BITX PROBES by EVEREST MEDICAL CORP.

The devices are Class II medical devices are similar in design to the referenced predicate devices. The BiTx devices are similar in construction and in component materials as compared to laparoscopic devices (Ref. BiLAP Probes submitted in 510(k) no's. K904993 and K945975). The devices are tubular instruments, either 3mm or 5mm in diameter, with shaft lengths of 12-15cm. The intended use of the device is to electrosurgically coagulate soft tissue during the performance of ENT procedures. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices with indications for ENT procedures. The device incorporates a return electrode on it's distal end, eliminating the need for a return pad.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device (BiTx Probe) and the FDA's "Substantially Equivalent" determination. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any other details related to a performance evaluation of the device against specific criteria.

The document is a regulatory submission for pre-market notification, focusing on demonstrating substantial equivalence to existing predicate devices, rather than presenting a detailed performance study with quantitative results.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. The input document simply does not contain this type of data.

Here's what the document does state, which is relevant to a 510(k) submission but not to a performance study:

Device Name: BiTx Probe
Intended Use: Electrosurgically coagulate soft tissue during the performance of ENT procedures.
Mechanism of Action: Bipolar Electrosurgical Energy, similar to predicate devices.
Comparison to Predicate Devices: The submission asserts that the device is similar in design, construction, component materials, function, and intended use as compared to predicate devices (BiLAP Probes and devices marketed by Elmed Incorporated and Ellman International).
Conclusion for 510(k): "Everest Medical believes that no new issues of safety and effectiveness are raised and that this device is substantially equivalent."
FDA Determination: The FDA found the device "substantially equivalent" to predicate devices, allowing it to be marketed.

Summary

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FEB 8 2000

I. 510(k) Summary

December 22, 1999
K 99 4336
Company:	Everest Medical Corporation13755 First Avenue NorthMinneapolis, MN 55441Tel. No. (612) 473-6262FAX. No. (612) 473-6465
Contact:	Frederick G. MadesQuality Assurance/Regulatory Affairs Manager
Common/Usual Name:	Electrosurgical Instruments
Classification Name:	Electrosurgical Cutting and Coagulation Device And Accessories(21 CFR 878.4400)
Proprietary Name:	BiTx Probe

In conclusion, as the design, materials of construction, function and intended use of the BiTx device are similar to that of the predicate devices currently marketed by Elmed Incorporated and Ellman International, Everest Medical believes that no new issues of safety and effectiveness are raised and that this device is substantially equivalent.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 8 2000

Mr. Frederick G. Mades Quality Assurance/Regulatory Affairs Manager Everest Medical Corporation 13755 First Avenue, North Minneapolis, Minnesota 55441-5454

K994336 Re: Trade Name: BiTx Probes Regulatory Class: II Product Code: GEI Dated: December 22, 1999 Received: December 23, 1999

Dear Mr. Frederick G. Mades:

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 Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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

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Page 2 - Mr. Frederick G. Mades

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 yours,

Russell Taylors.

80 James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) NUMBER (IF KNOWN): K994336

DEVICE NAME: BiTx Probe__

INDICATIONS FOR USE:

Electrosurgical Coagulation of soft tissue during ENT procedures.

Thurell Payne

(Division Sign-Off Division of General Restorative Devices 16554336 510(k) Number_

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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.