(24 days)
Not Found
No
The description focuses on image-guided tracking using infrared LEDs and does not mention AI or ML algorithms for image analysis, decision support, or other functions.
No
The device is an image-guided surgical system designed to assist surgeons in precisely locating anatomical structures during total knee procedures. It helps with navigation and tracking during surgery but does not directly treat or cure a disease or condition itself.
No
This device is designed to assist surgeons during knee procedures by providing image-guided tracking of instruments. It aids in surgical navigation and instrument placement rather than diagnosing a disease or condition. The text clearly states it "is intended to assist the surgeon in precisely locating anatomical structures."
No
The device description explicitly mentions "image-guided arrays to transmit or reflect infrared LEDs" and an "IGS Platform System," indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Smith & Nephew Image Guided Surgical System for Knee Applications is a surgical navigation system. It uses imaging and tracking technology to assist surgeons in precisely locating anatomical structures during knee surgery. It does not analyze samples from the body.
- Intended Use: The intended use clearly states it's for "total knee procedures" and "assisting the surgeon in precisely locating anatomical structures." This is a surgical tool, not a diagnostic test.
- Device Description: The description focuses on image-guided arrays, infrared LEDs, and tracking instruments in the surgical field. This aligns with surgical navigation, not in vitro testing.
Therefore, this device falls under the category of a surgical guidance system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew Image Guided Surgical System for Knee Applications is indicated for use in total knee procedures, including but not limited to, primary and revision total knee arthroplasty and unicompartmental knee arthroplasty, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure, such as a long bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The Smith & Nephew Image Guided Surgical System for Knee Applications is intended to assust the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Smth & Nephew Image Guided Surgical System for Knee Applications uses image-guided arrays to transmit or reflect infrared LEDs (light emitting diodes) that are emitted by an IGS Platform System. Thus allows the instruments to be recognized and tracked in real time in the surgical field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model or fluoroscopy images
Anatomical Site
Knee, long bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, surgical field
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)
Performance data was provided to support the claim of substantial equivalence.
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
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
AUG 1 9 2002
510(k) Summary
Smith & Nephew Image Guided Surgical System for Knee Applications
| Submitter's name: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's telephone number: | 901-399-6707 |
| Contact person: | Gino J. Rouss |
| Date summary prepared: | July 25, 2002 |
| Trade or proprietary device name: | Smith & Nephew Image Guided Surgical System for |
| Knee Applications | |
| Common or usual name: | Stereotaxic Instrument |
| Classification name: | Stereotaxic Instrument |
| Device Class: | Class II |
| Device Product Code: | HAW |
| Panel Code: | Neurology / 84 |
Subject device description:
The Smith & Nephew Image Guided Surgical System for Knee Applications is intended to assust the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Smth & Nephew Image Guided Surgical System for Knee Applications uses image-guided arrays to transmit or reflect infrared LEDs (light emitting diodes) that are emitted by an IGS Platform System. Thus allows the instruments to be recognized and tracked in real time in the surgical field.
Subject device intended use:
The Smith & Nephew Image Guided Surgical System for Knee Applications is indicated for use in total knee procedures, including but not limited to, primary and revision total knee arthroplasty and unicompartmental knee arthroplasty, in which the use of stereotactic surgery may be approprate, and where a reference to a rigid anatomical structure, such as a long bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.
Technological Characteristics:
The devices included in this 510(k) are substantially equivalent to the following devices: Smith & Nephew Image Guided Surgical Instruments for Knee Applications 510(k) K012938 Medtronic Surgical Navigation Technologies 510(k) K012937
Performance data was provided to support the claim of substantial equivalence.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2002
Smith & Nephew. Inc. Gino Rouss Clinical/Regulatory Affairs Specialist 1450 Brooks Road Memphis. Tennessee 38116
Re: K022460
Trade/Device Name: Smith & Nephew Image Guided Surgical System for Knee Applications Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: July 25, 2002 Received: July 26, 2002
Dear Mr. Rouss:
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 (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.
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.
2
Page 2 - Mr. Gino Rouss
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
for Mark A. Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): -022460
Smith & Nephew Image Guided Surgical System for Knee Applications Device Name:
Indications For Use:
The Smith & Nephew Image Guided Surgical System for Knee Applications is indicated for use in total knee procedures, including but not limited to, primary and revision total knee arthroplasty and unicompartmental knee arthroplasty, in which the use of stereotactic surgery may be appropriate, and where a reference to a rigid anatomical structure, such as a long bone can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
b. Munk N. Milliken
(Division Sign Division of Restorative and Neurologic
510(k) Number