(16 days)
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.
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.
This is a difficult request since the provided text is a 510(k) summary for a medical device modification, not a study report. Therefore, much of the requested information about acceptance criteria, study details, and AI performance is not present in the document.
The document describes a modification to an existing electrosurgical device (Rhytec, Inc. Portrait® PSR3) - specifically, a reusable/disposable Stand-off distance gauge accessory. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on presenting a detailed clinical study with acceptance criteria for a novel AI algorithm.
Therefore, many sections of your request cannot be fulfilled from the provided text. However, I will extract what can be found and clearly state what is missing.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) summary does not contain a table of acceptance criteria or a detailed study demonstrating that the device meets those criteria in the context of an AI system.
The "study" mentioned is a "bench test" to assure usability and function of a physical accessory.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for a physical accessory) | Reported Device Performance (Implied from "bench tested") |
|---|---|
| Usability of the Stand-off | Assured |
| Function of the Stand-off | Assured |
| Equivalence to non-contacting optical (LED) targeting system | Equivalent |
| Equivalence to Candela Gentle YAG Laser System distance gauges | Equivalent functional performance |
Explanation: The document does not explicitly state acceptance criteria in a quantitative or pass/fail manner. The "Clinical and Non-Clinical Data" section only states: "The Stand-off was bench tested to assure usability and function." This implies that the bench test served as the "study" to confirm that the accessory met basic functional requirements and usability, likely against internal specifications. The "Substantial Equivalence Comparison" section serves as the primary "performance" metric by comparing the new accessory's function to existing predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. (A "bench test" for an accessory would likely involve a small number of prototypes or production units).
- Data Provenance: Not applicable/not specified for a bench test of a physical accessory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable/not specified. The "bench test" would likely be conducted by engineering or quality control personnel.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC study was not done. This device and its modification are physical electrosurgical tools, not an AI system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone performance study as typically understood for an AI algorithm was not done. This device is a physical tool used by a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For the "bench test," the ground truth would have been the engineered specifications and expected functional behavior of the Stand-off. For the substantial equivalence argument, the "ground truth" is the established function of the predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document does not describe the development of an AI algorithm or a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable. This document does not describe the development of an AI algorithm or a training set.
Summary of Device and Evidence Presented in Document K072394:
The K072394 document is a 510(k) summary for a physical accessory (reusable/disposable Stand-off distance gauge) for an existing electrosurgical device (Rhytec, Inc. Portrait® PSR3 System). The primary "study" mentioned is a "bench test" to "assure usability and function" of this accessory. The safety and effectiveness argument relies on demonstrating substantial equivalence to previously cleared predicate devices and systems for maintaining distance during dermatological procedures. It does not involve any AI components, clinical trials with patient outcomes, or multi-reader studies.
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Ko72394
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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
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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.
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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
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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
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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 |
|---|---|
| --------------- | ---------- |
§ 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.