(58 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The description focuses on fluid delivery and pressure monitoring, and the performance studies listed are related to biocompatibility, electrical safety, and software validation, not AI/ML performance.
No.
The device is intended to dispense and monitor fluid pressure during spinal procedures. It does not actively treat a condition or disease, which is characteristic of a therapeutic device.
No
The device is intended to dispense and monitor the pressure of fluids during spinal procedures like discography, which is an interventional procedure, not solely a diagnostic one. While it monitors pressure, this is a part of the fluid delivery process for the procedure itself, not primarily to diagnose a condition.
No
The device description explicitly lists hardware components such as a control unit, fluid delivery module, remote control, syringe, tube set, and remote sleeve.
Based on the provided information, the Smith & Nephew CDS System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dispense and monitor the pressure of fluids during spinal procedures such as discography." This describes a device used during a medical procedure on a patient, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The components listed (control unit, fluid delivery module, syringe, tube set) are consistent with a system for delivering fluids and monitoring pressure within the body during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Smith & Nephew CDS System's function is procedural support, not diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.
Product codes
JAA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal
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
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.
Key Metrics
Not Found
Predicate Device(s)
Integra® Spinal Specialties Accu-Disc® Pressure Monitoring Syringe - K960082
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.
0
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: 978-749-1441 978-749-1443 Fax:
C. Device Name
| Trade Name: | Smith & Nephew CDS System |
|---|---|
| Common Name: | Discography System |
| Classification Name: | Image - intensified |
| Photofluorographic X-ray System Accessory | |
| 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.
1
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.
2
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.
3
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 (800) 638-2041 or (301) 443-6597 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
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________