(175 days)
Not Found
No
The document describes a standard electrosurgical system for dermatological conditions and makes no mention of AI, ML, or related concepts.
Yes
The device is intended for the treatment of dermatological conditions, which falls under therapeutic use.
No
Explanation: The device is described as being for "treatment of dermatological conditions" and "electrosurgical equipment." There is no mention of diagnosis.
No
The device description explicitly mentions hardware components such as a generator, cable assembly/instrument, power cable, and footswitch, indicating it is not a software-only device.
Based on the provided information, the Gyrus Medical PSR System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the system is for the treatment of dermatological conditions. IVD devices are used for the diagnosis or monitoring of diseases or conditions by examining samples taken from the human body (like blood, urine, tissue).
- Device Description: The description details a system used for treatment (electrosurgical equipment) and its accessories. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of sample collection, analysis of biological materials, or providing diagnostic information.
Therefore, the Gyrus Medical PSR System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Gyrus PSR System is intended for treatment of the following dermatological conditions:
- Superficial skin lesions .
- Actinic Keratosis
- Viral papillomata ●
- Sceborrhoeic Keratosis .
The Gyrus Medical PSR System is intended for treatment of dermatological conditions.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Product codes
GEI
Device Description
The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:
- Superficial skin lesions .
- Actinic Keratosis
- Viral papillomata ●
- Sceborrhoeic Keratosis .
Accessories included with the generator are a cable assembly/instrument, power cable and a footswitch.
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
qualified medical personnel trained in the use of electrosurgery.
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)
Comparison to Predicate Devices: The Gyrus PSR System has been carefully compared to legally marketed devices with respect to intended use and safety and effectiveness. In addition, performance validation testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arthrocare Visage (K992180), Thermage Thermacool TC System (K013639), Lumenis (Coherent) UltraPulse CO2 Laser (K974789)
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
510(k) Summary of Safety and Effectiveness
| Gyrus PSR System
| K 02311 | |
|---|---|
| Submitted by: | Gyrus Medical Inc. |
| 6655 Wedgwood Road, Suite 105 | |
| Maple Grove, MN 55311-3602 | |
| Contact Person: | Mark Jensen |
| Vice President RA/QA | |
| Telephone: 763-416-3005 | |
| Facsimile: 763-416-3070 | |
| Date Summary Prepared: | September 11, 2002 |
| Name of the Device: | |
| Proprietary Name: | Gyrus Plasma Skin Resurfacing (PSR) System |
| Common/Usual Name: | Electrosurgical Generator and Accessories |
| Classification Name: | Electrosurgical Device (per 21 CFR 878.4400) |
| Predicate Devices: | Arthrocare Visage (K992180) |
| Thermage Thermacool TC System (K013639) | |
| Lumenis (Coherent) UltraPulse CO2 Laser (K974789) |
Description: The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:
- Superficial skin lesions .
- Actinic Keratosis
- Viral papillomata ●
- Sceborrhoeic Keratosis .
Accessories included with the generator are a cable assembly/instrument, power cable and a footswitch.
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| Statement of Intended Use: | The Gyrus PSR System is intended for treatment of dermatological conditions. |
|---|---|
| This device is intended for use by qualified medical personnel trained in the use of electrosurgery. | |
| Comparison to Predicate Devices: | The Gyrus PSR System has been carefully compared to legally marketed devices with respect to intended use and safety and effectiveness. In addition, performance validation testing has been done to validate the performance of the device. The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use. |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2003
Mr. Mark Jensen Vice President RA/QA Gyrus Medical, Inc. 6655 Wedgwood Road, Suite 105 Maple Grove, Minnesota 55311
Re: K023111
Trade/Device Name: Gyrus Plasma Skin Resurfacing (PSR) System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 31, 2002 Received: December 31, 2002
Dear Mr. Jensen:
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 - Mr. Mark Jensen
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C Provost
Celia M. Witten, Ph.D., M.D. 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):
Not Yet Assigned
KO23111
Device Name:
Gyrus PSR System ELECTROSURGICAL GENERATOR
Indications For Use:
The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:
- Superficial skin lesions .
- . Actinic Keratosis
- Viral papillomata ●
- . Sceborrhoeic Keratosis
The-system-is-intended-for-use-by-qualified-medical-personnel-trained in-the-use-ofelectrosurgical equipment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ X (Per 21 CFR 801.109) (Optional Format 1-2-96)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
OR
510(k) Number K(23)11