(22 days)
The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.
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.
The provided text is a 510(k) summary for the Smith & Nephew CDS System. This document focuses on demonstrating substantial equivalence to an existing predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.
Therefore, the information requested in the prompt, such as acceptance criteria, detailed study results, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not available within the provided text.
Here's why and what can be inferred:
- Acceptance Criteria and Reported Device Performance: This information is typically found in dedicated verification and validation reports or clinical study summaries. The 510(k) summary states that "The proposed CDS System remote control underwent firmware and hardware modifications to improve its performance and reliability," and that "The changes made to the proposed CDS System represent improvements that will improve its performance over the predicate CDS System (K051136)." However, specific quantifiable performance metrics and acceptance thresholds are not provided.
- Sample Sizes and Data Provenance: The document makes no mention of a test set, training set, or any clinical data collection. It discusses modifications to an existing device.
- Experts, Adjudication, Ground Truth: These concepts are relevant to studies where human interpretation or a gold standard is used to validate a device's performance, especially for diagnostic or analytical devices. This document is for a fluid dispensing/monitoring system, and such detailed validation is not presented here.
- MRMC Comparative Effectiveness Study: There is no indication of an MRMC study. The comparison is primarily against a predicate device based on technological characteristics and intended use.
- Standalone Performance: The document does not describe a standalone performance study in the context of diagnostic accuracy (e.g., sensitivity, specificity). The "performance" mentioned refers to the functional improvements of the system's components (firmware, hardware).
- Type of Ground Truth: Not applicable, as detailed performance data based on a defined ground truth is not provided.
- Training Set Sample Size and Ground Truth for Training: Not applicable, as no training set for an AI/algorithm-based device is mentioned.
In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence of a modified medical device to a predicate device, rather than a detailed report of a study proving the device meets specific acceptance criteria with performance metrics, sample sizes, and ground truth information.
{0}------------------------------------------------
510(k) Summary of Safety and Effectiveness
| Submitted by: | Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116 | JUN 19 2008 |
|---|---|---|
| Date: | 5/27/2008 | |
| Contact Person: | Mason W. Robbins, RPCVRegulatory Affairs Specialist | |
| Proprietary Name:Common Name:Classification Name and Reference: | Smith & Nephew CDS SystemDiscography SystemImage-intensified fluoroscopic x-ray system21 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
§ 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.