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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the InPen Dose Calculator, based on the provided FDA 510(k) summary:

This document primarily focuses on demonstrating substantial equivalence to a predicate device (K160629) rather than presenting a novel clinical study with quantitative performance metrics against specific acceptance criteria. Therefore, the "acceptance criteria" discussed below are inferred from the demonstrated equivalence and risk management, not explicit numerical thresholds.

Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for demonstrating substantial equivalence to a previously cleared device (K160629) and not presenting new clinical performance data with explicit numerical acceptance criteria, the "acceptance criteria" are primarily established by the equivalence of the product's attributes and the successful completion of verification and validation activities. The reported "device performance" is therefore that it functions identically to the predicate device in its calculations and features, and that risks are mitigated.

Acceptance Criteria (Inferred from Equivalence & Risk Analysis)	Reported Device Performance (as demonstrated)
Functional Equivalence to Predicate Device:
- Same Indications For Use	Met: Indications for use are identical.
- Same Intended Use	Met: Intended use is identical.
- Same Technological Characteristics (Core Functionality)	Met: Core technological characteristics (e.g., insulin dose calculation algorithm, consideration of insulin on-board, manual dose entry) are identical. Minor differences are noted (Operating platform, UI Standards) but deemed not to raise new questions of safety/effectiveness.
- Same Principles of Operation	Met: Principles of operation (e.g., use of healthcare provider specified parameters) are identical.
Risk Mitigation:
- All identified risks are mitigated to an acceptable level.	Met: Risk analysis completed, all design controls implemented, verified, and validated.
Software Verification & Validation:
- Software functions according to specifications.	Met: Software V&V conducted; deemed appropriate for intended use.
- Software meets "Major" Level of Concern requirements.	Met: Documentation provided as recommended by FDA guidance for "major" level of concern software.
- Human Factors are adequate and do not introduce new risks.	Met: Human factors validation data from K160629 applies; changes to UI for critical tasks deemed to have negligible use-related risks.

Study Information

The submission details primarily focus on demonstrating substantial equivalence to a predicate device (InPen System K160629) and robust software verification and validation (V&V), rather than a traditional clinical study with a test set of patient cases.

Sample size used for the test set and the data provenance:
- No explicit "test set" of patient cases with clinical outcomes is mentioned in this summary for demonstrating diagnostic or predictive accuracy. The performance data section refers to "Software Verification and Validation Testing" and "Risk Analysis."
- It is likely that comprehensive software testing (unit testing, integration testing, system testing) was performed on a variety of input scenarios, but the specific "sample size" of test cases for these software tests is not quantified in this summary.
- Data provenance is not applicable in the context of a clinical test set from patient data, as no such study is described. The V&V activities would involve internally generated test data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there is no mention of a clinical test set requiring expert ground truth establishment for diagnostic or predictive accuracy. The "ground truth" for the software's calculations would be the mathematically correct output based on the predefined algorithm, parameters, and input data.
Adjudication method for the test set:
- Not applicable, as no clinical test set with expert adjudication is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned. The device is a "dose calculator" with specific instructions for healthcare professionals to program patient-specific parameters. It assists the patient in calculating doses based on these established parameters and user input, rather than augmenting human interpretation of complex medical images or data that would typically feature in an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The "Software Verification and Validation Testing" would essentially be a standalone evaluation of the algorithm's performance against its specifications, assuming various inputs. The summary states: "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." This indicates the algorithm's core functionality was evaluated.
The type of ground truth used:
- For the software's calculation accuracy: The ground truth would be the mathematically correct insulin dose or carbohydrate intake as determined by the predefined algorithms and formulas using the input parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity, insulin on-board, and user-entered data). This would be established by independent calculation or a trusted reference implementation of the algorithm.
- For risk management and safety: Ground truth is implicitly established by adherence to standards like ISO 14971 and relevant FDA guidance documents.
The sample size for the training set:
- Not applicable. This device is a rule-based dose calculator, not a machine learning model that typically requires a "training set" of data to learn from. Its "knowledge" is encoded within the algorithms and patient-specific parameters provided by a healthcare professional.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device. The algorithm's logic is based on established medical formulas and and a published study for insulin on-board (Mudaliar, et al., 1999).

Summary

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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.

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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

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Indications for Use

510(k) Number (if known)

K181327

Device Name InPen Dose Calculator

Indications for Use (Describe)

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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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

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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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 InPenapp, is indicated for the management of diabetes bypeople with diabetes age 12 and older by calculatingan insulin dose or carbohydrate intake based on userentered data. Prior to use, a healthcare professionalmust provide the patient-specific target bloodglucose, insulin-to- carbohydrate ratio, and insulinsensitivity parameters to be programmed into thesoftware.	Same
Prescription Use	Yes	Same
User Group	Diabetes patients treated with multiple daily insulininjection (MDI) therapy	Same
Communication with insulinpumps	No	Same
Software Level of Concern	Major	Same
Wireless Connectivity	Bluetooth Low Energy (BLE)	Same
Control or affect bloodglucose measurements	No	Same
Control or affect insulindelivery	No	Same
Reports, graphs, andElectronic 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 bolusinsulin to mitigate stacking	Yes	Same
Operating platform	Android platform	iOS platform
UI Standards	Android standards	iOS standards

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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.

Regulation Number and Section

§ 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).