(113 days)
No
The description focuses on electrothermal technology and temperature monitoring, with no mention of AI/ML terms or functionalities.
Yes
The device is described as treating symptomatic patients with annular disruption of contained herniated discs via coagulation and decompression of disc material, which are therapeutic actions.
No
The device is described as an electrothermal device used for coagulation and decompression of disc material, which is a treatment, not a diagnostic procedure. It monitors temperature during treatment, but this is for control during therapy, not for diagnosis.
No
The device description clearly states it is an "electrothermal device utilizing a flexible shaft design and thermally activated tip," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs." This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is an "electrothermal device utilizing a flexible shaft design and thermally activated tip" that delivers thermal energy. This is a surgical tool used for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is used to directly treat a condition within the body.
N/A
Intended Use / Indications for Use
The SpineCATH Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
The Oratec SpineCATH Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
Product codes
GEI
Device Description
The SpineCATH Intradiscal Catheter is a single use electrothermal device utilizing a flexible shaft design and thermally activated tip. The entire length of the shaft is fully insulated and when activated, only the tip delivers thermal energy. In addition, a thermocouple is located at the tip of the catheter to monitor temperature. The SpineCATH Intradiscal Catheter is for use only with the Oratec generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
disc material, intervertebral discs
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)
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
510(k) Summary of Safety and Effectiveness MAR 1 9 1998 SpineCATH Intradiscal Catheter
This 510(k) safety and effectiveness summary is being submitted in accordance with the requirements of Safe Medical Devices Act 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: | Michael Kwan, Ph.D.
Oratec Interventions, Inc. |
| Date Prepared: | December 1, 1997 |
Device Information
| Classification: | Class II |
|---|---|
| Trade Name: | SpineCATH Intradiscal Catheter |
| Classification Name: | Electrosurgical Device and Accessories |
| (878.4400) |
Intended Use
The SpineCATH Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.
Product Description
The SpineCATH Intradiscal Catheter is a single use electrothermal device utilizing a flexible shaft design and thermally activated tip. The entire length of the shaft is fully insulated and when activated, only the tip delivers thermal energy. In addition, a thermocouple is located at the tip of the catheter to monitor temperature. The SpineCATH Intradiscal Catheter is for use only with the Oratec generator.
Substantial Equivalence
The SpineCATH Intradiscal Catheter is substantially equivalent in design to the Oratec EndoTAC Monopolar Cautery Probe (K972358). The intended use of the SpineCATH Intradiscal Catheter, decompression of intervertebral discs, is substantially equivalent to currently available mechanical and laser devices,
1
Dynamics' Nucleotomes (K931109, K942987) and including Surgical Laserscope's KTP/532 and KTPY AG Laser Systems (K896183, K913758).
Biocompatibility
The SpineCATH Intradiscal Catheter meets the requirements of ISO 10993 for External Communicating Devices, Tissue/Bone/Dentin Limited Contact, Communicating.
Summary
Based upon the information described in this submission, the Oratec SpineCATH Intradiscal Catheter has been shown to be substantially equivalent to the Oratec EndoTAC Monopolar Cautery Probe, Surgical Dynamics' Nucleotomes and Laserscope's KTP/532 and KTP/Y AG Laser Systems.
Molhael Kuan
Michael Kwan
Michael Kwan
Oratec Interventions, Inc. November 26, 1997
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 1998
Dr. Michael Kwan Oratec Interventions, Incorporated 3700 Haven Court 94025 Menlo Park, California
K974464 Re: Oratec SpineCATH Intradiscal Catheter Trade Name: Regulatory Class: II Product Code: GEI February 4, 1998 Dated: February 5, 1998 Received:
Dear Dr. Kwan:
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 Requlation (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 In addition, FDA may publish further announcements action. 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 - Dr. Kwan
This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA findinq 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,
L. Stephen Phoebe
elia M. Witten, Ph.D., M.D. irector Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of
510(k) Number (if known):
Cavice Name: Oratec SpineCATH Intradiscal Catheter
Indications For Use:
The Oratec SpineCATH Intradiscal Catheter is intended for use The Oratec Spinechin Incrainers of disc material to treat
for the coagulation and decompression of constained symptomatic patients with annular disruption of contained herniated discs.
-EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF -NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stetson Rhodes
of General Restorative Devi 长974464
Prescription Use_X (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)