(224 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML-powered medical devices. The description focuses solely on the intended use for tissue coagulation via electrosurgery.
Yes
The device is indicated for coagulation of tissue, which is a therapeutic action.
No
The device is indicated for coagulation of tissue, which is a treatment or surgical function, not a diagnostic one.
No
The summary describes a device intended for "coagulation of tissue" using "electrosurgery." This strongly implies a hardware component (an electrosurgical generator and/or handpiece) is necessary to perform this function, which is not a software-only capability. The lack of a device description prevents definitive confirmation, but the intended use points away from a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation of tissue". This is a therapeutic procedure performed directly on a patient's body, not a diagnostic test performed on a sample outside the body.
- Device Description: While the description is "Not Found", the intended use strongly suggests a surgical or therapeutic device.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests in a lab setting, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's intended use falls outside of that definition.
N/A
Intended Use / Indications for Use
Indicated for coagulation of tissue These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
Product codes
GEI
Device Description
Genesis Medical, Inc. Electrosurgical Electrode Family: Model 4400 - Four Needle Electrode Single Balloon, Irrigation and Aspiration with Sponge option Model 4400 - Four Needle Electrode Single Balloon, Irrigation and Aspiration without Sponge option Model 4110 - Four Needle Electrode Dual Balloons, Irrigation and Aspiration with Sponge option Model 4110 - Four Needle Electrode Dual Balloons, Irrigation and Aspiration without Sponge option Model 4002 - Four Needle Electrode, Guidewire, Irrigation and Aspiration with Sponge option Model 4002 - Four Needle Electrode, Guidewire, Irrigation and Aspiration without Sponge option
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
Not Found
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
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle's head facing left, with three parallel lines extending from the back of the head to represent feathers or wings.
JAN 2 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thomas C. Wehman, Ph.D. Regulatory Affairs Genesis Medical, Inc. 524 Weddell Drive, Suite 4 Sunnyvale, California 94089
Re: K992045
Trade Name: Genesis Medical, Inc. Electrosurgical Electrode Family:
Model 4400 - Four Needle Electrode Single Balloon, Irrigation and Aspiration with Sponge option Model 4400 - Four Needle Electrode Single Balloon, Irrigation and Aspiration without Sponge option
Model 4110 - Four Needle Electrode Dual Balloons, Irrigation and Aspiration with Sponge option
Model 4110 - Four Needle Electrode Dual Balloons, Irrigation and Aspiration without Sponge option
Model 4002 - Four Needle Electrode, Guidewire, Irrigation and Aspiration with Sponge option
Model 4002 - Four Needle Electrode, Guidewire, Irrigation and Aspiration without Sponge option
Regulatory Class: II Product Code: GEI Dated: November 8, 1999 Received: November 17, 1999
Dear Dr. Wehman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good
1
Page 2 - Thomas C. Wehman, Ph.D.
Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Stpt. Riverda
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | Unknown K992045 |
|---|---|
| Device Name: | Genesis Medical, Inc. Electrosurgical Electrode Family |
| Indications for Use: | Indicated for coagulation of tissue |
| These devices are intended for use by qualified medical personn- | |
| trained in the use of electrosurgery. | |
| Contraindications: | The use of electrosurgery is contraindicated when, in the |
| judgment of the physician, electrosurgical procedures would | |
| be contrary to the best interest of the patient. |
Indications For Use
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE, IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stigh Ploder
(Division Sign-Off)
Division of General Restorative Devices 5 : 0(k) Number ______________________________________________________________________________________________________________________________________________________________
OR
Over-the-Counter Use (Optional format 1-2-96)
Prescription Use
(per 21 CFR 801.109)
Q