(152 days)
Not Found
No
The device description focuses on the electro-surgical mechanism using plasma energy and does not mention any AI or ML components. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is indicated for the treatment of various dermatological conditions, which is a therapeutic purpose.
No
The device is described as an "electro-surgical device for use in dermatological applications" and is indicated for the "treatment of the following dermatological conditions," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is an "electro-surgical device" that uses "UHF energy from the generator" and a "handpiece" to convert Nitrogen gas into plasma, indicating it is a hardware-based device.
Based on the provided information, the Portrait PSR3 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 dermatological conditions (wrinkles, lesions, etc.). IVD devices are used to diagnose diseases or conditions by examining samples taken from the body (like blood, urine, tissue).
- Device Description: The description details an electro-surgical device that uses plasma energy to treat skin directly. This is a therapeutic device, not a diagnostic one.
- No mention of samples or analysis: There is no mention of the device interacting with or analyzing biological samples.
Therefore, the Portrait PSR3 is a therapeutic device used for dermatological treatments, not an IVD.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Rhytec, Inc. 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 Nitrogen gas, individual plasma pulses are produced that will give predictable tissue effects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neck and chest skin and in the skin of the dorsum of the hands.
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)
A clinical study was conducted which included 10 subjects treated in 30 anatomical sites which showed significant improvement in each of the three anatomic regions observed. Reduction in skin dyspigmentation and wrinkle severity was observed in neck and chest skin and in the skin of the dorsum of the hands.
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.
K041999, K053365, K052778, K021402, and K013639
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
510(k) Summary for the Rhytec, Inc. Portrait PSR3
Page 1 of 2
000006
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | Rhytec, Inc.
1000 Winter Street
Waltham, MA 02451 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading, MA 01864
Telephone: 978-207-1245
Fax: 978-207-1246 |
| Summary Preparation Date: | March 31, 2006 |
- Names
| Device Name: | Portrait PSR3 |
|---|---|
| Classification Name: | Electrosurgical cutting and coagulation device |
| Product Code: GEI |
- Predicate Devices
The Portrait PSR3 is substantially equivalent to the Gyrus Medical, Inc. Plasma Skin Resurfacing (PSR) System (K041999) and the Thermage ThermaCool System (K053365, K052778, K021402, and K013639).
4. Device Description
The Rhytec, Inc. 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 Nitrogen gas, individual plasma pulses are produced that will give predictable tissue effects.
1
5. Indications for Use
Page 2 of (2)
00007
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. Performance Data
A clinical study was conducted which included 10 subjects treated in 30 anatomical sites which showed significant improvement in each of the three anatomic regions observed. Reduction in skin dyspigmentation and wrinkle severity was observed in neck and chest skin and in the skin of the dorsum of the hands.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three horizontal lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2006
Rhytec. Inc % Ms. Maureen O'Connell O'Connell Regulatory Consultants, Inc. 1000 Winter Street Waltham, Massachusetts 02451
Re: K060948
Trade/Device Name: Rhytec, Inc. Portrait PSR3 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting coagulation device and accessories Regulation Class: Class II Product Code: GEI Dated: August 7, 2006 Received: August 9, 2006
Dear Ms. O'Connell:
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 - Ms. Maureen O'Connell
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 (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) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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 (if known): _ K 060948
Device Name: Rhytec, Inc. Portrait PSR3
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
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Rob
(Division Sign-Off)
Division of Cenera' Restorative,
and Neurological Devices
Page 1 of 1
510 Number /060928
000005
$
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