VIVATRAK

K101109 · Wireless Medcare, LLC · KMI · Jul 15, 2010 · General Hospital

Device Facts

• Record ID: K101109
• Device Name: VIVATRAK
• Applicant: Wireless Medcare, LLC
• Product Code: KMI · General Hospital
• Decision Date: Jul 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2400
• Device Class: Class 1

Intended Use

The VivaTRAK™ system monitors in-bed activity and care delivery for patients susceptible to pressure ulcers and falls as well as those that require 24 hour monitoring of their general activity levels in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities. The system providers information related to patient status and care delivered. The VivaTRAK™ system is not intended to provide automated treatment decisions or used as a substitute for professional healthcare judgment. The VivaTRAK™ system is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

Device Story

System monitors in-bed patient activity and care delivery; utilizes BedSense under-mattress sensor pad to detect activity; ActivSense Bed Computer processes and wirelessly transmits activity data; system provides notifications via pager, email, phone, and display to nursing staff; RFID readers verify care delivery; care reports (notification, RFID scan, bed activity) stored in database for quality improvement and workflow analysis; used in medical, nursing, and long-term care facilities; operated by facility staff; output assists healthcare providers in monitoring patient status and care delivery; does not provide automated treatment decisions; not a substitute for vital signs monitoring.

Clinical Evidence

Bench testing only. Wireless MedCARE verified and validated that the system meets functional, performance, safety, and efficacy specifications.

Technological Characteristics

System includes under-mattress sensor pad (BedSense) and wireless bed computer (ActivSense). Utilizes RFID technology for care verification. Connectivity via wireless transmission to database. Software-based reporting system. No specific materials or energy standards cited.

Indications for Use

Indicated for patients in medical, nursing, long-term care, independent living, assisted living, and rehabilitation facilities who are susceptible to pressure ulcers, falls, or require 24-hour monitoring of general activity levels.

Regulatory Classification

Identification

A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.

Predicate Devices

• AFrame MobileCare Monitor (K090138)
• TABS Elite
• Roll-Check
• Home Guardian
• WellAWARE Systems
• SafeBed

Submission Summary (Full Text)

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K101109

## Pre Market Notification 510(k) Summary

#### 1. Sponsor Information:

| Company Name & Address: | Wireless MedCARE, LLC.<br>15 E. Salem Ave., Suite 201<br>Roanoke, VA 24011 |
|-------------------------|----------------------------------------------------------------------------|
|-------------------------|----------------------------------------------------------------------------|

JUL 1 5 2010

| Contact Person: | Kenneth D. Ferris |
|-----------------------|-------------------|
| Contact Title: | COO |
| Contact Phone Number: | 540-520-8707 |
| Contact Fax Number: | 540-344-2966 |

April 9, 2010 Date of Summary:

## 2. Device Name and Classification:

Common and Usual Name: Monitor, Bed Patient

VivaTRAK™ Proprietary Name:

| Classification Name: | Bed-Patient Monitor |
|----------------------------|---------------------|
| Classification Regulation: | 21CFR 880.2400 |
| Device Classification: | Class 1 |
| Product Code: | KMI |

Performance Standards:

No applicable performance standards have been issued under section 514 or under section 513 (b) of the Food, Drug and Cosmetic Act.

## 3. Predicate Device(s):

AFrame Digital, Inc., AFrame MobileCare Monitor (K090138), Stanley Security Solutions, Inc., TABS Elite (Class 1, 510(k) Exempt) Stanley Healthcare Solutions, Roll-Check (Class 1, 510(k) Exempt) Home Guardian, WellAWARE Systems (Class 1, 510(k) Exempt) Emfit Ltd., SafeBed (Class 1, 510(k) Exempt)

## 4. Description of Device:

The VivaTRAK 110 system is used for monitoring in-bed patient activity and care delivery. The system monitors in-bed patient activity with the BedSense sensor, an under-the-mattress activity sensing pad, processing and wireless transmission of activity data with the ActivSense "M Bed Computer, and providing pager, email, phone and display notifications and care reports to the nursing staff, and then verifying using RFID readers that care was actually delivered with the VivaTRAKTM application. Care reports consisting of a notification, a RFID scan and bed activity are stored in a database and form the basis for reports used to improve quality of care and work flows at the facility.

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#### 5. Indications for Use:

The VivaTRAK™ system monitors in-bed activity and care delivery for patients susceptible to pressure ulcers and falls as well as those that require 24 hour monitoring of their general activity levels in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities. The system providers information related to patient status and care delivered.

The VivaTRAK™ system is not intended to provide automated treatment decisions or used as a substitute for professional healthcare judgment. The VivaTRAK™ system is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

## 6. Comparison with Predicate Device (s):

The VivaTRAK™ system is substantially equivalent to the predicate devices (AFrame The Trial Inc.'s AFrame MobileCare Monitor Wonton No Tar Press (11 Marc, 1) Fulia
Digital, Inc.'s AFrame MobileCare Monitor™, Stanley Security Solution's TAS Stilite, and Emfit Ltd's SafeBed).

VivaTRAK is similar in characteristics, features, technological features, intended use, and indications for use, as the predicates. Any differences in the technology used when compared to the predicates have been satisfactorily addressed by conformance to FDA and Internationally recognized safety consensus standards as well as, to the company's design requirements. The VivaTRAK™ system is as safe and effective as the predicate devices.

## 7. Non-Clinical Performance Summary:

Wireless MedCARE has verified and validated that the VivaTRAK™ system meets its functional, performance, safety, and efficacy specifications and requirements.

#### 8. Conclusions:

In summary, Wireless MedCARE is of the opinion that the VivaTRAK™ system is as safe and effective as similar devices currently on the market, and concludes that the VivaTRAK™ is substantially equivalent to the predicate devices and those 510(k) exempt products being marketed in U.S. interstate commerce.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of three abstract shapes that resemble human figures or stylized waves, stacked on top of each other.

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

Wireless MedCARE, LLC C/O Mr. Paul Sumner Arkin Consulting Group 1733 Canton Lane Marietta, Georgia 30062

# JUL 1 6 2010

Re: K101109

Trade/Device Name: VivaTRAK™ Regulation Number: 21 CFR 880.2400 Regulation Name: Bed-Patient Monitor Regulatory Class: I Product Code: KMI Dated: July 7, 2010 Received: July 8, 2010

Dear Mr. Sumner:

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.

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Page 2- Mr. Sumner

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 (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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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### Indications for Use Statement

510(k) Number (if known): N/A

Device Name: VivaTRAK™M

Indications for Use:

י

The VivaTRAK™ System monitors in-bed activity and care delivery for patients susceptible to pressure ulcers and falls as well as those that require 24 hour monitoring of their general activity levels in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities. The system providers information related to patient status and care delivered.

The VivaTRAK™ System is not intended to provide automated treatment decisions or be used as a substitute for professional healthcare judgment. The VivaTRAK™ System is not a replacement or substitute for vital signs monitoring or alert equipment. All patient medical diagnosis and treatment are to be performed under direct supervision and oversight of an appropriate health care professional.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)

(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

Concurrence of CDRH, Office of Device Evaluation (ODE),
510(k) Number: K101109

Wireless MedCARE VivaTRAK