(24 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The device description and intended use are focused on a physical catheter and an electrothermal generator for a specific surgical procedure.
Yes
The device is intended for the "coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs," which describes a therapeutic action.
No
The device description states it is intended for "coagulation and decompression of disc material to treat symptomatic patients," which indicates a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is a sterile, disposable device intended for use with a generator, indicating it is a physical medical device (catheter) and 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 clearly states the device is for "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 body.
- Device Description: The device is described as a "sterile, disposable device intended for use with the ORATEC ElectroThermal Spine System Generator." This further reinforces its use in a surgical or interventional procedure.
- Anatomical Site: The anatomical site is "Intradiscal," indicating it is used within the intervertebral disc, which is part of the patient's anatomy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic or other health information. This device is used directly on the patient for treatment.
N/A
Intended Use / Indications for Use
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. The ORATEC SpineCATH™ Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.
Product codes
GEI
Device Description
The devices described in this 510(k) are sterile, disposable devices intended for use with the ORATEC ElectroThermal Spine System Generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
disc material (intradiscal)
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)
This submission is a Special 510(k): Device Modification as described in FDA's Guidance document "The New S10(k) Paradigm- Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications. " In support of this 510(k), ORATEC has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and the results of validation testing (performance testing) for the device modification.
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
510(k) Summary DEC 1 7 1999 ORATEC® SpineCATH™ Intradiscal Catheters
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: | K993967 |
|---|---|
| Submitter: | ORATEC® Interventions, Inc. |
| 3700 Haven Court | |
| Menlo Park, CA 94025 | |
| Establishment Registration # 2953127 | |
| Contact: | Jennifer Brennan |
| Regulatory Affairs Associate | |
| Telephone: (650) 369-9904 | |
| Fax: (650) 369-9902 | |
| Date Prepared: | November 22, 1999 |
| Device Names: | |
| Classification Name: | Electrosurgical device |
| Common/usual Name: | Electrosurgical accessory |
| Proprietary Name: | ORATEC® SpineCATH™ Intradiscal Catheter |
Predicate Device: SpineCATH™ Intradiscal Catheter, K974664
Device Description:
The devices described in this 510(k) are sterile, disposable devices intended for use with the ORATEC ElectroThermal Spine System Generator.
Intended Use:
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. The ORATEC SpineCATH™ Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.
Safety and Performance:
치
This submission is a Special 510(k): Device Modification as described in FDA's Guidance document "The New S10(k) Paradigm- Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications. " In support of this 510(k), ORATEC has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and the results of validation testing (performance testing) for the device modification.
Conclusion:
Based on the indications for use, fundamental scientific technology characteristics, performance, and comparison to the predicate device, the modified SpineCATH Intradiscal Catheter is substantially equivalent to the predicate SpineCATH Intradiscal Catheter under the Federal, Food, Drug and Cosmetic Act. The SpineCATH Intradiscal Catheter is manufactured and distributed by ORATEC Interventions, Inc.
Proprietary information: This document and the information contained herein may not be reproduced, used, or disclosed without prior written consent of Oratec Interventions, Inc.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of a stylized eagle with three heads.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 1999
Ms. Jennifer Brennan Regulatory Affairs Associate ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, California 94025
K993967 Re:
Trade Name: ORATEC® Spine CATH™ Intradiscal Catheter Regulatory Class: II Product Code: GEI Dated: November 22, 1999 Received: November 23, 1999
Dear Ms. Brennan:
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 - Ms. Jennifer Brennan
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,
Hamelin Laja
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page
Device Name: ORATEC® SpineCATH™ Intradiscal Catheters
Indications for Use:
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. The ORATEC SpineCATH Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rune/i/iyan
(Division Sign-Off)
Div. General Restorative Devices
510(K) Number 455 3467
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)