(291 days)
Not Found
No
The document describes a standard electrochemical blood glucose monitoring system with data storage and transmission capabilities. There is no mention of AI or ML being used for data analysis, interpretation, or feedback generation.
No
A therapeutic device is one that treats or prevents a disease. This device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels in diabetes management, not for direct treatment or prevention.
Yes
The device is described as an "in vitro diagnostic use only" device for the quantitative measurement of glucose in blood, which is a key characteristic of a diagnostic device. While it states it should not be used for initial diabetes diagnosis, it is explicitly for monitoring the effectiveness of a diabetes control program, aiding in disease management, making it a diagnostic tool in that context.
No
The device description explicitly lists multiple hardware components including a meter, test strips, lancing device, lancets, control solutions, AC adapter, USB charger, and carrying case. While it includes a data management system (which is likely software), the core system is a combination of hardware and software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The In Touch® BGMS is for in vitro diagnostic use only".
- Nature of the Test: The device measures glucose in a biological sample (whole capillary blood) outside of the body. This is the core definition of an in vitro diagnostic test.
- Purpose: The purpose is to provide quantitative measurement of glucose to aid in monitoring the effectiveness of a diabetes control program. This is a diagnostic purpose, even though it's not for initial diagnosis or screening.
N/A
Intended Use / Indications for Use
The In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch® BGMS is intended to be used by a single person and should not be shared.
The In Touch® Blood Glucose Test Strips (In Touch® strips) are used with the In Touch® Blood Glucose Meter (In Touch® meter) in the quantitative measurement of glucose in fresh capillary blood from the fingertip.
The In Touch® Control Solution is for use with the In Touch® meter and In Touch® strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
Device Description
The EosHealth, Inc. In Touch® BGMS, is an Over-The-Counter (OTC) system designed for the self-monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management. The system consists of the following components:
- In Touch® Blood Glucose Meter (In Touch® meter)
- In Touch® Blood Glucose Test Strips ●
- In Touch® Lancing Device ●
- In Touch® Lancets ●
- In Touch® Level 1 Control Solution
- In Touch® Level 2 Control Solution
- AC Adapter (wall charger) and USB Charger
- Carrying Case
- . In Touch® Data Management System (optional accessory to the In Touch® BGMS)
The In Touch® meter is an Over-The-Counter (OTC), handheld device that along with the primary components of the system, monitors glucose in the blood to help with the management and treatment of diabetes. The In Touch® meter also incorporates additional features to aid in self-monitoring of blood glucose including tables and logs, graphs, and a pedometer.
The test principle is based on electrochemical biosensor technology and the principle of capillary action. The electrical current generated by the reaction of glucose with the reagent of the strip is measured by the meter and is displayed as the corresponding blood glucose level. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. These blood glucose measurements are obtained through the use of disposable test strips.
These blood glucose levels are displayed on the screen and stored in In Touch® meter's memory. In addition to the immediate read-out on In Touch® meter's display, the readings can also be transmitted securely over the GSM cellular network to a secure server. The use on the GMS connection also provides the ability for direct feedback from the server to the In Touch® meter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
Adults and Children
Intended User / Care Setting
persons with diabetes in home settings
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 was conducted on the In Touch® to show substantial equivalence to the predicate device, including:
- Software verification and validation testing (IEC 62304, FDA Guidance, 5/2005)
- Electromagnetic Compatibility Study (ISO 15197, IEC 61326-1)
- Electrical Safety testing (IEC 61010-1, IEC 61010-2-101, IEC 62133, UL 61010-1, CSA C22#61010-1)
- Cleaning and Disinfection testing (FDA Guidance, 1/2014)
- Precision Evaluation (ISO 15197)
- Linearity Evaluation (ISO 15197)
- Accuracy Evaluation (non-user) (ISO 15197)
- Hematocrit Evaluation (ISO 15197)
- Interference Study (CLSI EP7-A2)
- Operating Temperature and Humidity Study (ISO 15197)
- Robustness Evaluation (FDA Guidance, 1.2014)
- FLEX Studies: Vibration and Drop Testing (FDA Guidance, 1/2014)
- Human Factors Studies (FDA Guidance, 6/2011)
- Transport Packaging (ISTA Standard 2A)
Key results from non-clinical studies:
- Precision Evaluation: The subject device within-run and between-run tests over the blood glucose concentration range of 20-600 mg/dL and Control Levels 1 and 2 showed less than 1.5% coefficient of variation within runs and between runs compared to the mass spectrometry and/or YSI reference standards over the course of ten days and less than 1.5% coefficient of variation with the predicate device.
- Linearity Evaluation: The In Touch® meter was shown to demonstrate high linearity over the range 10.46 mg/dL to 672.9 mg/dL. Linear regression showed a correlation of r²=0.9995 compared to the mass spectrometry reference standard and correlation of r =0.9988 with the predicate device over the range 24 mg/dL to 560 mg/dL, and a correlation coefficient of r'= 0.9986 over the range 10.46 mg/dL to 672.9 mg/dL compared to the YSI STAT standard reference.
- Accuracy Evaluation (non-user): The In Touch® meter was 100% accurate within ±15 mg/dL at blood glucose concentrations 3 mg/dL. Ascorbic acid levels > 3 mg/dL will interfere with the glucose reading.
- Operating Temperature and Humidity Study: Confirmed operation for temperature range of 5-45ºC and relative humidity range of 10-90%, noncondensing.
- Robustness Evaluation: Demonstrated robustness to cleaning, disinfection, and handling under simulated conditions, meeting acceptance criteria for cleaning and disinfection after 1,825 cleaning cycles.
- Flex Studies: Performance was unaffected by mechanical vibration testing (50 devices tested) or aging test (43°C for 120 days).
Clinical Performance Characteristics:
Lay Accuracy Evaluation (lay user): A system evaluation was performed per FDA's Draft Guidance Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring systems and ISO 15917. The study was performed using capillary whole blood from fingertip sample sites.
- Lay User Fingertip Site: System Accuracy Results for Glucose Concentration ≥75mg/dL
- Within ± 5%: 68/93 (73.1%)
- Within ± 10%: 87/93 (93.5%)
- Within ± 15%: 92/93 (98.9%)
- Within ± 20%: 93/93 (100.0%)
- Lay User Fingertip Site: System Accuracy Results for Glucose Concentration
§ 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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2014
EOSHEALTH, INC. CARRIE HETRICK SENIOR CONSULTANT, RA, C/O EMERGO GROUP 816 CONGRESS AVE, STE 1400 AUSTIN, TX 78701
Re: K133584
Trade/Device Name: In Touch Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: August 26, 2014 Received: August 27, 2014
Dear Ms. Hetrick:
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 (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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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. 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.
Courtney
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
2
Indications for Use
510(k) Number (if known) K133584
Device Name In Touch® Blood Glucose Monitoring System
Indications for Use (Describe)
The In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch® BGMS is intended to be used by a single person and should not be shared.
The In Touch® Blood Glucose Test Strips (In Touch® strips) are used with the In Touch® Blood Glucose Meter (In Touch® meter) in the quantitative measurement of glucose in fresh capillary blood from the fingertip.
The In Touch® Control Solution is for use with the In Touch® strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
Type of Use (Select one or both, as applicable)
- Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
for
In Touch® Blood Glucose Monitoring System
1. Submission Submitter
EosHealth, Inc. Williams Tower, 41st Floor 2800 Post Oak Boulevard Houston, Texas 77056 USA Phone: +1 (866) 435.5643 Email: https://www.eoshealth.com Contact: Kimon Angelides, Chief Scientific Officer
2. Submission Correspondent
Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: +1 (720) 838.4113 Office Phone: +1 (512) 327.9997 Fax: +1 (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com
3. Date Prepared
September 4, 2014
4. Proprietary and Established Names
In Touch® Blood Glucose Monitoring System
5. Regulatory Information
| Trade / Proprietary
Name | Classification | Regulation
Section | Product Code | Panel |
|--------------------------------------------------------------|----------------|-----------------------|-------------------------------------------------------|-------------------------------|
| In Touch® Blood Glucose
Monitoring System | Class II | 21 CFR §
862.1345 | NBW; System, Test, Blood
Glucose, Over The Counter | Clinical
Chemistry
(75) |
| In Touch® Blood Glucose
Meter (In Touch® Meter) | Class II | 21 CFR §
862.1345 | NBW; System, Test, Blood
Glucose, Over The Counter | Clinical
Chemistry
(75) |
| In Touch® Blood Glucose
Test Strips (In Touch®
Strips) | Class II | 21 CFR §
862.1345 | CGA; Glucose Oxidase,
Glucose | Clinical
Chemistry
(75) |
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| Trade / Proprietary
Name | Classification | Regulation
Section | Product Code | Panel |
|-------------------------------|----------------|-----------------------|------------------------------------------------------------------------|-------------------------------|
| In Touch® Control
solution | Class I | 21 CFR §
862.1660 | JJX; Single (Specified)
Analyte Controls (Assayed
And Unassayed) | Clinical
Chemistry
(75) |
6. Indication for Use Statement
The In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch® BGMS is intended to be used by a single person and should not be shared.
The In Touch® Blood Glucose Test Strips (In Touch® strips) are used with the In Touch® Blood Glucose Meter (In Touch® meter) in the quantitative measurement of glucose in fresh capillary blood from the fingertip.
The In Touch® Control Solution is for use with the In Touch® meter and In Touch® strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
7. Device Description
The EosHealth, Inc. In Touch® BGMS, is an Over-The-Counter (OTC) system designed for the self-monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management. The system consists of the following components:
- In Touch® Blood Glucose Meter (In Touch® meter)
- In Touch® Blood Glucose Test Strips ●
- In Touch® Lancing Device ●
- In Touch® Lancets ●
- In Touch® Level 1 Control Solution
- In Touch® Level 2 Control Solution
- AC Adapter (wall charger) and USB Charger
- Carrying Case
- . In Touch® Data Management System (optional accessory to the In Touch® BGMS)
The In Touch® meter is an Over-The-Counter (OTC), handheld device that along with the primary components of the system, monitors glucose in the blood to help with the management and treatment of diabetes. The In Touch® meter also incorporates additional features to aid in self-monitoring of blood glucose including tables and logs, graphs, and a pedometer.
The test principle is based on electrochemical biosensor technology and the principle of capillary action. The electrical current generated by the reaction of glucose with the reagent of the strip is measured by the meter and is displayed as the corresponding blood glucose
6
level. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. These blood glucose measurements are obtained through the use of disposable test strips.
These blood glucose levels are displayed on the screen and stored in In Touch® meter's memory. In addition to the immediate read-out on In Touch® meter's display, the readings can also be transmitted securely over the GSM cellular network to a secure server. The use on the GMS connection also provides the ability for direct feedback from the server to the In Touch® meter.
8. Legally Marketed Predicate Device(s)
ACON Laboratories, Inc. On Call® Vivid Blood Glucose Monitoring System, 510(k) Number K112653
ACON Laboratories, Inc. On Call® Diabetes Management Software, 510(k) Number K101371
9. In Touch® Substantial Equivalence Discussion
The comparison chart below provides information to demonstrate the substantial equivalence between the In Touch® Blood Glucose Monitoring System to the predicate device, the ACON On Call® Vivid Blood Glucose Monitoring System (K112653) with respect to intended use, technological characteristics, and principles of operation.
| Comparator | EosHealth, Inc. | ACON Laboratories, Inc. |
|---|---|---|
| Trade Name | In Touch® Glucose Monitoring System | On Call® Vivid Glucose Monitoring System |
| 510(k) Number | K133584 | K112653 |
| Product Code | NBW - System, Test, Blood Glucose, Over the Counter | NBW - System, Test, Blood Glucose, Over the Counter |
| Regulation Number | 21 CFR § 862.1345 | 21 CFR § 862.1345 |
| Panel | Clinical Chemistry (75) | Clinical Chemistry (75) |
| Over-the-Counter (OTC) and/or Rx | OTC | OTC |
| Indications for Use | The In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch® BGMS is intended to be used by a single person | The On Call® Vivid Blood Glucose Monitoring System uses an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip, forearm, and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly). The On Call®) Vivid Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing |
| Comparator | EosHealth, Inc. | ACON Laboratories, Inc. |
| and should not be shared. | multiple patients. It is for in vitro | |
| diagnostic use only. | ||
| The On Call® Vivid Blood Glucose | ||
| Monitoring System should not be used for | ||
| the diagnosis of or screening for diabetes | ||
| mellitus or neonatal use. | ||
| The In Touch® Blood Glucose Test Strips | ||
| (In Touch® strips) are used with the In | ||
| Touch® Blood Glucose Meter (In Touch® | ||
| meter) in the quantitative measurement | ||
| of glucose in fresh capillary blood from | ||
| the fingertip. | The On Call® Vivid Blood Glucose Test | |
| Strips are used with the On Call Vivid | ||
| Blood Glucose Meter in the quantitative | ||
| measurement of glucose in fresh capillary | ||
| blood from the fingertip, forearm, and | ||
| palm. | ||
| The In Touch® Control Solution is for use | ||
| with the In Touch® meter and In Touch® | ||
| strips as a quality control check to verify | ||
| that the meter and test strips are working | ||
| together properly and that the test is | ||
| performing correctly. | The On Call® Vivid Blood Glucose Control | |
| Solution is for use with the On Call® Vivid | ||
| Blood Glucose Meter and Test Strips as a | ||
| quality control check to verify that the | ||
| meter and test strips are working together | ||
| properly and that the test is performing | ||
| correctly. | ||
| Intended Users | Adults and Children | Adults and Children |
| Blood Glucose | ||
| Meter | In Touch® meter | On Call® Vivid meter |
| Test Strip | In Touch® Blood Glucose Test Strip* | ACON On Call® Vivid Blood Glucose Test |
| Strip (K112653) | ||
| Control | ||
| Solution | In Touch® Level 1 and Level 2 Control | |
| Solution* | On Call® Level 1 and Level 2 Control | |
| Solution | ||
| AC Adapter | AC Adapter (wall charger)** | None |
| USB Charger | USB Charger** | None |
| Carrying Case | Carrying Case** | Carrying Case |
| Technical | ||
| Support | Yes | Yes |
| User's Manual | Available on Internet while using program | Available on Internet while using program |
| Glucose | ||
| Methodology | Electrochemical enzymatic assay, Glucose | |
| Oxidase | Electrochemical enzymatic assay, Glucose | |
| Oxidase | ||
| Glucose Test | ||
| Results | mg/dL (Plasma values) | mg/dL (Plasma values) |
| Sample | Fresh Capillary whole blood | Fresh capillary whole blood |
| Blood Source | Fingertip | Fingertip, Forearm, Palm |
| Glucose | ||
| Minimum | ||
| Sample | ||
| Volume | 0.8 μL | 0.8 μL |
| Glucose Test | ||
| Range | 20 to 600 mg/dL (1.1-33.3 mmol/L) | 20 to 600 mg/dL (1.1-33.3 mmol/L) |
| Length of Test | 5 seconds | 5 seconds |
| Glucose Test | ||
| Strips Active | ||
| Reagent | Glucose Oxidase | Glucose Oxidase |
| Test Strip | ||
| Calibration | ||
| Coding | No Code | No Code |
| Comparator | EosHealth, Inc. | ACON Laboratories, Inc. |
| Glucose Test | ||
| Imprecision | 6% or 5.4 mg/dL (whichever is greater) | |
| CV @75 mg/dL | ||
| 3.68% | 6% or 5.4 mg/dl (whichever is greater) | |
| Glucose Test | ||
| Linearity | From 20-600 mg/dL 95% CI, r2=0.9986; | |
| mean slope 1.004±0.008 (95% CI), | ||
| intercept 2.36 | From 20-600 mg/dL 95% CI, r2=0.988; | |
| mean slope 0.99, intercept 6.0 | ||
| Glucose Test | ||
| Accuracy | 75 mg/dL 99.7% within ±15% | 75 mg/dL 100% within ±15% |
| Acceptable | ||
| Hematocrit | ||
| Range | 20% to 70% | 20% to 70% |
| Meter | ||
| Operating | ||
| Temperature | 41°F to 113°F (5°C to 45°C) | 41°F to 113°F (5°C to 45°C) |
| Meter | ||
| Operating | ||
| Relative | ||
| Humidity | 10% to 90% non-condensing | 10% to 90% non-condensing |
| Operating | ||
| Altitude | Up to 8,546 ft. (2,595 m) | Up to 8,546 ft. (2,595 m) |
| Dimensions | 3.6 x 2.3 x 0.9 in (91.4 x 58.4 x 22.9 mm) | 3.58" x 2.28" x 0.83" |
| Weight | 2.65 oz. (75 g) | Approximately 60 g (without battery |
| installed) | ||
| Display | ||
| language | English | English |
| Data display | Numerical & Icons | Numerical & Icons |
| Display | Color LCD-Touch | B & W LCD |
| Data Output | ||
| Port | GPRS Telit 865 QUAD GSM | USB, 9600 baud, 8 data bits, 1 stop bit, no |
| parity | ||
| Monitor data | ||
| storage | 1000 results with time and date | 500 results with time and date |
| Day average | 7-, 14-, 30-, 60-, 90- day average glucose | |
| result | 7-, 14-, 30-, 60-, 90- day average glucose | |
| result | ||
| Insulin Logging | Yes | No |
| Pedometer | Pedometer | Not applicable |
| Battery Type | 3.7 Li-Polymer Battery 1100 mAh, | |
| rechargeable, permanently installed | Two (2) CR 2032 3.0V coin cell batteries, | |
| 250 mA | ||
| Battery Charge | ||
| Time | 2 hours | Not applicable |
| Rated | IEC 61010-1, IEC 61010-2-101, IEC 61326 | IEC 61010-1, IEC 61010-2-101, IEC 61326 |
| Test Strips | ||
| Storage | ||
| Temperature | ||
| Range | 41°F to 86°F (5°C to 30°C) | 41°F to 86°F (5°C to 30°C) |
Table 1: Comparison of In Touch® Characteristics with Predicate Device
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The In Touch® Blood Glucose Monitoring System's Indications for Use statement is similar to the predicate device with minor variation. The device also has similar technological characteristics as the predicate device with minor variation. Both devices have similar firmware and utilize the same blood glucose test strips, lancing devices, lancets, and control solution. The data collection software functionality, communication method with data
9
management software functionality, communication method with the central server, implementation method of collecting data from the test strips, monitor software, connectivity, and communication are similar to the predicate device with minor variation. The subject and predicate devices use exactly the same firmware embedded in the same microcontroller that recognizes the same blood glucose strip, and no other, the same algorithm to calculate blood glucose, and all corrections including those for hematocrit.
Although the In Touch® device differs with a more vibrant and easier to use user interface, uses plain language rather than "device" codes, easy to find control buttons, icons, and a 16-bit color touch display, it is very similar in all other electronic, and technological characteristics related to blood glucose measurements of the predicate devices to assure equivalence. Performance data are provided to support this. The results of all non-clinical and clinical performance testing demonstrate substantial equivalence.
10. Non-Clinical Performance Characteristics
Non-clinical testing was conducted on the In Touch® and to show substantial equivalence to the predicate device:
- Software verification and validation testing (IEC 62304, FDA Guidance, 5/2005)
- Electromagnetic Compatibility Study (ISO 15197, IEC 61326-1)
- . Electrical Safety testing (IEC 61010-1, IEC 61010-2-101, IEC 62133, UL 61010-1, CSA C22#61010-1)
- Cleaning and Disinfection testing (FDA Guidance, 1/2014)
- Precision Evaluation (ISO 15197)
- Linearity Evaluation (ISO 15197)
- Accuracy Evaluation (non-user) (ISO 15197)
- Hematocrit Evaluation (ISO 15197)
- Interference Study (CLSI EP7-A2)
- Operating Temperature and Humidity Study (ISO 15197)
- Robustness Evaluation (FDA Guidance, 1.2014)
- FLEX Studies: Vibration and Drop Testing (FDA Guidance, 1/2014) ●
- Human Factors Studies (FDA Guidance, 6/2011)
- Transport Packaging (ISTA Standard 2A)
Testing demonstrated the In Touch® Blood Glucose Monitoring System meets all relevant standards requirements. Internal verification and validation testing confirms that the product specifications are met which are equivalent in design and technological characteristics to the predicate device. The testing results support that the disinfection, electrical safety testing, and functional testing of the monitor all met or exceeded the standards for the acceptance of the device. Testing of the In Touch® Blood Glucose Monitoring System supports the claims of substantial equivalence to the predicate device. Evaluation of the performance characteristics establishes that the performance, functionality and reliability of the In Touch® Blood Glucose Monitoring System are substantially equivalent to the predicate device. The evaluation included precision, linearity, accuracy, humidity and temperature, and hematocrit. The In Touch® Data Management System (DMS) (optional) software verification and validation demonstrated safety and effectiveness of the In Touch® DMS remote database and substantial equivalence to the predicates ACON On Call® Diabetes Management Software (K101371).
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Software: All documentation was prepared and submitted for the device in accordance with FDA guidance documents. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The device Hazard analysis was completed, and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The In Touch® Blood Glucose Monitor System device passed all testing and supports the claim of substantial equivalence and safe operation.
Electrical safety: The In Touch® Blood Glucose Monitoring System device complies with the applicable voluntary standards for Electromagnetic Compatibility, and Electrical Safety. The device passed all the electrical and safety testing according to national and international standards including IEC 61010-1 and IEC 61010-2. The Li-polymer battery is certified to IEC 62133 standards for medical devices.
Electromagnetic interference: The In Touch® Blood Glucose Monitoring System device has been tested and successfully met all of the relevant sections (Radiated Emissions, Electro Static Discharge Immunity Test, Radiated Radio-Frequency Electromagnetic Immunity, and Power Frequency Magnetic Field Immunity Test) to complies to all standards including EN 55011 ISM RF, IEC 60601-1-2, IEC 60610-1, IEC 60610-2-101, EN 6100-3-2 EMC, EN 6100-3-3 EMC Part 3-3, IEC 61326-1, and IEC 61326-2-6.
Disinfection/Cleaning: The In Touch® Blood Glucose Monitoring System device is intended for single-patient use. Disinfection studies showed that Dispatch® Hospital Cleaner Disinfectant Towels with Bleach disposable wipes (EPA Reg. No: 56392-8) were effective in reducing the risk of blood borne pathogens, particularly hepatitis B virus (HBV). The studies showed complete inactivation of live virus for use with the meter and lancing device.
Precision Evaluation: The In Touch® meter was evaluated in accordance with NCCLS EP5-A User Evaluation of Precision Performance of Clinical Chemistry Devices and ISO 15197:2013. The subject device within-run and between-run tests over the blood glucose concentration range of 20-600 mg/dL and Control Levels 1 and 2 showed less than 1.5% coefficient of variation within runs and between runs compared to the mass spectrometry and/or YSI reference standards over the course of ten days and less than 1.5% coefficient of variation with the predicate device.
Linearity Evaluation: The In Touch® meter was tested to determine the linearity in accordance with CLSI document EP6-A, "Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach" v23, no 16, and ISO 15197: 2003. The In Touch® meter was shown to demonstrate high linearity over the range 10.46 mg/dL to 672.9 mg/dL. The claimed blood glucose measuring range is 20 to 600 mg/dL, as with the predicate device. Linear regression showed a correlation of r²=0.9995 compared to the mass spectrometry reference standard and correlation of r =0.9988 with the predicate device over the range 24 mg/dL to 560 mg/dL, and a correlation coefficient of r'= 0.9986 over the range 10.46 mg/dL to 672.9 mg/dL compared to the YSI STAT standard reference.
Accuracy Evaluation (non-user): The In Touch® meter was evaluated for accuracy (non-user) using YSI as the reference standard. The In Touch® meter was 100% accurate within ±15
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mg/dL at blood glucose concentrations 3 mg/dL (above therapeutic levels). Ascorbic acid levels > 3 mg/dL will interfere with the glucose reading; therefore, the following limitation has been included in the labeling:
"Ascorbic acid (vitamin C) (when occurring in blood at normal or at high therapeutic concentration) do not significantly affect results. However, abnormally high concentration ) in blood may cause inaccurately high results."
Operating Temperature and Humidity Study: This study confirmed the operation of the In Touch® Blood Glucose Monitoring System for the temperature range of 5-45ºC and the relative humidity range of 10-90%, noncondensing.
Robustness Evaluation: In Touch® demonstrated robustness to cleaning, disinfection, and handling under simulated conditions. The subject device was found to be substantially equivalent to the predicate device across the entire claimed measuring range, before and after the 1,825 cleaning cycles of cleaning and disinfection with Dispatch® Hospital Cleaner Disinfectant Towels with Bleach disposable wipes (EPA Reg. No: 56392-8).The In Touch® Blood Glucose Meter is robust to multiple cleaning and disinfection cycles under normal user simulated conditions of a 5 year period with no alteration in the physical, operational, mechanical, or analytical performance characteristics and meets the acceptance criteria for cleaning and disinfection.
Flex Studies: The In Touch® Blood Glucose Monitoring System was examined to test the operational limits of the system and to validate the insensitivity of the system to performance variation under stress conditions. Accordingly, the following were carried out:
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- Risk Analysis, a systematic and comprehensive risk analysis that has identified all potential sources of error, including test system failures and operator error. Control measures are identified including fail-safe and failure alert mechanisms;
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- Mechanical Vibration testing. Fifty (50) In Touch® devices were subjected to 0.7 mm amplitude, 1 cycle, 10-60 MHz, 2 minutes for a total of 1.5 hours;
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- Aging test at 43°C for 120 days. All studies showed the performance to be unaffected by vibration or aging.
Human Factors Studies: A number of ergonomic factors were tested with users including meter size, display size, the placement of buttons, height of the numerals, and meter carrying case. The studies show that users find In Touch® to be easy to use and that the ergonomic factors designed into the system reduce user error through clear display and easy to understand language. The usability testing and results were considered in the Risk Analysis. As problems were identified, both software and mechanical changes were made.
ISTA Standard 2A Transportation & Packaging: Testing demonstrated compliance with ISTA Standard 2A, Partial Simulation Performance Testing for Medical Devices.
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Summary: All testing met acceptance criteria. The In Touch® Blood Glucose Monitoring System is substantially equivalent to the predicate devices that are subject to this 510(k) submission. The In Touch® Blood Glucose Monitoring System meets all the requirements for the overall design, disinfection/cleaning, biocompatibility and electrical safety and confirms that the output meets the design inputs and specifications. The In Touch® Blood Glucose Monitoring System passed all testing stated above as shown by the acceptable results obtained.
The In Touch® Blood Glucose Monitoring System complies with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.
11. Clinical Performance Characteristics
As part of demonstrating safety and effectiveness of In Touch® and to show substantial equivalence to the predicate devices, EosHealth completed the following clinical performance testing:
Lay Accuracy Evaluation (lay user): A system evaluation (Method Comparison of subject device verses a reference standard) of lay user accuracy and performance was performed on the In Touch® Blood Glucose Monitoring System per FDA's Draft Guidance Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring systems and ISO 15917.
The user performance study demonstrated that lay consumers could obtain accurate results using the In Touch® Blood Glucose Monitoring System and meet the ISO 15197:2003 and ISO 15197:2013 accuracy standards, as well as meeting the current FDA standards (2003) and those proposed in the Guidance Document issued January 2014. The study was performed using capillary whole blood from fingertip sample sites.
| Lay User Fingertip Site: System Accuracy Results for Glucose Concentration ≥75mg/dL | |||
|---|---|---|---|
| Within ± 5% | Within ± 10% | Within ± 15% | Within ± 20% |
| 68/93 (73.1%) | 87/93 (93.5%) | 92/93 (98.9%) | 93/93 (100.0%) |
| Lay User Fingertip Site: System Accuracy Results for Glucose Concentration |