SYMCARE DIABETES MANAGEMENT PROGRAM

K083263 · Symcare Personalized Health Solutions, Inc. · NBW · Mar 13, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083263
• Device Name: SYMCARE DIABETES MANAGEMENT PROGRAM
• Applicant: Symcare Personalized Health Solutions, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The SymCare 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. The SymCare 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.

Device Story

SymCare Diabetes Management Program (DMP) is an internet-based software tool for diabetes management. Input: blood glucose readings from meters via Polytel GMA Bluetooth accessory to a cellular phone. Process: mobile phone transmits data to a centralized repository database; system analyzes data to identify health patterns, trends, and provide personalized information. Output: trend reports and health information for patients, healthcare providers, and insurance entities. Used in home settings by patients; providers access data for clinical oversight. Benefits: facilitates remote monitoring and data-driven diabetes management. Does not provide treatment decisions; requires professional healthcare supervision.

Clinical Evidence

No clinical efficacy data provided. A usability study was conducted to evaluate human factors, comprehension of the system by doctors and patients, and ease of use. Results demonstrated appropriate human factors and system usability.

Technological Characteristics

Internet-based software device. Functions as an accessory to blood glucose meters. Connectivity via Bluetooth accessory (Polytel GMA) to cellular phone for data transmission to a centralized repository database.

Indications for Use

Indicated for people with diabetes aged 18 and older in home settings to assist patients and healthcare professionals in reviewing and evaluating historical blood glucose data for diabetes management.

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

• MCT-Diabetes™ by MyCare Team Inc. (K073699)
• Think Positive (t+) Diabetes Management System by e-San Limited (K061328)

Submission Summary (Full Text)

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## 510(k) Summary

| Date | March 9, 2008 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Rae Ann DeLay<br>Director, Quality, Regulatory and Health Care Compliance<br>SymCare Personalized Health Solutions, Inc.<br>200 Lawrence Drive<br>West Chester, PA 19380<br>Phone: [phone]<br>Email: [e-mail]. |
| Device Name | SymCare Diabetes Management Program |
| Common Name | Accessory to glucose test system |
| Classification | 862.1345 - Glucose Test System - Class II<br>862.2100 - Calculator/Data Processing Module for Clinical Use – Class I |
| Predicate Devices | <ul><li>MCT-Diabetes™ by MyCare Team Inc. cleared most recently via 510(k) K073699</li><li>Think Positive (t+) Diabetes Management System by e-San Limited cleared most recently via 510(k) K061328</li></ul> |
| Device Description | The SymCare Diabetes Management Program (DMP) is an online tool that helps patients to manage their diabetes and communicate their blood glucose readings to their healthcare providers, healthcare providers manage their diabetes patient population, and insurance companies manage their diabetes patient and health care provider populations. The DMP enables a blood glucose meter to connect via a Bluetooth accessory, the Polymap Wireless |

Polytel® GMA Glucose Meter Accessory (GMA), to a cellular phone. Once the mobile phone has gathered the data from the meter, it transmits the data to a centralized repository database. The data is analyzed to recognize health patterns, show trends, and offer personalized health information.

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Kor 3263

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# 510(k) Summary, Continued

| Indications | The SymCare Diabetes Management Program is intended for use in home<br>settings to aid people with diabetes and healthcare professionals in the review-<br>analysis and evaluation of historical blood glucose test results to support<br>effective diabetes management. It is intended for use as an accessory to blood<br>glucose meters with data management capabilities. This system is intended<br>for use by people 18 years of age and older. The SymCare Diabetes<br>Management Program is not intended to provide treatment decisions or to be<br>used as a substitute for professional healthcare judgment. All patient medical<br>diagnoses and treatment are to be performed under the supervision and<br>oversight of an appropriate healthcare professional. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | The SymCare Diabetes Management Program, like the predicate devices, is<br>an internet-based software device. |
| Nonclinical<br>Tests | Extensive software verification and validation testing was conducted and<br>demonstrated compliance to requirements and design specifications. |
| Clinical Tests | A study to measure the usability of the SymCare DMP was conducted. The<br>study demonstrated:<br>• comprehension of the study doctors, medical team members, and<br>participants with the DMP,<br>• appropriate human factors related to the DMP, and<br>• ease of use of the DMP. |
| Conclusions | In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR<br>Part 807, and based on the information provided in this premarket<br>notification, SymCare Personalized Health Solutions, Inc., concludes that the<br>new device, the SymCare Diabetes Management Program, is safe, effective<br>and substantially equivalent to the predicate devices as described herein. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 3 2009

Symcare Personalized Health Solutions, Inc . c/o Rae Ann DeLay Director, Quality, Regulatory & Health Care Compliance 200 Lawrence Drive West Chester, PA 19380

Re: k083263

> Trade/Device Name: Symcare Diabetes Management Program Regulation Number: 21CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, JOP Dated: February 27, 2009 Received: March 2, 2009

Dear Ms. DeLay:

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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part.1807.97). 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 the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

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

产品的技术的

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### Indication for Use

#### 510(k) Number (if known): k083263

Device Name: SymCare Diabetes Management Program

Indication For Use:

The SymCare 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. The SymCare 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.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Ruth Chosler

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 0 83263