(111 days)
Not Found
No
The summary describes a navigation system that uses optical tracking and pre-operative imaging for spatial measurements and intra-operative assessments. There is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No
The device is a software module that assists surgeons with measurements and assessments during total knee replacement surgery. It does not directly treat or prevent a disease, but rather provides information to guide surgical procedures. Therefore, it is not a therapeutic device.
No
The device is described as measuring spatial orientation and limb alignment during surgery and assessing soft tissue balance and changes in mechanical axis for surgical guidance, rather than diagnosing a disease or condition.
No
The device description explicitly states it uses an "optical localizing camera and infra-red Navil 10 - Navigation 173.60m" which are hardware components, making it a system that includes hardware, not a software-only device.
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 Function: The NaviPro™ Knee Software Module is a surgical navigation system used during total knee replacement surgery. It uses optical tracking and pre-operative imaging to guide the surgeon and assess the spatial orientation of instruments and the limb.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. Its function is based on spatial measurements and image data.
Therefore, the NaviPro™ Knee Software Module falls under the category of a surgical navigation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NaviPro™ Knee Software Module is an extension of the NaviPro™ Navigation System whose purpose is to measure the spatial orientation of the resection guides and limb alignment during total knee replacement surgery, and for assessing soft tissue balance and changes in the limb mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The NaviPro™ Knee Software Module is an extension of the previously cleared The Navil Navigation System. It uses an optical localizing camera and infra-red Navil 10 - Navigation 173.60m. 'It ucces an valial position of bones and medical instruments during knee replacements obtained from the system allow for intra-operative assessments of implant position, orientation, and soft-tissue balance.
Summary of technological characteristics: Sunlinary of recument generts the position of the tibial and femur resection guides during knee replacement surgery, and measures changes in the mechanical axis of the limb as a result of prosthetic implantation. Pre-operative CT or fluoroscopic imaging the min as a reader of problement patient and computer is established by infra-red 15 untiecessary. The this betrocely attached to the patient and surgical instruments. An felfective trackers that are books is linked to the computer calculates the position and orientation of the trackers. A calibrated measurement probe is also outfitted with infra-red trackers and can be A canorated measurement prove is allent. NaviPro™ Knee requires only the information provided by the trackers and palpated landmarks to determine the spatial mionnations of the resection guides. joint centers, and mechanical axis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon user
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)
Not Found
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
MAR 1 1 2004
510(k) Summary
| Submitter: | Kinamed, Inc. |
|---|---|
| Address: | 820 Flynn Road |
| Camarillo, CA 93012 | |
| Phone number: | (805) 384-2748 |
| Fax number: | (805) 384-2792 |
| Contact person: | Vineet K. Sarin Ph.D. |
| Date prepared: | November 21, 2003 |
| Trade name: | NaviPro™ Knee Software Module |
Substantial equivalence claimed to: 1. OrtholYilot® (K003347) filed by Kinaned Inc. 2. NaviPro™ (K020764) filed by Kinamed, Inc.
Description:
The NaviPro™ Knee Software Module is an extension of the previously cleared The Navil Navigation System. It uses an optical localizing camera and infra-red Navil 10 - Navigation 173.60m. 'It ucces an valial position of bones and medical instruments during knee replacements obtained from the system allow for intra-operative assessments of implant position, orientation, and soft-tissue balance.
Intended use:
The NaviPro" Knee Software Module is an extension of the NaviPro" Navigation The Navil 10 - Rife® Ourpose is to measure the spatial orientation of the resection guides and System whose parpose is to tinee replacement surgery, and for assessing soft tissue mino angininent daming toan mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
Summary of technological characteristics:
Sunlinary of recument generts the position of the tibial and femur resection guides during knee replacement surgery, and measures changes in the mechanical axis of the limb as a result of prosthetic implantation. Pre-operative CT or fluoroscopic imaging the min as a reader of problement patient and computer is established by infra-red 15 untiecessary. The this betrocely attached to the patient and surgical instruments. An felfective trackers that are books is linked to the computer calculates the position and orientation of the trackers.
A calibrated measurement probe is also outfitted with infra-red trackers and can be A canorated measurement prove is allent. NaviPro™ Knee requires only the information provided by the trackers and palpated landmarks to determine the spatial mionnations of the resection guides. joint centers, and mechanical axis.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three wavy lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2004
Mr. Vineet K. Sarin, Ph.D. Director of Research and Development Kinamed. Inc. 820 Flynn Road Camarillo, California 93012
Re: K033668
Trade/Device Name: NaviPro™ Knee Software Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 23, 2004 Received: January 23, 2004
Dear Dr. Sarin:
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 sct 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.
2
Page 2 - Mr. Vineet K. Sarin, Ph.D.
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
3
(2) Indications for Use
510(k) Number (if known): K033668
Device Name:
NaviPro™ Knee Software Module
Indications For Use:
The NaviPro™ Knee Software Module is an extension of the NaviPro™ Navigation System whose purpose is to measure the spatial orientation of the resection guides and limb alignment during total knee replacement surgery, and for assessing soft tissue balance and changes in the limb mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
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 Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number K033668