(23 days)
Not Found
No
The document describes a standard electrosurgical device with temperature and impedance feedback, but makes no mention of AI or ML.
Yes
The device is intended for electro-coagulation of soft tissues in arthroscopic procedures, which falls under the definition of a therapeutic intervention.
No
The device is described as an electrosurgical device intended for electro-coagulation of soft tissues, which is a therapeutic function, not a diagnostic one. It delivers radiofrequency energy to treat tissue, not to diagnose conditions.
No
The device description clearly outlines physical components such as a shaft, tip, thermocouple, handle, and cables, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The TAC-S™ Monopolar Cautery Probes are used directly on soft tissues within the body during arthroscopic procedures. They deliver radiofrequency energy for electro-coagulation. This is an in vivo (within the living body) procedure, not an in vitro diagnostic test.
- Intended Use: The intended use clearly states "to be used in arthroscopic procedures where electro-coagulation of soft tissues is desired." This describes a surgical intervention, not a diagnostic test performed on a specimen.
Therefore, based on the provided information, the TAC-S™ Monopolar Cautery Probes are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The TAC-S™ Monopolar Cautery Probes are disposable electrosurgical devices intended to be used in arthroscopic procedures where electro-coagulation of soft tissues is desired. They are intended to be used with Oratec™ Interventions ElectroThermal™ Generators.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The ORATEC Interventions TAC-S, MiniTAC-S, and MicroTAC-S Monopolar Cautery Probes are single-use electrosurgical devices designed for use in arthroscopic procedures where electro-coagulation of soft tissues is desired. They are designed to provide minimally invasive access to the targeted tissue, and to deliver radiofrequency energy in a controlled fashion. The modified probes consist of the following features:
- a shaft with a radiofrequency-energized tip for percutaneous or intraoperative access to perform tissue coagulation;
- a thermocouple at the distal end of the shaft for measuring tip temperature during RF energy delivery;
- handle and cable connection receptacle at the proximal end;
- accessory connector cables which are designed to fit standard RF control units with temperature and impedance feedback.
The only modifications made from the predicate device are: - Using teflon as an insulating material on the probe shaft.
- Decreasing handle, probe shaft, and electrode dimensions for the smaller versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues (in 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): 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.
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
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
K98418 The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
- A. Submitter:
Oratec Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025
(650) 369-9904 phone: fax: (650) 369-9902
Contact: Sheila Ramerman Date Prepared: November 18, 1998
- B. Device Names:
| Classification Name: | Electrosurgical Device |
|---|---|
| Common/usual Name: | Electrosurgical Accessory |
| Proprietary Name: | TAC-STM Monopolar Cautery Probe Family: |
| TAC-S Monopolar Cautery Probe | |
| MiniTACTM-S Monopolar Cautery Probe | |
| MicroTAC-STM Monopolar Cautery Probe |
- C. Predicate Device: TAC-STM Monopolar Cautery Probe, K963157
- D. Device Description:
The ORATEC Interventions TAC-S, MiniTAC-S, and MicroTAC-S Monopolar Cautery Probes are single-use electrosurgical devices designed for use in arthroscopic procedures where electro-coagulation of soft tissues is desired. They are designed to provide minimally invasive access to the targeted tissue, and to deliver radiofrequency energy in a controlled fashion. The modified probes consist of the following features:
- . a shaft with a radiofrequency-energized tip for percutaneous or intraoperative access to perform tissue coagulation;
- . a thermocouple at the distal end of the shaft for measuring tip temperature during RF energy delivery;
- � handle and cable connection receptacle at the proximal end;
- � accessory connector cables which are designed to fit standard RF control units with temperature and impedance feedback.
1
The only modifications made from the predicate device are:
- . Using teflon as an insulating material on the probe shaft.
- Decreasing handle, probe shaft, and electrode dimensions for the smaller versions. .
- E. Intended Use:
The TAC-STM Monopolar Cautery Probe is a disposable electrosurgical device intended to be used in arthroscopic procedures where electro-coagulation of soft tissues is desired. It is intended to be used with OratecTM Interventions ElectroThermal™ Generators.
-
Comparison with the Predicate Device: F.
The TAC-S Monopolar Cautery Probe and the modified TAC-S probes are similar in that they: -
. have the same indicated use:
-
use the same operating principle: .
-
. use the same basic probe design:
-
. use the same shaft material;
-
. are packaged and sterilized in the same manner.
The TAC-S Monopolar Cautery Probe and the modified TAC-S probes differ in that the modified TAC-S probes:
- use teflon as an insulating material on the probe shaft. .
- have smaller probe shaft dimensions and electrode surface areas. .
Based on the data and information presented here, the modified TAC-S probes are substantially equivalent to the existing TAC-S probes manufactured and distributed by Oratec Interventions, Inc.
Image /page/1/Picture/18 description: The image shows the characters IV-2. The 'IV' is written in Roman numerals, followed by a hyphen and the number 2. The text is written in a bold, sans-serif font and appears to be handwritten. The image is a close-up of the characters, with a white background.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 1998
Ms. Sheila Ramerman Director, Regulatory and Clinical Affairs Oratec Interventions, Incorporated 3700 Haven Court Menlo Park, California 94025
Re: K984185
Trade Name: Mini TAC-STM Monopolar Cautery Probe and Micro TAC-STM Monopolar Cautery Probe Regulatory Class: II Product Code: GEI Dated: November 20, 1998 Received: November 23, 1998
Dear Ms. Ramerman:
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 (OS) 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
3
Page 2 - Ms. Sheila Ramerman
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 tollfree number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
4
Page of
510(k) Number (if known): K984185
Device Name: Oratec™ Interventions TAC-STM Monopolar Cautery Probes
Indications for Use:
The TAC-S™ Monopolar Cautery Probes are disposable electrosurgical devices intended to be used in arthroscopic procedures where electro-coagulation of soft tissues is desired. They are intended to be used with Oratec™ Interventions ElectroThermal™ Generators.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K984185 |
|---|---|
| --------------- | --------- |
| Prescription Use ✓
(Per 21 CFR 801.109) | OR | Over-The-Counter Use _____
(Optional Format 1-2-96) |
| -------------------------------------------------------------------------------------------- | ---- | -------------------------------------------------------------------------------------------------------- |
|---|