(61 days)
Not Found
No
The 510(k) summary describes an adaptor cable, a passive accessory, and makes no mention of AI or ML capabilities.
No
The device is an adaptor cable for connecting a denervation probe to RF lesion generators, acting as an accessory for a therapeutic system rather than being therapeutic itself.
No
The device is an adaptor cable for a radiofrequency denervation system, used to create heat lesions for pain treatment, not to diagnose a condition.
No
The device is described as a physical adaptor cable, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect a probe to a generator for creating heat lesions for pain treatment. This is a therapeutic procedure performed in vivo (within the body).
- Device Description: The description confirms its use in a system for creating RF heat lesions for pain treatment, again an in vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, disease, or condition.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on delivering energy for therapeutic treatment within the body.
N/A
Intended Use / Indications for Use
The Smith & Nephew Adaptor Cable is intended for connecting a Smith & Nephew Radiofrequency Denervation Probe to Smith & Nephew RF Lesion Generators.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Smith & Nephew Adaptor Cable has been designed as an accessory device to the Smith & Nephew Electrothermal Spine System and will provide the option of bipolar energy distribution. The subject device is designed to be used with Smith & Nephew Electrothermal generators, Radiofrequency (RF) denervation probes, and cannulae to create RF heat lesions for the treatment of pain. This configuration eliminates the need of a grounding pad, allowing for return of the delivered energy via a secondary non-active RF probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): 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.
Neurotherm NT 1000 RF Lesioning System K052878, Stryker RF Parallel Bipolar Adapter Cable K061660
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
083528
510k Summary of Safety and Effectiveness
| Submitted By: | Smith & Nephew, Inc.
1450 Brooks Road
Memphis, TN 38116 |
|-------------------|---------------------------------------------------------------------------------------|
| Date: | November 26, 2008 |
| Contact Person: | Kim P. Kelly, Director, Regulatory Affairs
Tel: (901) 399-6566 Fax: (901) 399-1557 |
| Proprietary Name: | Smith & Nephew Adaptor Cable |
| Common Name: | Accessory, Electrosurgical cutting and coagulation
device |
Classification Name and Reference:
21 CFR 878.4400,Electrosurgical cutting and coagulation device and accessories - Class II
Device Product Code and Panel Code: GEI
Device Description:
The Smith & Nephew Adaptor Cable has been designed as an accessory device to the Smith & Nephew Electrothermal Spine System and will provide the option of bipolar energy distribution. The subject device is designed to be used with Smith & Nephew Electrothermal generators, Radiofrequency (RF) denervation probes, and cannulae to create RF heat lesions for the treatment of pain. This configuration eliminates the need of a grounding pad, allowing for return of the delivered energy via a secondary non-active RF probe.
Intended Use:
The Smith & Nephew Adaptor Cable is intended for connecting a Smith & Nephew Radiofrequency Denervation Probe to Smith & Nephew RF Lesion Generators.
Technological Characteristics:
The Smith & Nephew Adaptor Cable is similar to legally marketed devices in that they share similar indications for use and incorporate similar technological characteristics.
Substantial Equivalence Information:
When compared to the predicate device listed below, substantial equivalence is based on similarities in design features and overall indications for use:
- Neurotherm NT 1000 RF Lesioning System K052878 .
- Stryker RF Parallel Bipolar Adapter Cable K061660 .
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 8 2009
Smith & Nephew, Inc. % Ms. Kim P. Kelly Director, Regulatory Affairs 1980 Nonconnah Boulevard Memphis, Tennessee 38132
Re: K083528
Trade/Device Name: Smith & Nephew Adaptor Cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 26, 2008 Received: November 28, 2008
Dear Ms. Kelly:
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 - Ms. Kim P. Kelly
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. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Indications for Use Statement
510(k) Number (if known):
083528
Device Name:
Smith & Nephew Adaptor Cable
Indications for Use:
The Smith & Nephew Adaptor Cable is intended for connecting a Smith & Nephew Radiofrequency Denervation Probe to Smith & Nephew RF Lesion Generators.
Prescription Use:
OR .
Over-The-Counter
(Per 21 CFT 801.109)
(PLEASE DO NOT WHITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRHL Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number
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