(219 days)
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description or performance studies. The focus is on electrosurgical treatment and clinical validation against a predicate device.
Yes.
The device is intended for the treatment of various dermatological conditions, which is a therapeutic purpose.
No
The document states that the device is "intended for treatment of the following dermatological conditions" and does not mention any diagnostic capabilities.
No
The device description explicitly mentions a generator, cable assembly/instrument, power cable, and footswitch, which are all hardware components.
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 (rhytides, skin lesions, actinic keratosis, viral papillomata, seborrhoeic keratosis). IVDs are used for the diagnosis of conditions, typically by analyzing samples from the human body (like blood, urine, tissue).
- Device Description: The description mentions a generator, cable assembly/instrument, power cable, and footswitch. These are components of a therapeutic device used for electrosurgery, not a diagnostic device that analyzes samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is a therapeutic device used for electrosurgical treatment of skin conditions.
N/A
Intended Use / Indications for Use
The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:
- Rhytides of the face ●
- Superficial skin lesions .
- Actinic Keratosis .
- Viral papillomata .
- Seborrhoeic Keratosis .
The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:
- Rhytides of the face .
- Superficial skin lesions .
- . Actinic Keratosis
- . Viral papillomata
- Seborrhoeic 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
face (for Rhytides)
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)
clinical studies have been done to validate the performance of the device. The clinical data results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to legally marketed devices with respect to intended use and technological characteristics, and is safe and effective in its intended use.
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.
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
Page 1 of (2)
MAR 2 - 2005
| Gyrus PSR System | K041999 |
|---|---|
| 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: | May 5, 2004 |
| 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 Device: | Gyrus Plasma Skin Resurfacing (PSR) System |
| (K023111) |
510(k) Summary of Safety and Effectiveness
Description: The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:
- Rhytides of the face .
- Superficial skin lesions .
- . Actinic Keratosis
- . Viral papillomata
- Seborrhoeic Keratosis .
Accessories included with the generator are a cable assembly/instrument, power cable and a footswitch.
1
Page 2 of 2
Statement of Intended Use:
PSR System is intended for The Gyrus treatment of dermatological conditions.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Comparison to Predicate Device:
The Gyrus PSR System has been carefully compared to legally marketed devices with respect to intended use and safety and effectiveness. In addition, clinical studies have been done to validate the performance of the device. The clinical data results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to legally marketed devices with respect to intended use and technological characteristics, and is safe and effective in its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 - 2005
Mr. Mark Jensen Vice President, RA/QA Gyrus Medical, Inc. 6655 Wedgwood Road, Suite 105 Maple Grove, Minnesota 55311
Re: K041999
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: November 22, 2004 Received: November 23, 2004
Dear Mr. Jensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications forcrone stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreation of the enactment date of the Medical Device Amendments, or to commerce proc to may 20, 20, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 19, 10, 19, 1 de need that have 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 cither class II (Special Controls) or class III (PMA), it n your device 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 r reade of the 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 or any I outhall 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 read at 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) I his letter will anow you to begin hancemis your antial equivalence of your device to a legally premarket notification. The PDA maing of substanted vice 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
s and the may on any and 11, 2011 and 11:50 am and 11, and 11, meet the reg If you desire specific advice for your ac not of the same note the regulation entitled, Contact the Office of Comphance at (210) = F & eart 807.97). You may obtain "Misoranuing by reference to premailer.com.com the Act from the Division of Small other general information on your responsible in toll-free number (800) 638-204) or and find and Manufacturers, International and Consults +4.6www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
uriam C. Provost
Colia 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
4
Indications for Use
510(k) Number (if known): K041999
Device Name: Gyrus PSR System ELECTROSURGICAL GENERATOR
Indications For Use:
The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:
- Rhytides of the face ●
- Superficial skin lesions .
- Actinic Keratosis .
- Viral papillomata .
- Seborrhoeic Keratosis .
The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Page 1 of 1 -
(Division Sign - )ff) Division of General, Restorative. and Neurological Devices
510(k) Number K641799