(128 days)
Not Found
Unknown
The description mentions data analysis to "recognize health patterns, show trends, and offer personalized health information," which could involve AI/ML, but it doesn't explicitly state the use of these technologies. The lack of mention of AI, DNN, or ML, and the absence of details about training or test sets, make it impossible to definitively confirm the presence of AI/ML.
No.
The "Intended Use" states that the device is "not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment." It is an accessory for data review and analysis to support diabetes management.
No
The device is intended 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 explicitly states that it is "not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment." This indicates it is a data management and analysis tool, not a diagnostic device that makes medical diagnoses.
No
The device description explicitly states that the SymCare Diabetes Management Program enables a blood glucose meter to connect via a Bluetooth accessory, the Polymap Wireless Polytel® GMA Glucose Meter Accessory (GMA), to a cellular phone. This indicates the system includes hardware components beyond just software.
Based on the provided information, the SymCare Diabetes Management Program is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the program is for the "review, analysis and evaluation of historical blood glucose test results to support effective diabetes management." It is an accessory to blood glucose meters, which are the IVD devices that perform the actual diagnostic test (measuring blood glucose).
- Function: The device description explains that it gathers data from a blood glucose meter, transmits it, and analyzes it to show trends and patterns. It does not perform any diagnostic testing itself.
- Disclaimer: The intended use explicitly states that it is "not intended to provide treatment decisions or to be used as a substitute for professional healthcare judgment." IVD devices are used to provide information that informs diagnostic or treatment decisions, but this device is focused on managing and analyzing data after the diagnostic test has been performed by a separate device.
- Predicate Devices: The listed predicate devices (MCT-Diabetes and Think Positive) are also diabetes management systems, not IVD blood glucose meters.
In summary, the SymCare Diabetes Management Program is a data management and analysis tool that works with an IVD device (the blood glucose meter), but it is not an IVD itself.
N/A
Intended Use / Indications 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.
Product codes
NBW, JOP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age and older
Intended User / Care Setting
people with diabetes and healthcare professionals 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
A study to measure the usability of the SymCare DMP was conducted. The study demonstrated:
• comprehension of the study doctors, medical team members, and participants with the DMP,
• appropriate human factors related to the DMP, and
• ease of use of the DMP.
Summary of Performance Studies
Study type: Usability study.
Sample size: Not specified.
AUC: Not Found.
MRMC: Not Found.
Standalone performance: Not Found.
Key results: Demonstrated comprehension of the study doctors, medical team members, and participants with the DMP, appropriate human factors related to the DMP, and ease of use of the DMP.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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510(k) Summary
| Date | March 9, 2008 |
|---|---|
| Contact | Rae Ann DeLay |
| Director, Quality, Regulatory and Health Care Compliance | |
| SymCare Personalized Health Solutions, Inc. | |
| 200 Lawrence Drive | |
| West Chester, PA 19380 | |
| Phone: (484) 686-4650 | |
| Email: rdelay@its.jnj.com. | |
| Device Name | SymCare Diabetes Management Program |
| Common Name | Accessory to glucose test system |
| Classification | 862.1345 - Glucose Test System - Class II |
| 862.2100 - 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 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. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The SymCare Diabetes Management Program, like the predicate devices, is
an internet-based software device. |
| Nonclinical
Tests | Extensive software verification and validation testing was conducted and
demonstrated compliance to requirements and design specifications. |
| Clinical Tests | A study to measure the usability of the SymCare DMP was conducted. The
study demonstrated:
• comprehension of the study doctors, medical team members, and
participants 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 CFR
Part 807, and based on the information provided in this premarket
notification, SymCare Personalized Health Solutions, Inc., concludes that the
new device, the SymCare Diabetes Management Program, is safe, effective
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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Page - 2
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
4
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