(74 days)
Not Found
No
The summary describes a medical device system for intradiscal procedures using thermal energy, with no mention of AI or ML capabilities in its function, description, or performance studies.
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 directly addresses a medical condition in patients.
No
The device is intended for the coagulation and decompression of disc material to treat symptomatic patients, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states that the system consists of physical catheters and requires the use of a generator to deliver radiofrequency energy, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure performed within the body (intradiscal space) to treat a physical condition (herniated discs). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a catheter system used with a generator to deliver energy to the disc material. This is an interventional device, not a diagnostic one that analyzes samples.
- Anatomical Site: The anatomical site is the "Intradiscal space," which is inside the body. IVDs work with samples taken from the body.
The device is clearly an interventional medical device used for a therapeutic procedure.
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 Acutherm Decompression Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The proposed Intradiscal Catheter System, consisting of the Spinecath Intradiscal Catheter and the Acutherm Decompression Catheter, is used as part of the Intradiscal Electrothermal Therapy (IDET) and Targeted Disc Decompression (TDD) procedures. The procedures require the use of an introducer needle and the ORA-50S Electrothermal Spine System Generator or the Smith & Nephew Electrothermal 20S Spine Generator. The introducer needle transects the disc annulus and assists the surgeon in the placement of the catheters in the intradiscal space. The ORA-50S Electrothermal Spine System Generator or the Smith & Nephew Electrothermal 20S Spine System delivers radiofrequency energy to the catheters where the energy is converted to thermal energy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
disc
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)
Performance testing of the proposed Intradiscal Catheter System demonstrates that it performs identically to the predicate Nucleotomy Catheter (K013622) and Spinecath Intradiscal Catheter (K993967). Biocompatibility testing of the proposed device demonstrates that like the predicate devices, the proposed Intradiscal Catheter System does not pose a substantial biocompatibility risk to patients who undergo an IDET or a TDD procedure. The results of all performance and biocompatibility testing are enclosed.
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
Orthopaedics Smith & Nephew, Inc. 1450 Brooks Bd. Memphis, TN 38116 U.S.A. 901-396-212 800-821-5700 www.smith-nephew.com
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We are smith&nephew
FEB 22 200
510(k) Summary of Safety and Effectiveness Smith & Nephew Intradiscal Catheter System
| Submitted By: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| 1450 East Brooks Road | |
| Memphis, TN 38116 | |
| Date: | 12/7/2007 |
| Contact Person: | Mason W. Robbins, Regulatory Affairs Specialist |
| Tel: (901) 399-6021 | |
| Fax: (901) 399-1557 | |
| Proprietary Name: | Smith & Nephew Intradiscal Catheter System |
| Common Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Classification Name and Reference: | 21 CFR 888.4400, Electrosurgical cutting and coagulation device and accessories |
| Device Product Code and Panel Code: | GEI/ Orthopedics / 87 |
Device Description:
The proposed Intradiscal Catheter System, consisting of the Spinecath Intradiscal Catheter and the Acutherm Decompression Catheter, is used as part of the Intradiscal Electrothermal Therapy (IDET) and Targeted Disc Decompression (TDD) procedures. The procedures require the use of an introducer needle and the ORA-50S Electrothermal Spine System Generator or the Smith & Nephew Electrothermal 20S Spine Generator. The introducer needle transects the disc annulus and assists the surgeon in the placement of the catheters in the intradiscal space. The ORA-50S Electrothermal Spine System Generator or the Smith & Nephew Electrothermal 20S Spine System delivers radiofrequency energy to the catheters where the energy is converted to thermal energy.
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.
The Acutherm Decompression Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.
Technological Characteristics:
The proposed Intradiscal Catheter System is identical to the oredicate Nucleotomy Catheter (K013622) and Spinecath Intradiscal Catheter (K993967) w
Substantial Equivalence Information:
Performance testing of the proposed Intradiscal Catheter System demonstrates that it performs identically to the predicate Nucleotomy Catheter (K013622) and Spinecath Intradiscal Catheter (K993967). Biocompatibility testing of the proposed device demonstrates that like the predicate devices, the proposed Intradiscal Catheter System does not pose a substantial biocompatibility risk to patients who undergo an IDET or a TDD procedure. The results of all performance and biocompatibility testing are enclosed.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is 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 symbol. The logo is black and white.
FEB 22 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Mr. Mason W. Robbins Regulatory Affairs Specialist 1450 East Brooks Road Memphis. Tennessee 38116
K073466 Re: Trade/Device Name: Smith & Nephew Intradiscal Catheter System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: February 04, 2008 Received: February 05, 2008
Dear Mr. Robbins:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Mason W. Robbins
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
L073466
p. l of i
Premarket Notification Indications for Use Statement
510(k) Number (if known): _
Device Name: Smith & Nephew Intradiscal Catheter System
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 Acutherm Decompression Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.
Mark A. Millkern
(Division Sigu-Oi Division of General, Restorative, and Neurological Devices
510(k) Number K073466
Prescription Use X (Part 21 CFR 801.109)
AND/OR
Over-the-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)