(72 days)
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.
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 their HCPs can engage in new self-management activities, including 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.
The provided text describes the "InTouch™•diabetes Version 2.1" device, an accessory to a glucose test system intended for aiding people with diabetes and healthcare professionals in reviewing, analyzing, and evaluating historical blood glucose test results.
Here's an analysis of the acceptance criteria and the study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not explicitly state specific numerical acceptance criteria for the device's performance in terms of accuracy or efficacy (e.g., specific thresholds for blood glucose deviation, or target user comprehension percentages). Instead, the studies focused on software functionality and usability.
However, based on the general statements and the nature of the device (an accessory for data management, not a diagnostic tool), the implicit acceptance criteria are:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Equivalence | The device performs as well as, or better than, the legally marketed predicate device (SymCare Diabetes Management Program(DMP) V2.03, K083263; MCT Diabetes Version 2.0; K073699; Think Positive (t+) Diabetes Management System, K061328). |
| Software Functionality and Design Compliance | The software must meet all specified requirements and design specifications. |
| Usability | The device and its labeling (user manual, website) must be comprehensible and usable by the intended user (people 18 years of age and older) for safe and effective use. |
| Safety and Effectiveness | The device must be safe and effective for its intended use (review, analysis, and evaluation of historical blood glucose). |
| No Treatment Decisions/Alarms | The device must not provide alerts/alarms, specific treatment or insulin recommendations, or advertisements. Additionally, it must adhere to HIPAA privacy requirements. |
2. Sample Size for Test Set and Data Provenance
The document mentions "a human factors/usability study was performed" but does not specify the sample size for this study (the number of participants).
The document does not provide information on the data provenance (e.g., country of origin, retrospective or prospective data) for the usability study. It does discuss transmitting meter readings via a Bluetooth accessory and cellular phone, implying prospective data collection during use, but no details are given about the study's data collection methodology.
3. Number of Experts and Qualifications for Ground Truth
For the human factors/usability study, it's not explicitly stated that "experts" were used to establish ground truth in the traditional sense of clinical interpretations. Instead, the study measured the "usability of the InTouch™diabetes" and identified "critical areas that require modification to improve comprehensibility." The "ground truth" here would be user experience and comprehension, evaluated directly from the study participants' interactions and feedback.
The readability assessment used the Fry Scale, which is an objective measure of text complexity, so no human experts were needed to establish "ground truth" for readability; it's a calculated score.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned. Given the nature of the "human factors/usability study," the evaluation likely involved direct observation, questionnaires, and interviews with users, rather than expert judgment on discrete diagnostic outcomes requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done or reported. The device is a data management accessory, not a diagnostic imaging device that typically uses MRMC studies. The focus was on software functionality, usability, and demonstrating substantial equivalence to predicate devices.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
A standalone performance study of the "algorithm only" (without human-in-the-loop) was effectively performed as part of the "Non-clinical Testing." This included:
- Software verification and validation testing: This covers unit, integration, and system-level testing, which evaluates the software's internal logic and data processing capabilities independently of human interaction.
- Load testing: This assesses the system's performance under various loads, demonstrating its robustness and functional capacity.
These tests confirm the software's ability to process and display data correctly as intended without human intervention in the data processing itself, though the interpretation of that processed data is always intended for human users (patients and HCPs).
7. Type of Ground Truth Used
- For Software Verification and Validation: The ground truth was the defined requirements and design specifications for the software. The tests ensured the software's output matched the expected output based on these specifications.
- For Human Factors/Usability Study: The ground truth was the observed user behavior and direct feedback regarding comprehensibility and ease of use. There was also an objective readability score (Fry Scale) for the manuals and website content.
8. Sample Size for the Training Set
The document does not mention a training set in the context of an AI/ML model, as this device appears to be a rule-based software system for data management and display, rather than an adaptive AI system that learns from a training set. The "analysis to recognize health patterns, show trends" likely refers to pre-programmed algorithms rather than machine learning trained on data.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned or implied for an AI/ML model, this question is not applicable based on the provided information.
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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.Wayne, PA 19087 |
| EstablishmentRegistration Number | 3007710797 |
| Date of Summary | 08-December-2009 |
| Telephone NumberFax Number | 484.686.4650610.455.2334 |
| 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 IIProduct Code: NBWCalculator/Data Processing Module for Clinical Use,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 aidpeople with diabetes and healthcare professionals in the review,analysis and evaluation of historical blood glucose test results tosupport effective diabetes management. It is intended for use as anaccessory to blood glucose meters with data managementcapabilities. This system is intended for use by people 18 years ofage and older. InTouch™•diabetes is not intended to providetreatment decisions or to be used as a substitute for professionalhealthcare judgment. All patient medical diagnoses andtreatment are to be performed under the supervision andoversight of an appropriate healthcare professional. |
| Identification of theLegally Marketed Device(Predicate Device) | • SymCare Diabetes Management Program(DMP) V2.03,K083263• MCT Diabetes Version 2.0; K073699• Think Positive (t+) Diabetes Management System, K061328 |
.
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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.
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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.
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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.
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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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 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
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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
§ 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.