(98 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on manual instruments with tracking sensors and digitized landmarks, not AI/ML processing.
No
The device is described as "accessories to Image Guided Surgery systems" and "orthopedic manual hip instruments", which are tools used during surgery, not devices that directly treat a disease or condition.
No
The document states that the instruments are intended as "accessories to Image Guided Surgery systems" and are used for "stereotaxic surgery" and "orthopedic procedures." They help in identifying anatomical structures relative to imaging data or digitized landmarks. There is no mention of the device performing any diagnostic function, such as detecting or diagnosing a disease or condition. The performance and conclusion sections also explicitly state that no testing was needed for these devices and no clinical data was needed, which would contradict the requirements for a diagnostic device.
No
The device description explicitly states it is for "Zimmer orthopedic manual hip instruments that each have a slot which accommodates a Medtronic electromagnetic tracking sensor," indicating physical hardware components.
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 Description and Intended Use: The description clearly states that these are "Zimmer orthopedic manual hip instruments" intended as "accessories to Image Guided Surgery systems" for use in "hip orthopedic medical conditions." They are used during surgical procedures on the patient's body, not on samples taken from the body.
- Input Modality: The input modalities are imaging techniques (CT, MR, fluoroscopy) and digitized landmarks of the anatomy, which are used for surgical guidance, not for analyzing biological samples.
The device is a surgical instrument used in conjunction with image guidance systems for orthopedic procedures. This falls under the category of medical devices used in vivo (within the living body), not in vitro (in glass, referring to laboratory tests).
N/A
Intended Use / Indications for Use
Zimmer Hip Computer Assisted Solutions Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any hip 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 or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization of Repair of Pelvic/Femoral Fractures
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
This submission is for:
Zimmer orthopedic manual hip instruments that each have a slot which accommodates a Medtronic electromagnetic tracking sensor, andThe 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
Anatomical Site
Hip (rigid anatomical structure, such as a 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)
Non-Clinical Performance and Conclusions: No testing was needed for these devices. QSR validation and verification testing 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 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.
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
Image /page/0/Picture/0 description: The image contains the word "zimmer" with a stylized "Z" in a circle to the left of the word. The "Z" is black and bolded, and the circle is a thin black line. The word "zimmer" is in a smaller, sans-serif font and is also black and bolded. The image appears to be a logo or brand name.
Summary of Safety and Effectiveness
NOV - 8 2006
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patricia Jenks
Specialist, Corporate Regulatory Affairs
Telephone: (574) 371-8354
Fax: (574) 372-4605 |
| Date: | July 31, 2006 |
| Trade Name: | Zimmer® Computer Assisted Solutions -
Electromagnetic and Imageless Hip Instrumentation |
| Common Name: | Image Guided Instrument |
| Classification Name
and Reference: | Stereotaxic Instrument
21 CFR § 882.4560 |
| Predicate Devices: | Zimmer Ortho Guidance Systems - Hip
Instruments, K033223, cleared February 18, 2004. |
| Device Description: | This submission is for: |
| | Zimmer orthopedic manual hip instruments that
each have a slot which accommodates a
Medtronic electromagnetic tracking sensor, andThe addition of digitized landmark (imageless)
referencing to the indications for use for both
optical and electromagnetic tracking sensors. |
| Intended Use: | Zimmer Hip Computer Assisted Solutions
Instruments are intended as accessories to Image
Guided Surgery systems and are indicated for any
hip 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 |
Pg 1 of 2
0022
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 lowercase letters. The "Z" in the circle is black, and the word "zimmer" is also black.
procedures for these instruments include, but are not limited to:
- Total or Hemi-Hip Arthroplasty (Primary and . Revision)
- . Minimally Invasive Hip Orthopedic Procedures
- Tumor Resection and Bone/Joint Reconstruction .
- Stabilization of Repair of Pelvic/Femoral . Fractures
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 testing 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 this device.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
$\frac{1}{2}$ 2 of 2
0023
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 circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" written around it. Inside the circle is an abstract symbol that resembles an eagle or a bird with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 8 2006
Zimmer, Inc. % Ms. Patricia Jenks Specialist, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K062228
Trade/Device Name: Zimmer Ortho Guidance "Systems -- Hip Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 28, 2006 Received: December 12, 2006
Dear Ms. Jenks:
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
3
Page 2 - Ms. Patricia Jenks
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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
For
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Kobozz8 510(k) Number (if known):
Device Name:
Zimmer® Hip Computer Assisted Solutions - Electromagnetic and Imageless Instrumentation
Indications for Use:
Zimmer Hip Computer Assisted Solutions Instruments are intended as accessories to Image Guided Surgery systems and are indicated for any hip 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 or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization of Repair of Pelvic/Femoral Fractures
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)
Division of General, Restoral ... and Neurological Devices
510(k) Number K041228
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