(98 days)
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
This submission is for:
Zimmer orthopedic manual hip instruments that each have a slot which 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.
The provided document describes a 510(k) premarket notification for the Zimmer® Computer Assisted Solutions - Electromagnetic and Imageless Hip Instrumentation. This submission is for accessory instruments used in image-guided hip surgery systems.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria or quantitative device performance metrics are explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting predefined performance benchmarks.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No testing was needed for these devices." and "Clinical data and conclusions were not needed for this device." Therefore, there was no test set used for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no test set was used, no experts were needed to establish ground truth.
4. Adjudication Method for the Test Set
Since no test set was used, no adjudication method was applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No MRMC comparative effectiveness study was conducted or mentioned. The device's purpose is to assist surgeons with navigation, not to interpret medical images or influence human reader performance in diagnostic tasks.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone performance study was conducted or mentioned. The device is described as "accessories to Image Guided Surgery systems," implying that it operates with human oversight and interaction, not as a standalone algorithm.
7. The Type of Ground Truth Used
No ground truth was used as no performance studies were conducted.
8. The Sample Size for the Training Set
No training set information is provided, as no machine learning algorithm development (in the sense of requiring a training set for performance evaluation) is described. The device is a navigation instrument, not an AI / machine learning diagnostic or predictive tool.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
Summary of the Document's Stated Performance and Compliance:
The submission explicitly states that no non-clinical or clinical testing was needed for these devices, and therefore no performance data (acceptance criteria, test sets, or ground truth) is presented from such studies. The basis for clearance is substantial equivalence to an existing predicate device: "Zimmer Ortho Guidance Systems - Hip Instruments, K033223, cleared February 18, 2004." The primary changes described are:
- Addition of Zimmer orthopedic manual hip instruments with slots for Medtronic electromagnetic tracking sensors.
- Addition of digitized landmark (imageless) referencing to the indications for use for both optical and electromagnetic tracking sensors.
The FDA's letter confirms substantial equivalence, allowing the device to proceed to the market subject to general controls and existing regulations.
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Summary of Safety and Effectiveness
NOV - 8 2006
| Submitter: | Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Patricia JenksSpecialist, Corporate Regulatory AffairsTelephone: (574) 371-8354Fax: (574) 372-4605 |
| Date: | July 31, 2006 |
| Trade Name: | Zimmer® Computer Assisted Solutions -Electromagnetic and Imageless Hip Instrumentation |
| Common Name: | Image Guided Instrument |
| Classification Nameand Reference: | Stereotaxic Instrument21 CFR § 882.4560 |
| Predicate Devices: | Zimmer Ortho Guidance Systems - HipInstruments, K033223, cleared February 18, 2004. |
| Device Description: | This submission is for: |
| Zimmer orthopedic manual hip instruments thateach have a slot which accommodates aMedtronic electromagnetic tracking sensor, andThe addition of digitized landmark (imageless)referencing to the indications for use for bothoptical and electromagnetic tracking sensors. | |
| Intended Use: | Zimmer Hip Computer Assisted SolutionsInstruments are intended as accessories to ImageGuided Surgery systems and are indicated for anyhip orthopedic medical condition in which the useof stereotaxic surgery may be appropriate, andwhere reference to a rigid anatomical structure, suchas a long bone, can be identified relative to a CT orMR based model, fluoroscopy images, or digitizedlandmarks of the anatomy. Example orthopedic |
Pg 1 of 2
0022
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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
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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
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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
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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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§ 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).