(88 days)
Not Found
No
The description focuses on optical tracking and spatial measurements based on infra-red markers, with no mention of AI or ML algorithms for analysis or decision-making.
No.
The device aids in surgical instrument navigation and provides measurements, but it does not directly treat or diagnose a disease or condition.
No
The device is described as a system for computer-aided navigation of surgical instruments, providing intra-operative measurements and aiding in the accurate positioning of an acetabular shell during hip replacement surgery. It measures changes in rotational center, limb length, and femoral offset as a result of prosthetic implantation, but does not diagnose diseases or conditions.
No
The device description explicitly states that the system uses an optical localizing camera and infra-red reflective markers ("trackers") to track spatial position, which are hardware components.
Based on the provided information, the NaviPro™ system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- NaviPro™ Function: The NaviPro™ system is a surgical navigation system that uses optical tracking to guide surgical instruments and provide real-time measurements during hip replacement surgery. It operates directly on the patient's body and instruments, not on specimens taken from the body.
The description clearly states its purpose is to aid in the surgical procedure itself by tracking the position of bones and instruments, and providing measurements related to the surgical outcome (acetabular shell position, limb length, femoral offset). This is a surgical aid, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
NaviPro™ is a system for computer-aided navigation of surgical instruments whose purpose is to optimally position the acetabular shell during hip replacement surgery, and to report changes in rotational center, limb length, and femoral offset as a result of prosthetic implantation. The system aids the surgeon in accurately positioning the acetabular shell during hip replacement and provides intra-operative measurements of femoral position and orientation in relation to the pelvis. 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
NaviPro™ uses an optical localizing camera and infra-red reflective markers ("trackers") to track the spatial position of bones and medical instruments during hip replacement surgery. Measurements obtained from the system allow for intra-operative assessments of implant position and orientation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
JUN 0 3 2002
510(k) Summarv
. - . . .
| 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: | March 8, 2002 |
| Trade name: | NaviProTM |
Substantial equivalence claimed to: OrthoPilot® (K003347), also filed by Kinamed Inc.
Description:
NaviPro™ uses an optical localizing camera and infra-red reflective markers ("trackers") to track the spatial position of bones and medical instruments during hip replacement surgery. Measurements obtained from the system allow for intra-operative assessments of implant position and orientation.
Intended use:
NaviPro™ is a system for computer-aided navigation of surgical instruments whose purpose is to optimally position the acetabular shell during hip replacement surgery, and to report changes in rotational center, limb length, and femoral offset as a result of prosthetic implantation. The system aids the surgeon in accurately positioning the acetabular shell during hip replacement and provides intra-operative measurements of femoral position and orientation in relation to the pelvis.
Summary of technological characteristics:
NaviPro™ intra-operatively reports the position of the acetabular shell relative to the pelvis as well as the changed relationship between femur and pelvis as a result of joint The patient data needed to carry out this procedure is recorded intrareplacement. operatively. Pre-operative CT or fluoroscopic imaging is unnecessary. The link between patient and computer is established by infra-red reflective trackers that are securely attached to the patient. An infra-red localizing camera that is linked to the computer calculates the position and orientation of the trackers.
Surgical instruments, such as an acetabular shell impactor tool and a calibrated measurement probe, are also outfitted with infra-red trackers and can be brought into a spatial relationship with the patient. The NaviPro™ system requires only the information provided by the trackers to determine the orientation of the acetabular shell, as well as changes in limb length and femoral offset.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2002
Vineet K. Sarin, Ph.D. Director of Research and Development Kinamed, Inc. 820 Flynn Road Camarillo, CA 93012-8701
Re: K020764
Trade/Device Name: NaviPro Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 7, 2002 Received: March 7, 2002
Trade/Dev
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 mav 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 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 – 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Stupt Rhodes
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
510(k) Number (if known):
Device Name: NaviPro™
Indications for Use:
NaviPro™ is a system for computer-aided navigation of surgical instruments whose purpose is to optimally position the acetabular shell during hip replacement surgery, and to report changes in rotational center, limb length, and femoral offset as a result of prosthetic implantation. The system aids the surgeon in accurately positioning the acetabular shell during hip replacement and provides intra-operative measurements of femoral position and orientation in relation to the pelvis. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Prescription Use
(Per 21 CFR 801.109)
510(k) Number K020764 Over-the-Counter Use