BITX PROBES

K993412 · Everest Medical Corp. · GEI · Mar 31, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K993412
• Device Name: BITX PROBES
• Applicant: Everest Medical Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

electrosurgical cutting and coagulation of soft tissue. Arthroscopic

Device Story

BiTx Probe is a tubular electrosurgical instrument (3mm or 5mm diameter, 15cm length) used for cutting and coagulating soft tissue during arthroscopic procedures. Operated by physicians in a clinical setting, the device utilizes bipolar electrosurgical energy. It features a return electrode on the distal end of the shaft, eliminating the need for an external return pad. The device functions by delivering energy directly to the target tissue, allowing for precise cutting and coagulation. This design simplifies the surgical setup and reduces the need for additional patient grounding equipment, potentially improving procedural efficiency and patient safety during arthroscopic surgery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and functional similarity to predicate devices.

Technological Characteristics

Tubular electrosurgical instrument; 3mm or 5mm diameter; 15cm shaft length; Bipolar electrosurgical energy source; Integrated distal return electrode; Materials of construction are identical to predicate laparoscopic devices.

Indications for Use

Indicated for electrosurgical cutting and coagulation of soft tissue during arthroscopic procedures.

Regulatory Classification

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.

Predicate Devices

• BiLAP Probes (K904993)
• BiLAP Probes (K945975)
• BiLAP Probes (K955001)

Submission Summary (Full Text)

{0}------------------------------------------------

**MAR 31 2000**

99 3412

Revised 01/21/2000

J. 510(k) Summary

January 21, 2000

| Company: | Everest Medical Corporation 13755 First Avenue North Minneapolis, MN 55441 Tel. No. [phone] FAX. No. [phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Frederick G. Mades Quality 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 |

The devices are Class II medical devices. The BiTx devices are similar in construction and in component materials when compared to laparoscopic devices. In particular they are similar to the BiLAP Probes submitted in 510(k) no's. K904993, K945975 and K955001. The devices are tubular instruments, either 3mm or 5mm in diameter, with shaft lengths of 15cm. The intended use of the device is to electrosurgically cut and coagulate soft tissue during the performance of arthroscopic procedures. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the previously cleared laparoscopic and thorascopic devices. The devices are constructed from the same materials and are processed similarly to the predicate devices. The device incorporates a return electrode on the distal end of the shaft eliminating the need for a return pad.

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

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2000

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

Re: K993412 Trade Name: BiTx Probes Regulatory Class: II Product Code: GEI Dated: January 21, 2000 Received: January 24, 2000

Dear Mr. 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.

{2}------------------------------------------------

## Page 2 - Mr. Frederick G. Mades

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Styptn Rhodes

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

510(k) NUMBER (IF KNOWN) : _ K_993412

BITX PROBES DEVICE NAME:

INDICATIONS FOR USE:

electrosurgical cutting and coagulation of soft tissue. Arthroscopic

> (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)

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

(Division Sign-Off) Division of General Restorative I k993412 510(k) Number _