(130 days)
Not Found
No
The document describes a manual pen injector and an app with a dose calculator based on user-entered data and pre-programmed parameters. There is no mention of AI or ML in the device description, intended use, or performance studies. The dose calculation algorithm is stated to have no changes and is based on clinical literature and a published study.
Yes
The device delivers insulin and provides a dose calculator, both of which are used to manage diabetes, a chronic condition. This direct intervention in managing a disease classifies it as therapeutic.
No
The device description indicates that the InPen is a pen injector for self-injection of insulin and an app for managing insulin dose data and aiding mealtime insulin dose calculations. While the app calculates an insulin dose or carbohydrate intake based on user-entered data and pre-programmed parameters, it does not diagnose a condition or disease.
No
The device description clearly states that the InPen System consists of a "manually-controlled pen injector" and an app. The pen injector is a physical hardware component with a battery, electronics, and mechanical parts for insulin delivery. While the app is software, it is part of a system that includes hardware.
Based on the provided text, the InPen device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- InPen Function: The InPen is a pen injector used for the delivery of insulin into the body. While it has a dose calculator component in the app, this calculator uses user-entered data (blood glucose, carbohydrate intake) and pre-programmed parameters from a healthcare professional to calculate an insulin dose. It does not perform any diagnostic testing on a biological sample.
The InPen is a medical device for drug delivery and dose calculation support, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 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.
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, FMF
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.
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
home-use, self-injection by people with diabetes
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)
The InPen pen injector has been determined to be compatible with Fiasp® cartridges by demonstrating conformance to ISO 11608-1, Needle-Based Injection Systems For Medical Use -Requirements And Test Methods - Part 1: Needle-Based Injection Systems and Part 2:Needles and demonstrating that the InPen remains appropriate for its intended use through the use of hazard analysis according to ISO 14971, Medical devices — Application of risk management to medical devices.. Additionally, the labeling changes were validated through human factors testing. The InPen dose calculator has been shown to be compatible with Fiasp drug product through clinical literature review of both the drug properties and clinical safety when used in place of Novolog and considering for insulin on-board based on the published study by Mudaliar et al (1999) for the duration of insulin action. Therefore, no changes have been made to the dose calculation algorithm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
February 10, 2020
Companion Medical, Inc. Jasper Benke Vice President, RA/OA/CA 11011 Via Frontera, Suite D San Diego, California 92127
Re: K192841
Trade/Device Name: InPen System Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: Class II Product Code: NDC, FMF Dated: January 9, 2020 Received: January 13, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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
2
Indications for Use
510(k) Number (if known) K192841
Device Name InPen System
Indications for Use (Describe)
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 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.
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)
X 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.
11011 Via Frontera, Suite D
San Diego, California 92127 |
|----------------|---------------------------------------------------------------------------------------|
| Phone: | (858) 522-0252 |
| Contact: | Mr. Jasper Benke |
| Date Prepared: | October 1, 2019 |
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 |
lll. PREDICATE DEVICES
InPen™ System (K160629)
IV. 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).
4
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.
V. INDICATIONS FOR USE
The InPen is a home-use reusable pen injector for single-patient use by people with diabetes age 12 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 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
The subject InPen pen injector is substantially equivalent to the predicate InPen pen injector (K160629) cleared on July 26, 2016. The InPen pen injector 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 pen injector and the predicate device is shown in Table 1. The differences in Indications for Use do not raise new questions of safety or effectiveness.
The additional insulin (Fiasp®) type does not change the intended use or raise new questions of safety and effectiveness, as the insulin types are the same concentration, and marketed as comparable therapeutically. Additionally, the labeling was updated to include the new insulin and warnings to mitigate medication errors. These differences are supported by verification and validation data to demonstrate substantial equivalence to the predicate. See Performance Data discussion in Section VII below.
| Table 1 | ||
|---|---|---|
| Attribute | Subject Device | Predicate Device |
| InPen Pen Injector | InPen Pen Injector (K160629) | |
| Classification | (Class II - FMF - 21 CFR §880.5860) | Same |
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| Indications For Use | The InPen is a home-use reusable | The InPen is a home-use reusable | |
|---|---|---|---|
| pen injector for single-patient use | pen injector for single-patient use | ||
| by people with diabetes age 12 | by people with diabetes age 12 | ||
| and older for the self-injection of | and older for the self-injection of | ||
| a desired dose of insulin. The pen | a desired dose of insulin. The pen | ||
| injector is compatible with Lilly | injector is compatible with Lilly | ||
| Humalog® U-100, Novo Nordisk | Humalog® U-100 3.0 mL | ||
| Novolog®, and Novo Nordisk | cartridges of insulin and single- | ||
| Fiasp® 3.0 mL cartridges of insulin | use detachable and disposable | ||
| and single-use detachable and | pen needles (not included). The | ||
| 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. | 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 is a home-use reusable | |||
| pen injector for single-patient use | |||
| by people with diabetes age 12 | |||
| and older for the self-injection of | |||
| a desired dose of insulin. The pen | |||
| injector is compatible with Novo | |||
| Nordisk Novolog® U-100 3.0 mL | |||
| cartridges of insulin 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. | |||
| 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 clicks | ||
| per 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 increments | ||
| after 0.5 Unit | Same | ||
| Dimensions | 6.5″ x ø0.6″ | Same | |
| Weight | 35 grams | Same | |
| Fluid Pathway | |||
| Contact | None | Same | |
| Dose Calculator | |||
| Communication | Yes | Same | |
| Table 2 | |||
| Attribute | Subject Device | ||
| InPen App | Predicate Device | ||
| InPen App (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 | |
| Meal Size Entry | Grams of carbohydrates | Same | |
| Insulin Dose Calculator | Calculates insulin doses for meals | ||
| and corrections while accounting | |||
| for insulin on board | 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 and iOS platforms | Same | |
| UI Standards | Android and iOS standards | Same |
6
7
The subject InPen app is substantially equivalent to the predicate InPen app (K160629) cleared on July 26, 2016. The InPen app has the same intended use, 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 and its predicate device is shown in Table 2. No changes were made to the InPen app. Therefore, there are no differences in Indications for Use, technological characteristics, or principles of operation.
8
VII. PERFORMANCE DATA
The InPen pen injector has been determined to be compatible with Fiasp® cartridges by demonstrating conformance to ISO 11608-1, Needle-Based Injection Systems For Medical Use -Requirements And Test Methods - Part 1: Needle-Based Injection Systems and Part 2:Needles and demonstrating that the InPen remains appropriate for its intended use through the use of hazard analysis according to ISO 14971, Medical devices — Application of risk management to medical devices.. Additionally, the labeling changes were validated through human factors testing. The InPen dose calculator has been shown to be compatible with Fiasp drug product through clinical literature review of both the drug properties and clinical safety when used in place of Novolog and considering for insulin on-board based on the published study by Mudaliar et al (1999) for the duration of insulin action. Therefore, no changes have been made to the dose calculation algorithm.
CONCLUSIONS VIII.
The subject device is substantially equivalent to the predicate devices, as demonstrated by literature and leveraged performance data. It has the same intended use, technological characteristics, and principles of operation as the predicate device.