(139 days)
Not Found
No
The document describes manual instruments used with an image guidance system, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as "accessories to Image Guided Surgery systems" and "orthopedic manual knee instruments modified to accept an Medtronic Image Guidance System (IGS) array". Its intended use is for guiding surgical procedures, not directly treating a medical condition itself.
No
Explanation: The device is described as an accessory to Image Guided Surgery systems, intended for use during orthopedic procedures like knee arthroplasty to guide instruments. It does not diagnose medical conditions but rather assists in surgical navigation.
No
The device description explicitly states it is for "Zimmer orthopedic manual knee instruments modified to accept an Medtronic Image Guidance System (IGS) array". This indicates the device includes physical instruments, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instruments are accessories to Image Guided Surgery systems for orthopedic procedures on the knee. This involves surgical planning and execution based on imaging data, not the examination of specimens derived from the human body for diagnostic purposes.
- Device Description: The description confirms they are modified manual knee instruments used with an image guidance system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The focus is entirely on surgical guidance.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or other conditions. This device's function is to aid in surgical procedures, which is a different category of medical device.
N/A
Intended Use / Indications for Use
Zimmer Knee Ortho Guidance Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee orthopedic medical condition in which the use of stereotaxic 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 orthopedic procedures for these instruments include, but are not limited to:
- Total Knee Arthroplasty (Primary and Revision)
- Unicompartmental Knee Arthroplasty (Primary and Revision)
- Minimally Invasive Knee Orthopedic Procedures
Product codes
HAW
Device Description
This submission is for Zimmer orthopedic manual knee instruments modified to accept an Medtronic Image Guidance System (IGS) array and to be used with the Medtronic StealthStation® System
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 orthopedic medical condition, long bone
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)
No testing was needed for these devices. QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems. Clinical data and conclusions were not needed for these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Ko33011
Image /page/0/Picture/1 description: The image shows the Zimmer logo. The logo consists of a stylized letter Z inside a circle, followed by the word "zimmer" in a bold, sans-serif font. The letter Z is black, and the word "zimmer" is also black.
Traditional 510(k) Premarket Notification
FEB 1 2 2004
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen McKelvey
Manager, Regulatory Affairs
Telephone: (574) 372-4944
Fax: (574) 372-4605 |
| Date: | September 25, 2003 |
| Trade Name: | Zimmer Ortho Guidance Systems - Knee
Instruments |
| Common Name: | Image Guided Instrument |
| Classification Name
and Reference: | Stercotaxic Instrument
21 CFR § 882.4560 |
| Predicate Device: | Catheter Introducer for the StealthStation System,
manufactured by Medtronic Surgical Navigation
Technologies, K022126, cleared January 3, 2003. |
| Device Description: | This submission is for Zimmer orthopedic manual
knee instruments modified to accept an Medtronic
Image Guidance System (IGS) array and to be used
with the Medtronic StealthStation® System |
| Intended Use: | Zimmer Knee Ortho Guidance Instruments are
intended as accessories to Image Guided Surgery
systems and are indicated for any knee orthopedic
medical condition in which the use of stereotaxic
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 orthopedic procedures for these
instruments include, but are not limited to: |
1
Image /page/1/Picture/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle, followed by the word "zimmer" in a smaller, sans-serif font. The letter "Z" is black, and the word "zimmer" is also black.
Traditional 510(k) Premarket Notification
- ﺖ Total Knee Arthroplasty (Primary and Revision)
- -Unicompartmental Knee Arthroplasty (Primary and Revision)
- Minimally Invasive Knee Orthopedic -Procedures
Both the predicate and proposed devices are indicated for use with Image Guidance Surgery systems. Both are accessory instruments.
Non-Clinical Performance and Conclusions:
No testing was needed for these devices. QSR validation and verification will be conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the wings and body. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2004
Mr. Stephen H. McKclvey Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K033011
Trade/Device Name: Zimmer Ortho Guidance Systems - Knee Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 10, 2003 Received: December 11, 2003
Dear Mr. McKelvey:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 gencral 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 madc 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 - Mr. Stephen II. McKelvey
This letter will allow you to begin marketing your device as described in your Scetion 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promatted 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 11 you t the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html
Sincerely yours,
C. Miriam C. Provost
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
Indications for Use
510(k) Number (if known):
Device Name:
Zimmer Ortho Guidance Systems - Knee Instruments
Indications for Use:
Zimmer Knee Ortho Guidance Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any knee orthopedic medical condition in which the Burgery systems and are may be appropriate, and where reference to a rigid anatomical use of stereoumn's a long bone, can be identified relative to a CT or MR based model or Straters of the anatomy. Example orthopedic procedures for these instruments include, but are not limited to:
Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knce Arthroplasty (Primary and Revision) Minimally Invasive Knec Orthopedic Procedures
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General, Restorative. and Neurological Devices
Page 1 of 1
510(k) Number K033011