(99 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard vital sign monitoring technologies.
No
The device is described as a vital signs monitor, intended for measurement and tracking of physiological parameters, not for direct treatment or therapy.
Yes
The “Indications for Use” section explicitly states that "Skin temperature is used as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature for hyperthermia and hypothermia conditions," which indicates a diagnostic purpose.
No
The device description explicitly states it is comprised of a Forehead Sensor Unit and a Handheld Display Unit, which are hardware components. It also mentions integrated sensors (SpO2, infrared temperature) and ECG electrodes.
Based on the provided information, the mini-Medic™ system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- mini-Medic™ Function: The mini-Medic™ system measures vital signs directly from the patient's body (in vivo). It uses sensors placed on the forehead and chest to measure SpO2, pulse rate, heart rate (from ECG), forehead skin surface temperature, and pulse wave transit time.
- Lack of Sample Analysis: The description does not mention the collection or analysis of any biological samples from the patient.
Therefore, the mini-Medic™ system falls under the category of a vital signs monitor, which is a type of medical device used for direct patient monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The mini-Medic™ system is comprised of a minimum of one
Forehead Sensor Unit and one Handheld Display Unit, and
is intended for use on patients who are eighteen (18) years
and over.
The mini-Medic™ system is indicated as a single or multi-
parameter vital signs monitor for SpO₂ and pulse rate via an
integrated SpO₂ forehead sensor, and/or heart rate from
ECG electrodes, and forehead skin surface temperature
from an infrared temperature sensor. Pulse wave transit time
(PWTT) is obtained utilizing pulse measurements from the
integrated SpO₂ forehead sensor and ECG electrodes
placed on the upper chest. Pulse wave transit time (PWTT)
is used to track changes in blood pressure. Skin
temperature is used as an adjunct to other clinical diagnostic
procedures in the diagnosis, quantifying, and screening of
relative skin surface temperature for hyperthermia and
hypothermia conditions.
Patient data may be entered on the Handheld Display Unit.
The mini-Medic™ system provides vital parameter alarms
and a patient composite/summary alarm.
Patient information and system commands are transmitted
using wireless radio communications between the Forehead
Sensor Unit and the Handheld Display Unit. Stored patient
data may be output, printed, downloaded and saved via a
dedicated mini-Medic™ PC Software application.
Typical locations for the use of the mini-Medic™ system are:
pre-hospital (i.e., at the point of injury or trauma scene),
hospital, healthcare facility, emergency medical application,
and during ground or air transport. The monitor is intended
to be used by trained healthcare providers in military and
civilian roles including doctors, nurses, combat medics,
combat lifesavers, EMT's, and paramedics.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, FLL, DRT. DRG
Device Description
The Athena GTX mini-Medic™ wireless vital signs monitor
system is a small, lightweight, rugged, and highly portable
patient monitor designed to measure SpO₂, cardiotachometer, skin temperature and pulse wave transit
time (PWTT). Vital signs are displayed directly on the
forehead sensor and transmitted wirelessly to a handheld
display unit. Reports and data file saving is done via wireless
download to a PC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead, upper chest
Indicated Patient Age Range
eighteen (18) years and over
Intended User / Care Setting
trained healthcare providers in military and civilian roles including doctors, nurses, combat medics, combat lifesavers, EMT's, and paramedics.
pre-hospital (i.e., at the point of injury or trauma scene), hospital, healthcare facility, emergency medical application, and during ground or air transport.
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 mini-Medic™ 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.
Athena GTX Wireless Vital Signs Monitor (WVSM) K101674, Envitec-Wismar GmbH OxiPen Pulse Oximeter K070193, Exergen Temporal Scanner Thermometer K011291, Nihon Kohden BSM-2300 Series Bedside Monitors K011918, Nonin 8000R Reflectance Sensor (specified accessory in Nonin 2500A monitor) K050056
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
K113165 P1/3
FEB - 2 2012
ﺐ ﻟﻤ
Section 5 – Summary of Safety and Effectiveness
| Submission Date: | October 21, 2011 |
|---|---|
| 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: | mini-Medic ™ |
| Common Name: | Patient Physiological Monitor |
| Classification Name: | Patient Physiological Monitor (Refer to 21 CFR 870.2300) |
| Cardiac Monitor (Including cardio tachometer and rate | |
| alarm) (Refer to 21 CFR 870.2300) | |
| Clinical Electronic Thermometer | |
| (Refer to 21 CFR 880.2910) | |
| 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: | Athena GTX Wireless Vital Signs Monitor (WVSM) K101674 |
| Envitec-Wismar GmbH OxiPen Pulse Oximeter K070193 | |
| Exergen Temporal Scanner Thermometer K011291 | |
| Nihon Kohden BSM-2300 Series Bedside Monitors K011918 | |
| Nonin 8000R Reflectance Sensor (specified accessory in | |
| Nonin 2500A monitor) K050056 |
510(k) Summary of Safety and Effectiveness
1
Section 5 – Summary of Safety and Effectiveness
| Device Description: | The Athena GTX mini-Medic™ wireless vital signs monitor
system is a small, lightweight, rugged, and highly portable
patient monitor designed to measure SpO₂, cardiotachometer, skin temperature and pulse wave transit
time (PWTT). Vital signs are displayed directly on the
forehead sensor and transmitted wirelessly to a handheld
display unit. Reports and data file saving is done via wireless
download to a PC. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device
Overview: | The mini-Medic™ is designed for the same application and
intended use as the combination of listed predicate devices.
The mini-Medic™ is capable of the same heart rate,
functional oxygen saturation, pulse rate, pulse wave transit
time and IR temperature measurements as have been
provided by the combination of predicate devices referenced
above. |
| Intended Use: | The mini-Medic™ system is comprised of a minimum of one
Forehead Sensor Unit and one Handheld Display Unit, and
is intended for use on patients who are eighteen (18) years
and over.
The mini-Medic™ system is indicated as a single or multi-
parameter vital signs monitor for SpO₂ and pulse rate via an
integrated SpO₂ forehead sensor, and/or heart rate from
ECG electrodes, and forehead skin surface temperature
from an infrared temperature sensor. Pulse wave transit time
(PWTT) is obtained utilizing pulse measurements from the
integrated SpO₂ forehead sensor and ECG electrodes
placed on the upper chest. Pulse wave transit time (PWTT)
is used to track changes in blood pressure. Skin
temperature is used as an adjunct to other clinical diagnostic
procedures in the diagnosis, quantifying, and screening of
relative skin surface temperature for hyperthermia and
hypothermia conditions.
Patient data may be entered on the Handheld Display Unit.
The mini-Medic™ system provides vital parameter alarms
and a patient composite/summary alarm.
Patient information and system commands are transmitted
using wireless radio communications between the Forehead
Sensor Unit and the Handheld Display Unit. Stored patient |
| | data may be output, printed, downloaded and saved via a
dedicated mini-Medic™ PC Software application. |
| | Typical locations for the use of the mini-Medic™ system are:
pre-hospital (i.e., at the point of injury or trauma scene),
hospital, healthcare facility, emergency medical application,
and during ground or air transport. The monitor is intended
to be used by trained healthcare providers in military and
civilian roles including doctors, nurses, combat medics,
combat lifesavers, EMT's, and paramedics. |
| Summary of
Testing: | Testing on the mini-Medic™ 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 mini-Medic™
wireless vital signs monitor system is safe and effective, and
is substantially equivalent to the above listed predicate
devices. |
2
Section 5 – Summary of Safety and Effectiveness
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles an eagle or bird-like figure, with its wings spread. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 2 2012
Athena GTX c/o Mr. Sean Mahoney Chief Technical Officer 3620 SW 61st Street, Suite 395 Des Moines. Iowa 50321
Re: K113165
Trade/Device Name: mini-Medic™ Wireless Vital Signs Monitor System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Codes: MWI, DQA, FLL, DRT. DRG Dated: January 10, 2012 Received: January 11, 2012
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.
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 or any Federal statutes and regulations administered by other Federal agencies. You must
4
Page 2 - Mr. Sean Mahoney
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/CDRH/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,
Bran D. Zuckerman, M.D.
Director
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4 - Indications for Use Statement
Indications for Use Statement
510(k) Number: KIJ 3165
Device Name: mini-Medic™ System
Indications for Use:
The mini-Medic™ system is comprised of a minimum of one Forehead Sensor Unit and one Handheld Display Unit, and is intended for use on patients who are eighteen (18) years and over.
The mini-Medic™ system is indicated as a single or multi-parameter vital signs monitor for SpO2 and pulse rate via an integrated SpO2 forehead sensor, and/or heart rate from ECG electrodes. and forehead skin surface temperature from an infrared temperature sensor. Pulse wave transit time (PWTT) is obtained utilizing pulse measurements from the integrated SpO2 forehead sensor and ECG electrodes placed on the upper chest. Pulse wave transit time (PWTT) is used to track changes in blood pressure. Skin temperature is used as an adjunct to other clinical diagnostic procedures in the diagnosis, quantifying, and screening of relative skin surface temperature for hyperthermia and hypothermia conditions.
Patient data may be entered on the Handheld Display Unit. The mini-Medic™ system provides vital parameter alarms and a patient composite/summary alarm.
Patient information and system commands are transmitted using wireless radio communications between the Forehead Sensor Unit and the Handheld Display Unit. Stored patient data may be output, printed, downloaded and saved via a dedicated mini-Medic™ PC Software application.
Typical locations for the use of the mini-Medic™ system are: pre-hospital (i.e., at the point of injury or trauma scene), hospital, healthcare facility, emergency medical application, and during ground or air transport. The monitor is intended to be used by trained healthcare providers in military and civilian roles including doctors, nurses, combat lifesavers, EMT's, and paramedics.
Prescription Use (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)
| (Division Sign-Off) |
|---|
| Division of Cardiovascular Devices |
| 510(k) Number | K113165 |
|---|---|
| --------------- | --------- |
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