(117 days)
Not Found
No
The description focuses on manual instruments with tracking sensors and digitized landmarks, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
No.
The Zimmer Knee Computer Assisted Solutions Instruments are described as accessories to Image Guided Surgery systems, not as therapeutic devices themselves. They assist in surgical procedures but do not directly treat a disease or condition.
No
Explanation: The device is described as instruments that act as accessories to image-guided surgery systems for orthopedic procedures. Its purpose is to assist in surgical navigation, not to diagnose a medical condition.
No
The device description explicitly states it is for "Zimmer orthopedic manual knee instruments" which are physical hardware components, even though they accommodate tracking sensors. The submission also includes the addition of digitized landmark referencing, which is a software-related function, but the core device being described includes physical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that these are "Zimmer Knee Computer Assisted Solutions Instruments" intended as "accessories to Image Guided Surgery systems." Their purpose is to assist in surgical procedures on the knee by providing guidance based on imaging or digitized landmarks.
- Lack of Biological Sample Testing: There is no mention of the device interacting with or analyzing any biological samples from a patient. Its function is entirely focused on surgical guidance and navigation within the body.
Therefore, this device falls under the category of surgical instruments or accessories for image-guided surgery, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Zimmer Knee Computer Assisted Solutions 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, fluoroscopy images, or digitized landmarks 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 (comma separated list FDA assigned to the subject device)
HAW
Device Description
This submission is for:
- Zimmer orthopedic manual knee instruments that have a slot that accommodates a Medtronic electromagnetic tracking sensor, and
- The addition of digitized landmark (imageless) referencing to the indications for use for both optical and electromagnetic tracking sensors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Anatomical Site
Knee, 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)
Accuracy validation and verification testing was conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems. Clinical data and conclusions were not needed for this device.
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.
Zimmer Ortho Guidance Systems - Knee Instruments, manufactured by Zimmer, Inc., K033011, cleared February 12, 2004.
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
DEC 2 8 2005
Summary of Safety and Effectiveness
K052425
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen H. McKelvey
Manager, Corporate Regulatory Affairs
Telephone: (574) 372-4944
Fax: (574) 372-4605 |
| Date: | September 1, 2005 |
| Trade Name: | Zimmer® Computer Assisted Solutions -
Electromagnetic and Imageless Knee
Instrumentation |
| Common Name: | Image Guided Instrument |
| Classification Name
and Reference: | Stereotaxic Instrument
21 CFR § 882.4560 |
| Predicate Device: | Zimmer Ortho Guidance Systems - Knee
Instruments, manufactured by Zimmer, Inc.,
K033011, cleared February 12, 2004. |
| Device Description: | This submission is for: |
| | • Zimmer orthopedic manual knee instruments
that have a slot that accommodates a Medtronic
electromagnetic tracking sensor, and
• The addition of digitized landmark (imageless)
referencing to the indications for use for both
optical and electromagnetic tracking sensors. |
| Intended Use: | Zimmer Knee Computer Assisted Solutions
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, fluoroscopy images, or digitized |
1
landmarks 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
Both the predicate and proposed devices are indicated for use with image guidance surgery systems. Both are accessory instruments.
Non-Clinical Performance and Conclusions:
Accuracy validation and verification testing was conducted for instruments used in conjunction with Medtronic StealthStation Image Guidance Systems.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A." is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 8 2005
Mr. Stephen H. McKelvey, MA, RAC Manager, Corporate Regulatory Affairs Zimmer, Inc. 345 East Main Street Warsaw, Indiana 46581-0708
Re: K052425
K032425
Trade/Device Name: Zimmer® Computer Assisted Solutions-Electromagnetic and Imageless Knee Instrumentation Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: December 15, 2005 Received: December 19, 2005
Dear Mr. McKelvey:
We have reviewed your Section 510(k) premarket notification of intent to market the device t we nave reviewed your bection 910(x) proximatially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encrosure) to regary inate of the Medical Device Amendments, or to devices that prior to May 20, 1770, the onactions with the provisions of the Federal Food, Drug, and Cosmetic Italy bech recuired in accordinal of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, mance mo device, sabject to an essent of annual registration, listing of devices, good controls provibitions or and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sublicitions. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal 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 I DA mas muse a were mations 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 iaceming (DS) 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
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 promaticate 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 Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Barbara Bouchard
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KOSSHAS 510(k) Number (if known):
Device Name:
Zimmer® Computer Assisted Solutions - Electromagnetic and Imageless Knee Instrumentation
Indications for Use:
Zimmer Knee Computer Assisted Solutions 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, fluoroscopy images, or digitized landmarks 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
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)
5245 Barbara Buend
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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510(k) Number K052425