(141 days)
No reference devices were used in this submission.
No
The description focuses on a manual pen injector and a dose calculator based on user-entered parameters and pre-programmed settings, with no mention of AI or ML.
Yes
The device is described as a "pen injector" for the self-injection of insulin, which is used for the management of diabetes. It directly delivers a therapeutic substance (insulin) to the patient.
No
The InPen is primarily a drug delivery device (insulin pen injector) with an accompanying app that includes a dose calculator. While the app's dose calculator uses patient-entered data to calculate an insulin dose, this is a calculation based on user input and pre-programmed parameters, not a diagnostic assessment of a medical condition. It aids in managing a condition, not in diagnosing it.
No
The device description explicitly states the system consists of a "manually-controlled pen injector" and an app. The pen injector is a hardware component with a battery and electronics, and the app is a software component. Therefore, the device is not software-only.
Based on the provided information, the InPen is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- InPen's Function: The InPen is a pen injector used for the delivery of insulin. 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 analyze a biological specimen.
The InPen is a drug delivery device with a supporting software component for dose calculation and logging. It does not perform any diagnostic testing 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 self-injection of a desired dose of insulin. The pen injector is compatible with Lilly Humalog® 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.
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.
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 (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® and Novolog®. 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 12 and older
Intended User / Care Setting
home-use / single-patient use
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)
Biocompatibility: The InPen System has been evaluated for biocompatibility according to ISO 10993-1. The patient contacting materials were identified and tested as a limited duration (≤ 24 hours), surface device, with skin contact. The following assays were completed: Cytotoxicity, Sensitization, Irritation / Intracutaneous Reactivity. The InPen System is considered biocompatible and acceptable for use.
Electromagnetic Compatibility and Electrical Safety: The InPen System has been tested and shown to comply with the electrical safety and electromagnetic compatibility requirements in IEC 60601-1 and IEC 60601-1-2. It also complies with IEC 60601-1-11.
Software Verification and Validation Testing: Software verification and validation testing were conducted. The software was considered a "major" level of concern.
Bench Testing: The InPen System has been shown to meet the requirements of ISO 11608-1 and Part 2:Needles, with modifications for ISO 11608-4. Testing was completed for general design requirements, mechanical characterization, and dose accuracy. In all instances, the InPen System functioned as intended and met the acceptance criteria.
Clinical Evidence: Companion Medical has demonstrated the InPen System 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 series of Formative Studies and a comprehensive Human Factors Summative Study. In the Summative Study, patients with sufficient diabetes knowledge completed self-training and then completed a series of critical tasks using the InPen System. The Summative Study demonstrated that after self-training, patients are able to use the InPen System without making critical errors that could lead to a hazard. No new use-related hazards were identified during the study. The InPen System 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 study. The dose calculator uses the standard approach using healthcare provider specified insulin-to-carbohydrate ratio and insulin sensitivity factors for making calculations, and 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
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2016
Companion Medical, Inc. Mr. Jasper Benke Vice President, RA/QA 16486 Bernardo Center Drive, Suite 300 San Diego, California 92128
Re: K160629
Trade/Device Name: Inpen® System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, NDC Dated: Julv 7, 2016 Received: July 8, 2016
Dear Mr. 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.
1
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 (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-s
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
2
Indications for Use
510(k) Number (if known) K160629
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 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.
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 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.
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) |
|---|
| ☑ 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 Companion Medical InPen® System
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 26, 2016 |
ll. 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 code: FMF, NDC
III. PREDICATE DEVICES
NovoPen® Echo (K123766) ACCU-CHEK® Bolus Advisor (K150910)
These predicates have not been subject to a design-related recall. No reference devices were used in this submission.
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® and Novolog®. 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 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.
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.
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 InPen pen injector is substantially equivalent to other legally marketed pen injectors. Specifically, the InPen pen injector is substantially equivalent to the Novo Nordisk NovoPen Echo® (K123766) cleared on August 15, 2013. The InPen pen injector has the same intended use and similar indications, 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 1. The minor differences in technological characteristics do not raise new questions of safety or effectiveness. The differences in indications for use (patient age, insulin type) do not change the intended use, or raise new questions of safety and effectiveness; the subject patient age is a limitation of the predicate device patient age, thus the risk margin is decreased. The additional insulin 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.
5
| Attribute | Subject Device | Predicate Device |
|---|---|---|
| InPen Pen Injector | NovoPen Echo (K123766) | |
| 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 age 12 | ||
| 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® 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. | The Novo Pen Echo is a re-usable | |
| pen injector designed for single- | ||
| patient use by diabetics for the | ||
| self-injection of a desired dose of | ||
| insulin. The pen injector uses | ||
| PenFill 3.0 mL cartridges of Novo | ||
| Nordisk insulin and a single use | ||
| detachable and disposable pen | ||
| needle (supplied separately). 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" | 6.4" x ø0.7" |
| Weight | 35 grams | 51 grams |
| Fluid Pathway | None | Same |
| Contact | ||
| Dose History | Full; Displayed on app | Last Dose; Displayed on device |
| Dose Calculator | Yes | No |
| Communication | ||
| Attribute | Subject Device | |
| InPen Dose Calculator | Predicate Device | |
| ACCU-CHEK® Bolus Advisor | ||
| (K150910) | ||
| 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. | The ACCU-CHEK Bolus Advisor, as | |
| a component of the ACCUCHEK | ||
| Connect Diabetes Management | ||
| App, is indicated for the | ||
| management of diabetes by | ||
| calculating an insulin dose or | ||
| carbohydrate intake based on | ||
| user entered data. Before its use, | ||
| a physician or healthcare | ||
| professional must activate the | ||
| bolus calculator and provide the | ||
| patient-specific target blood | ||
| glucose, insulin-to-carbohydrate | ||
| ratio, and insulin sensitivity | ||
| parameters to be programmed | ||
| into the software. | ||
| 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 |
| Attribute | Subject Device | |
| InPen Dose Calculator | Predicate Device | |
| ACCU-CHEK® Bolus Advisor | ||
| (K150910) | ||
| Reports, graphs, and | ||
| Electronic Log Book | Yes | Same |
| Carbohydrate | ||
| Calculator | Calculates carbohydrate intake | |
| based on user-entered data | Same | |
| Manual Dose Entry | Yes | Same |
| InPen Dose Entry | Yes | No |
| Tracking of residual | ||
| bolus insulin to | ||
| mitigate stacking | Yes | Same |
| Operating | ||
| platform | iOS platform | Same |
| UI Standards | iOS standards | Same |
6
The InPen app is substantially equivalent to other legally marketed dose calculators. Specifically, the InPen app is substantially equivalent to the Roche ACCU-CHEK® Bolus Advisor (K150910) cleared on June 3, 2015. The InPen app has the same intended use and similar indications, 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. The minor differences in technological characteristics do not raise new questions of safety or effectiveness. The difference in indications for use (patient age) does not change the intended use, or raise new questions of safety and effectiveness, as the subject patient age is a limitation of the predicate device patient age, thus the risk margin is decreased.
Table 2
7
VII. Performance Data
Biocompatibility
The InPen System has been evaluated for biocompatibility according to ISO 10993-1 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. The InPen System does not contact any part of the insulin fluid path. The patient contacting materials were identified and tested as a limited duration (≤ 24 hours), surface device, with skin contact. The following assays were completed:
- . Cytotoxicity
- Sensitization .
- . Irritation / Intracutaneous Reactivity
The InPen System is considered biocompatible and acceptable for use.
Electromagnetic Compatibility and Electrical Safety
The InPen System has been tested and shown to comply with the electrical safety and electromagnetic compatibility requirements in IEC 60601-1 Medical Electrical Equipment, Part 1: General Requirements For Basic Safety And Essential Performance and IEC 60601-1-2 – Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
Additionally, the InPen System complies with IEC 60601-1-11 Medical Electrical Equipment -Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment.
8
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.
Bench Testing
The InPen System has been shown to meet the requirements of ISO 11608-1, Needle-Based Injection Systems For Medical Use - Requirements And Test Methods - Part 1: Needle-Based Injection Systems and Part 2:Needles. Where appropriate, requirements were modified to reflect ISO 11608-4, Pen-Injectors For Medical Use -- Part 4: Requirements And Test Methods For Electronic And Electromechanical Pen-Injectors. Testing was completed for general design requirements, mechanical characterization, and dose accuracy. In all instances, the InPen System functioned as intended and met the acceptance criteria.
Clinical Evidence
Companion Medical has demonstrated the InPen System 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 series of Formative Studies and a comprehensive Human Factors Summative Study. In the Summative Study, patients with sufficient diabetes knowledge completed self-training and then completed a series of critical tasks using the InPen System. The Summative Study demonstrated that after self-training, patients are able to use the InPen System without making critical errors that could lead to a hazard. No new use-related hazards were identified during the study. The InPen System 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 study.
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.