profiles are connected by flowing lines, creating a sense of unity and movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rhytec Incorporated % Mr. Robert Zoletti Director, Regulatory Affairs 130 Turner Street, Building Two Waltham, Massachusetts 02453
JUL 26 2007
Re: K071786
Trade/Device Name: Rhytec, Inc. Portrait® Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 27, 2007 Received: July 2, 2007
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, permitte your device to proceed to the market.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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) 633-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Milliken
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 (if known): | K071786 |
|---|---|
| Device Name: | Rhytec, Inc. Portrait® |
| PSR 3 |
The Portrait® PSR³ is indicated for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides .
- Superficial skin lesions .
- Actinic Keratosis ●
- Viral Papillomata .
- Seborrhoeic Keratosis .
Indications for Use are unchanged from K060948
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milken
(Division Sign-Off) (Division Sign-On) Restorative, and Neurological Devices
510(k) Number
§ 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.