(46 days)
None
No
The summary describes a computer-aided navigation system using optical tracking and pre-operative CT data, with no mention of AI or ML terms, training/test sets, or performance metrics typically associated with AI/ML devices.
No.
The device provides intra-operative reporting and measurements for surgical navigation, assisting the surgeon in proper implant positioning but does not directly treat or restore a function.
Yes
The device is described as providing "intra-operative assessments of implant position and orientation" and reporting "the orientation of the glenoid and humeral components." This information is used to evaluate the current state during surgery, which falls under the definition of diagnostics.
No
The device description explicitly states it uses an optical localizing camera and infra-red reflective markers ("trackers") to track spatial position, indicating the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The NaviPro Shoulder Software Module is a surgical navigation system. Its purpose is to assist surgeons during shoulder replacement surgery by tracking the position and orientation of instruments and implants. It uses optical tracking and pre-operative imaging data.
- Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens from the patient. The system operates on spatial data and pre-operative images, not on samples taken from the body.
Therefore, the NaviPro Shoulder Software Module falls under the category of surgical navigation systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The NaviPro" Shoulder Software Module is a system for computer-aided navigation of surgical instruments whose purpose is to intra-operatively report the orientation of the glenoid and humeral components during shoulder replacement surgery. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
Product codes
HAW
Device Description
The NaviPro" Shoulder Software Module is an extension of the previously cleared NaviPro Navigation System. It uses an optical localizing camera and infra-red reflective markers ("trackers") to track the spatial position of bones and medical instruments during shoulder replacement surgery. The 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
Shoulder
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary 4.
| 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: | April 6, 2005 |
| Trade name: | NaviProTM Shoulder Software Module |
Substantial equivalence claimed to (see Section 9):
- NaviPro™ (K020764) filed by Kinamed, Inc. .
- NaviPro™ Knee Software Module (K033668) filed by Kinamed Inc. .
Description:
The NaviPro" Shoulder Software Module is an extension of the previously cleared NaviPro Navigation System. It uses an optical localizing camera and infra-red reflective markers ("trackers") to track the spatial position of bones and medical instruments during shoulder ( truckers ) to track the easurements obtained from the system allow for intra-operative assessments of implant position and orientation.
Summary of technological characteristics:
NaviPro "Shoulder intra-operatively reports the position of the glenoid component relative to the ravil to - Shoulder mad openitor of the humeral resection relative to the humerus. The patient Scapala as well as the orrentais procedure is recorded intra-operatively. Pre-operative CT or data needed to can'y our may of the link between patient and computer is established by infra-red reflective trackers that are securely attached to the patient. An infra-red localizing mira rechat is linked to the computer calculates the position and orientation of the trackers.
Surgical instruments, such as a glenoid reamer 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 Shoulder system requires only the information provided by the trackers to determine the orientation of the glenoid component and humeral resection.
Intended use:
The NaviPro" Shoulder Software Module is a system for computer-aided navigation of surgical instruments whose purpose is to intra-operatively report the orientation of the glenoid and mistrainents whoos parpose shoulder replacement surgery. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2005
Vineet K. Sarin, Ph.D. Director of Research and Development Kinamed Incorporated 820 Flynn Road Camarillo, California 93012-8701
Re: K050897
K030677
Trade/Device Name: NaviPro™ Shoulder Software Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 6, 2005 Received: April 8, 2005
Dear Dr. Sarin:
We have reviewed your Section 510(k) premarket notification of intent to market the device t We have reviewed your Section 510(x) premained institutially equivalent (for the indications referenced above and nave decembled the actress are devices marketed in interstate for use stated in the encrosule) to regary manated provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1976, the enactions as the Federal Food. Drug, devices that have been recults in accordance was artest approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that to not require approval controls provisions of the Act. The You may, inerelore, market the device, seejoe, so tire grouped registration, listing of
general controls provisions of the Act include requires michrending and general controls provisions of the receiners and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (sec above) into entrols. Existing major regulations affecting your device. FDA it may be subject to such additional controls: "Distributions, Title 21, In addition, FDA
can be found in the Code of Federal Regulations, Title Saderal Register can be found in the Code of Federal Regarations, wour device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substance orgalies with other requirements of the Act
that FDA has made a determination that your device complies with of any must that FDA has made a delcrimiation that Jour avereed by other Federal agencies. You must and listing or any Federal statutes and regulations administered of registration and listing (21 l
esses of the Act's requirements, including, but not limited to registraments as set comply with all the Act s requirements, mendants, our manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); government (20); and if smalleghle CFK Part 807), labeling (21 CFR 1 at 601), god Frances (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000-1050 forth in the quality systems (QD) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin manically your antial equivalence of your device to a legally premitation of the PDT Imaning of casion 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 If you desire specific advice for your as (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Misolanding of Telefone to premarker in the Act from the Division of Small other general International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Prosisions of carbitindustry/support/index.html.
Sincerely yours,
signature
Miriam C. Provost, Ph.D. t Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use 6.
KUSO897 510(k) Number (if known):
Device Name:
NaviPro"" Shoulder Software Module
Indications For Use:
The NaviPro"" Shoulder Software Module is a system for computer-aided navigation of surgical instruments whose purpose is to intra-operatively report the orientation of the glenoid and humeral components during shoulder replacement surgery. 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 NEFDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
bron lign-Off) ben of General, " ... Live ..... Neurological Dev. wss