INTOUCH DIABETES

K093789 · Symcare Personalized Health Solutions, Inc. · NBW · Feb 19, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093789
• Device Name: INTOUCH DIABETES
• Applicant: Symcare Personalized Health Solutions, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

InTouch™•diabetes is intended for use in home settings to aid people with diabetes and healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data management capabilities. This system is intended for use by people 18 years of age and older. InTouch™•diabetes is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Device Story

InTouch™•diabetes is an online diabetes management tool for home use by patients (18+) and healthcare professionals. It functions as an accessory to blood glucose meters; data is transmitted from the meter via a Bluetooth accessory (Polymap Wireless Polytel® GMA) to a cellular phone, then uploaded to a central repository database. The system analyzes blood glucose readings to identify health patterns and trends; these are displayed visually alongside educational content. The device facilitates communication between patients and caregivers/educators. It does not provide treatment recommendations, insulin dosing advice, or alerts/alarms. Healthcare providers use the displayed data to support clinical decision-making and patient self-management activities. The system is designed to improve patient understanding of their condition through trend visualization and interactive communication.

Clinical Evidence

No clinical efficacy data provided. Evidence consists of a human factors/usability study to assess device comprehensibility and identify areas for modification. A readability assessment of the user manual and website was conducted using the Fry Scale, resulting in a 9th-grade level for the manual and 7th-8th grade level for the website. Non-clinical testing included extensive software verification and validation (unit, integration, system, load, and user acceptance testing).

Technological Characteristics

System consists of a mobile application, central repository database, and website. Connectivity via Bluetooth (Polymap Wireless Polytel® GMA). Software-based data processing module for clinical use. Operates on cellular phones and web-accessible platforms. Complies with HIPAA privacy requirements.

Indications for Use

Indicated for people 18 years of age and older with diabetes to aid in the review, analysis, and evaluation of historical blood glucose test results in home settings. Not for treatment decisions or as a substitute for professional healthcare judgment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• SymCare Diabetes Management Program (DMP) V2.03 (K083263)
• MCT Diabetes Version 2.0 (K073699)
• Think Positive (t+) Diabetes Management System (K061328)

Reference Devices

• Polymap Wireless Polytel® GMA Glucose Meter Accessory (K091296)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY INSTRUMENT ONLY TEMPLATE

A. 510(k) Number:
k093789

B. Purpose for Submission:
Symcare is seeking OTC clearance for the InTouch (formerly Symcare) Diabetes Management Program cleared for prescription use under k083263 using the Polymap Wireless Polytel GMA glucose meter data transmission accessory originally cleared under k070559 for prescription use and more currently cleared for OTC use under k091296.

The Symcare Diabetes Management Program has been renamed InTouch Diabetes Management Program.

C. Manufacturer and Instrument Name:
Symcare Personalized Health Solutions, Inc
InTouch Diabetes

D. Type of Test or Tests performed:
Glucose data transmission

E. System Descriptions:

1. Device Description:
The InTouch Diabetes Management Program (DMP) is an online tool that helps patients to manage their diabetes and communicate their blood glucose readings to their invited healthcare professionals, who they partner with in managing their diabetes. A validated blood glucose meter connected via a Bluetooth accessory, “the Polymap Wireless Polytel Glucose Meter Accessory (GMA)” (k091296), to a validated cellular phone, is used to transmit glucose readings from the glucose meter to the DMP online system, which is accessible by the healthcare provider, as well as the patient.

2. Principles of Operation:
Not applicable

3. Modes of Operation:
Not applicable

4. Specimen Identification:
Not applicable

5. Specimen Sampling and Handling:

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Not applicable

6. Calibration:
Not applicable

7. Quality Control:
External quality control is not applicable for data transmission.

8. Software:
FDA has reviewed the applicant’s Hazard Analysis and software
Documentation: Yes ☐ X or No ☐

Subject of k083263 review

F. Regulatory Information:

1. Regulation Section:
21CFR §862.1345 -Glucose test system.
21CFR §862.2100 - Calculator/Data Processing Module for Clinical Use.

2. Classification:
Class 2, I respectively

3. Product Code:
NBW, JQP

4. Panel:
Chemistry (75)

G. Intended Use:

1. Indication(s) for Use:

InTouch Diabetes Management Program is intended for use in home settings to aid people with diabetes and healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data management capabilities. This system is intended for use by people 18 years of age and older. InTouch Diabetes Management Program is not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment. All patient medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

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2. Special Condition for use Statement(s):
None

H. Substantial Equivalence Information:

1. Predicate device name(s) and 510(k) numbers:
MCT Diabetes™ V2.0 k073699

2. Comparison with Predicate Device:

| | InTouch™•diabetes Version 2.1 | Original SymCare DMP 2.03 K083263 | MCT Diabetes™ V2.0 K073699 |
| --- | --- | --- | --- |
| Intended Users | Home users, healthcare providers (including SymCare healthcare professionals), and insurance payers | Home users by prescription, healthcare providers (including SymCare healthcare professionals), and insurance payers | Home use or clinical assist diabetics, families, and professionals in management of blood glucose support diabetes management |
| Prescription or OTC Use | OTC & Prescription | Prescription | OTC |
| Software Use | Single (individual) or multiple user (clinical) settings | Single (individual) or multiple user (clinical) settings | Single (individual) or multiple user (clinical) settings |
| Installation of Program | Internet link | Internet link | Internet link |
| Communication Method | Cellular phone | Cellular phone | Cellular phone |
| Connectivity | Bluetooth | Bluetooth | Bluetooth |
| Display | Cellular telephone and monitors connected to a central server | Cellular telephone and monitors connected to a central server | Cellular telephone and monitors connected to a central server |
| Type of devices that can be interfaced | LifeScan OneTouch® Ultra® and Ultra® II Meters
As additional software protocols are obtained and devices are validated, capabilities will be broadened to include other meters | LifeScan OneTouch® Ultra® and Ultra® II Meters
As additional software protocols are obtained and devices are validated, capabilities will be broadened to include other meters | Wide range of supported meters are listed on website;
As additional software protocols are obtained and devices are validated, capabilities will be broadened to include other meters |

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I. Standard/Guidance Document Referenced (if applicable):
None were referenced.

J. Performance Characteristics:

1. Analytical Performance:
a. Accuracy:
Not applicable
b. Precision/Reproducibility:
Not applicable
c. Linearity:
Not applicable
d. Carryover:
Not applicable
e. Interfering Substances:
Not applicable

2. Other Supportive Instrument Performance Data Not Covered Above:
Human Factors studies for the entire system with U.S. labeling, using lay people were performed to support the OTC claim.

K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

L. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.