The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

The InPen dose calculator, a component of the InPen app, is indicated for the management of diabetes by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for calculating an insulin dose or carbohydrate intake based on user entered data.

For an insulin dose based on amount of carbohydrates, a healthcare professional must provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.

For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.

Device Description

The InPen System consists of a manually-controlled pen injector and an app containing a logbook and a dose (bolus) calculator.

The InPen is a manual pen injector containing a non-replaceable battery and electronics to communicate via Bluetooth® with the app on an iOS® mobile device. The intended dose is manually set by the user by rotating a dose knob. The insulin is injected by manually depressing the dose knob which causes the piston in the insulin cartridge to expel the intended dose. The InPen is provided in two different models for compatibility with the available U-100 insulin cartridges, i.e. Humalog®, Novolog®, and Fiasp®. The device is provided with Instructions For Use and a Quick Start Guide. The device is used with sterile needles and U-100 insulin cartridges (supplied separately).

The 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 System, based on the provided FDA 510(k) summary:

Important Note: The provided document is a 510(k) summary for a substantial equivalence determination. This means the device is being compared to a previously cleared predicate device (K190487). The performance data presented often focuses on demonstrating that the new device meets the same standards as the predicate and that any changes (like expanded indications for use) do not raise new questions of safety or effectiveness. It does not typically include detailed, de novo clinical trial results for the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device must achieve)	Reported Device Performance (How the device performed)
InPen Pen Injector:
Dose Accuracy (Meets ISO 11608-1 requirements)	Meets ISO 11608-1 requirements
Biocompatibility (Meets ISO 10993-1 requirements)	Meets ISO 10993-1 requirements
Compliance with regulations for a Piston Syringe (21 CFR 880.5860; Class II)	Classified as Class II, Product Codes FMF, NDC
InPen App Dose Calculator:
Ability to calculate insulin dose or carbohydrate intake based on user-entered data for people with diabetes (including pediatric users age 7 and older)	Indicated for calculating an insulin dose or carbohydrate intake based on user-entered data for patients age 7 and older (with adult caregiver supervision or self-injection). Specific parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity, fixed/variable meal sizes) must be programmed by a healthcare professional.
Compliance with regulations for a Medical Device Data System (21 CFR 868.1890)	Classified as Class II, Product Codes FMF, NDC
Appropriate for pediatric patients and their healthcare providers	Human Factors evaluation and literature review determined appropriateness for pediatric patients. Updated labeling provides further information regarding potential risks for pediatric users.
Ensure safety and effectiveness when expanding indications for Fiasp compatibility.	Drug compatibility was updated to reflect the addition of Fiasp compatibility in a previous submission. (Implies previous demonstration of safety/effectiveness with Fiasp).
Ensure safety and effectiveness despite changes in Indications For Use (specifically, the expanded age range for pediatric users and Fiasp compatibility).	The document states: "The differences in Indications For Use do not raise new questions of safety or effectiveness." This is supported by human factors evaluations and the existing technological characteristics being the same as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a numerical sample size for a "test set" in the context of an algorithm's performance evaluation.

Provenance: The primary basis for comparison is a previously cleared predicate device (K190487). The "study" referenced for the current submission primarily relates to human factors evaluation and literature review to support the expanded indications (pediatric use). This suggests the data provenance is a combination of:
- Previously established performance of the predicate device (likely from earlier submissions).
- New human factors data (prospective) related to the pediatric use case.
- Literature review (retrospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not explicitly provided in the summary. Since the evaluation primarily relies on demonstrating substantial equivalence to a predicate and conducting human factors testing for expanded use, it's unlikely a separate "ground truth" establishment by a panel of experts, as might be done for an AI diagnostic device, occurred for this specific 510(k) submission. Human factors may involve usability experts, but their role is different from establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

This information is not explicitly provided. Given the nature of the device (insulin pen and dose calculator) and the type of evaluation described (human factors, substantial equivalence), an adjudication method for a "test set" in the context of expert review for diagnostic ground truth is not typically applicable or detailed in this type of submission.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study is not mentioned or explicitly described. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. The InPen system is an insulin delivery and dose calculation device, not a diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance Study

While the device includes a "dose calculator" component (an algorithm), the document does not describe a standalone "algorithm only" performance study in the way one might for a diagnostic AI. The substantial equivalence argument relies on the overall system (pen injector + app) meeting the same performance standards as the predicate, and the clinical parameters used by the dose calculator are provided by a healthcare professional. Human factors testing focuses on the user interface and interaction, rather than an isolated algorithm's numerical output accuracy.

7. Type of Ground Truth Used

For the InPen pen injector:

Engineering standards: Adherence to ISO 11608-1 (dose accuracy) and ISO 10993-1 (biocompatibility). These standards define the ground truth for mechanical and material performance.

For the InPen App dose calculator (algorithm):

Clinical parameters/guidelines: The algorithm's calculations rely on patient-specific parameters (target blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity, fixed/variable meal sizes) programmed by a healthcare professional. The "ground truth" for the dose calculation would be its accurate application of these parameters (as per established medical guidelines for insulin dosing) to user-entered data.
Human Factors Evaluation: For the expanded pediatric indication, human factors testing serves as the ground truth for user interface and usability safety/effectiveness in the intended population.

8. Sample Size for the Training Set

This information is not provided. The document is concerned with the current device's performance relative to a predicate, not the development or training of a de novo AI algorithm. The "dose calculator" is likely based on established physiological formulas and clinical guidelines rather than machine learning trained on a large dataset in the conventional AI sense.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" in the context of de novo machine learning is not implied or described, the method for establishing ground truth for such a set is not applicable or provided. The dose calculation logic is based on well-established medical algorithms and clinical parameters set by healthcare professionals.

Summary

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June 18, 2020

Companion Medical, Inc. Jasper Benke Vice President, RA/OA/CA 12230 World Trade Drive, Suite 100 San Diego, California 92128

Re: K201337

Trade/Device Name: InPen System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, NDC Dated: May 15, 2020 Received: May 20, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201337

Device Name

InPen System

Indications for Use (Describe)

For an insulin dose based on amount of carbohydrates, a healthcare provide patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software prior to use.

For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/ meal sizes to be programmed into the software prior to use.

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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Companion Medical, Inc.

510(k) SUMMARY InPen™ System

l. SUBMITTER

Address:	Companion Medical, Inc.
	12230 World Trade Drive, Suite 100
	San Diego, California 92128
Phone:	(858) 522-0252
Contact:	Mr. Jasper Benke
Date Prepared:	May 15, 2020

II. DEVICE

Name of Device:	InPen™ System
Common Name:	Pen Injector with Dose Calculator
Classification Name:	Piston Syringe
Classification Regulation:	21 CFR 880.5860; Class II
Product Codes:	FMF, NDC

III. PREDICATE DEVICES

InPen™ System (K190487)

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

The InPen System consists of a manually-controlled pen injector and an app containing a logbook and a dose (bolus) calculator.

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Companion Medical, Inc.

V. INDICATIONS FOR USE

The InPen is a home-use reusable pen injector for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for the selfinjection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® U-100 3.0 mL cartridges, Novo Nordisk Novolog® U-100 3.0 mL cartridges, and Novo Nordisk Fiasp® U-100 3.0 mL cartridges and single-use detachable and disposable pen needles (not included). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in one-half (1/2) unit increments.

For an insulin dose based on fixed/variable meal sizes, a healthcare professional must provide patient-specific fixed doses/meal sizes to be programmed into the software prior to use.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject InPen pen injector is substantially equivalent to the predicate InPen pen injector (K190487) cleared on February 18, 2020. The InPen system has the same intended use, technological characteristics, and principles of operation as the previously cleared predicate device. A substantial equivalence chart of the similarities and differences between the InPen system and the predicate device is shown in Table 1. The differences in Indications For Use do not raise new questions of safety or effectiveness.

Table 1
Attribute	Subject DeviceInPen Pen Injector	Predicate DeviceInPen Pen Injector (K190487)
Classification	(Class II - FMF - 21 CFR §880.5860)	Same
Indications For Use	The InPen is a home-use reusablepen injector for single-patient useby people with diabetes under the	The InPen is a home-use reusablepen injector for single-patient useby people with diabetes age 12

	supervision of an adult caregiver,or by a patient age 7 and older forthe self-injection of a desired doseof insulin. The pen injector iscompatible with Lilly Humalog® U-100 3.0 mL cartridges, NovoNordisk Novolog® U-100 3.0 mLcartridges, and Novo NordiskFiasp® U-100 3.0 mL cartridgesand single-use detachable anddisposable pen needles (notincluded). The pen injector allowsthe user to dial the desired dosefrom 0.5 to 30 units in one-half(1/2) unit increments.	and older for the self-injection ofa desired dose of insulin. The peninjector is compatible with LillyHumalog® U-100, Novo NordiskNovolog®, and Novo NordiskFiasp® 3.0 mL cartridges of insulinand single-use detachable anddisposable pen needles (notincluded). The pen injectorallows the user to dial the desireddose from 0.5 to 30 units in one-half (1/2) unit increments.
Cartridge Volume	3 ml (300 units)	Same
Drug	U-100 insulin	Same
Syringe Type	Piston Syringe	Same
Single Patient Use	Yes	Same
Reusable Device	Yes	Same
Dose Accuracy	Meets ISO 11608-1 requirements	Same
Biocompatibility	Meets ISO 10993-1 requirements	Same
Maximum Dose	30 Units	Same
User Feedback	Audible and tactile clicksper increment	Same
Dose Dialing	Two-way	Same
Battery	Non-rechargeable	Same
Electronics	Folded Flex Circuit	Same
Software	Yes	Same
Dose Delivery	Mechanical	Same
Unit Increments	Half-Unit incrementsafter 0.5 Unit	Same
Dimensions	6.5" x ø0.6"	Same
Weight	35 grams	Same
Fluid Pathway	None	Same
Contact
Dose CalculatorCommunication	Yes	Same
Table 2
Attribute	Subject DeviceInPen App	Predicate DeviceInPen App (K190487)
Classification	(Class II - NDC - 21 CFR §868.1890)	Same
Indications For Use	The InPen dose calculator, acomponent of the InPen app, isindicated for the management ofdiabetes by people with diabetesunder the supervision of an adultcaregiver, or by a patient age 7and older for calculating aninsulin dose or carbohydrateintake based on user entereddata.	The InPen dose calculator, acomponent of the InPen app, isindicated for the management ofdiabetes by people with diabetesage 12 and older by calculating aninsulin dose or carbohydrateintake based on user entereddata. The device is indicated foruse with NovoLog® or Humalog®U-100 insulin.
	For an insulin dose based onamount of carbohydrates, ahealthcare professional mustprovide patient-specific targetblood glucose, insulin-to-carbohydrate ratio, and insulinsensitivity parameters to beprogrammed into the softwareprior to use.	For an insulin dose based onamount of carbohydrates, ahealthcare professional mustprovide patient-specific targetblood glucose, insulin-to-carbohydrate ratio, and insulinsensitivity parameters to beprogrammed into the softwareprior to use.
	For an insulin dose based onfixed/variable meal sizes, ahealthcare professional mustprovide patient-specific fixeddoses/meal sizes to beprogrammed into the softwareprior to use.	For an insulin dose based onfixed/variable meal sizes, ahealthcare professional mustprovide patient-specific fixeddoses/meal sizes to beprogrammed into the softwareprior to use.
Prescription Use	Yes	Same
User Group	Diabetes patients treated withmultiple daily insulin injection (MDI)therapy	Same
Communication withinsulin pumps	No	Same
Software Level of	Major	Same
Concern
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
Meal Size Entry	Grams of carbohydrates	Same
Insulin Dose Calculator	Calculates insulin doses for mealsand corrections while accountingfor insulin on board	Same
Carbohydrate Calculator	Calculates carbohydrate intakebased on user-entered data	Same
Manual Dose Entry	Yes	Same
InPen Dose Entry	Yes	Same
Tracking of residualbolus insulin to mitigatestacking	Yes	Same
Operating platform	Android and iOS platforms	Same
UI Standards	Android and iOS standards	Same

Table 1

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The subject InPen app is substantially equivalent to the predicate InPen app (K190487) cleared on February 18, 2020. The InPen app has the same intended us, technological characteristics, and principles of operation as the previously cleared predicate device. A substantial equivalence chart comparing the similarities and differences between the InPen pen injector

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Companion Medical, Inc.

and its predicate device is shown in Table 2. The differences in Indications For Use do not raise new questions of safety or effectiveness.

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VII. PERFORMANCE DATA

The InPen pen injector and dose calculator have been determined to be appropriate for pediatric patients and their healthcare providers through human factors evaluation and literature review. Human Factors testing supports substantially equivalent use of the device in pediatric populations. Updated labeling provides further information regarding the potential risks of the InPen system for pediatric users. Drug compatibility was updated to reflect the addition of Fiasp compatibility in a previous submission.

VIII. CONCLUSIONS

The subject device is considered substantially equivalent to the predicate device, as demonstrated by human factors data while maintaining the same intended use, 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).