(355 days)
No reference devices were used in this submission.
No
The document describes a dose calculator based on user-entered data and pre-programmed parameters, with no mention of AI or ML technologies.
No
The device is a dose calculator that aids in managing diabetes by calculating insulin doses or carbohydrate intake based on user-entered data; it does not directly treat the condition.
No
The device is a dose calculator that manages diabetes by calculating insulin doses. It does not diagnose any 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 separate hardware component (as indicated by the predicate device K160629 InPen System). While the app contains software for dose calculation, it is part of a system that includes hardware.
Based on the provided information, this 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The InPen dose calculator is a software component that calculates insulin doses or carbohydrate intake based on user-entered data (blood glucose, carbohydrate intake, and pre-programmed parameters). It does not analyze biological samples.
- Intended Use: The intended use is for the management of diabetes by calculating insulin doses or carbohydrate intake, not for diagnosing or monitoring a condition through the analysis of biological samples.
The device is a software application that aids in the management of diabetes by providing dose calculations based on user input and pre-configured parameters. This falls under the category of a medical device, but not specifically an in vitro diagnostic device.
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. 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 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)
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
Not Found
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)
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.
Clinical Evidence:
Companion Medical has demonstrated the InPen dose calculator is appropriate for its intended use through the use of hazard analysis according ISO 14971. Verification and validation of the user interface was completed through a comprehensive usability evaluation. In the summative evaluation, patients with sufficient diabetes knowledge completed self-training and then completed a series of critical tasks using the InPen dose calculator. The summative evaluation demonstrated that after self-training, patients were able to use the InPen dose calculator without making critical errors that could lead to a hazard. No new use-related hazards were identified during the study. The InPen dose calculator satisfies all functional performance and safety requirements, meets its intended use, and is safe for the intended user population. Substantial equivalence was based in part on the evaluation.
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.
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). On the left is the Department of Health & 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.
February 18, 2020
Companion Medical, Inc. Jasper Benke Vice President, RA/QA/CA 11011 Via Frontera, Suite D San Diego, CA 92127
Re: K190487
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: January 16, 2020 Received: January 17, 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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190487
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. The device is indicated for use with NovoLog® or Humalog® U-100 insulin.
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 ) | |
|---|---|
| ---------------------------------------------------------- | -- |
X 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 - K190487 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: | February 18, 2020 |
II. DEVICE
Name of Device: InPen Dose Calculator Common Name: Insulin Dose Calculator Classification Name: Predictive pulmonary-function value calculator (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.
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. The device is indicated for use with NovoLog® or Humalog® U-100 insulin.
4
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 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.
| Attribute | Subject Device
(K190487) | 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. | 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. |
| | 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. | |
5
| 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 | Pre-specified meal/dose sizes (fixed or variable) | Grams of carbohydrates |
| 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 |
VII. Performance Data
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.
Clinical Evidence
Companion Medical has demonstrated the InPen dose calculator is appropriate for its intended use through the use of hazard analysis according ISO 14971. Verification and validation of the
6
user interface was completed through a comprehensive usability evaluation. In the summative evaluation, patients with sufficient diabetes knowledge completed self-training and then completed a series of critical tasks using the InPen dose calculator. The summative evaluation demonstrated that after self-training, patients were able to use the InPen dose calculator without making critical errors that could lead to a hazard. No new use-related hazards were identified during the study. The InPen dose calculator satisfies all functional performance and safety requirements, meets its intended use, and is safe for the intended user population. Substantial equivalence was based in part on the evaluation.
The dose calculator uses the standard approach using healthcare provider specified insulin-tocarbohydrate 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.
VIII. CONCLUSIONS
The subject device is substantially equivalent to the predicate devices, as demonstrated by performance data. It has the same intended use/indications for use, and substantially equivalent technological characteristics and principles of operation.