(135 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on manual instruments used with an image guidance system, not on automated analysis or decision-making.
No
The device description states it is "orthopaedic manual instruments modified to accept a Medtronic Image Guidance System array and are to be used with the Medtronic StealthStation® System," indicating it is an accessory or tool for surgical guidance, not a device that directly treats or diagnoses a medical condition.
No
The device description states it is an accessory to Image Guided Surgery systems, used as orthopaedic manual instruments modified to accept an image guidance system array. Its purpose is to aid in surgical procedures, not to diagnose medical conditions or diseases.
No
The device description explicitly states that the Zimmer Ortho Guidance Hip Instruments are "orthopaedic manual instruments modified to accept a Medtronic Image Guidance System array," indicating they are physical instruments, not software only.
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 "orthopaedic manual instruments" used as "accessories to Image Guided Surgery systems" for "hip orthopaedic medical conditions." They are used during surgical procedures on the patient's body, not on samples taken from the body.
- Input Imaging Modality: The input is imaging data (CT, MR, fluoroscopy) of the patient's anatomy, not laboratory test results from biological samples.
The device is a surgical instrument designed to be used in conjunction with an image guidance system during orthopedic surgery. This falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Zimmer Ortho Guidance Hip Instruments can be used as accessories to Image Guided Surgery systems and are indicated for any hip orthopaedic medical condition resulting from disease or trauma in which the use of stereotaxic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone or pelvis, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures for these instruments include, but are not limited to:
Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopaedic 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
The Zimmer Ortho Guidance Hip Instruments are orthopaedic manual instruments modified to accept a Medtronic Image Guidance System array and are 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
hip, long bone or pelvis
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 guidance documents exist for these instruments. 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 this devices.
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 shows the Zimmer company logo. The logo consists of a circle with a stylized "Z" inside, followed by the text "zimmer" in a bold, sans-serif font. The "Z" in the circle is black, while the rest of the logo is white.
Summary of Safety and Effectiveness
| Submitter: | Zimmer, Inc.
P.O. Box 708
Warsaw, IN 46581-0708 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karen Cain
Manager, Regulatory Affairs
Telephone: (574) 372-4219
Fax: (574) 372-4605 |
| Date: | October 3, 2003 |
| Trade Name: | Zimmer Ortho Guidance™ Systems – Hip
Instruments |
| Common Name: | Image Guided Instrument |
| Classification Name
and Reference: | Stereotaxic Instrument
21 CFR § 888.4560 |
| Predicate Device: | Catheter Introducer for the StealthStation System
manufactured by Medtronic Surgical Navigation
Technologies, K022126, cleared January 3, 2003. |
| Device Description: | The Zimmer Ortho Guidance Hip Instruments are
orthopaedic manual instruments modified to accept
a Medtronic Image Guidance System array and are
to be used with the Medtronic StealthStation®
System. |
| Intended Use: | Zimmer Ortho Guidance Hip Instruments can be
used as accessories to Image Guided Surgery
systems and are indicated for any hip orthopaedic
medical condition resulting from disease or trauma
in which the use of stereotaxic surgery may be
appropriate, and where reference to a rigid
anatomical structure, such as a long bone or pelvis,
can be identified relative to a CT or MR based
model or fluoroscopy images of the anatomy.
Example procedures for these instruments include,
but are not limited to: |
1
Image /page/1/Picture/0 description: The image shows the Zimmer logo. The logo consists of a stylized letter Z inside of a circle, followed by the word "Zimmer" in a simple, sans-serif font. The letter Z and the word "Zimmer" are both in black, while the circle is white with a black outline.
Traditional 510(k) Premarket Notification
Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopaedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization of Repair of Pelvic/Femoral Fractures
The proposed devices can be used as accessory instruments (like the predicate). Both predicate and proposed devices are indicated for use with Image Guidance Surgery Systems.
Comparison to Predicate Device:
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
No guidance documents exist for these instruments. 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 this devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2004
Ms. Karen Cain Manager, Regulatory Affairs Zimmer, Inc. P.O. Box 708 Warsaw, Indiana 46581-0708
Re: K033223
Trade/Device Name: Zimmer Ortho Guidance™ Systems – Hip Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Codc: HAW Dated: December 11, 2003 Received: December 12, 2003
Dear Ms. Cain:
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 complics 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. Karen Cain
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 (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.
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 - Hip Instruments
Indications for Use:
Zimmer Ortho Guidance Systems Hip Instruments can be used as accessories to Image Guided Surgery systems and are indicated for any hip orthopaedic 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 or pelvis, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures for these instruments include, but are not limited to:
Total or Hemi-Hip Arthroplasty (Primary and Revision) Minimally Invasive Hip Orthopaedic Procedures Tumor Resection and Bone/Joint Reconstruction Stabilization or 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)
Concellers Edit GDBH Agics of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
K033 22.3 510(k) Number