(62 days)
- Insulclock® is for use by patients using disposable insulin diagnosed with type I or type II diabetes mellitus.
- Insulclock® is for use by people from 18 to 65 years old. Out of this age range, the Insulclock® must be used under supervision.
- Insulclock® is designed for use in any home environment.
- Using a compatible App.
INTENDED USE: INSULCLOCK® v2.0 pro is intended to detect, store and transfer insulin dose-related data, the time of injection and the temperature to which the disposable insulin pen has been exposed to. All this information is sent to a mobile app via integrated SDK.
The INSULCLOCK® v2.0 pro is a reusable data transmitter with Software Development Kit (SDK) that detects and stores insulin dose- related data when attached to a disposable insulin pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology which can display the brand of insulin, dose amount, injection time, and ambient temperature.
Models:
- INSULCLOCK® v2.0 PRO for Kwikpen® (Lilly®)
- INSULCLOCK® v2.0 PRO for Flex-touch® (Novo Nordisk®)
The provided FDA 510(k) summary for the INSULCLOCK® v2.0 PRO focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and does not contain information about acceptance criteria and a study proving those criteria are met in the context of device performance metrics typically reported for AI/ML devices (e.g., sensitivity, specificity, accuracy against a ground truth dataset).
This document mainly describes:
- The device's intended use and technological characteristics.
- Comparison of the device with a predicate device (Tempo Smart Button K212217).
- Summary of non-clinical testing performed to meet various safety, performance, and software standards (e.g., Biocompatibility, Software and Cybersecurity, Electrical Safety and EMC, Performance standards like UNE-EN 11608-1 for dose accuracy).
- A brief mention of a Human Factors validation study.
- A statement that clinical testing was not required for substantial equivalence.
Therefore, most of the information requested in your prompt regarding acceptance criteria for device performance/AI metrics, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/ML models cannot be extracted from this document.
However, I can provide what information is available concerning the requested points:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, or accuracy that would be relevant to an AI/ML device's diagnostic or predictive capabilities. Instead, it refers to compliance with established industry standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 10993-1 (Biocompatibility) | Meets requirements |
| IEC 62304 (Software Life Cycle) | Meets requirements |
| UL 2900-1, UL 2900-2-1 (Cybersecurity) | Meets requirements |
| IEC 60601-1, IEC 60601-1-2 (Electrical Safety & EMC) | Meets requirements |
| ANSI C63.27, AIM 7351731, AAMI TIR69:2017 (Wireless Coexistence) | Meets requirements |
| UNE-EN 11608-1 (Dose Accuracy) | Meets requirements when evaluated with compatible pens |
| Human Factors validation study | Intended users were able to operate the device as intended |
2. Sample size used for the test set and the data provenance
Not applicable to the information provided. The document outlines non-clinical engineering and usability testing, not performance evaluation against a labeled dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no ground truth establishment for a diagnostic or predictive AI/ML model is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device, INSULCLOCK® v2.0 PRO, is a hardware device with an SDK that detects and transmits data, rather than a standalone AI algorithm making diagnostic or predictive decisions. Its performance is related to accurate data capture and transmission, which is evaluated through engineering standards compliance.
7. The type of ground truth used
For the specific performance aspect mentioned (Dose Accuracy via UNE-EN 11608-1), the ground truth would be the actual dose delivered by the compatible insulin pens, measured by standard metrological methods defined within that standard. For other standards, compliance is verified against the requirements of the standard itself (e.g., electrical safety tests, biocompatibility tests). There is no "expert consensus" or "pathology" ground truth described here.
8. The sample size for the training set
Not applicable. The document does not describe the development or training of an AI/ML model on a dataset.
9. How the ground truth for the training set was established
Not applicable.
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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.
August 22, 2024
INSULCLOUD S.L.
% Dulciana Chan Principal Consultant ROM+ 2790 Mosside Blvd. Suite 800 Monroeville, Pennsylvania 15146
Re: K241803
Trade/Device Name: INSULCLOCK® v2.0 PRO Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QOG Dated: June 18, 2024 Received: June 21, 2024
Dear Dulciana Chan:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Shruti N. Mistry -S
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
INSULCLOCK® v2.0 PRO
Indications for Use (Describe)
-
Insulclock® is for use by patients using disposable insulin diagnosed with type I or type II diabetes mellitus.
-
Insulclock® is for use by people from 18 to 65 years old.
Out of this age range, the Insulclock® must be used under supervision.
- Insulclock® is designed for use in any home environment.
- Using a compatible App.
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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510(k) Summary
DATE PREPARED
June 18, 2024
MANUFACTURER AND 510(k) OWNER
INSULCLOUD S.L. Avenida Sabino Arana, #8, 48013 Telephone: Official Contact: Pilar Aranda, Quality Technician
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Dulciana Chan, MSE RQM+ Telephone: +1 (877) 652-0830 Email: akomiyama@rqmplus.com dchan@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | INSULCLOCK® v2.0 PRO |
|---|---|
| Common Name: | Piston Syringe |
| Regulation Number: | 880.5860 |
| Class: | II |
| Product Code: | QOG |
| Premarket Review: | OHT3: Office of Gastrorenal, OBGyn, General Hospital, and |
| Urology Devices, Office of Product Evaluation and Quality | |
| Review Panel: | General Hospital and Personal Use Devices |
PREDICATE DEVICE IDENTIFICATION
The INSULCLOCK®v2.0 PRO is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K212217 | Tempo Smart Button | ✓ |
The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION
The INSULCLOCK® v2.0 pro is a reusable data transmitter with Software Development Kit (SDK) that detects and stores insulin dose- related data when attached to a disposable insulin pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology which can display the brand of insulin, dose amount, injection time, and ambient temperature.
Models:
- INSULCLOCK® v2.0 PRO for Kwikpen® (Lilly®) ।
- INSULCLOCK® v2.0 PRO for Flex-touch® (Novo Nordisk®) -
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INDICATIONS FOR USE
-
Insulclock® is for use by patients using disposable insulin diagnosed with type I or type II diabetes mellitus.
-
Insulclock® is for use by people from 18 to 65 years old.
Out of this age range, the Insulclock® must be used under supervision. -
Insulclock® is designed for use in any home environment.
-
Using a compatible App.
INTENDED USE: INSULCLOCK® v2.0 pro is intended to detect, store and transfer insulin doserelated data, the time of injection and the temperature to which the disposable insulin pen has been exposed to. All this information is sent to a mobile app via integrated SDK.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
INSULCLOCK® v2.0 pro is substantially equivalent to the Tempo Smart Button (K212217) predicate device based on the similarities summarized in the following Table of Substantial Equivalence.
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| Attribute | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| INSULCLOUD S.L.INSULCLOCK® v2.0 pro | Eli Lilly and CompanyTempo Smart ButtonK212217 | ||
| Intended Use ofElectronicFunctionality | Detect, store, and transfer insulin dose- related data from the pen to a compatible application | Detect, store, and transfer insulin dose- related data from the pen to a compatible application | Same |
| Indications for Use | Insulclock® is for use by patients using disposable insulin diagnosed with type I or type II diabetes mellitus.- Insulclock® is for use by people from 18 to 65 years old.Out of this age range, the Insulclock® must be used under supervision.- Insulclock® is designed for use in any home environment.- Using a compatible App. | The Tempo Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application such as the myTempo App (App). The tempo Smart button is indicated for single-patient use by patients 18 years or older who are:Diagnosed with type 1 or 2 diabetes mellitusUsing pre-filled insulin Tempo pens (Basaglar® Tempo Pen (insulin glargine) injection 100 units/mL, Lyumjev® Tempo Pen (insulin lispro-aabc) injection 100 units/mL, Humalog®Tempo Pen (insulin lispro injection) 100 units/mL]Using compatible application (APP) | Similar |
| Intended Users | Patients between the ages of 18 and 65 who are diagnosed with type 1 or type 2 diabetes mellitus. If the user is outside this age range, the device must be used under supervision. | People with diabetes age 18 and older | Similar |
| Single Patient Use | Yes | Yes | Same |
| Availability | Prescription only | Prescription only | Same |
| Classification | Class II - 21 CFR 880.5860 | Class II - 21 CFR 880.5860 | Same |
| Drug Contact | None | None | Same |
| Biocompatibilitydefined by ISO 10993-1 | Meets requirements for intact skin contact | Meets requirements for intact skin contact | Same |
| Dose Accuracy | Meets ISO 11608-1 requirements when evaluated with compatible pens | Meets ISO 11608-1 requirements when evaluated with compatible pens | Same |
| Attribute | Subject Device | Predicate Device | Comparison |
| INSULCLOUD S.L.INSULCLOCK® v2.0 pro | Eli Lilly and CompanyTempo Smart ButtonK212217 | ||
| Reusable Device | Yes | Yes | Same |
| Digital Dose Display | No | No | Same |
| ElectronicallyControlled Dosing | No | No | Same |
| Battery | Rechargeable battery meetingUNE-EN 62133-2:2017,UN 38.3and UL 1642. | Non-rechargeable | Different |
| Electronic Structure | Foiled flex circuit | Foiled flex circuit | Same |
| Electrical Safety | Meets IEC 60601-1 Requirements | Meets IEC 60601-1 Requirements | Same |
| Embedded Firmware | Meets IEC 62304 requirements:Class BEnhanced documentation inaccordance with Content ofPremarket Submissions forDevice Software Functions | Meets IEC 62304 requirements:Major level of concern | Same |
| Electronic Data forInsulin Identification | Insulin Identification manuallyselected by the user during setup. | Insulin Identification detected bysystem. | Different |
| Insulin identification displayed onmobile application. | Insulin identification displayed onmobile application. | Same | |
| Electronic Data forDose InformationCapture | Dose-related data recorded; doseinformation displayed on mobileapplication. | Dose-related data recorded; doseinformation displayed on mobileapplication. | Same |
| Dose History | Full; Displayed on mobileapplication. | Full; Displayed on mobileapplication. | Same |
| Data Transfer | Bluetooth. | Bluetooth. | Same |
| Insulin Disposable Pencompatibilities | • Kwikpen® model (Lilly)• Flextouch® model (NovoNordisk) | Tempo Pens (Basaglar® U-100Tempo Pen, Lyumjev® U-100Tempo Pen, Humalog® U-100Tempo Pen) | Different |
| Compatible MobileApplications | Mobile applications for Android8.0 or higher or iOS 15.0 orhigher, using theINSULCLOCK® v2.0 proSoftware Development Kit (SDK) | My Tempo App | Different |
| TemperatureMeasurement | Ambient temperaturemeasurement | No | Different |
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The following technological differences exist between the subject and predicate devices:
- Tempo Smart Button is indicated for use in people with diabetes over 18 years of age and -INSULCLOCK® v2.0 pro intended users are patients between the ages of 18 and 65 who are diagnosed with type 1 or type 2 diabetes mellitus. If the user is outside this age range, the device must be used under supervision.
- The INSULCLOCK® v2.0 pro battery is rechargeable, whereas the predicate battery is not rechargeable.
- Both INSULCLOCK® v2.0 pro and Tempo Smart Button display Insulin identification on the mobile application. However, with INSULCLOCK® v2.0 pro, insulin is identified by the user in the app during setup, while it is detected by the system when using Tempo Smart Button.
- -The subject and predicate devices are compatible with different Insulin Disposable Pens. Tempo Smart Button is compatible with Tempo pens (i.e., Basaglar® U-100 Tempo Pen, Lyumjev® U-100 Tempo Pen, Humalog® U-100 Tempo Pen). INSULCLOCK® v2.0 pro features two device models, one compatible with the Kwikpen® model (Lilly) and one with the Flextouch® model (Novo Nordisk).
- -Compatible Mobile Applications: Tempo Smart Button is only compatible with My Tempo App. whereas INSULCLOCK® v2.0 pro is compatible with Mobile applications for Android 8.0 or higher or iOS 15.0 or higher using the INSULCLOCK® v2.0 pro Software Development Kit (SDK).
- -INSULCLOCK® v2.0 pro can measure ambient temperature whereas Tempo Smart Button cannot.
In summary, INSULCLOCK® v2.0 pro has the same intended use and similar indications, technological features, and operating principles to the predicate device. The minor differences in technological characteristics do not raise new or different questions of safety or effectiveness.
SUMMARY OF NON-CLINICAL TESTING
The INSULCLOCK® v2.0 pro was tested to evaluate its performance based on the following standards:
| Standard | Version | Title |
|---|---|---|
| Biocompatibility | ||
| ISO 10993-1 | 2018 | Biological evaluation of medical devices — Part 1: Evaluation and testingwithin a risk management process |
| Software and Cybersecurity | ||
| IEC 62304 | 2006 | Medical device software. Software Life Cycle Processes |
| UL 2900-1 | 2023 | Software Cybersecurity for Networks-Connectable Products, Part 1: GeneralRequirements |
| UL 2900-2-1 | 2023 | Software Cybersecurity for Networks-Connectable Products, Part 2-1:Particular Requirements for Network Connectable Components of Healthcareand Wellness Systems |
| Electrical Safety and EMC | ||
| IEC 60601-1 | 2005 + | Medical electrical equipment - Part 1: General requirements for basic safety |
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| Standard | Version | Title |
|---|---|---|
| IEC 60601-1-2 | Amd1:2012 | and essential performance. |
| IEC 60601-1-2 | 2014 | Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests. |
| IEC 60601-1-2:2020 (4.1Edition) | 2020 | Medical Electrical Equipment - Part 1-2: General Requirements For BasicSafety And Essential Performance - Collateral Standard: ElectromagneticDisturbances - Requirements And Tests |
| ANSI C63.27 | 2017 | American National Standard for Evaluation of Wireless Coexistence |
| AIM 7351731 | N/A | Medical Electrical Equipment & System Electromagnetic Immunity Test forExposure to RFID Readers |
| AAMI TIR69:2017(R2020) | 2017 | American National Standard for Evaluation of Wireless Coexistence |
| Performance | ||
| UNE-EN 11608-1 | ISO 2022 | Needle-based injection systems for medical use - Requirements and testmethods - Part 1: Needle-based injection systems |
HUMAN FACTORS PERFORMANCE DATA
A human factors validation study was conducted on participants who were representative of intended users. The results of the study showed that intended users were able to operate the device as intended.
SUMMARY OF CLINICAL TESTING
Clinical testing was not required to demonstrate the substantial equivalence of the INSULCLOCK® v2.0 pro to its predicate device.
CONCLUSION
Based on the information presented in this 510(k) premarket notification, the INSULCLOCK® v2.0 pro is considered substantially equivalent to the predicate device, Tempo Smart Button (K212217). The differences noted between the INSULCLOCK® v2.0 pro and the predicate device do not impact substantial equivalence based on the successfully conducted testing of the subject device.
§ 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).