The Neurovision Medical Motion Sensor is intended to detect, monitor and/or record limb movements on a physiological recorder, in adult patient sleep disorder studies, in a clinical setting.

Device Description

The Neurovision Medical Motion Sensor is a disposable, multipurpose piezo accelerometer sensor configured to be self-powered (by "watch" type battery), disposable, and capable of being read by a small signal electrophysiologic monitor.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Neurovision Medical Motion Sensor, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Ability to signal gross motor movement with 2 different model EMG units	Demonstrated
Ability to signal gross motor movement with a standard ECG unit	Demonstrated
Compliance with IEC 60601-1:1988 + A1:1991 + A2:1995; EN 60601-1:1990+A1+A2+A13, UL 60601-1:2003 R4.06, CAN/CSA-C22.2	Demonstrated
Comparable sensitivity to the predicate device (Gereonics Ultra-Piezo Limb Movement Sensor) for typical patient movements expected under intended use conditions	Demonstrated (based on testing submitted by the predicate for 510k review)

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is "Bench testing," implying laboratory-based testing rather than patient-based clinical studies with human participants.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Information regarding the number and qualifications of experts used to establish ground truth for the test set is not provided in the document. The testing described focuses on technical performance and comparison to a predicate device, not on expert-adjudicated clinical outcomes.

4. Adjudication Method for the Test Set

An adjudication method is not applicable/not specified as the testing described is bench testing focusing on technical performance. It doesn't involve subjective interpretation that would require expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this device. The submission focuses on substantial equivalence through bench testing.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical sensor, not an algorithm, so a "standalone algorithm only" study is not applicable. The performance testing described is inherent to the device's function.

7. The Type of Ground Truth Used

The ground truth for the performance testing appears to be based on physical movement and established electrical signal detection. For the sensitivity comparison, it relied on the "testing submitted by the predicate for 510k review," suggesting the predicate's established performance as a benchmark.

8. The Sample Size for the Training Set

This device is a hardware sensor, not an AI/ML algorithm that requires a training set. Therefore, information regarding a "training set sample size" is not applicable/not provided.

9. How the Ground Truth for the Training Set Was Established

As the device is a hardware sensor and not an AI/ML algorithm, a "training set" and its associated ground truth establishment are not applicable.

Summary

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K120570

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DEC 2 6 2013

5. 510K Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807 and in particular 21 CFR §807.92, the following summary of information is provided:

Applicant Information

Christine Vergely Regulatory Affairs Manager Neurovision Medical Products, Inc. 2225 Sperry Ave., Suite 1000 Ventura, CA 93003 Ph 866-815-6999 Fax: 413-410-4579 christie@neurovisionmedical.com

Date of Summary: 11/4/13

Device Identification:

Trade or Proprietary Name: Common or Usual Name: Classification Name: Device Class: Classification: Product Code:

Neurovision Medical Motion Sensor Medical Motion Sensor Breathing Frequency Monitor Class II $868.2375 BZQ

Predicate Devices

The Neurovision Medical Motion Sensor is substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:

K062883; Gereonics Ultra-Piezo Limb Movement Sensor .

Device Description

Indication for Use

The Neurovision Medical Motion Sensor is intended to detect, monitor and/or record limb movements on a physiological recorder, in adult patient sleep disorder studies, in a clinical setting.

Technological Characteristics of Device in Relation to Predicate Devices

The Neurovision Medical Motion Sensor is similar to the Gereonics Ultra-Piezo Limb Movement Sensor in terms of materials, design, performance and indications for use, differing only in being battery powered whereas the predicate is powered by a dedicated monitor.

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Table 1 Device Comparison Table

	K062883	Subject Device
Brand Name	Gereonics Ultra-Piezo Limb Motion Sensor	Medical Motion Sensor
Description	Piezo Sensor, attachable	Piezo Sensor, attachable
Indications for Use	For adult use. The Gereonics Ultra-PiezoLimb Movement Sensor (LMS) is used todetectperiodic limb movements for recording ormonitoring on a physiological amplifier.The LMS is intended for use in sleepdisorders studies.	The Neurovision Medical Motion Sensor is intendedto detect, monitor and/or record limb movements on aphysiological recorder, in adult patient sleep disorderstudies, in a clinical setting.
Product Code	BZQ	BZQ
Materials and Design	Nonsterile attachment electrode withunpowered Piezo Sensor	Nonsterile attachment device with battery poweredPiezo Accelerometer
Blo-compatibility	N/A	N/A
Compatible devices	Dedicator Monitor (Gereonics)	Electrophysiologic Monitors
Sterillty	Non-sterile	Non-sterile
Attachment to Monitor	DIN connector	DIN connector

Performance Testing

Compatibility with representative testing equipment was demonstrated.

Bench testing included in the submission includes:

Demonstrated ability of the Neurovision Medical Motion Sensor to signal gross . motor movement with 2 different model EMG units.
. Demonstrated ability of the Neurovision Medical Motion Sensor to signal gross motor movement with a standard ECG unit.
. Compliance with IEC 60601-1:1988 + A1:1991 + A2:1995; EN 60601-1:1990+A1+A2+A13, UL 60601-1:2003 R4.06, CAN/CSA-C22.2
. Comparable sensitivity of the Neurovision Medical Products Motion Sensor to typical patient movements expected under the conditions of intended use to the sensitivity of the Predicate Devices, Gereonics Ultra-Piezo Limb Movement Sensor, to similar movements, based on the testing submitted by the predicate for 510k review.

Conclusion

The Neurovision Medical Motion Sensor is substantially equivalent to the Gereonics Ultra-Piezo Limb Movement Sensor in terms of materials, design, performance and indications for use, differing only in being battery powered whereas the predicate is powered by a dedicated monitor. There are no additional safety or effectiveness risks associated with this design difference. (End of 510(k) Summary)

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

December 26, 2013

Neurovision Medical Products Inc. Christine Vergely Regulatory Affairs Manager 2225 Sperry Ave, Suite 1000 VENTURA, CA 93003

Re: K130570

Trade/Device Name: Neurovision Medical Motion Sensor Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: BZQ Dated: November 25, 2013 Received: November 26, 2013

Dear Ms. Vergely:

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

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Page 2 - Ms. Christie Vergely

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame FOAmer-S for

Erin I. Keith Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) KI30570

Device Name

Neurovision Medical Motion Sensor

Indications for Use (Describe)

The Newrovision Medical Motion Seasor is intended to detect, manitor and/or record limb movements on a physiological recorder, in actuat patient sleep disorder studies in a clinical setting.

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)

Please Do not WRITE BELOW THIS LINE - Continue on a SEPARATE PAGE IF NEEDED.

Image /page/4/Figure/12 description: The image shows a document with the heading "FOR FDA USE ONLY". It includes the text "Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)". There is a digital signature by Richard C. Chapman, dated 2013.12.26 at 12:26:15 -05'00'. The form number "FORM FDA 3881 (9/13)" is at the bottom left.

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).