SMITH & NEPHEW CDS SYSTEM

K081491 · Smith & Nephew, Inc. · JAA · Jun 19, 2008 · Radiology

Device Facts

• Record ID: K081491
• Device Name: SMITH & NEPHEW CDS SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: JAA · Radiology
• Decision Date: Jun 19, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.

Device Story

The Smith & Nephew CDS System is a medical device used during spinal procedures, such as discography, to dispense fluids and monitor pressure. The system comprises a control unit with a fluid delivery module, a user interface, a remote control, and sterile, single-use components including a syringe, tube set, and remote sleeve. Operated by clinical staff, the device provides real-time pressure monitoring during fluid delivery, assisting the physician in managing the procedure. The system is designed to improve performance and reliability through firmware and hardware modifications to the remote control. By providing precise control and monitoring of fluid delivery, the device supports the clinician in performing spinal diagnostic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes a control unit, fluid delivery module, remote control, and sterile single-use accessories (syringe, tube set, sleeve). Operates via electronic control unit with firmware-based logic. Modifications to remote control hardware and firmware were implemented to improve performance and reliability.

Indications for Use

Indicated for patients undergoing spinal procedures, specifically discography, requiring controlled fluid dispensing and pressure monitoring.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Smith & Nephew CDS System (K051136)

Submission Summary (Full Text)

{0}------------------------------------------------

K081491

## 510(k) Summary of Safety and Effectiveness

| Submitted by: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 Brooks Road<br>Memphis, TN 38116 | JUN 19 2008 |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------|
| Date: | 5/27/2008 | |
| Contact Person: | Mason W. Robbins, RPCV<br>Regulatory Affairs Specialist | |
| Proprietary Name:<br>Common Name:<br>Classification Name and Reference: | Smith & Nephew CDS System<br>Discography System<br>Image-intensified fluoroscopic x-ray system<br>21 CFR 892.1650 | |
| Device Product Code and Panel Code: | JAA/Radiology/90 | |

#### Device Description:

The Smith & Nephew CDS System consists of a control unit with a fluid delivery module with user interface, a remote control and a sterile, single-use fluid delivery syringe, tube set and remote sleeve.

#### Intended Use:

The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.

#### Technological Characteristics:

The proposed Smith & Nephew CDS System is substantially equivalent to the predicate Smith & Nephew CDS System (K051136). The proposed CDS System remote control underwent firmware and hardware modifications to improve its performance and reliability.

#### Substantial Equivalence Information:

The changes made to the proposed CDS System represent improvements that will improve its performance over the predicate CDS System (K051136). The proposed CDS System is substantially equivalent to its predicate device.

{1}------------------------------------------------

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 in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUN 1 9 2008

Mr. Mason W. Robbins Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road MEMPHIS TN 38116

Re: K081491

Trade/Device Name: Smith & Nephew CDS System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: May 27, 2008 Received: May 28, 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, 1796, 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.

{2}------------------------------------------------

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.

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 one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely vours.

Nancy Brogdon

Nancy C. Brogdon

Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Premarket Notification Indications for Use Statement

510(k) Number (if known):

Device Name: Smith & Nephew CDS System

Indications for Use:

The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.

Prescription Use __ × (Per 21 CFR 801.109)

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)

(Division Sign-Off)
Division of Reproductive, Abdominal, and

Division of Reproductive. Abdominal, and Radiological Devices 510(k) Number