SMITH & NEPHEW CDS SYSTEM

K051136 · Smith & Nephew, Inc. · JAA · Jul 1, 2005 · Radiology

Device Facts

• Record ID: K051136
• Device Name: SMITH & NEPHEW CDS SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: JAA · Radiology
• Decision Date: Jul 1, 2005
• Decision: SESE
• Submission Type: Traditional
• 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 an automated 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 fluid delivery syringe, tube set, and remote sleeve. Unlike manual predicate devices, this system provides automated fluid delivery with integrated data display and storage capabilities. It is operated by clinicians in a clinical setting. The device assists the physician by providing real-time pressure monitoring during the procedure, which informs clinical decision-making. The automated nature of the system aims to improve the precision of fluid delivery and monitoring compared to manual methods.

Clinical Evidence

Bench testing only. The device met biocompatibility requirements per ISO 10993-1 and electrical safety standards including UL 60601-1-1, IEC 60601-1-1, IEC 60601-1-2, and EN 55011. Software verification and validation testing were performed to demonstrate safety and effectiveness equivalent to the predicate device.

Technological Characteristics

Automated fluid delivery system with data display and storage. Components include a control unit, fluid delivery module, remote control, and sterile single-use syringe/tube set. Complies with ISO 10993-1 (biocompatibility), UL 60601-1-1, IEC 60601-1-1, IEC 60601-1-2, and EN 55011 (electrical safety/EMC).

Indications for Use

Indicated for patients undergoing spinal procedures, specifically discography, requiring 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

• Integra® Spinal Specialties Accu-Disc® Pressure Monitoring Syringe (K960082)

Submission Summary (Full Text)

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## KOS1136

# JUL 1 - 2005

#### SECTION IV

#### 510(k) SUMMARY

#### Date Prepared: May 2, 2005

#### A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

### B. Company Contact:

Diane Minear Director, Regulatory Affairs Phone: [phone] Fax:

#### C. Device Name

| Trade Name: | Smith & Nephew CDS System |
|----------------------|-----------------------------------------------------------------------------------|
| Common Name: | Discography System |
| Classification Name: | Image - intensified<br>Photofluorographic X-ray System Accessory<br>892.1736 1650 |

#### D. Predicate Devices

The Smith & Nephew CDS System is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed device in commercial distribution: The Integra® Spinal Specialties Accu-Disc® Pressure Monitoring Syringe - K960082.

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#### Description of Device ﻟﻨﺎ

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 F.

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

### G. Comparison of Technological Characteristics

The Smith & Nephew CDS System is substantially equivalent in function and intended use to the Integra® Spinal Specialties Accu-Disc® Pressure Monitoring Syringe - K960082. The main technological difference between the two devices is that the Smith & Nephew device is an automated system with data display and storage capacity and the Integra device is operated manually.

#### G. Summary Performance Data

The Smith & Nephew CDS System meets the biocompatibility requirements of ISO 10993-1 and electrical safety standards in UL 60601-1-1, and IEC 60601-1-1, and IEC 60601-1-2 and EN 55011. Software verification and validation testing and additional bench performance testing all demonstrate that the Smith & Nephew CDS System is as safe and effective, and performs at least as well as the legally marketed devices for the same intended use.

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Image /page/2/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.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diane E. Minear Director, Regulatory Affairs Smith & Nephew, Inc. Endoscopy 150 Minuteman Road ANDOVER MA 01810

Re: K051136

JUL I - 2005

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 2, 2005 Received: May 9, 2005

Dear Ms. Minear:

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 (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 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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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 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" (21 CFR 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

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#### Indications for Use

510(k) Number (if known): - Kost 36 --

Smith & Nephew CDS System Device Name:

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 J J _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Marcyc Brogdon

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(Division Sign-Off)

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