(90 days)
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No
The document describes a simple electrosurgical device for tissue coagulation and makes no mention of AI or ML technology.
Yes
The device is described as an electrosurgical device intended to create controlled coagulative lesions in tissues, which is a therapeutic intervention.
No.
The device description clearly states its purpose is to "create controlled coagulative lesions in tissues," indicating a therapeutic function rather than a diagnostic one. It is used in conjunction with a generator for electrosurgery, which is a treatment modality.
No
The device description clearly details a physical probe with a tip electrode, shaft, and handle, indicating it is a hardware device, not software only.
Based on the provided information, the Oratec TAC-C™ Monopolar Cautery Probe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an "electrosurgical device intended to be used to create controlled coagulative lesions in tissues." This describes a device used on the body for a therapeutic purpose (tissue coagulation), not a device used with samples taken from the body for diagnostic purposes.
- Device Description: The description details a probe with a tip electrode, shaft, and handle, designed for direct application to tissue. This aligns with a surgical or therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Oratec TAC-C™ Monopolar Cautery Probe does not fit this description.
N/A
Intended Use / Indications for Use
The Oratec TAC-C™ Monopolar Cautery Probe is a single-use electrosurgical device intended to be used to create controlled coagulative lesions in tissues. It is intended to be used only in conjunction with the Oratec Electrothermal Generator.
The Oratec TAC-C™ Monopolar Cautery Probe is a disposable electrosurgical device designed to create controlled coagulative lesions in tissues.
Product codes
79GEI
Device Description
The Oratec TAC-C™ Monopolar Cautery Probe has a tip electrode oriented at a right angle from the axis of the shaft in the shape of a half dome. This tip configuration provides the ability to coagulate tissues that lie in the same plane as the angle of the shaft. The probe shaft is made of stainless steel which is malleable and may be bent to any shape that is necessary. Only the tip is heated; the adjacent/rest of the tube is insulated with a protective insulative coating. The proximal end of the shaft is attached to a plastic handle.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Oratec TAC-S™ Monopolar Cautery Probe
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
23 100
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K982971
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) safety and effectiveness summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.
General Information
| Manufacturer: | Oratec Interventions, Inc.
3700 Haven Court
Menlo Park, CA 94025
Phone: (650) 369-9904 |
|----------------------|-------------------------------------------------------------------------------------------------|
| Contact Person: | Sheila Ramerman
Oratec Interventions, Inc. |
| Date Prepared: | August 24, 1998 |
| Device Information | |
| Classification Name: | Electrosurgical cutting and coagulation device and accessories |
| Common/Usual Name: | Electrosurgical accessory |
| Proprietary Name: | Oratec Interventions, Inc., TAC-Cᵀᴹ Monopolar Cautery Probe |
| Device Class: | II, at 21 CFR 878.4400 |
| Product Code: | 79GEI |
Intended Use
The Oratec TAC-C™ Monopolar Cautery Probe is a single-use electrosurgical device intended to be used to create controlled coagulative lesions in tissues. It is intended to be used only in conjunction with the Oratec Electrothermal Generator.
Product Description
O RATE C Interventions, lnc.
3700 Haven Court Menlo Park, CA 94025
Phone: (650) 369-9904 Fax: (650) 369-9905 The Oratec TAC-C™ Monopolar Cautery Probe has a tip electrode oriented at a right angle from the axis of the shaft in the shape of a half dome. This tip configuration provides the ability to coagulate tissues that lie in the same plane as the angle of the shaft. The probe shaft is made of stainless steel which is malleable and may be bent to any shape that is necessary. Only the tip is heated; the adjacent/rest of the tube is insulated with a protective insulative coating. The proximal end of the shaft is attached to a plastic handle.
1
510(k) Premarket Notification Submission, TAC-C™ Probe Modification to Oratec TAC -STM Probe
Substantial Equivalence
The TAC-CTM and TAC-STM probes are similar in that:
- Both probes are designed for general surgical use; ●
- Both probes are designed to create controlled coagulative lesions in tissues;
- Both probes use the T-type (combination of copper and constantan) ● thermocouple that terminates with the probe tip; and,
- Both probes are the same size, with the same shaft length, . diameter, and handle.
The TAC-C™ and TAC-S™ probes differ in that:
- The TAC-C™ tip is oriented at a right angle to the axis of the . shaft, whereas the TAC-S™ is oriented in the same plane as the shaft;
- The TAC-C™ tip is formed in the shape of a half-dome, whereas . the TAC-S™ tip is formed in the shape of a bullet;
- The TAC-C™ tip is made of silver solder, whereas the TAC-STM ● tip is made of stainless steel; and,
- ្រី . The TAC-C™ tip's surface area is smaller than the surface area of the TAC-STM tip.
Table III-C, in Section III, lists the similarities and differences between the two devices.
Biocompatibility
The Oratec TAC -C™ Monopolar Cautery Probe meets the requirements of ISO 10993 for Limited Contact, External Communicating Devices, Tissue/Bone/Dentin Communicating.
Summary
Based upon the information described in this submission, the Oratec TAC-C™ Monopolar Cautery Probe is substantially equivalent to the Oratec TAC-S™ Monopolar Cautery Probe.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 23 1998
Ms. Sheila Ramerman Director. Regulatory and Clinical Affairs Oratec Intervention, Inc. 3700 Haven Court Menlo Park, California 94025
Re: K982971 Trade Name: TAC-CTM Monopolar Cautery Probe Regulatory Class: II Product Code: GEI Dated: August 24, 1998 Received: August 25, 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 legally marketed predicate 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 requirements, 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 provisions, or other Federal laws or regulations.
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 toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html",
Sincerely yours.
poolefa
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
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: TAC-C™ Monopolar Cautery Probe
Indications for Use:
The Oratec TAC-C™ Monopolar Cautery Probe is a disposable electrosurgical device designed to create controlled coagulative lesions in tissues.
Contraindications for Use:
None known.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Optional Format 1-2-96) ion Sign-Off) Division of Ceneral Restorative D 510(k) Number.