(112 days)
Not Found
No
The document describes a software system that uses a motion tracking sensor to facilitate exercises and collect data. There is no mention of AI or ML being used for assessment, guidance, or data analysis. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated to "support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned reach exercises for the upper extremities." This aligns with the definition of a therapeutic device as it is intended to treat a condition.
No.
The Recovr Rehabilitation System is indicated to support physical rehabilitation by providing exercises and collecting data on performance, not for diagnosis.
No
The device description explicitly states that the system consists of software, a computer, a primary display monitor, a secondary monitor, and a Microsoft Kinect motion-tracking sensor. This includes hardware components beyond just software.
Based on the provided information, the Recovr Rehabilitation System 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.
- Recovr's Intended Use: The Recovr system is intended to support physical rehabilitation of adults via performance of exercises. It uses motion tracking to guide exercises and collect performance data.
- Lack of Specimen Analysis: The description clearly states the system uses a Microsoft Kinect motion-tracking sensor to track movement. There is no mention of collecting or analyzing any biological specimens from the patient.
The Recovr Rehabilitation System falls under the category of a medical device used for rehabilitation, but it does not meet the criteria for an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Recovr Rehabilitation System is software for use with the Microsoft Kinect motion tracking system that is indicated to support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned reach exercises for the upper extremities. Patient assessment, exercise guidance, and approval by the medical professional are required prior to use.
Product codes
LXJ
Device Description
The Recovr Rehabilitation System (RRS) is a software system that presents games to facilitate the completion of therapist designed and prescribed upper extremity repetitive reaching exercises and that collects data for the therapist on the user's game play. The system was designed in collaboration with an experienced neurorehabilitation occupational therapist and rehabilitation research team. The RRS is intended for use in the clinic or at home. Patient assessment, exercise guidance, and approval by the medical professional are required prior to use.
The system consists of software, a computer, a primary display monitor, a secondary monitor, and a Microsoft Kinect motion-tracking sensor. Users sit on a bench or stand 6-8 feet away from the primary display monitor. The Kinect sensor is placed along the top or bottom edge of the primary display monitor, and the therapist controls the system from a secondary monitor, mouse, and keyboard off to the side of the primary display monitor. The games are based on a traditional carnival shooting gallery, with targets that pop–up to present reaching tasks. The virtual reality environment incorporates video game principles to engage and motivate users to perform the amount of rehabilitation assigned by the rehabilitation therapist. The system collects data on participant movement and actions throughout each session that allows therapists to track participant performance and improvement across therapy sessions.
The device is not supplied sterile or intended to be sterilized by the operator prior to use, and is not intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremities
Indicated Patient Age Range
adults
Intended User / Care Setting
medical professional / clinic and at home
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)
No mandatory performance standards have been established for this device (Section 514 of the Act). Software testing was conducted to verify performance in accordance with FDA's May 2005 quidance document entitled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern, as there is no risk of harm to the user or operator in the case of device failure or latent flaw.
No biocompatibility, electrical safety and electromagnetic compatibility, animal, or clinical testing was deemed necessary to support the current finding of substantial equivalence to the predicate Jintronix device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Jintronix Rehabilitation System (K130847)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5360 Measuring exercise equipment.
(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a flowing design element below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2015
Recovr, Inc % Kathryn Cole Principle Translational Science Solutions LLC 92 Hasell Street, Suite 401 Charleston, South Carolina 29401
Re: K151446
Trade/Device Name: Recovr Rehabilitation System Regulatory Class: Unclassified Product Code: LXJ Dated: August 4, 2015 Received: August 10, 2015
Dear Kathryn Cole:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -5D/Δ
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151446
Device Name Recovr Rehabilitation System
Indications for Use (Describe)
The Recove Rehabilitation System is software for use with the Microsoft Kinect motion tracking system that is indicated to support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned reach exercises for the upper extremities. Patient assessment, exercise guidance, and approval by the medical professional are required prior to use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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5.0 510(K) SUMMARY
| Submission Date: | September 17, 2015 |
|---|---|
| ------------------ | -------------------- |
Submitter Information:
| Submitted By: | Recovr, Inc.
Post Office Box 772
Clemson, SC 29633 |
| --------------- | ---------------------------------------------------------- |
|---|
- Contact Person: Austen Hayes, MS Chief Executive Officer Tel: (843) 425-1606 Email: austen@recovrinc.com
Device Information:
| Trade Name: | Recovr Rehabilitation System |
|---|---|
| Common Name: | Software system utilizing optical position recording for |
| rehabilitation exercises | |
| Classification Name: | System, Optical Position/Movement Recording (Product |
| Code LXJ) | |
| Regulatory Class: | Unclassified |
| Predicate Device: | Jintronix Rehabilitation System (K130847) |
| Jintronix, Inc. | |
| Unclassified (Product Code LXJ) | |
| Device Description: | The Recovr Rehabilitation System (RRS) is a software |
| system that presents games to facilitate the completion | |
| of therapist designed and prescribed upper extremity | |
| repetitive reaching exercises and that collects data for | |
| the therapist on the user's game play. The system was | |
| designed in collaboration with an experienced | |
| neurorehabilitation occupational therapist and | |
| rehabilitation research team. The RRS is intended for | |
| use in the clinic or at home. Patient assessment, | |
| exercise guidance, and approval by the medical | |
| professional are required prior to use. |
The system consists of software, a computer, a primary
display monitor, a secondary monitor, and a Microsoft
Kinect motion-tracking sensor. Users sit on a bench or
stand 6-8 feet away from the primary display monitor.
The Kinect sensor is placed along the top or bottom
edge of the primary display monitor, and the therapist
controls the system from a secondary monitor, mouse,
and keyboard off to the side of the primary display
monitor. The games are based on a traditional carnival |
4
shooting gallery, with targets that pop–up to present reaching tasks. The virtual reality environment incorporates video game principles to engage and motivate users to perform the amount of rehabilitation assigned by the rehabilitation therapist. The system collects data on participant movement and actions throughout each session that allows therapists to track participant performance and improvement across therapy sessions.
The device is not supplied sterile or intended to be sterilized by the operator prior to use, and is not intended for single use.
Indications for Use: The Recovr Rehabilitation System is software for use with the Microsoft Kinect motion tracking system that is indicated to support physical rehabilitation of adults in the clinic and at home via performance of therapistassigned reach exercises for the upper extremities. Patient assessment, exercise quidance, and approval by the medical professional are required prior to use.
The Indications for Use statement for RRS is not identical to the predicate device in that the Indications for Use for the subject device do not include "remotely accessible patient performance metrics for the medical professional" at this time. That minor difference does not affect the intended use of the subject device as a software system utilizing optical position recording for physical rehabilitation exercises nor do they affect the safety and effectiveness of the device relative to the predicate when used as labeled.
Comparison to The RRS and the predicate Jintronix Rehabilitation Predicate Device: System (JRS) are substantially equivalent in terms of intended use and performance and technology. Both platforms are software systems utilizing optical position recording for physical rehabilitation exercises that use the Microsoft Kinect motion tracking system. Both systems require patient assessment and exercise quidance from a clinical or medical professional prior to any exercise prescription. Both devices track the movements assigned by the clinician, providing audiovisual feedback and graphic representations of the user movement, as well as reporting to the clinician on kinematic parameters like velocity and joint angular changes during movement. The devices are also identical in safety, as they are software platforms for use with the Microsoft Kinect motion tracking system. At this point in time, the subject device does not include remotely accessibly patient performance metrics for the
5
medical professional, but that does not affect the safety or effectiveness of the device compared to the predicate.
Performance Testing: No mandatory performance standards have been established for this device (Section 514 of the Act). Software testing was conducted to verify performance in accordance with FDA's May 2005 quidance document entitled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern, as there is no risk of harm to the user or operator in the case of device failure or latent flaw.
No biocompatibility, electrical safety and electromagnetic compatibility, animal, or clinical testing was deemed necessary to support the current finding of substantial equivalence to the predicate Jintronix device.
Conclusion: The RRS falls within the generic type of device regulated by the LXJ Product Code (System, Optical Position/Movement Recording). Differences in the design and presentation of the RRS from the predicate device do not affect the safety, effectiveness, or performance of the subject device for its intended use. Software verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. Therefore, the RRS is substantially equivalent to the Jintronix Rehabilitation System.