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

Intended 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)

{0}------------------------------------------------

16093785

SymCare Personalized Health Solutions, Inc. 965 Chesterbrook Blvd. Wayne, PA 19087

# FEB 1 9 2010

InTouch™+diabetes
Traditional 510(k) December 8, 2009

### 5.0 510(K) SUMMARY

| Submitter's Name | SymCare Personalized Health Solutions, Inc. |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 965 Chesterbrook Blvd.<br>Wayne, PA 19087 |
| Establishment<br>Registration Number | 3007710797 |
| Date of Summary | 08-December-2009 |
| Telephone Number<br>Fax Number | 484.686.4650<br>610.455.2334 |
| Contact Person | Rae Ann DeLay, Director Quality, Regulatory & Compliance |
| Name of the Device | InTouch™•diabetes Version 2.1 |
| Common or Usual Name | Accessory to a glucose test system |
| Classification Name | Glucose Test System, 21 CFR 862.1345, Class II<br>Product Code: NBW<br>Calculator/Data Processing Module for Clinical Use,<br>21 CFR 862.2100, Class I, Product Code: JQP |
| Performance Standards | There are no performance standards promulgated for this device. |
| Indications for Use | InTouch™•diabetes is intended for use in home settings to aid<br>people with diabetes and healthcare professionals in the review,<br>analysis and evaluation of historical blood glucose test results to<br>support effective diabetes management. It is intended for use as an<br>accessory to blood glucose meters with data management<br>capabilities. This system is intended for use by people 18 years of<br>age and older. InTouch™•diabetes is not intended to provide<br>treatment decisions or to be used as a substitute for professional<br>healthcare judgment. All patient medical diagnoses and<br>treatment are to be performed under the supervision and<br>oversight of an appropriate healthcare professional. |
| Identification of the<br>Legally Marketed Device<br>(Predicate Device) | • SymCare Diabetes Management Program(DMP) V2.03,<br>K083263<br>• MCT Diabetes Version 2.0; K073699<br>• Think Positive (t+) Diabetes Management System, K061328 |

.

{1}------------------------------------------------

SymCare Personalized Health Solutions, Inc. 965 Chesterbrook Blvd. Wayne, PA 19087

#### 510(k) SUMMARY, continued

- InTouch™ediabetes 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.
- . InTouch™diabetes enables a blood glucose meter to connect via a Bluetooth accessory, the Polymap Wireless Polytel® GMA Glucose Meter Accessory (GMA), to a cellular phone in order to transmit meter readings to online system, which is accessible by the the InTouch™.diabetes healthcare provider as well as the patient. The Polymap Wireless Polytel® GMA(s) that are utilized by InTouch™.diabetes are currently marketed accessories cleared for OTC use via 510(k) K091296.
- Patients are offered insights into their condition and in partnership with . Device their HCPs can engage in new self-management activities, including Description . monitoring regimens. Education content and interactive communications with their caregivers, disease managers, or educators, are available.
- The InTouchTModiabetes application software that resides on the mobile . phone transmits the patient's blood glucose measurement data from a glucose meter to the InTouch™, diabetes central repository database. The data is analyzed to recognize health patterns, show trends, and this information is displayed visually along with personalized health information and education.
- InTouch™odiabetes does not provide alerts/alarms, specific treatment or ● insulin does recommendations; or any advertisements and it meets the applicable HIPAA privacy requirements.

#### Substantial Equivalence

InTouch™.diabetes is similar to MCT-Diabetes K073699 and Think Positive (t+) Diabetes Management System K061328 in that all include software which is intended to assist in the review, analysis and evaluation of blood glucose test results. These systems share similar product components (cellular phone, blood glucose meter, website) and product interfaces (bluetooth connectivity). Both MCT-Diabetes K073699 and Think Positive (t+) Diabetes Management System K061328 are indicated for Over the Counter Use. inTouch™diabetes was cleared by the FDA under the previous name, SymCare Diabetes Management Program in K083263.

{2}------------------------------------------------

#### 510(k) SUMMARY, continued

#### Non-clinical Testing:

Extensive software verification and validation testing was conducted and demonstrated compliance to requirements and design specifications. This testing included unit, integration and system level testing as well as user acceptance and load testing.

#### Clinical Testing:

Description and Conclusion of Testing

A human factors/usability study was performed to measure the usability of the InTouch™diabetes and/or to identify critical areas that require modification to improve comprehensibility. Additionally, a readability assessment of the user manual and the website was performed using the Fry Scale. The readability for user manual is at the 9th grade level while the website is the between 7th and 8th grade levels. This labeling provides adequate directions for use for the intended user (people 18 years of age and older) to use InTouch™ediabetes safely and for the purposes for which it is intended.

#### Conclusion:

The successful non-clinical testing and clinical testing demonstrates the safety and effectiveness of the InTouch™diabetes Version 2.1 when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a bird in flight.

Symcare Personalized Health Solutions, Inc c/o Rae Ann Delay Quality, Regulatory & HealthCare Compliance 965 Chesterbrook Blvd. Wayne, PA 19087

#### Re: k093789

Trade/Device Name: Intouch Diabetes Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW, JQP Dated: December 8, 2009 Received: December 9, 2009

Dear: Ms. Delay:

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

FEB 1 9 2010

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 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.

{4}------------------------------------------------

#### Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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 [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications for Use

#### 510(k) Number (if known): k093789

Device Name: InTouchTModiabetes

Indications for Use:

In Touch™ diabetes is intended for use in home settings to aid people with diabetes and healthcare professionals in the review, 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, In Touch™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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __x_ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson

of In Vitro Diagnostic Device and Safety

Page 1 of

K 09 3789