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 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.

AI/ML Overview

The SymCare Diabetes Management Program is an online tool that helps patients manage their diabetes and communicate blood glucose readings to healthcare providers. It also assists healthcare providers and insurance companies in managing diabetes patient populations. The device connects a blood glucose meter via a Bluetooth accessory (Polytel® GMA Glucose Meter Accessory) to a cellular phone, which then transmits data to a centralized database for analysis, trend identification, and personalized health information.

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not specify quantitative acceptance criteria in terms of accuracy, sensitivity, or specificity for the SymCare Diabetes Management Program. Instead, the "Nonclinical Tests" and "Clinical Tests" sections describe the device's performance in terms of software verification, validation, and usability.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with software requirements and design specifications	Extensive software verification and validation testing conducted, demonstrating compliance.
Comprehension by study doctors, medical team members, and participants	Demonstrated comprehension of the DMP.
Appropriate human factors	Demonstrated appropriate human factors related to the DMP.
Ease of use	Demonstrated ease of use of the DMP.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for the Test Set: The document does not explicitly state the sample size for the usability study (referred to as "Clinical Tests"). It mentions "study doctors, medical team members, and participants," but gives no numbers.
Data Provenance: The document does not specify the country of origin for the data or whether the study was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, expert consensus on imaging) is not directly applicable here. The "Clinical Tests" section focuses on usability and comprehension.

Number of Experts: Not specified. The study involved "study doctors" and "medical team members."
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Since the study described is a usability study and not an evaluation of diagnostic accuracy, an adjudication method for establishing a "ground truth" (e.g., 2+1, 3+1) is not relevant or described. The study assessed comprehension, human factors, and ease of use.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided information. The study described focuses on the usability of the device for a single user (patient or healthcare professional).

6. Standalone Performance Study

A standalone performance study, in the sense of an algorithm-only performance without human-in-the-loop, is not explicitly described in terms of diagnostic accuracy. The "Nonclinical Tests" section refers to "extensive software verification and validation testing" demonstrating compliance to requirements and design specifications, which would cover software functionality and integrity. However, this is distinct from quantifying the clinical performance of an AI algorithm in isolation. The SymCare DMP is described as an "online tool that helps patients to manage their diabetes and communicate their blood glucose readings to their healthcare providers," implying a human-in-the-loop design where the data analysis is presented to and used by individuals.

7. Type of Ground Truth Used

The type of ground truth used is related to usability and comprehension assessments. The "Clinical Tests" evaluated:

Comprehension by users (doctors, medical team members, and participants) regarding the DMP.
Appropriateness of human factors.
Ease of use.

This is a qualitative form of "ground truth" based on user feedback and observation rather than a definitive medical outcome or diagnosis.

8. Sample Size for the Training Set

The document does not provide any information about a "training set" or sample size for it. This typically applies to machine learning models that are trained on data. While the device does "analyze data to recognize health patterns, show trends, and offer personalized health information," there is no description of an AI/ML model training process. The submission focuses on software validation and system usability.

9. How the Ground Truth for the Training Set Was Established

Since no training set is described or implies a machine learning model, information on how its ground truth was established is not applicable or provided.

Summary

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510(k) Summary

Date	March 9, 2008
Contact	Rae Ann DeLayDirector, Quality, Regulatory and Health Care ComplianceSymCare Personalized Health Solutions, Inc.200 Lawrence DriveWest Chester, PA 19380Phone: (484) 686-4650Email: rdelay@its.jnj.com.
Device Name	SymCare Diabetes Management Program
Common Name	Accessory to glucose test system
Classification	862.1345 - Glucose Test System - Class II862.2100 - Calculator/Data Processing Module for Clinical Use – Class I
Predicate Devices	MCT-Diabetes™ by MyCare Team Inc. cleared most recently via 510(k) K073699Think Positive (t+) Diabetes Management System by e-San Limited cleared most recently via 510(k) K061328
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.

Continued on next page

Kor 3263

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510(k) Summary, Continued

Indications	The SymCare Diabetes Management Program is intended for use in homesettings to aid people with diabetes and healthcare professionals in the review-analysis and evaluation of historical blood glucose test results to supporteffective diabetes management. It is intended for use as an accessory to bloodglucose meters with data management capabilities. This system is intendedfor use by people 18 years of age and older. The SymCare DiabetesManagement Program is not intended to provide treatment decisions or to beused as a substitute for professional healthcare judgment. All patient medicaldiagnoses and treatment are to be performed under the supervision andoversight of an appropriate healthcare professional.
TechnologicalCharacteristics	The SymCare Diabetes Management Program, like the predicate devices, isan internet-based software device.
NonclinicalTests	Extensive software verification and validation testing was conducted anddemonstrated compliance to requirements and design specifications.
Clinical Tests	A study to measure the usability of the SymCare DMP was conducted. Thestudy demonstrated:• comprehension of the study doctors, medical team members, andparticipants with the DMP,• appropriate human factors related to the DMP, and• ease of use of the DMP.
Conclusions	In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFRPart 807, and based on the information provided in this premarketnotification, SymCare Personalized Health Solutions, Inc., concludes that thenew device, the SymCare Diabetes Management Program, is safe, effectiveand 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 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.