(49 days)
No reference devices were used in this submission.
No
The description explicitly states the dose calculator uses a "standard approach using healthcare provider specified insulin-to-carbohydrate ratio and insulin sensitivity factors" and a published study for insulin on-board, indicating rule-based calculations rather than AI/ML. There is no mention of AI, ML, or training/test data sets.
No
The device is a dose calculator for managing diabetes and provides calculations to aid mealtime insulin dose, not directly treating a condition.
No
The device is described as an "insulin dose calculator" and its purpose is to aid in "mealtime insulin dose calculations" and "management of diabetes by people with diabetes". While it helps manage a condition, it does not diagnose a condition.
No
The device description explicitly states that the InPen app is designed to manage the wireless transfer of insulin dose data from the InPen, which is a hardware device. The summary also mentions "hardware and software hazards" and refers to the predicate device as the "InPen® System," indicating a hardware component is integral to the overall system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "calculating an insulin dose or carbohydrate intake based on user entered data." This involves processing user-provided information (blood glucose, carbohydrate intake) and applying pre-programmed parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity) to provide a calculation.
- Device Description: The description reinforces this by stating it "provide[s] a dose calculator to aid mealtime insulin dose calculations."
- Lack of In Vitro Testing: An IVD device is specifically designed to perform tests on specimens taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. There is no mention of the InPen app performing any such tests or analyzing biological samples.
The InPen app is a software-based medical device that assists in the management of diabetes by providing dose calculations based on user input and pre-set parameters. It does not perform diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
Product codes
NDC
Device Description
The InPen app is designed to manage the wireless transfer of insulin dose data from the InPen, log insulin dose data, and provide a dose calculator to aid mealtime insulin dose calculations. The insulin dose calculations provided by the app are meant for patients undergoing multiple daily injection (MDI) therapy. The InPen app is not intended to serve as an accessory to an insulin pump.
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
12 and older
Intended User / Care Setting
People with diabetes for management of diabetes. A healthcare professional must provide patient-specific parameters.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk Analysis
A risk analysis was completed to account for potential new hazards associated with the device's intended use, including both hardware and software hazards related to the Android version of the InPen dose calculator. All design controls implemented to mitigate risks were verified and validated.
- Risk analysis was conducted according to ANSI/AAMI/ISO 14971:2007®2010 – Medical Devices - Application of risk management to medical devices
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Companion Medical has demonstrated the InPen dose calculator is appropriate for its intended use through the use of hazard analysis according ISO 14971. The dose calculator uses the standard approach using healthcare provider specified insulin-to-carbohydrate ratio and insulin sensitivity factors for making calculations. In addition, the calculator includes a consideration for insulin on-board based on the published study by Mudaliar, et.al. (1999) for the duration of insulin action.
Software information was provided as recommended in the following FDA guidance documents:
- . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- . Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Offthe-Shelf (OTS) Software
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff
Human Factors
Human factors validation data was provided in K160629, consistent with the recommendations provided in FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff.
Changes to any user interface elements for all critical tasks were evaluated and it was determined that use-related risks associated with the changes are negligible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 6, 2018
Companion Medical, Inc. Jasper Benke Vice President, RA/QA/CA 16486 Bernardo Center Drive. # 300 San Diego, California 92128
Re: K181327
Trade/Device Name: InPen Dose Calculator Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC Dated: June 19, 2018 Received: June 21, 2018
Dear Jasper Benke:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Alan M. Stevens
Digitally signed by Alan M. Stevens -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300 189211, cn=Alan M. Stevens -S Date: 2018.07.06 11:02:33 -04'00'
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K181327
Device Name InPen Dose Calculator
Indications for Use (Describe)
The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. Prior to use, a healthcare professional must 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)
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3
510(k) SUMMARY InPen® Dose Calculator
l. SUBMITTER
| Address: | Companion Medical, Inc. |
|---|---|
| 16486 Bernardo Center Drive, Suite 300 | |
| San Diego, California 92128 | |
| Phone: | (858) 522-0252 |
| Contact: | Mr. Jasper Benke |
| Date Prepared: | July 6, 2018 |
II. DEVICE
| Name of Device: | InPen® Dose Calculator |
|---|---|
| Common Name: | Insulin Dose Calculator |
| Classification Name: | Predictive pulmonary-function value calculator |
| Regulation: | 21 CFR 868.1890; Class II |
| Product Codes: | NDC |
III. PREDICATE DEVICES
InPen® System (K160629)
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
The predicate 510(k) submission for the InPen System was a bundled submission with a pen injector and insulin dose calculator. The K181327 submission is demonstrating equivalence to the predicate insulin dose calculator device cleared under K160629.
IV. DEVICE DESCRIPTION
The InPen app is designed to manage the wireless transfer of insulin dose data from the InPen, log insulin dose data, and provide a dose calculator to aid mealtime insulin dose calculations. The insulin dose calculations provided by the app are meant for patients undergoing multiple daily injection (MDI) therapy. The InPen app is not intended to serve as an accessory to an insulin pump.
V. INDICATIONS FOR USE
The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes age 12 and older by calculating an insulin dose or carbohydrate intake based on user entered data. Prior to use, a healthcare professional must provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
4
The InPen dose calculator is substantially equivalent to other legally marketed dose calculators. Specifically, the InPen dose calculator is substantially equivalent to the InPen dose calculator (K160629) cleared on July 26, 2016. The InPen dose calculator has the same intended use and indications, technological characteristics, and principles of operation as the previously cleared predicate device. A substantial equivalence chart of the similarities and differences between the InPen dose calculator and the predicate device is shown in Table 1. The minor differences in technological characteristics do not change the intended use or raise new questions of safety or effectiveness.
| Table 1 | ||
|---|---|---|
| Attribute | Subject Device | |
| (InPen) | Predicate Device | |
| (K160629) | ||
| Classification | (Class II - NDC - 21 CFR §868.1890) | Same |
| Indications For Use | The InPen dose calculator, a component of the InPen | |
| app, is indicated for the management of diabetes by | ||
| people with diabetes age 12 and older by calculating | ||
| an insulin dose or carbohydrate intake based on user | ||
| entered data. Prior to use, a healthcare professional | ||
| must provide the patient-specific target blood | ||
| glucose, insulin-to- carbohydrate ratio, and insulin | ||
| sensitivity parameters to be programmed into the | ||
| software. | Same | |
| Prescription Use | Yes | Same |
| User Group | Diabetes patients treated with multiple daily insulin | |
| injection (MDI) therapy | Same | |
| Communication with insulin | ||
| pumps | No | Same |
| Software Level of Concern | Major | Same |
| Wireless Connectivity | Bluetooth Low Energy (BLE) | Same |
| Control or affect blood | ||
| glucose measurements | No | Same |
| Control or affect insulin | ||
| delivery | No | Same |
| Reports, graphs, and | ||
| Electronic Log Book | Yes | Same |
| Carbohydrate Calculator | Calculates carbohydrate intake based on user- | |
| entered data | Same | |
| Manual Dose Entry | Yes | Same |
| InPen Dose Entry | Yes | Same |
| Tracking of residual bolus | ||
| insulin to mitigate stacking | Yes | Same |
| Operating platform | Android platform | iOS platform |
| UI Standards | Android standards | iOS standards |
5
VII. Performance Data
Risk Analysis
A risk analysis was completed to account for potential new hazards associated with the device's intended use, including both hardware and software hazards related to the Android version of the InPen dose calculator. All design controls implemented to mitigate risks were verified and validated.
- Risk analysis was conducted according to ANSI/AAMI/ISO 14971:2007®2010 – Medical Devices - Application of risk management to medical devices
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Companion Medical has demonstrated the InPen dose calculator is appropriate for its intended use through the use of hazard analysis according ISO 14971. The dose calculator uses the standard approach using healthcare provider specified insulin-to-carbohydrate ratio and insulin sensitivity factors for making calculations. In addition, the calculator includes a consideration for insulin on-board based on the published study by Mudaliar, et.al. (1999) for the duration of insulin action.
Software information was provided as recommended in the following FDA guidance documents:
- . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- . Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Offthe-Shelf (OTS) Software
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff
Human Factors
Human factors validation data was provided in K160629, consistent with the recommendations provided in FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices - Guidance for Industry and Food and Drug Administration Staff.
Changes to any user interface elements for all critical tasks were evaluated and it was determined that use-related risks associated with the changes are negligible.
VIII. CONCLUSIONS
The subject device is substantially equivalent to the predicate device. It has the same intended use/indications for use, and substantially equivalent technological characteristics and principles of operation.