(36 days)
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
No.
The "Intended Use / Indications for Use" states that the device is a "patient monitor" used to measure vital signs (ECG, NIBP, SpO2) and transmit the data. It does not mention any therapeutic function; its purpose is solely for monitoring.
No
Explanation: A diagnostic device is used to identify or determine the nature of a disease or condition. This device is specified as a "patient monitor" and "vital signs monitor" that measures and transmits data for ECG, NIBP, and SpO2. Its intended use is to monitor, not diagnose.
No
The device description explicitly states it is a "patient monitor designed to measure SpO2, NIBP and ECG," indicating it includes hardware components for vital sign acquisition.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states the device is a "Wireless Vital Signs Monitor" that measures "ECG, noninvasive blood pressure (NIBP) and SpO2". These are physiological measurements taken directly from the patient's body, not from samples in vitro (in a lab setting).
- Intended Use: The intended use describes monitoring vital signs of adult patients in various healthcare settings. This aligns with a patient monitoring device, not an IVD.
The device is a patient monitoring device that measures vital signs in vivo (within the living body).
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 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, DXN, 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) or Personal Digital Assistant (PDA).
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
Testing On the WVSM 5.0 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
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K033378, K071285, K040799, K052160, K022453
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 – 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 GTX | |
| 3620 SW 61st Street, Suite 395 | ||
| Des Moines, lowa 50321 | ||
| Ph.: 515.288.3360 Fax.: 515.288.3394 | ||
| Company Contact: | Sean Mahoney (Chief Technical Officer) | |
| Office Phone Number: 515.288.3360 | ||
| Email: 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 870.1130 | ||
| 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: | 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 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 |
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1
Section 5 – Summary of Safety and Effectiveness
| | communication to a Personal Computer (PC) or Personal
Digital Assistant (PDA). |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device
Overview: | The WVSM is designed for the same application and
intended use as the combination of listed predicate devices.
The WVSM 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
combination of predicate devices 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 5.0 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 is safe and effective, and is
substantially equivalent to the above listed predicate
devices. |
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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
4
Indications for Use Statement
510(k) Number (if known): K101674
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 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.
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)
at
| (Division Sign-Off) Division of Cardiovascular Devices | |
|---|---|
| 510(k) Number | K101674 |
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