(108 days)
Not Found
No
The document describes a standard electrosurgical generator with controls for power and waveform, and mentions no features or components related to AI or ML.
Yes
The device is used for ablation, removal, resection, and coagulation of soft tissue, which are therapeutic actions to treat or modify body tissue.
No
The device is described as an electrosurgical device intended for ablation, removal, resection, and coagulation of soft tissue. Its function is to perform surgical procedures, not to diagnose conditions.
No
The device description explicitly states it is an "Electrosurgical device" and lists hardware components like a generator, connectors, foot pedal, electrodes, and cables. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Gyrus PlasmaKinetic Superpulse System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an IVD).
- Device Description: The description details an electrosurgical device used for cutting and coagulating tissue during surgery. This aligns with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing diagnostic tests, or providing diagnostic information.
Therefore, the Gyrus PlasmaKinetic Superpulse System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Gyrus PlasmaKinetic Superpulse System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Product codes
GEI
Device Description
The Gyrus PlasmaKinetic Superpulse System Generator is an Electrosuraical device with a bipolar mode of operation: The generator has controls for output waveform type and power. The unit has readouts for set power and waveform. The two physically identical connectors on the front panel support PlasmaKinetic, PlasmaKinetic Superpulse (RHS only) and 4mm bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the generator are the electrodes, connector cable, footswitch and a power cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
performance 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)
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
Gyrus Inc, Maple Grove, MN March 28, 2003 Accessories
JUL 2 1 2003 510(k) Premarket Notification Gyrus PlasmaKinetic Superpulse Generator System &
KO31085
510(k) Summary of Safety and Effectiveness
Gyrus PlasmaKinetic Superpulse System (Generator & Accessories)
| Submitted by: | Gyrus Inc
6655 Wedgwood Road Suite 105
Maple Grove
Minnesota 55311 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mercedes Bayani
Director Regulatory Affairs and Clinical |
| Telephone: | (763) 416-3015 |
| Facsimile: | (763) 416-3070 |
| Date Summary Prepared: | 2003 |
| Name of the Device: | |
| Proprietary Name: | Gyrus PlasmaKinetic Superpulse System (Generator & Accessories) |
| Project Name: | Superpulse |
| Common/Usual Name: | Electrosurgical Generator and Accessories |
| Classification Name: | Electrosurgical Cutting & Coagulation Device and
Accessories (per 21 CFR 878.4400) |
| Brand Name: | Not yet assigned |
| Predicate Devices: | |
| | Gyrus Inc PlasmaKinetic Generator (K003060)
Gyrus Medical Ltd PlasmaKinetic Endourology Generator
(K003569)
Gyrus Medical Ltd Endourology Axipolar Resectoscope
Electrode (K001270) |
1
equivalent to predicate devices and is safe and effective
The Gyrus PlasmaKinetic Superpulse System Generator Description: is an Electrosuraical device with a bipolar mode of operation: The generator has controls for output waveform type and power. The unit has readouts for set power and waveform. The two physically identical connectors on the front panel support PlasmaKinetic, PlasmaKinetic Superpulse (RHS only) and 4mm bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the generator are the electrodes, connector cable, footswitch and a power cable. The Gyrus PlasmaKinetic Superpulse System is intended Statement of Intended Use: for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required This device is intended for use by qualified medical personnel trained in the use of electrosurgery. Comparison to Predicate Devices: The Gyrus PlasmaKinetic Superpulse System has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, performance 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
in its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
JUL 2 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mercedes Bayani Director, Regulatory Affairs and Clinical Gyrus, Inc. 6655 Wedgwood Road, Suite 105 Maple Grove, Minnesota 55311
Re: K031085
Trade/Device Name: Gyrus PlasmaKinetic Superpulse System (Generator & Accessories) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 3, 2003 Received: April 24, 2003
Dear Ms. Bayani:
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. Mercedes Bayani
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,
Miriam 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 '
4
Gyrus Inc, Maple Grove, MN July 17, 2003
Indications for Use
510(k) Number (if known):
Device Name:
Gyrus PlasmaKinetic Superpulse System Generator & Accessories ELECTROSURGICAL GENERATOR
Indications For Use:
The Gyrus PlasmaKinetic Superpulse System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
The device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031085
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR (Per 21 CFR 801.109) 1-2-96)
Over-The-Counter Use (Optional Format