(16 days)
Not Found
No
The document describes an electro-surgical device that uses plasma energy for dermatological treatments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies.
Yes
The device is described as treating various dermatological conditions such as wrinkles, skin lesions, and keratosis, indicating its use for therapeutic purposes.
No
The device description clearly states it is an "electro-surgical device for use in dermatological applications" intended for "treatment of wrinkles and rhytides, superficial skin lesions, Actinic Keratosis, Viral Papillomata, Seborrhoeic Keratosis." There is no mention of diagnostic capabilities.
No
The device description clearly states it is an electro-surgical device that uses UHF energy and nitrogen gas to create plasma for skin treatment, indicating it is a hardware-based system. The modification is a physical accessory (standoff distance gauge).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of dermatological conditions. IVDs are used for the diagnosis or monitoring of diseases or conditions using samples from the human body (like blood, urine, tissue).
- Device Description: The description details an electro-surgical device that uses plasma to treat skin. This is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, 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 .
The Portrait® PSR³is indicated for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides t
- Superficial skin lesions .
- Actinic Keratosis .
- Viral Papillomata .
- Seborrhoeic Keratosis .
Product codes
GEI
Device Description
The Rhytec, Inc. Portrait® PSR3 System is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts itrogen 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 predicy able tissue effects. The detachable Nozzle Stand-off (distance gauge) assists the user in maintaining the proper distance between the Nozzle and the skin.
The modification is a reusable/disposable Standoff distance gauge accessory to the Portrait® PSR3 system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (dermatological applications)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Stand-off was bench tested to assure usability and function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Ko72394
Image /page/0/Picture/1 description: The image shows a handwritten note inside of a circle. The note says "pg. 1 of 1". The handwriting is cursive and the ink is black. The circle is also drawn in black ink.
510(k) Summary
For the Rhytec, Inc. Portrait® PSR3
SEP 1 2 2007
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 3, 2007
Names
Portrait® PSR3 System Trade Name: Classification Name: Electrosurgical cutting and coagulation device Product Code: GEI
Legally Market Predicate Devices
K071786 Portrait® PSR3
Device Description
The Rhytec, Inc. Portrait® PSR3 System is an electro-surgical device for use in dermatological applications. UHF energy from the generator converts itrogen 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 predicy able
1
Image /page/1/Picture/1 description: The image shows the text "Pg. 2 of 2" inside of an oval shape. The text is written in a handwritten style. The oval shape is drawn with a thin black line.
tissue effects. The detachable Nozzle Stand-off (distance gauge) assists the user in maintaining the proper distance between the Nozzle and the skin.
The modification is a reusable/disposable Standoff distance gauge accessory to the Portrait® PSR3 system.
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 .
The indications are unchanged from K071886.
Technological Characteristics
The Stand-off is provided in two sizes: 5 mm and 25 mm. Materials include Ultem 1000 and Accura® DuraForm™ PA Polyamide (nylon). It is used in place of the noncontacting LED targeting ring to establish the distance between the Nozzle and the patient's skin.
Substantial Equivalence Comparison
The Stand-off is equivalent to the current non-contacting optical (LED) targeting system. It also provides the equivalent function of the distance gauges provided with the Candela Gentle YAG Laser System.
Clinical and Non-Clinical Data
The Stand-off was bench tested to assure usability and function.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2007
Rhytec, Inc. % Mr. Robert Zoletti Director, Regulatory Affairs and Quality 130 Turner Street Building Two Waltham, Massachusetts 02543
Re: K072394
Trade/Device Name: Rhytec, Inc. Portrait® PSR3 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 24, 2007 Received: August 27, 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
3
Page 2 - Mr. Robert Zoletti
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.
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,
P. N. M.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K072394
Indications for Use
510(k) Number (if known): _
Device Name: __ Rhytec, Inc. Portrait® PSR3 ...
The Portrait® PSR³is indicated for treatment of the following dermatological conditions:
- Treatment of wrinkles and rhytides t
- Superficial skin lesions .
- Actinic Keratosis .
- Viral Papillomata .
- Seborrhoeic Keratosis .
Indications for Use are unchanged from K071786
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | /6072359 |
|---|---|
| --------------- | ---------- |