(25 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard vital signs monitoring and wireless data transmission, with no mention of AI/ML capabilities.
No
The device is a monitor used to collect and display vital signs data and does not have a therapeutic function.
No
This device is described as a "Vital Signs Monitor" that measures physiological parameters like ECG, NIBP, and SpO2 for patient monitoring. It does not state that it analyzes data to determine the nature or cause of a disease or condition, which is the definition of a diagnostic device.
No
The device description explicitly states it is a "patient monitor designed to measure SpO2, NIBP and ECG" and that vital signs are "displayed directly on the device," indicating it includes hardware components for measurement and display, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "patient monitor" for measuring vital signs (ECG, NIBP, SpO2) directly from the patient.
- Device Description: The description reinforces that it measures these vital signs directly from the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs are used in vitro (outside the body) to analyze these specimens.
This device is a patient-contacting medical device used for monitoring physiological parameters directly from a living patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
74 MWI, DXN, DQA, DRG
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), Personal Digital Assistant (PDA) or Mobile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult
Intended User / Care Setting
used by trained healthcare providers. It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 GTX | |
| 3620 SW 61st Street, Suite 395 | ||
| Des Moines, Iowa 50321 | ||
| Ph.: 515.288.3360 Fax.: 515.288.3394 | ||
| Company Contact: | Sean Mahoney (Chief Technical Officer) | |
| Office Phone Number: 515.288.3360 x103 | ||
| Email: 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 870.1130 | ||
| Oximeter (Refer to 21 CFR 870.2700) | ||
| Radiofrequency Physiological Signal Transmitter and | ||
| Receiver (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 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. | ||
| Predicate Device | ||
| Overview: | The WVSM iOS Mobile App Accessory is designed for the | |
| 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. |
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. | |
1
K130957 P 2/2
5 - 2
: :
2
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 eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
· |
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
3
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
4
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'