(297 days)
Not Found
No
The device description and performance studies focus on basic sensor technology and signal detection, with no mention of AI/ML algorithms or data processing beyond simple signal monitoring.
No
The device is described as a sensor intended to detect, monitor, and record limb movements, which serves a diagnostic or monitoring function rather than providing therapy.
Yes
The device is intended to "detect, monitor and/or record limb movements... in adult patient sleep disorder studies," which implies collecting information to assist in the diagnosis or assessment of sleep disorders.
No
The device description explicitly states it 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," indicating it is a hardware device with a physical sensor and battery.
Based on the provided information, the Neurovision Medical Motion Sensor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Neurovision Medical Motion Sensor detects, monitors, and records limb movements on a physiological recorder. This is a measurement of a physical physiological parameter (movement), not an analysis of a biological sample taken from the body.
- Intended Use: The intended use is for sleep disorder studies, focusing on physical movement during sleep.
- Device Description: The description highlights it as a piezo accelerometer sensor, which measures acceleration and vibration, directly related to physical movement.
The device operates externally to the body and measures a physical characteristic, not analyzing biological samples. Therefore, it falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Newrovision Medical 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.
Product codes
BZQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
limb
Indicated Patient Age Range
adult patient
Intended User / Care Setting
clinical setting
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)
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.
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
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Underneath, there is a line with a heartbeat symbol, and the word "MEDICAL" is in smaller, bold, black letters.
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
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.
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.
1
Image /page/1/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is in large, bold, black letters. Underneath the word "neurovision" are two horizontal lines with a heartbeat symbol in the middle, followed by the word "MEDICAL" in smaller, bold, black letters.
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-Piezo | |
| Limb Movement Sensor (LMS) is used to | ||
| detect | ||
| periodic limb movements for recording or | ||
| monitoring on a physiological amplifier. | ||
| The LMS is intended for use in sleep | ||
| disorders studies. | 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. | ||
| Product Code | BZQ | BZQ |
| Materials and Design | Nonsterile attachment electrode with | |
| unpowered Piezo Sensor | Nonsterile attachment device with battery powered | |
| Piezo 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure embracing a globe, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
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.