(10 days)
Not Found
No
The description focuses on the physical design and function of electrosurgical probes for tissue coagulation and cutting, with no mention of AI or ML capabilities.
Yes
The device is used for electro-coagulation and cutting of soft tissues in general surgical procedures, which are therapeutic interventions.
No
The device is an electrosurgical device intended for cutting and coagulation of soft tissues, not for diagnosis.
No
The device description clearly outlines physical components such as a shaft, tip, handle, and cable connection receptacle, indicating it is a hardware device. The modifications also relate to physical aspects of the probe.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electro-coagulation and cutting of soft tissues" during "general surgical procedures." This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The device description details a surgical instrument with a shaft, tip, handle, and cable connection, designed to deliver radio-frequency energy for tissue modification. This is consistent with a surgical device, not a device used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly interact with and modify tissue within the body during surgery.
N/A
Intended Use / Indications for Use
The Electrosurgical Probes are disposable electrosurgical devices intended to be used in general surgical procedures where electro-coagulation and cutting of soft tissues is desired. They are intended to be used with ORATEC Interventions ElectroThermal™ Generators.
Product codes
GEI
Device Description
The ORATEC Interventions Electrosurgical Probes are single-use electrosurgical devices designed for use in minimally invasive procedures where electro-coagulation and cutting of soft tissues is desired. They are designed to provide minimally invasive access to the targeted tissue, and to deliver radio-frequency energy in a controlled fashion. The modified probes consist of the following features:
- a shaft with a radiofrequency-energized tip for minimally invasive access to . perform tissue coagulation and/or cutting;
- different electrode tip configurations to provide optimal access to tissue; .
- . handle and cable connection receptacle at the proximal end.
The modifications made from the predicate device are:
- Adding alternate electrode tip materials; .
- Adding alternate insulating materials on the probe shaft; .
- Adding different tip configurations; .
- 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
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
Not Found
Key Metrics
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
JUL 30 1990
Image /page/0/Picture/1 description: The image is a black and white abstract design. It features a black background with white, curved lines that appear to be stylized representations of a human figure, possibly a back. The lines create a sense of movement and flow within the rectangular frame. A circled "R" symbol is visible in the lower right corner.
Special 510(k): Device Modification ORATEC TAC-S Monopolar Cautery Probe
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.
| The assigned 510(k) number is: | K992408 |
|---|---|
| -------------------------------- | --------- |
- A. Submitter:
ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025
(650) 369-9904 Telephone: (650) 369-9902 Fax:
Sheila Ramerman Contact: July 19, 1999 Date Prepared:
- B. Device Names:
| Classification Name: | Electrosurgical Device |
|---|---|
| Common/usual Name: | Electrosurgical Probes |
| Proprietary Name: | Electrosurgical Probes Family: |
| Ligament Chisels™ | |
| MicroLigament Chisels™ | |
| Ablator™ Probes |
- Electrosurgical Probes, K965007 C. Predicate Device:
- Device Description: D.
The ORATEC Interventions Electrosurgical Probes are single-use electrosurgical devices designed for use in minimally invasive procedures where electro-coagulation and cutting of soft tissues is desired. They are designed to provide minimally invasive access to the targeted tissue, and to deliver radio-frequency energy in a controlled fashion. The modified probes consist of the following features:
- a shaft with a radiofrequency-energized tip for minimally invasive access to . perform tissue coagulation and/or cutting;
- different electrode tip configurations to provide optimal access to tissue; .
- . handle and cable connection receptacle at the proximal end.
3700 Haven Court Menlo Park, CA 94025
ORATEC
lnc.
Interventions,
Phone: (650) 369-9904 fax: (650) 369-9905
1
Special 510(k): Device Modification ORATEC TAC-S Monopolar Cautery Probe
The modifications made from the predicate device are:
- Adding alternate electrode tip materials; .
- Adding alternate insulating materials on the probe shaft; .
- Adding different tip configurations; .
- Decreasing handle, probe shaft, and electrode dimensions for the smaller versions. ●
- Intended Use: E.
The Electrosurgical Probes are disposable electrosurgical devices intended to be used in general surgical procedures where electro-coagulation and cutting of soft tissues is desired. They are intended to be used with ORATEC Interventions ElectroThermal™ Generators.
-
Comparison with the Predicate Device: F.
The Electrosurgical Probes and the modified Electrosurgical 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 Electrosurgical Probes and the modified Electrosurgical Probes differ in that the modified probes:
- use alternate electrode tip materials; .
- . use alternate insulating materials on the probe shaft;
- use different tip configurations; ●
- have smaller probe shaft dimensions and electrode surface areas. .
Based on the data and information presented here, the modified Electrosurgical Probes are substantially equivalent to the existing Electrosurgical Probes manufactured and distributed by ORATEC Interventions, Inc.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 30 1999
Ms. Sheila Ramerman Director, Regulatory & Clinical Affairs ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, California 94025
K992408 Re:
Trade Name: ORATEC Interventions Electrosurgical Probes Regulatory Class: II Product Code: GEI Dated: July 19, 1999 Received: July 20,1999
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 (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.
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/dsmamain.html".
Sincerely yours,
P. Coello
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
510(k) Number (if known): _ K 992408
Device Name: _ORATEC Interventions Electrosurgical Probes
Indications for Use:
The Electrosurgical Probes are disposable electrosurgical devices intended to be used in general surgical procedures where electro-coagulation and cutting 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 | K992408 |
| Prescription Use X
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ______ |
|---|---|---|
| -------------------------------------------------------------------------------------------- | ---- | ----------------------------- |
(Optional Format 1-2-96)