(25 days)
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.
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), Personal Digital Assistant (PDA) or Mobile device.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device compliance:
Based on the provided 510(k) summary, the device in question is the "WVSM Wireless Vital Signs Monitor" with an iOS Mobile App Accessory. This submission is for a device modification, and the focus of the testing appears to be on verifying the compliance of this mobile app accessory with established standards.
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "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."
However, the provided text does not contain a table detailing specific acceptance criteria and reported device performance metrics (e.g., accuracy, sensitivity, specificity, or specific numerical targets for physiological measurements like ECG, NIBP, SpO2). It only broadly states that testing verified compliance with standards. It also mentions: "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." This implies that the performance of the iOS app accessory meets the established performance of the predicate device.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for testing.
4. Adjudication method for the test set
The document does not describe any adjudication method used for a test set.
5. 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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a vital signs monitor, not typically an AI-assisted diagnostic tool that would involve human readers interpreting output in the same way as, for example, an imaging AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as a "Wireless Vital Signs Monitor" to be used by "trained healthcare providers." The iOS Mobile App Accessory is stated to display vital signs, and the device transmits data. It's not a purely standalone algorithm; it's a device that measures and displays vital signs for human interpretation. The testing performed was to ensure the device (including the app accessory) meets performance and safety standards, implying its standalone measurement capabilities are being assessed. However, the document does not explicitly describe a "standalone" algorithm-only performance assessment in the context of, for instance, an AI diagnostic tool. The compliance testing would inherently evaluate the device's ability to accurately measure vital signs independently.
7. The type of ground truth used
Given that the device measures physiological parameters (ECG, NIBP, SpO2), the ground truth for performance testing would typically be established using calibrated reference standards or other gold-standard medical devices for each parameter. For example, a highly accurate blood pressure cuff for NIBP, a reference SpO2 monitor, or a medical-grade ECG machine. The document does not explicitly state the type of ground truth used.
8. The sample size for the training set
The device is a vital signs monitor, not an AI/machine learning device that typically involves a "training set" in the conventional sense. Therefore, the document does not mention a training set sample size. The development likely involved software engineering, hardware calibration, and verification against known physiological signals or simulated data inputs, rather than training on a separate dataset.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for an AI/ML algorithm, this information is not applicable and not provided in the document.
In summary, the 510(k) Summary emphasizes compliance with recognized national and international standards for safety and performance of medical devices. However, it lacks specific details on the methodologies, sample sizes, expert involvement, and concrete performance metrics that would typically be found in a detailed study report. The acceptance criteria are broadly described as meeting these standards and achieving performance comparable to the predicate device.
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Section 5 – 510(k) Summary of Safety and Effectiveness
ﮭ ﮨ
510(k) Summary of Safety and Effectiveness
| Submission Date: | April 1st, 2013 | APR 30 2013 |
|---|---|---|
| 510(k) Submitter/Holder: | Athena GTX3620 SW 61st Street, Suite 395Des Moines, Iowa 50321Ph.: 515.288.3360 Fax.: 515.288.3394 | |
| Company Contact: | Sean Mahoney (Chief Technical Officer)Office Phone Number: 515.288.3360 x103Email: smahoney@athenagtx.com | |
| Trade Name: | WVSM Wireless Vital Signs Monitor | |
| Common Name: | Cardiac Monitor with Mobile App | |
| 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: | Device Modification | |
| Legally Marketed(Predicate) Devices: | The Athena GTX (WVSM) Wireless Vital Signs Monitor,(K101674) | |
| 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 frequencycommunication to a Personal Computer (PC), PersonalDigital Assistant (PDA) or Mobile device. | |
| Predicate DeviceOverview: | The WVSM iOS Mobile App Accessory is designed for thesame 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.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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K130957 P 2/2
5 - 2
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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 (800) 638-2041 or (301) 796-7100 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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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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Owen P. Faris -S
2013.04.30 14:20:57
-04'00'
§ 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).