(171 days)
Not Found
No
The summary describes a standard electrosurgical device and makes no mention of AI, ML, image processing, or any related concepts.
Yes
The device is used for electrosurgical cutting and coagulation of soft tissue, which are procedures intended to treat or alleviate a medical condition.
No
Explanation: The device is described as an electrosurgical cutting and coagulation device for soft tissue, which indicates a therapeutic function rather than a diagnostic one.
No
The device description clearly describes physical, tubular instruments with specific dimensions and materials, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states the device is used for "electrosurgical cutting and coagulation of soft tissue" during arthroscopic procedures. This is a surgical procedure performed on the body, not a test performed on a specimen taken from the body.
The device is an electrosurgical instrument used for surgical intervention, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The intended use of the device is to electrosurgically cut and coagulate soft tissue during the performance of arthroscopic procedures.
Product codes
GEI
Device Description
The devices are tubular instruments, either 3mm or 5mm in diameter, with shaft lengths of 15cm. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue (arthroscopic procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
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. (612) 473-6262 FAX. No. (612) 473-6465 |
|---|---|
| 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 (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,
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 _