(29 days)
No reference devices were used in this submission.
No
The document describes a manual pen injector and an app with a dose calculator based on user-entered data and pre-programmed parameters from a healthcare professional. There is no mention of AI or ML algorithms being used for dose calculation or any other function.
Yes
The device delivers insulin and provides a dose calculator for managing diabetes, which is a medical condition, making it a therapeutic device.
No
Explanation: The InPen is described as a pen injector for insulin delivery and an app with a dose calculator and logbook. While the dose calculator aids in managing diabetes by suggesting insulin doses based on user-entered data and healthcare professional parameters, it does not diagnose a condition. Its function is to facilitate the administration of medication, not to identify or characterize a disease or medical condition.
No
The device description clearly states the system consists of a "manually-controlled pen injector" and an app. The pen injector is a physical hardware component with a battery and electronics.
Based on the provided text, the InPen is not an IVD (In Vitro Diagnostic) device.
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 designed for the delivery of insulin into the body. It also includes an app with a dose calculator to help users determine the appropriate insulin dose based on user-entered data and parameters provided by a healthcare professional.
- No Sample Analysis: The InPen does not analyze any biological samples from the patient. Its function is to administer medication and assist with dose calculation, not to diagnose or monitor a condition through sample analysis.
Therefore, the InPen falls under the category of a drug delivery device with a supporting software component, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FMF, NDC
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
age 7 and older
Intended User / Care Setting
Home-use; people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older for self-injection.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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). 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.
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
1
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
2
Indications for Use
510(k) Number (if known) K201337
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 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 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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3
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.
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
Companion Medical, Inc.
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 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.
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.
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 Device | |
| InPen Pen Injector | Predicate Device | |
| InPen Pen Injector (K190487) | ||
| Classification | (Class II - FMF - 21 CFR §880.5860) | Same |
| Indications For Use | The InPen is a home-use reusable | |
| pen injector for single-patient use | ||
| by people with diabetes under the | The InPen is a home-use reusable | |
| pen injector for single-patient use | ||
| by people with diabetes age 12 | ||
| 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. | and older for the self-injection of | |
| a desired dose of insulin. The pen | ||
| injector is compatible with Lilly | ||
| Humalog® U-100, Novo Nordisk | ||
| Novolog®, and Novo Nordisk | ||
| Fiasp® 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 | None | Same |
| Contact | ||
| Dose Calculator | ||
| Communication | Yes | Same |
| Table 2 | ||
| Attribute | Subject Device | |
| InPen App | Predicate Device | |
| InPen App (K190487) | ||
| 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 | ||
| 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. | 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. The device is indicated for | ||
| use with NovoLog® or Humalog® | ||
| U-100 insulin. | ||
| 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 | |
| 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. | 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. | ||
| 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 | Major | Same |
| Concern | ||
| 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 |
Table 1
5
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
6
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.
7
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.