WVSM (WIRLESS VITAL SIGNS MONITOR)

K130957 · Athena Gtx · MWI · Apr 30, 2013 · Cardiovascular

Device Facts

• Record ID: K130957
• Device Name: WVSM (WIRLESS VITAL SIGNS MONITOR)
• Applicant: Athena Gtx
• Product Code: MWI · Cardiovascular
• Decision Date: Apr 30, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2. It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer. The monitor is intended to be used by trained healthcare providers.

Device Story

WVSM is a small, lightweight, rugged, portable patient monitor; measures ECG, NIBP, and SpO2. Vital signs displayed on device; transmitted via WiFi 802.11b/g to PC, PDA, or mobile device (iOS app). Used by trained healthcare providers in hospitals, clinics, emergency settings, and transport. Provides real-time vital sign data to clinicians to support patient assessment and clinical decision-making. Benefits include portability and wireless monitoring capability in diverse clinical environments.

Clinical Evidence

Bench testing only. Compliance with recognized national and international standards for safety and performance verified.

Technological Characteristics

Portable, rugged patient monitor; measures ECG, NIBP, SpO2. Connectivity via WiFi 802.11b/g to PC/mobile devices. Class II device.

Indications for Use

Indicated for adult patients requiring single or multi-parameter monitoring of ECG, NIBP, and SpO2 in hospitals, healthcare facilities, emergency medical settings, and during transport. Intended for use by trained healthcare providers.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Athena GTX (WVSM) Wireless Vital Signs Monitor (K101674)

Submission Summary (Full Text)

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# Section 5 – 510(k) Summary of Safety and Effectiveness

K130957

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## 510(k) Summary of Safety and Effectiveness

| Submission Date: | April 1st, 2013 | APR 30 2013 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510(k) Submitter/Holder: | Athena GTX<br>3620 SW 61st Street, Suite 395<br>Des Moines, Iowa 50321<br>Ph.: 515.288.3360 Fax.: [phone] | |
| Company Contact: | Sean Mahoney (Chief Technical Officer)<br>Office Phone Number: 515.288.3360 x103<br>Email: [e-mail] | |
| Trade Name: | WVSM Wireless Vital Signs Monitor | |
| Common Name: | Cardiac Monitor with Mobile App | |
| Classification Name: | Cardiac Monitor (Including cardiotachometer and rate alarm)<br>(Refer to 21 CFR 870.2300)<br>NIBP Measurement System (Refer to 21 CFR 870.1130<br>Oximeter (Refer to 21 CFR 870.2700)<br>Radiofrequency Physiological Signal Transmitter and<br>Receiver (Refer to 21 CFR 870.2910) | |
| Classification Regulation: | Class II | |
| Basis for Submission: | Device Modification | |
| Legally Marketed<br>(Predicate) Devices: | The Athena GTX (WVSM) Wireless Vital Signs Monitor,<br>(K101674) | |
| Device Description: | The Athena GTX (WVSM) Wireless Vital Signs Monitor is a<br>small, lightweight, rugged, and highly portable patient<br>monitor designed to measure SpO2, NIBP and ECG. Vital<br>signs are displayed directly on the device, and may be<br>transmitted via WiFi 802.11b/g radio frequency<br>communication to a Personal Computer (PC), Personal<br>Digital Assistant (PDA) or Mobile device. | |
| Predicate Device<br>Overview: | The WVSM iOS Mobile App Accessory is designed for the<br>same application and intended use as the PDA Accessory | |
| | listed predicate device. The WVSM with iOS Mobile App- accessory is capable of the same ECG, heart rate, systolic and diastolic blood pressure, functional oxygen saturation, and pulse rate measurements as have been provided by the predicate device referenced above. | |
| Intended Use: | The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2. It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer.<br><br>The monitor is intended to be used by trained healthcare providers. | |
| Summary of Testing: | Testing on the WVSM iOS Mobile App has been completed to verify compliance with recognized national and international standards for safety and performance for medical devices, and particular requirements applicable to this device. | |
| Conclusion: | Based on the results for all safety and compliance testing performed, it is the opinion of Athena GTX the WVSM Wireless Vital Signs Monitor with iOS Mobile App Accessory is safe and effective, and is substantially equivalent to the above listed predicate device. | |

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#### Public Health Service

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

April 30, 2013

Athena GTX, Inc. c/o Mr. Sean Mahoney Chief Technical Officer 3620 SW 613 Street, Suite 395 Des Moines, IA 50321

Re: K130957

Trade/Device Name: Wireless Vital Signs Monitor, Model WVSM 5.0 Regulatory Number: 21 CFR 870.2300 Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI, DXN, DQA, DRG Dated: March 29, 2013 Received: April 4, 2013

Dear Mr. Mahoney:

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

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Page 2 - Mr. Sean Mahoney

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.

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/CDRH0ffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/3/Picture/6 description: The image shows the name "Owen Paris -S" in a bold, sans-serif font. The word "Owen" is clearly legible, followed by a stylized and somewhat abstract representation of the word "Paris". The "-S" is separated by a dash and is in the same font as the rest of the text. The overall impression is a logo or title with a distinctive design.

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K130957

### Indications for Use Statement

510(k) Number (if known):

Device Name: Wireless Vital Signs Monitor

Indications for Use:

The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or mufti-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2. It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer.

The monitor is intended to be used by trained healthcare providers.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen P. Faris -S
2013.04.30 14:20:57
-04'00'