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-patients 18 years or older who are:

. diagnosed with type 1 or type 2 diabetes mellitus,
using prefilled 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 a compatible application (App).

Device Description

The Tempo Smart Button is a reusable data transmitter that detects and stores insulin doserelated data when attached to a disposable Tempo Pen and then transfers information to a compatible mobile application via Bluetooth® wireless technology. The insulin dose-related data is used by the mobile application which can display the brand of insulin, dose amount, date, and time.

Additionally, the Tempo Smart Button is available as part of a Welcome Kit. The Tempo Welcome Kit and Refill Kit provide the convenience of having a single kit that contains devices needed for insulin administration and blood glucose monitoring.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study description for the Tempo Smart Button's performance related to its primary function of detecting, storing, and transferring insulin dose-related data. While general statements about meeting acceptance criteria and various tests are made, the specifics requested in your prompt are largely absent.

Here's an analysis of what information is available:

1. A table of acceptance criteria and the reported device performance:

The document broadly states:

"Lilly completed module testing for general design requirements, mechanical characterization, and accuracy of electronic dose capture. In all instances, the module met the acceptance criteria."
"Bench Testing: Testing confirms that the module does not impact Tempo Pen compliance to specifications for dialing torque, injection force, and dose accuracy, nor does it impact Tempo Pen compliance to ISO 11608-1."

However, specific numerical acceptance criteria (e.g., accuracy percentage, tolerance levels) and the corresponding reported performance values for "accuracy of electronic dose capture" or other key functions are not provided in the text.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "Bench Testing" and "module testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified.

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:

This device is an "injection data capture device" and not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance would not be applicable or expected for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device's core function is autonomous data capture and transfer. The statement "accuracy of electronic dose capture. In all instances, the module met the acceptance criteria" implies standalone performance testing was conducted for this functionality. However, detailed results are missing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "accuracy of electronic dose capture," the ground truth would likely be the actual dose dialed on the pen, measured independently, or validated through mechanical means, rather than expert consensus or pathology. This is inferred from the bench testing context, but not explicitly stated.

8. The sample size for the training set:

The document mentions "Software Verification and Validation" but does not refer to machine learning model training or a "training set" in the context of data used for algorithm development. This suggests the primary function is not based on a learnable AI model from a training set, but rather on direct electronic sensing and data processing.

9. How the ground truth for the training set was established:

As a "training set" in the context of machine learning is not mentioned, this information is not applicable and hence not provided.

Summary of Available Information from the Provided Text:

The document confirms that the Tempo Smart Button underwent "Bench Testing" and "module testing for general design requirements, mechanical characterization, and accuracy of electronic dose capture," and "In all instances, the module met the acceptance criteria." It also states the device "does not impact Tempo Pen compliance to ISO 11608-1."

However, the specific quantitative acceptance criteria and the detailed results of these tests (e.g., specific accuracy rates for dose capture), along with the sample sizes, data provenance, and ground truth establishment methods for those specific performance aspects, are not disclosed in the provided FDA letter and 510(k) summary. The information focuses more on regulatory compliance (biocompatibility, electrical safety, software validation, cybersecurity) and substantial equivalence to a predicate device rather than in-depth performance study results for the core data capture function.

Summary

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September 16, 2022

Eli Lilly and Company Marcia Arentz Sr. Director Lilly Corporate Center Indianapolis, Illinois 46285

Re: K212217

Trade/Device Name: Tempo Smart Button Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QOG, OCN Dated: July 11, 2022 Received: July 12, 2022

Dear Marcia Arentz:

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

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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,

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

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Indications for Use

510(k) Number (if known) K212217

Device Name

Tempo Smart Button

Indications for Use (Describe)

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-patients 18 years or older who are:

. diagnosed with type 1 or type 2 diabetes mellitus,
using prefilled 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 a compatible application (App).

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

l. Submitter

Name and Address:	Eli Lilly and CompanyLilly Corporate CenterIndianapolis, IN 46285
Contact:	Marcia Arentz, MBA, MS-RA/QA, RACSenior Director Global Regulatory Affairs -Drug Delivery & Digital HealthMobile: (317) 864-4676marcia.arentz@lilly.com
Date Prepared:	September 16, 2022
II.	Device
Trade Name:	Tempo Smart Button
Classification Name:	Injection Data Capture Device
Regulation	21 CFR §880.5860 Piston Syringe
Product Codes:	QOG, OCN
Class:	II

lll. Predicate Device

InPen System (K160629)

IV. Device Description

V. Intended Use and Indications for Use

The Tempo Smart Button is intended to detect, store, and transfer insulin dose-related data from a Tempo Pen to a compatible application.

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The Tempo Smart Button is indicated for single-patient use by patients 18 years or older who are:

diagnosed with type 1 or type 2 diabetes mellitus, ●
. using prefilled 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 a compatible application (App). .

VI. Comparison of Technological Characteristics

The Tempo Smart Button, when used with a Tempo Pen, is substantially equivalent to the InPen pen injector (K160629). A substantial equivalence chart comparing the subject and predicate attributes is shown in the following table.

Attribute	InPen pen injectorelectronic functionality(predicate device, K160629)	Tempo Smart Button(subject device)
Intended Use of ElectronicFunctionality	Detect, store, and transfer insulin dose-related data from the pen to a compatibleapplication	Same
Indications for Use
Intended Users	People with diabetes age 12 and older	People with diabetes age 18 and older
Single Patient Use	Yes	Same
Availability	Prescription only	Same
Preparation for Injection	User installs cartridge and attachesneedle to pen	User attaches module and attachesneedle to pen
Classification	Class II - 21 CFR 880.5860	Same
Drug Contact	None	Same
Biocompatibility definedby ISO 10993-1	Meets requirementsfor intact skin contact	Same
Dose Accuracy	Meets ISO 11608-1 requirements whenevaluated with compatible pre-filledcartridges	Meets ISO 11608-1 requirements whenevaluated with compatible pens
Reusable Device	Yes	Same
Digital Dose Display	No	Same
Electronically ControlledDosing	No	Same
Battery	Non-rechargeable	Same
Electronic Structure	Folded flex circuit	Same
Electrical Safety	Meets IEC 60601-1 requirements	Same
Embedded Firmware	Meets IEC 62304 requirements;Major level of concern	Same
Electronic Data for InsulinIdentification	Insulin Identification manually selectedby user during setup and displayed onmobile application during dosing	Insulin Identification detected by systemand displayed on mobile application
Electronic Data for DoseInformation Capture	Nominal dose recorded	Dose-related data recorded; doseinformation displayed on mobileapplication
Dose History	Full; Displayed on mobile application	Same
Data Transfer	Bluetooth (proprietary profile)	Similar

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When attached to a Tempo Pen, the Tempo Smart Button has the same intended use and similar indications, technological characteristics, and principles of operation as the predicate device. The intended user group of the subject module falls within the intended user group of the predicate pen. The minor differences in technological characteristics do not raise different questions of safety or effectiveness.

VII. Nonclinical Performance Data

Biocompatibility: The module was evaluated according to the criteria in ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1 : Evaluation and Testing. All patient-contact components passed the cytotoxicity, sensitization, and irritation testing requirements.

Electromagnetic Compatibility and Electrical Safety: The module was evaluated according to the electrical safety and electromagnetic compatibility criteria 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. The module 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.

Software Verification and Validation: Lilly conducted software verification and validation and provided documentation in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005).

Cybersecurity: Lilly evaluated cybersecurity in accordance with FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (2014 and 2018 Draft) and identified no unacceptable or uncontrolled security verification test findings.

Bench Testing: Testing confirms that the module does not impact Tempo Pen compliance to specifications for dialing torque, injection force, and dose accuracy, nor does it impact Tempo Pen compliance to ISO 11608-1. Needle-Based Injection Systems For Medical Use -Requirements And Test Methods – Part 1: Needle-Based Injection Systems.

Lilly completed module testing for general design requirements, mechanical characterization, and accuracy of electronic dose capture. In all instances, the module met the acceptance criteria.

Risk Management: Lilly's Quality System complies with the requirements of ISO 14971:2012 Medical devices - Application of risk management to medical devices. Lilly followed applicable procedures during development of the module and app.

VIII. Human Factors Performance Data

Lilly developed the user interface (UI) through a comprehensive Human Factors (HF) Engineering Process. In the HF Validation Test, intended users successfully completed a series of simulated use scenarios used to evaluate critical tasks. which demonstrated that the module is safe and effective for the intended use by the intended user population in the intended use

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environments.

IX. Conclusions

The subject device is substantially equivalent to the predicate device because it has the same intended use, indications for use that fall within those of the predicate device, and minor differences in technological characteristics that do not raise different questions of safety and effectiveness. Performance data demonstrate substantial equivalence.

Regulation Number and Section

§ 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).