JointPoint

K160284 · Jointpoint, Inc. · LLZ · Aug 3, 2016 · Radiology

Device Facts

• Record ID: K160284
• Device Name: JointPoint
• Applicant: Jointpoint, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

JointPoint is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images. JointPoint is also indicated for assisting healthcare professionals in preoperative planning and postoperative analysis of orthopedic surgery in Total Hip Replacement, Total Knee Replacement, and Intertrochanteric Fracture Reduction. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

Device Story

JointPoint is a non-invasive, client/server software system for orthopedic surgical planning and intraoperative guidance. Input consists of radiological images; software allows overlaying of prosthesis templates and performs measurements on images to assist in component positioning. Used by healthcare professionals in clinical and OR settings; operates on laptops or tablets. System architecture includes a primary server for data storage and a client package for user interaction; components communicate via internet but support offline functionality in ORs without connectivity. Output provides visual templates and measurements to assist surgeons in precise implant positioning. Clinical benefit includes improved accuracy in component placement and surgical planning. Requires clinical judgment; not for primary image interpretation.

Clinical Evidence

Bench testing only. Performance validated via software verification testing in laboratory settings. Clinical validation performed using clinical data to compare templated versus actual implant sizes for preoperative planning. Cadaver data used to validate intraoperative positioning functionality.

Technological Characteristics

Client/server software system; operates on laptops or tablets. Supports offline functionality for OR use. Non-invasive image-processing software. Provides prosthesis template overlay and measurement tools. HIPAA-compliant data communication.

Indications for Use

Indicated for healthcare professionals performing preoperative planning, intraoperative positioning of total hip replacement components, and postoperative analysis for Total Hip Replacement, Total Knee Replacement, and Intertrochanteric Fracture Reduction. Not for primary image interpretation or mobile phone use.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• ORTHOsoft, Inc. Navitrack™ System (K022364)
• TraumaCad (K142923)
• TraumaCad (K073714)
• TraumaCad (K042816)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 3, 2016

JointPoint, Inc. % Ms. Michelle McDonough Senior Associate, Regulatory & Clinical Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street, NW, 12th Floor WASHINGTON DC 20005

Re: K160284

Trade/Device Name: JointPoint Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, HAW Dated: June 30, 2016 Received: July 5, 2016

Dear Ms. McDonough:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160284

Device Name JointPoint

#### Indications for Use (Describe)

Joint is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images.

JointPoint is also indicated for assisting healthcare professionals in preoperative analysis of orthopedic surgery in Total Hip Replacement, Total Knee Replacement, and Intertrochanteric Fracture Reduction. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

| Manufacturer: | JointPoint, Inc. |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | 402 Buttonwood Lane |
| | Largo, FL 33770 |
| Contact: | Michelle McDonough, MS<br>Musculoskeletal Clinical Regulatory Advisers, LLC<br>1331 H Street, NW, 12th Floor<br>Washington, DC 20005 |
| | 202.552.5800 (phone)<br>202.552.5798 (fax) |
| Date Prepared: | August 2, 2016 |
| Device Trade Name: | JointPoint |
| Common Name: | Picture archiving and communications system (PACS) |
| Classification: | 21 CFR 892.2050 |
| Class: | II |
| Product Code: | LLZ: HAW |

## Indications For Use:

JointPoint is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images.

JointPoint is also indicated for assisting healthcare professionals in preoperative planning and postoperative analysis of orthopedic surgery in Total Hip Replacement, Total Knee Replacement, and Intertrochanteric Fracture Reduction. The device allows for overlaying of prosthesis templates on radiological images, and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

#### Device Description:

JointPoint is a non-invasive software system intended to provide preoperative templating for orthopaedic procedures and intraoperative data for total hip arthroplasties (THA). The JointPoint software is a client/server based software product wherein a primary server software component and database store user, patient and case information and a client software package is installed on

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user devices such as laptops or tablets. The two software components communicate with each other over the internet in a fully HIPAA compliant manner. The medical aspects of the software can function on the laptop or tablet alone, without the user of the internet, so that the system will still function in an OR that does not have internet connectivity.

### Predicate Devices:

JointPoint is substantially equivalent to ORTHOsoft, Inc. Navitrack™ System (K022364) and TraumaCad (K142923, K073714, K042816).

## Substantial Equivalence:

Testing performed on this device demonstrates that JointPoint is substantially equivalent to the predicate devices. Performance testing of the JointPoint system included the FDA recommended verification and validation testing. Software verification testing was performed in the laboratory to evaluate setup, accuracy and functionality of the system in supporting orthopedic procedures. Further testing was performed using clinical data to compare the templated versus actual size of the implants in order to validate the system's pre-operative intended use, as well as, cadaver data to validate the system's intra-operative intended uses.

### Conclusion

JointPoint is shown to be substantially equivalent to previously cleared devices with respect to its intended use, indications for use, technological characteristics, and performance characteristics.