(161 days)
Not Found
No
The description focuses on real-time tracking of instruments using infrared markers and image guidance based on pre-operative CT/MR or intra-operative fluoroscopy, without mentioning any AI or ML algorithms for image analysis, decision support, or other functions.
No.
The device is described as surgical instruments intended to assist the surgeon in precisely locating anatomical structures during knee procedures, not to treat or cure a disease itself.
No
The device is described as surgical instruments that aid in precisely locating anatomical structures during knee procedures, rather than diagnosing a condition.
No
The device description explicitly states that the device is comprised of commercially available instruments modified with a dovetail mount for infrared LED or passive markers, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is a surgical instrument used during a surgical procedure to assist the surgeon in locating anatomical structures. It interacts directly with the patient's body during surgery, not with a specimen taken from the body.
- Intended Use: The intended use is to guide surgical procedures on the knee, not to diagnose a condition based on laboratory analysis of a sample.
The device is a surgical navigation tool that uses imaging data (CT, MR, fluoroscopy) to help the surgeon during the operation. This falls under the category of surgical instruments or navigation systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Image Guided Surgical Instruments for Knee Applications are intended to assis the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Knee Applications are 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.
Image Guided Surgical Instruments for Knee Applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Knee Applications are indicated for any medical condition of the knee in which the use of stereotactic surgery may be appropriate, and where 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.
Example procedures include, but are not limited to:
Orthopedic Procedures:
Primary Total Knee Arthroplasty
Revison Total Knee Arthroplasty
Unicompartmental Knee Replacement
Product codes
HAW
Device Description
The Smith & Nephew Image Guided Instruments for Knee Applications are commercially available instruments that have been modified by incorporating a dovetail mount that will allow infrared LED (light emitting diodes) or passive markers image guided arrays to be fixed onto the instruments. This will allow the instruments to be tracked in real time in the surgical field.
Image Guided Surgical Instruments for Knee Applications are similar to currently legally marketed Class II stereotactic instruments in that they incorporate infrared LED (light emitting diodes) or passive markers onto the instruments that allow the instruments to be 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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
K960309, K973307, K974635, K990710, K000494, K001476
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ko12938 1/2
510(k) Summary Image Guided Surgical Instruments For Knee Applications
" FEB 0 8 2002
| Submitter's name: | Smith & Nephew, Inc., Orthopaedic Division |
|---|---|
| Submitter's address: | 1450 Brooks Road, Memphis, TN 38116 |
| Submitter's telephone number: | 901-399-5007 |
| Contact person: | Trude C Naff |
| Date summary prepared: | August 30, 2001 |
| Trade or proprietary device name: | Not determined |
| Common or usual name: | Stereotactic Instrument |
| Classification name: | Stereotactic Instrument |
| Device Class: | Class II |
| Device Product Code: | HAW |
| Panel Code: | Neurology/84 |
Subject device description:
The Smith & Nephew Image Guided Instruments for Knee Applications are commercially available instruments that have been modified by incorporating a dovetail mount that will allow infrared LED (light emitting diodes) or passive markers image guided arrays to be fixed onto the instruments. This will allow the instruments to be tracked in real time in the surgical field.
B. Applicable 510(k)'s
| Manufacturer | Submission Name | FDA
Clearance
Date |
|----------------------------------|---------------------------------------------------------|--------------------------|
| Kinamed | Ortho Pilot | |
| Surgical Navigation Technologies | StealthStation | 1-24-96 |
| Surgical Navigation Technologies | StealthStation™ System Passive Instrument Option | 9-16-97 |
| Surgical Navigation Technologies | StealthStation™ System -ENT Application Addendum | 1-21-98 |
| Surgical Navigation Technologies | StealthStation® FluoroNav™ Module | 4-22-99 |
| Surgical Navigation Technologies | Indications Modifications for the StealthStation System | 2-22-00 |
| Surgical Navigation Technologies | StealthStation Generation 3 | 5-3-00 |
Subject device intended use:
Image Guided Surgical Instruments for Knee Applications are intended to assis the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Knee Applications are 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.
1
K012936 2/2
Technolocgical Characteristics:
... ..
Image Guided Surgical Instruments for Knee Applications are similar to currently legally marketed Class II stereotactic instruments in that they incorporate infrared LED (light emitting diodes) or passive markers onto the instruments that allow the instruments to be tracked in real time in the surgical field.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in a sans-serif font and is arranged to follow the curve of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 8 2002
Ms. Trude C. Naff Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis. Tennessee 38116
Re: K012938
Trade/Device Name: Smith & Nephew Image Guided Surgical Instruments for knee applications Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 21, 2001 Received: November 23, 2001
Dear Ms. Naff:
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.
3
Page 2 - Ms. Trude C. Naff
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" (21CFR 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,
Miriam C. Provost
- for 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
4
KO12938 510(k) Number (if known):
Device Name: Image Guided Surgical Instruments for Knee Applications
Indications For Use:
Image Guided Surgical Instruments for Knee Applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Image Guided Surgical Instruments for Knee Applications are indicated for any medical condition of the knee in which the use of stereotactic surgery may be appropriate, and where 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.
Example procedures include, but are not limited to:
Orthopedic Procedures:
Primary Total Knee Arthroplasty
Revison Total Knee Arthroplasty
Unicompartmental Knee Replacement
(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)
Muriam C. Provost
(Division Sign-Off) Division of General Restorative and Neurological Devices
510(k) Number K012938