(430 days)
No
The summary describes a standard blood glucose monitoring system with wireless data transfer. There is no mention of AI, ML, or any algorithms that would suggest their use in data analysis or interpretation.
No.
The device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels to aid in the management of diabetes, not for direct therapeutic treatment.
No
The device is explicitly stated as "not to be used for the diagnosis of or screening for diabetes". Instead, it serves as an aid to monitor the effectiveness of glucose control for people already diagnosed with diabetes.
No
The device description explicitly states the system is comprised of a "MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip," which are all hardware components. The software component is described as an "embedded cellular module within the meter."
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The MyGlucoHealth Wireless System is intended for self-testing outside the body (in vitro diagnostic use)..."
- Measurement of Biological Sample: The device is intended for the "quantitative measurement of glucose (sugar) in whole blood samples drawn from the fingertip, ventral palm, hand,upper arm, forearm, calf and/or thigh." This involves testing a biological sample outside of the body.
- Aid to Monitor: The intended use is "as an aid to monitor the effectiveness of glucose control," which is a diagnostic purpose related to a medical condition (diabetes).
Therefore, based on the provided text, the MyGlucoHealth Wireless System fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MyGlucoHealth Wireless System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of glucose control. The system is comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The system is intended to be used for the quantitative measurement of glucose (sugar) in whole blood samples drawn from the fingertip, ventral palm, hand, upper arm, forearm, calf and/or thigh. The MyGlucoHealth Wireless Meter is intended to be used by a single patient and should not be shared. The MyGlucoHealth Wireless System is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steady-state times (when glucose is not changing rapidly).
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The MyGlucoHealth Wireless System comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The MyGlucoHealth Wireless Meter is different from the MyGlucoHealth Blood Glucose Meter (MGH-BT1) only by the way the glucose data is transferred to the data repository. An embedded cellular module within the meter enables Wireless communication between the meter and the Entra Health Systems remote database called MyHealthPoint TeleHealth Manager (K132930).
The test strip (proprietary to the MyGlucoHealth Wireless Meter) is used only with the MyGlucoHealth Wireless Meter. It is for the quantitative measurement of the concentration of glucose in whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. The results obtained are plasma calibrated to allow for easy comparison to the laboratory method. The MyGlucoHealth Wireless System is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, ventral palm, hand, upper arm, forearm, calf and/or thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
self-testing ... by people with diabetes at home ... by diabetic patients or health care professionals. The MyGlucoHealth Wireless Meter is intended to be used by a single patient and should not be shared.
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)
Non-Clinical Testing: Test Report for IEC 61010-1/ EN61010-1 "Safety Requirements for electrical equipment for measurement, control and laboratory use", FCC Test Report, EMC Test Report, Cleaning Validation Test Reports. All testing demonstrated the safety and effectiveness of the MyGlucoHealth Wireless Meter and substantial equivalence to the predicate.
Clinical Testing: Human Factor testing was conducted to evaluate the ease of use of the MyGlucoHealth Wireless Meter and ease of understanding the user manual it is paired with.
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.
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ENTRA HEALTH SYSTEMS RICHA PADHY A RAQA COORDINATOR 3111 CAMINO DEL RIO NORTH SUITE 101 SAN DIEGO CA 92108
January 8, 2016
Re: K143169
Trade/Device Name: MyGlucoHealth Wireless System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: December 3, 2015 Received: December 11, 2015
Dear Richa Padhya:
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 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Katherine Serrano -S
For :
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143169
Device Name MyGlucoHealth Wireless System
Indications for Use (Describe)
The MyGlucoHealth Wireless System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of glucose control. The system is comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The system is intended to be used for the quantitative measurement of glucose (sugar) in whole blood samples drawn from the fingertip, ventral palm, hand,upper arm, forearm, calf and/or thigh. The MyGlucoHealth Wireless Meter is intended to be used by a single patient and should not be shared. The MyGlucoHealth Wireless System is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steady-state times (when glucose is not changing rapidly).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E," "h," and "S," separated by vertical lines. The "h" is inside a maroon circle. Below the letters is the text "Entra Health Systems" in a red serif font.
Date: September 1 2015
Entra Health Systems LLC 3111 Camino del Rio North Suite 101 San Diego, CA 92108 Main 877 458 2646 Fax 619 584 4504
510(k) Summary
| A. Submitter: | Entra Health Systems |
|---|---|
| B. Address: | 3111 Camino Del Rio North |
| Suite 101 | |
| San Diego CA 92108 | |
| C. Corporate Contact: | Richard Strobridge, CEO |
| Entra Health Systems | |
| D. Telephone: | Ph: 877-458-2646 |
| Fax: 619-584-4504 | |
| E. Submission Contact: | Richa Padhya - Quality |
| Entra Health Systems | |
| 3111 Camino Del Rio North | |
| Suite 101 | |
| San Diego CA 92108 | |
| Ph: 877-458-2646 Extension# 723 | |
| rpadhya@entrahealth.com | |
| F. Trade Name: | MyGlucoHealth Wireless System |
| G. Predicate Device(s): | MyGlucoHealth Glucose Monitoring System, |
| Model MGH-BT1, | |
| Entra Health Systems (K081703) | |
| H. Common Name: | Glucose Test System |
| I. Classification: | Class II |
| Regulation
Number | Product
Code | Classification Name | Device
Class |
|----------------------|-----------------|--------------------------|-----------------|
| 862.1345 | NBW | Glucose Test System | II |
| 862.1345 | CGA | Glucose Oxidase, Glucose | II |
J. Device Description
The MyGlucoHealth Wireless System comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The MyGlucoHealth Wireless Meter is different from the MyGlucoHealth Blood Glucose Meter (MGH-BT1) only by the way the glucose data is transferred to the data repository. An embedded cellular module within the meter enables Wireless communication between the meter and the Entra Health Systems remote database called MyHealthPoint TeleHealth Manager (K132930).
The test strip (proprietary to the MyGlucoHealth Wireless Meter) is used only with the MyGlucoHealth Wireless Meter. It is for the quantitative measurement of the concentration of glucose in whole blood that can be taken from the fingertip, ventral palm, dorsal hand,
4
Image /page/4/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S", with the "h" being inside of a red circle. The letters are separated by vertical lines. Below the letters is the text "Entra Health Systems" in a red font.
Entra Health Systems LLC 3111 Camino del Rio North Suite 101 San Diego, CA 92108 Main 877 458 2646 Fax 619 584 4504
upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. The results obtained are plasma calibrated to allow for easy comparison to the laboratory method. The MyGlucoHealth Wireless System is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.
-
K. Intended Use
The MyGlucoHealth Wireless System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of glucose control. The system is comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The system is intended to be used for the quantitative measurement of glucose (sugar) in whole blood samples drawn from the fingertip, ventral palm, hand, upper arm, calf and/or thigh. The MyGlucoHealth Wireless Meter is intended to be used by a single patient and should not be shared. The MyGlucoHealth Wireless System is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steadystate times (when glucose is not changing rapidly). -
L. Predicate Device(s)
L.1 MyGlucoHealth Wireless System is substantially equivalent to the following FDA cleared predicate device:
| Predicate #1 |
|---|
| -------------- |
| 510(k) Number: | K081703 |
|---|---|
| Trade Name: | MyGlucoHealth Glucose Monitoring System |
| Manufacturer: | Entra Health Systems |
| Common/Usual Name: | Glucose Test System |
| Regulation Number: | 862.1345 |
| Product Codes: | NBW |
| Classification: | II |
- M. Substantial Equivalence
| Feature | Predicate device | Candidate Device |
|---|---|---|
| MyGlucoHealth | MyGlucoHealth Wireless | |
| MGH-BT1 | MGH-CL1 | |
| Intended Use | The MyGlucoHealth glucose monitoring | |
| system provides a quick and easy way for | ||
| diabetic patients to measure and self- | ||
| monitor blood glucose levels. The system | ||
| is comprised of the MyGlucoHealth | ||
| Bluetooth meter (MGH-BT1 w/Bluetooth | ||
| Wireless download capability) or the | ||
| MGH-1 (w/o Bluetooth) blood glucose | ||
| meter, control solution and test strips | ||
| that carry a biosensor used for the | ||
| quantitative measurement of the | ||
| concentration of glucose in capillary | ||
| whole blood that can be taken from the | The MyGlucoHealth Wireless System | |
| is intended for self-testing outside the | ||
| body (in vitro diagnostic use) by | ||
| people with diabetes at home as an aid | ||
| to monitor the effectiveness of glucose | ||
| control. The system is comprised of | ||
| the MyGlucoHealth Wireless Meter, | ||
| MyGlucoHealth Control Solutions and | ||
| MyGlucoHealth Wireless Test Strip. | ||
| The system is intended to be used for | ||
| the quantitative measurement of | ||
| glucose (sugar) in whole blood | ||
| samples drawn from the fingertip, |
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Image /page/5/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S", with the "h" being inside of a red circle. The letters are separated by vertical lines. Below the letters, the words "Entra Health Systems" are written in red.
Entra Health Systems LLC 3111 Camino del Rio North Suite 101 San Diego, CA 92108 Main 877 458 2646 Fax 619 584 4504
| | fingertip, ventral palm, hand, upper arm,
forearm, calf and/or thigh by diabetic
patients or health care professionals. The
results obtained are plasma calibrated to
allow for easy comparison to the
laboratory method. Further, results from
either meter may be uploaded to a
memory device through a standard RS32
connection, or, with the -BT1 model,
Wirelessly transmitted to a Bluetooth
capable PC or Cell phone. The
MyGlucoHealth glucose monitoring
systems are not to be used for the
diagnosis or screening of diabetes or for
neonatal use. Alternate site testing
should be done during steady-state times
when glucose is not changing rapidly. | ventral palm, hand, upper arm,
forearm, calf and/or thigh. The
MyGlucoHealth Wireless Meter is
intended to be used by a single patient
and should not be shared. The
MyGlucoHealth Wireless System is
not to be used for the diagnosis of or
screening for diabetes or for neonatal
use. Alternate site testing should be
done during steady-state times (when
glucose is not changing rapidly). |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Control solution | Single (Specified) Analyte Controls
(Assayed And Unassayed) | Same as Predicate device |
| Test strips | Glucose Oxidase | Same as Predicate device |
| Test range | 10600 Mg/dL | Same as Predicate device |60% | Same as Predicate device |
| Hematocrit | 20
| Range | | |
| Test time | 3 sec | Same as Predicate device |
| Sample Volume | 0.3 uL | Same as Predicate device |
| Operating Temp
& Humidity | 50104°F40°C
10
10~90% | Same as Predicate device |
| Speaking
Function | No | Same as Predicate device |
| Test Strip Open
use time | 3 months | Same as Predicate device |
| Coding | Coding | Same as Predicate device |
| Memory
capability | 250 readings | Same as Predicate device |
| Day Averages | 7, 14, 21-day average | Same as Predicate device |
| Battery | Two Triple A's | Lithium Ion Battery |
| Battery Life | 2,000 tests | Rechargeable |
| Size (LxWxH) | 52.2 x 98.5 x 23.4 mm | 53 x 102 x 20.5 mm |
| Weight | 74.5g (2.5 oz.) with battery | 87g (3.06 oz.) with battery |
| Warranty | 2 years | Same as Predicate device |
| Software | MyHealthPoint TeleHealth Manager
(K132930) | Same as Predicate device |
| Data transferring
capability | MGH-BT1 adds Wireless uploading to Bluetooth paired PC, USB cord or cell phone | MCH-CL1 uploads through a cellular radio |
| Technological
Characteristics | The MyGlucoHealth Bluetooth meter
(MGH-BT1) consists of a glucose meter | The MyGlucoHealth Wireless Meter
consists of a glucose meter that can |
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Image /page/6/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E", "h", and "S", with the "h" in a red circle. The words "Entra Health Systems" are written in a red font below the logo. The letters are separated by thin vertical lines.
| | that can Wirelessly transmit data to a
remote database using standard
Bluetooth technology embedded within
the glucose meter. The meter uses
biosensor test strips. MyHealthPoint
TeleHealth Manager consists entirely of
software run on a central server. | wirelessly transmit data to a remote
database using standard cellular
technology embedded within the
glucose meter. The meter uses
biosensor test strips. MyHealthPoint
TeleHealth Manager consists entirely
of software run on a central server. |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Color | Silver | Black |
| LED light where
the test strip is
inserted | No LED Light | The LED light is to help the consumer
know where to insert the test strip.
Also, if they take a reading in the dark
it is easier to locate where the test
strip needs to be inserted. |
| Alarm | Yes | Same as Predicate device |
| Screen Display | LCD | Same as Predicate device |
- N. Standard/Guidance Document References
- ISO 15197:2003, In Vitro Diagnostic Test Systems Requirements for Blood Glucose ● Monitoring Test Systems for Self Managing Diabetes Mellitus
- ISO 14971:2012, Medical Devices, Application of risk management to medical devices
- IEC 61010-1:2001, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
- IEC 61010-2-101:2002, Safety requirements for electrical equipment for measurement, ● control, and laboratory use - Part 2-101: Particular requirements for IVD medical equipment
- O. Non-Clinical Testing
-
- Test Report for IEC 61010-1/ EN61010-1 "Safety Requirements for electrical equipment for measurement, control and laboratory use.
- FCC Test Report 2.
- EMC Test Report 3.
-
- Cleaning Validation Test Reports
-
All testing demonstrated the safety and effectiveness of the MyGlucoHealth Wireless Meter and substantial equivalence to the predicate.
- P. Clinical Testing
-
- Human Factor testing was conducted to evaluate the ease of use of the MyGlucoHealth Wireless Meter and ease of understanding the user manual it is paired with.
-
- Q. Infection Control
Robustness Testing: Cleaning and disinfection can be accomplished by wiping the meter with Caviwipes XL (EPA Reg. No. 46781-8). The robustness study was conducted on three different meters and the results demonstrated that there was no change in functional
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Image /page/7/Picture/0 description: The image shows the logo for Entra Health Systems. The logo consists of the letters "E," "h," and "S," separated by vertical lines. The "h" is in lowercase and is inside a red circle. Below the letters is the text "Entra Health Systems" in a red serif font.
Entra Health Systems LLC 3111 Camino del Rio North Suite 101 San Diego, CA 92108 Main 877 458 2646 Fax 619 584 4504
performance or in the visual external materials of the meter after 156 cleaning and 156 disinfection cycles to simulate 3 years of use for single patient use. Each robustness cycle tested consisted of one cleaning wipe and one disinfecting wipe.
Cleaning Validation test: Disinfection efficacy/Cleaning Validation studies were performed on the materials comprising the meter by an outside testing laboratory demonstrating complete inactivation of duck hepatitis B virus with the chosen disinfectant, Caviwipes XL (EPA Registration #46781-8. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.
- R. Conclusion
The MyGlucoHealth Wireless System is substantially equivalent to the predicate device.