(243 days)
The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format.
The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose. insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
The ACCU-CHEK Connect Diabetes Management App is designed to facilitate efficient collecting, transmitting, and analyzing of blood glucose results and other diabetes management data. The App helps:
• Wireless transfer of data from ACCU-CHEK Aviva Connect Blood Glucose Meter.
• Assist in general diabetes management through logging of contextual data.
• ACCU-CHEK Bolus Advisor support of mealtime insulin dosing calculations.
• Perform structured testing.
• Wireless transfer of data from mobile devices to ACCU-CHEK Connect Online Diabetes Management System and optionally share this data with healthcare provider (HCP) or caregiver.
The insulin bolus calculations provided by the app are meant for patients undergoing multiple daily injection therapy. Bolus calculators, such as the ACCU-CHEK Bolus Advisor, have been demonstrated to facilitate the optimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and under the supervision of healthcare professional experienced in managing insulin-treated patients. Such calculators have also been shown to reduce patient fear of hypoglycemia and improve patient confidence in diabetes management.
The ACCU-CHEK Connect Diabetes Management App is not intended to serve as an accessory to an insulin pump.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ACCU-CHEK Connect Diabetes Management App, structured as requested:
Acceptance Criteria and Device Performance for ACCU-CHEK Connect Diabetes Management App
The provided FDA 510(k) summary (K141929) for the ACCU-CHEK Connect Diabetes Management App primarily focuses on demonstrating substantial equivalence to a predicate device (ACCU-CHEK Aviva Combo meter). While it mentions "performance requirements" and "algorithm validation," it does not explicitly state specific quantitative acceptance criteria (e.g., in terms of accuracy, sensitivity, specificity, or precision) with corresponding reported device performance values in a table. Instead, it refers to a qualitative assessment that the device "meets the performance requirements for its intended use" and "demonstrated that the device functions as intended."
The document emphasizes that the Bolus Advisor algorithm within the app is "unchanged as compared to the predicate device." Therefore, the performance of the algorithm is implicitly tied to the cleared performance of the predicate.
Here's an attempt to structure the available information, noting the absence of explicit quantitative criteria in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) | Notes |
|---|---|---|---|
| Bolus Calculation Accuracy | Functionality and accuracy should be equivalent to the predicate device (ACCU-CHEK Aviva Combo meter's bolus calculator). | Algorithm is unchanged from predicate device, therefore deemed to perform equivalently. | The submission relies on the prior clearance of the predicate's algorithm. No new specifics are provided. |
| Usability | Device functions as intended for users (persons with diabetes and caregivers) and adheres to safety risk-mitigating controls. | "Human Factors clinical study demonstrated the diabetes management app fulfilled all predefined requirements for safety risk-mitigating controls when handled by persons with diabetes mellitus or their caregivers, according to its intended use." | Qualitative assessment from human factors study. No quantitative error rates or specific usability metrics are provided. |
| Software Functionality | Software components (data transfer, logging, display, reporting) operate correctly as designed. | "Software testing and performance testing of the device demonstrate the device functions as intended." | General statement of verification and validation. No specific bugs, errors, or performance metrics are detailed. |
| Data Transfer | Wireless data transfer from ACCU-CHEK Aviva Connect Blood Glucose Meter to app, and from app to ACCU-CHEK Connect Online Diabetes Management System works reliably. | Implicitly demonstrated as part of "software testing" and "performance testing." | No specific success rates or error rates are given for data transfer. |
2. Sample Size for the Test Set and Data Provenance
The document mentions "software testing and performance testing of the device" and a "Human Factors clinical study."
- Software and Performance Testing: No specific sample size (e.g., number of test cases, specific data points) is provided for the device's main software and performance testing.
- Human Factors Clinical Study: No specific sample size (e.g., number of participants) is provided for the "Human Factors clinical study."
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given it's a 510(k) submission to the FDA, it's highly likely that the studies were conducted with data relevant to the US market or in a manner acceptable to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given document. The submission focuses on demonstrating substantial equivalence to a predicate device whose bolus calculation algorithm is adopted directly. The Human Factors study involved "persons with diabetes mellitus or their caregivers," but these are considered users, not experts establishing ground truth for algorithmic performance.
4. Adjudication Method for the Test Set
This information is not provided in the given document. Given the nature of a software application for diabetes management and bolus calculation, adjudication might not be relevant in the same way it would be for diagnostic imaging where expert consensus is often used. For software functionality, ground truth often comes from predefined requirements and expected outputs based on established medical formulas.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as described in the provided text. The device is a "Drug Dosing Calculator" and a "diabetes management app," not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases. The document states that the Bolus Advisor algorithm is unchanged from the predicate device, implying that its effectiveness has already been established and accepted with that predicate. No effect size of human improvement with AI assistance is mentioned because this type of study was not conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was Done
Yes, implicitly, a standalone assessment of the algorithm was done. The document states: "The insulin bolus calculator algorithm is unchanged as compared to the predicate device." This means the algorithm's performance was previously validated in its standalone form within the predicate device (ACCU-CHEK Aviva Combo meter). The current submission leverages that prior validation. There's no new, separate standalone study explicitly described for the ACCU-CHEK Connect Diabetes Management App, beyond the confirmation that it uses the same algorithm.
7. The Type of Ground Truth Used
For the bolus calculation algorithm, the ground truth would be based on established medical formulas and diabetes management guidelines for insulin dosing and carbohydrate intake calculations. The accuracy of these calculations against the established formulas would have been the ground truth for the predicate device. For the ACCU-CHEK Connect App, the ground truth for its software functionality relies on validated software requirements and the expected output of its operations.
8. The Sample Size for the Training Set
This information is not applicable/not provided in the context of this device. The ACCU-CHEK Connect Diabetes Management App, particularly its Bolus Advisor, is a rule-based system employing an "unchanged" algorithm from a predicate device. It is not an AI/Machine Learning model that would typically have a "training set" in the conventional sense. The algorithm is based on well-defined clinical parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity, etc.) provided by a healthcare professional.
9. How the Ground Truth for the Training Set was Established
As noted above, this device does not appear to involve machine learning or AI that would require a "training set" with ground truth established through typical methods like expert annotation or pathology. The "ground truth" for the bolus calculation algorithm stems from established medical science and clinical practice guidelines for insulin dosing, which determine the correct output for given input parameters. The validation of such an algorithm would involve testing it against a wide range of clinically relevant scenarios, where the "correct" insulin dose is derived from these established medical principles.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16. 2015
Roche Diagnostics Corporation Ms. Chunhong Tao Regulatory Affairs Specialist 9115 Hague Road Indianapolis, IN 46250
Re: K141929
Trade/Device Name: ACCU-CHEK Connect Diabetes Management App Regulation Number: 21 CFR 868.1890 Regulation Name: Drug Dosing Calculator Regulatory Class: II Product Code: NDC, LZG, LFR, JQP Dated: February 9, 2015 Received: February 12, 2015
Dear Ms. Tao:
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.
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141929
Device Name
ACCU-CHEK Connect Diabetes Management App
Indications for Use (Describe)
The ACCU-CHEK Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
510(k) Number (if known) K141929
Device Name
ACCU-CHEK Connect Diabetes Management App
Indications for Use (Describe)
The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEK Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose. insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/0 description: The image shows the Roche logo. The logo consists of the word "Roche" in bold, black letters, centered within a white hexagon. The hexagon is outlined in black. The logo is simple and recognizable.
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. | |
|---|---|---|
| 1) Submittername,address,contact | Primary contact: | Secondary contact: |
| Mike Flis | Chunhong (Emma) Tao | |
| Roche Diagnostics Corporation | Roche Diagnostics Corporation | |
| 9115 Hague Rd. | 9115 Hague Rd. | |
| Indianapolis, IN 46250 | Indianapolis, IN 46250 | |
| (317) 521-2110 | (317) 521-7227 | |
| 2) Devicename | Date Prepared: January 27, 2015 | |
| Proprietary Name: ACCU-CHEK Connect Diabetes Management AppCommon Name: diabetes management software | ||
| PrimaryClassification Name: drug dosing calculatorClassification Regulation: 21 C.F.R. § 868.1890; Class IIProduct Code: NDC | ||
| SecondaryClassification Name: calculator/data processing module for clinical useClassification Regulations: 21 C.F.R. § 880.5725, 862.1345, 862.2100; Class IIProduct Code: LZG, LFR, JQP |
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- Predicate ACCU-CHEK Aviva Combo meter, cleared as a component of the ACCUdevice CHEK Combo System in #K111353.
The ACCU-CHEK Combo System consists of three (3) main components:
- . ACCU-CHEK Aviva Combo blood glucose meter
- . ACCU-CHEK Spirit Combo insulin pump
- ACCU-CHEK 360° Insulin Pump Configuration Software .
The ACCU-CHEK Aviva Combo meter serves as a hub for the ACCU-CHEK Combo System. The monitor has three main functions:
- . Blood glucose monitor
- Remote control of ACCU-CHEK Spirit Combo insulin pump .
- Calculation of insulin bolus י
The ACCU-CHEK Aviva Combo blood glucose meter is intended for the quantitative measurement of blood glucose. The ACCU-CHEK Aviva Combo meter is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitoring the effectiveness of diabetes control. The ACCU-CHEK Aviva Combo meter can be used to interface with and remotely control the ACCU-CHEK Spirit Combo insulin infusion pumps via radio frequency communication. The ACCU-CHEK Aviva Combo meter is also indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data.
Continued on next page
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| 4) DeviceDescription | The ACCU-CHEK Connect Diabetes Management App is designed tofacilitate efficient collecting, transmitting, and analyzing of blood glucoseresults and other diabetes management data. The App helps:• Wireless transfer of data from ACCU-CHEK Aviva Connect BloodGlucose Meter.• Assist in general diabetes management through logging of contextualdata.• ACCU-CHEK Bolus Advisor support of mealtime insulin dosingcalculations.• Perform structured testing.• Wireless transfer of data from mobile devices to ACCU-CHEKConnect Online Diabetes Management System and optionally sharethis data with healthcare provider (HCP) or caregiver.The insulin bolus calculations provided by the app are meant for patientsundergoing multiple daily injection therapy. Bolus calculators, such as theACCU-CHEK Bolus Advisor, have been demonstrated to facilitate theoptimization of glycemic control in patients who are trained in multiple daily insulin injection therapy and under the supervision of healthcare professional |
|---|---|
| 5) Intendeduse | For Over-the-Counter Use:The ACCU-CHEK Connect Diabetes Management App is indicated as an aidin the treatment of diabetes. The software provides for electronic downloadof blood glucose meters, manual data entry, storage, display, transfer, andself-managing of blood glucose and other related health indicators which canbe shown in report and graphical format. |
| For Prescription Use:The ACCU-CHEK Bolus Advisor, as a component of the ACCU-CHEKConnect Diabetes Management App, is indicated for the management ofdiabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional mustactivate the bolus calculator and provide the patient-specific target bloodglucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to beprogrammed into the software. | |
| 6) Substantialequivalence | The ACCU-CHEK Connect Diabetes Management App utilizes theprocessing power of a mobile phone operating system platform to transferdata from a blood glucose meter, transfer data to an online diabetesmanagement system, facilitate structured testing data collection, assist ingeneral diabetes management through logging of contextual data, andcalculate insulin bolus in response to blood glucose, health events, andcarbohydrate input. These software functions were built within the predicatedevice's embedded software and PC-platform software. The App movesthese functions outside the glucose meter. The App is compatible withglucose meters with BLE transmitter. The insulin bolus calculator algorithmis unchanged as compared to the predicate device. The App will not interactwith an insulin pump. The insulin bolus calculations provided by the App aremeant for patients undergoing conventional multiple daily injection therapy.The ACCU-CHEK Connect Diabetes Management App is substantially |
| equivalent to the drug dosage calculator function of the ACCU-CHEK AvivaCombo meter.Continued on next page |
experienced in managing insulin-treated patients. Such calculators have also been shown to reduce patient fear of hypoglycemia and improve patient confidence in diabetes management.
The ACCU-CHEK Connect Diabetes Management App is not intended to serve as an accessory to an insulin pump.
Continued on next page
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7) Data demonstrating substantial equivalence
All necessary performance testing was conducted on the ACCU-CHEK Connect Diabetes Management App to support a determination of substantial equivalence. The results of usability testing of representative users of the device, software testing and performance testing of the device demonstrate the device functions as intended. The non-clinical testing included software verification and algorithm validation to demonstrate the functionality of the software application and the performance of the algorithms. The Human Factors clinical study demonstrated the diabetes management app fulfilled all predefined requirements for safety risk-mitigating controls when handled by persons with diabetes mellitus or their caregivers, according to its intended use.
Performance testing on the ACCU-CHEK Connect Diabetes Management App demonstrated that the device meets the performance requirements for its intended use. The data demonstrate that the device is substantially equivalent to the predicate device.
Continued on next page
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| 8) | The following is a listing of the key similarities and differences between the |
|---|---|
| Similarities/ | ACCU-CHEK Connect Diabetes Management App and the predicate device. |
| Differences |
| Feature /Claim | ACCU-CHEK Connect DiabetesManagement App | ACCU-CHEK Combo System(#K111353) |
|---|---|---|
| Intended Use | The ACCU-CHEK ConnectDiabetes Management App isindicated as an aid in the treatmentof diabetes. The software providesfor electronic download of bloodglucose meters, manual data entry,storage, display, transfer, and self-managing of blood glucose andother related health indicators whichcan be shown in report andgraphical format.The ACCU-CHEK Bolus Advisor,as a component of the ACCU-CHEK Connect DiabetesManagement App, is indicated forthe management of diabetes bycalculating an insulin dose orcarbohydrate intake based on user-entered data. Before its use, aphysician or healthcare professionalmust activate the bolus calculatorand provide the patient-specifictarget blood glucose, insulin-to-carbohydrate ratio, and insulinsensitivity parameters to beprogrammed into the software. | The ACCU-CHEK Aviva Comboblood glucose meter is intended forthe quantitative measurement ofblood glucose. The ACCU-CHEKAviva Combo meter is intended forself-testing outside the body (invitro diagnostic use) by people withdiabetes at home as an aid tomonitoring the effectiveness ofdiabetes control. The ACCU-CHEK Aviva Combo meter can beused to interface with and remotelycontrol the ACCU-CHEK SpiritCombo insulin infusion pumps viaradio frequency communication.The ACCU-CHEK Aviva Combometer is also indicated for themanagement of diabetes bycalculating an insulin dose orcarbohydrate intake based on user-entered data. |
| Prescription /over-the-counteruse? | Over-the-counter distribution ofApp, with bolus calculator functiondisabled until activated by physician | Prescription use due to relationshipwith insulin pump |
| User Group | Diabetes patients treated withmultiple daily insulin injection(MDI) therapy | Diabetes patients treated withinsulin pump therapy or multipledaily insulin injection (MDI)therapy |
| Bolus CalculatorSet-up stage | During the ACCU-CHEK ConnectDiabetes Management App's boluscalculator set-up stage, thefollowing information must be | No difference, the same informationis inputted into the ACCU-CHEKCombo meter during the bolus |
| Feature /Claim | ACCU-CHEK Connect DiabetesManagement App | ACCU-CHEK Combo System(#K111353) |
| entered.Time BlocksTarget RangeCarb RatioInsulin SensitivityHealth Event PercentagesMeal RiseSnack SizeActing TimeOffset Time | calculator set-up stage. | |
| Bolus Calculatorinputs | Once the set-up stage has beencompleted, the patient may beginusing the ACCU-CHEK BolusAdvisor in the ACCU-CHEKConnect Diabetes ManagementApp. Bolus recommendations canbe triggered by inputting thefollowing information prior to eachmeal:Measure blood glucoseEnter carbohydratesEnter Health Event | No difference, the same informationis inputted by the patient prior toeach meal to trigger arecommendation. |
| Communicatewith insulinpumps? | No | Yes |
| Software Level ofConcern | Major | Major |
| Operatingplatform | Mobile based application | Built within the blood glucose meter |
| Connectivity toMeter | Bluetooth Low Energy (BLE) | N/A |
| Control or affectthe blood glucosemeter'smeasurements? | No | No |
| Reports, graphs,and ElectronicLog Book | Yes | No |
| CarbohydrateCalculator | Calculate carbohydrate intake basedon user-entered data | Calculate carbohydrate intake basedon user-entered data |
| Feature /Claim | ACCU-CHEK Connect DiabetesManagement App | ACCU-CHEK Combo System(#K111353) |
| Bolus Calculator | Yes | Yes |
| Bolus CalculatorSecurity | Bolus calculator function iscontrolled as a prescription device;the bolus calculator must beactivated by licensed healthcareprovider. Access to the boluscalculator function requires licensedhealthcare provider activation. | The bolus calculator software isembedded within a prescriptiondevice. |
| Allow manualentry? | Yes | No |
| Back-calculationprevents insulinstacking? | Yes | Yes |
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§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).