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 far 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 Description

The Athena GTX (WVSM) Wireless Vital Signs Monitor is a small, lightweight, rugged, and highly portable patient monitor designed to measure SpO2, NIBP and ECG. Vital signs are displayed directly on the device, and may be transmitted via WiFi 802.11b/g radio frequency communication to a Personal Computer (PC) or Personal Digital Assistant (PDA).

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Athena GTX Wireless Vital Signs Monitor (WVSM), based on the provided text:

Summary of Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria with numerical targets. Instead, it broadly states that testing 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." The conclusion is that the WVSM is "safe and effective, and is substantially equivalent to the above listed predicate devices."

Therefore, the implicit acceptance criteria are that the device performs comparably to the predicate devices and meets relevant safety and performance standards for its intended physiological measurements (ECG, NIBP, SpO2), and wireless communication.

A placeholder table is provided below, reflecting the performance claims made in relation to the predicate devices.

Metric / Parameter	Acceptance Criteria (Implicit)	Reported Device Performance
ECG Measurement	Performance comparable to the Welch Allyn Propaq LT (K033378)	The WVSM is capable of the same ECG measurements as the combination of predicate devices.
Heart Rate	Performance comparable to the Welch Allyn Propaq LT (K033378)	The WVSM is capable of the same heart rate measurements as the combination of predicate devices.
Systolic BP	Performance comparable to the Welch Allyn Propaq LT (K033378)	The WVSM is capable of the same systolic blood pressure measurements as the combination of predicate devices.
Diastolic BP	Performance comparable to the Welch Allyn Propaq LT (K033378)	The WVSM is capable of the same diastolic blood pressure measurements as the combination of predicate devices.
SpO2 (Functional)	Performance comparable to the Nonin Medical, Inc. Model # 7500 (K071285) and Welch Allyn Propaq LT (K033378)	The WVSM is capable of the same functional oxygen saturation measurements as the combination of predicate devices.
Pulse Rate	Performance comparable to the Nonin Medical, Inc. Model # 7500 (K071285) and Welch Allyn Propaq LT (K033378)	The WVSM is capable of the same pulse rate measurements as the combination of predicate devices.
Wireless Comm.	Reliable wireless transmission of vital signs data to a handheld or PC computer.	The monitor uses wireless communications (WiFi 802.11b/g) to transmit vital signs data to a handheld or PC computer. Testing confirmed compliance with recognized national and international standards for performance applicable to this device, which would include wireless communication functionality.
Safety	Compliance with recognized national and international safety standards for medical devices and relevant regulations	Testing confirmed compliance with recognized national and international standards for safety for medical devices. The device is determined to be "safe and effective."
Effectiveness	Performance comparable to predicate devices for intended use case.	"Based on the results for all safety and compliance testing performed, it is the opinion of Athena GTX the WVSM Wireless Vital Signs Monitor is safe and effective, and is substantially equivalent to the above listed predicate devices." The WVSM is designed for the same application and intended use as the combination of listed predicate devices and is capable of the same measurements.

Study Details from the Provided Text:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document states "Testing On the WVSM 5.0 has been completed," but does not provide details on the number of subjects, cases, or data points used in the testing.
- Data Provenance: Not specified. It's unclear if the testing involved human subjects, simulated data, or a combination, and if location data was collected.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document describes technical testing against recognized standards and comparison to predicate devices, rather than a clinical study requiring expert ground truth establishment in a diagnostic context.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This type of adjudication is relevant for studies where human interpretation or diagnosis is being evaluated against expert consensus. The provided text outlines technical and performance testing against standards.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The testing described is of the device's performance itself, measuring vital signs and transmitting data, which represents its standalone functionality. However, the exact methodology and results of this "standalone" testing are not detailed beyond "compliance with recognized national and international standards for safety and performance."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth would have been established by reference standards or highly accurate clinical measurement devices/calibrated equipment used during the "testing... to verify compliance with recognized national and international standards for safety and performance." For example, for NIBP, a reference invasive blood pressure measurement system or a highly accurate non-invasive system would be used as ground truth. For SpO2, a co-oximeter or other reference method would be used. The document does not specify these reference standards.
The sample size for the training set:
- Not applicable/Not specified. This device is described as a monitor that directly measures physiological parameters, not a machine learning model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. The device does not explicitly mention using a training set as it would be understood in the context of AI/ML.

Summary

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Section 5 – Summary of Safety and Effectiveness

510(k) Summary of Safety and Effectiveness

Submission Date:	June 11th, 2010	JUL 21 2010
510(k) Submitter/Holder:	Athena GTX3620 SW 61st Street, Suite 395Des Moines, lowa 50321Ph.: 515.288.3360 Fax.: 515.288.3394
Company Contact:	Sean Mahoney (Chief Technical Officer)Office Phone Number: 515.288.3360Email: smahoney@athenagtx.com
Trade Name:	WVSM Wireless Vital Signs Monitor
Common Name:	Cardiac Monitor
Classification Name:	Cardiac Monitor (Including cardiotachometer and rate alarm)(Refer to 21 CFR 870.2300)NIBP Measurement System (Refer to 21 CFR 870.1130Oximeter (Refer to 21 CFR 870.2700)Radiofrequency Physiological Signal Transmitter andReceiver (Refer to 21 CFR 870.2910)
Classification Regulation:	Class II
Basis for Submission:	New device design
Legally Marketed(Predicate) Devices:	Welch Ally Propaq LT Vital Signs Monitor, (K033378)Nonin Medical, Inc. Model # 7500 Digital Pulse Oximeter(K071285)HomMed Genesis Patient Monitor System (K040799)Welch Allyn Acuity Central Monitoring Station(K052160, K022453)
Device Description:	The Athena GTX (WVSM) Wireless Vital Signs Monitor is asmall, lightweight, rugged, and highly portable patientmonitor designed to measure SpO2, NIBP and ECG. Vitalsigns are displayed directly on the device, and may betransmitted via WiFi 802.11b/g radio frequency

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Section 5 – Summary of Safety and Effectiveness

	communication to a Personal Computer (PC) or PersonalDigital Assistant (PDA).
Predicate DeviceOverview:	The WVSM is designed for the same application andintended use as the combination of listed predicate devices.The WVSM is capable of the same ECG, heart rate, systolicand diastolic blood pressure, functional oxygen saturation,and pulse rate measurements as have been provided by thecombination of predicate devices referenced above.
Intended Use:	The Wireless Vital Signs Monitor (WVSM) is intended to beused as an adult patient monitor. It is indicated as a singleor multi-parameter vital signs monitor for ECG, noninvasiveblood pressure (NIBP) and SpO2. It may be used in thefollowing locations: Hospitals, healthcare facilities,emergency medical applications, during transport, and otherhealthcare applications. The monitor uses wirelesscommunications to transmit vital signs data to a handheld orPC computer.The monitor is intended to be used by trained healthcareproviders.
Summary ofTesting:	Testing On the WVSM 5.0 has been completed to verifycompliance with recognized national and internationalstandards for safety and performance for medical devices,and particular requirements applicable to this device
Conclusion:	Based on the results for all safety and compliance testingperformed, it is the opinion of Athena GTX the WVSMWireless Vital Signs Monitor is safe and effective, and issubstantially equivalent to the above listed predicatedevices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with flowing lines representing its wings and body.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Sean Mahoney Chief Technical Officer Athena GTX 3620 SW 61st Street, Suite 395 Des Moines, Iowa 50321

JUL 21 2010

Re: K101674

Device Name: Athena GTX Wireless Vital Signs Monitor (WVSM) Regulation Number: 21 CFR 870.2300 Regulation Name: Patient Physiological Monitor (Without Arrhythmia Detection or Alarms) Regulatory Class: Class II (Two) Product Codes: MWI, DQA, DXN, DRG Dated: June 14, 2010 Received: June 15, 2010

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 Footd, Orug 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. Sean Mahoney

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 (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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

To: 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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Indications for Use Statement

510(k) Number (if known): K101674

Device Name: Wireless Vital Signs Monitor

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

W.W

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number	K101674

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Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).