(22 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description focuses on fluid delivery and pressure monitoring, which are typically hardware-controlled functions.
No
The device is used to dispense and monitor fluid pressure during spinal procedures; it does not directly treat a disease or condition.
No
The device is intended to dispense and monitor the pressure of fluids during spinal procedures, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly lists hardware components: a control unit, fluid delivery module, user interface, 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 in vivo (within the body) during a medical procedure, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The components listed (control unit, fluid delivery module, syringe, tube set) are consistent with a system for delivering fluids during a procedure, not for analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the Smith & Nephew CDS System is a medical device used during a surgical or interventional procedure, not an IVD.
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 (comma separated list FDA assigned to the subject device)
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 (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.
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
§ 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
510(k) Summary of Safety and Effectiveness
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 Brooks Road
Memphis, TN 38116 | JUN 19 2008 |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------|
| Date: | 5/27/2008 | |
| Contact Person: | Mason W. Robbins, RPCV
Regulatory Affairs Specialist | |
| Proprietary Name:
Common Name:
Classification Name and Reference: | Smith & Nephew CDS System
Discography System
Image-intensified fluoroscopic x-ray system
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 (800) 638-2041 or (240) 276-3150 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