(101 days)
Smith & Nephew RF Cannulae are intended to facilitate placement of Smith & Nephew RF Denervation Probes. The Smith & Nephew RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.
Smith & Nephew RF Cannulae are intended to facilitate the placement of Smith & Nephew RF Denervation Probes for the use in RF heat lesion procedures. The RF Cannulae are offered in a variety of lengths, gauges and tip configurations to accommodate various anatomical locations and differences in patient anatomy.
I am sorry, but the provided text, while being a 510(k) summary, does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document is a submission for a medical device (Smith & Nephew RF Cannulae) for the purpose of demonstrating substantial equivalence to a previously cleared device (K063467). It focuses on:
- Device Description: What the cannulae are and their purpose.
- Intended Use: How they are meant to be used (facilitating placement of RF Denervation Probes for RF heat lesion procedures for pain relief).
- Technological Characteristics: Stating they are similar to the predicate device with minor improvements for insertion performance.
- Substantial Equivalence Information: Explicitly stating equivalence based on design, indications for use, and material composition to the predicate device.
- List of Models: Various gauges, lengths, and tip configurations.
- FDA Clearance Letter: Confirming the 510(k) clearance based on substantial equivalence.
There is no mention of any performance studies, clinical trials, or validation data that would include acceptance criteria or reported device performance metrics. The approval appears to be based on the similarity to an already cleared device, implying that the safety and effectiveness are established through that predicate.
Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement as that information is not present in the provided text.
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510(k) Summary of Safety and Effectiveness Smith & Nephew RF Cannulae
090955
JUL 1 6 2009
Submitted By:
Date:
Contact Person:
Proprietary Name:
Common Name: Classification Name and Reference:
Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116
April 03, 2009
Mason W. Robbins, RPCV Regulatory Affairs Specialist Tel: (901) 399-6021 Fax: (901) 399-1557
Smith & Nephew RF Cannulae
Probe. Radiofrequency Lesion 21 CFR 882.4725, Radiofrequency lesion probe
Device Product Code and Panel Code:
GXI / Neurology / 84
Device Description:
Smith & Nephew RF Cannulae are intended to facilitate the placement of Smith & Nephew RF Denervation Probes for the use in RF heat lesion procedures. The RF Cannulae are offered in a variety of lengths, gauges and tip configurations to accommodate various anatomical locations and differences in patient anatomy.
Intended Use:
Smith & Nephew RF Cannulae are intended to facilitate placement of Smith & Nephew RF Denervation Probes. The Smith & Nephew RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.
Technological Characteristics:
The proposed Smith & Nephew RF Cannulae are technologically similar to the predicate Smith & Nephew RF Cannulae previously cleared under K063467. Several design modifications were made to the proposed RF Cannulae including changes to improve cannula insertion performance.
Substantial Equivalence Information:
The proposed RF Cannulae are substantially equivalent to the predicate device listed below based on similarities in design features, overall indications for use and material composition.
- . Smithy & Nephew RF Cannulae (K063467)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is depicted in a simple, line-art style, and the text is in a sans-serif font. The overall design is clean and professional, reflecting the department's role in public health and welfare.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2009
Smith & Nephew, Inc. c/o Mason W. Robbins, RPCV Regulatory Affairs Specialist 1450 Brooks Rd. Memphis, TN 38116
Re: K090955
Trade/Device Name: Smith & Nephew RF Cannulae (See Enclosed list for Models) Regulation Number: 21 CFR 882.4725
Regulation Name: Radiofrequency Lesion Probe
Regulatory Class: II
Product Code: GXI
Dated: June 25, 2009
Received: June 30, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Malvina B. Eydelman, M.
Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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cc: HFZ- 401 DMC HFZ- 404 510(k) Staff HFZ- 460 (DONED - Marsha L. Burke Nicholas) D.O.
OC Numbers:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices andRadiological Devices | 240-276-0120 |
Drafted: Marsha L. Burke Nicholas, July 7, 2009 Edited: Marisol Lendor, July 7, 2009 Final: Marisol Lendor, July 7, 2009 Typed: Marisol Lendor, July 7, 2009
IMAGE COPY
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Enclosure 1
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Smith & Nephew RF Cannulae Models
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. :
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| Catalogue Number | Description |
|---|---|
| 7210273 | 22 Gauge RF Cannula |
| 72200031 | 22 gauge, 5cm, 4mm sharp, curved tip |
| 72200032 | 22 gauge, 5cm, 4mm sharp, curved tip |
| 72200033 | 22 gauge, 10cm, 10mm sharp, curved tip |
| 22 gauge, 10cm, 10mm sharp, straight tip | |
| 7210274 | 20 Gauge RF Cannula |
| 7210275 | 20 gauge, 10cm, 10mm blunt, curved tip |
| 7210276 | 20 gauge, 10cm, 10mm sharp, curved tip |
| 7210277 | 20 gauge, 10cm, 5mm sharp, straight tip |
| 7210278 | 20 gauge, 15cm, 10mm blunt, curved tip |
| 7210279 | 20 gauge, 15cm, 10mm sharp, curved tip |
| 72200805 | 20 gauge, 15cm, 5mm sharp, straight tip |
| 72200806 | 18 Gauge RF Cannula |
| 18 Gauge, 10cm, 10 mm sharp, curved tip | |
| 18 Gauge, 15cm, 10 mm sharp, curved tip |
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Premarket Notification Indications for Use Statement
510(k) Number (if known): K090955
Smith & Nephew RF Cannulae Device Name:
Indications for Use:
Smith & Nephew RF Cannulae are intended to facilitate placement of Smith & Nephew RF Denervation Probes. The Smith & Nephew RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.
Prescription Use (Part 21 CFR 801.109) AND/OR
Over-the-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE OŇ ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MLB Nicholas
Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K090955
Page 1 of 1
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).