← Product Code [QOG](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG) · K212217 # Tempo Smart Button (K212217) _Eli Lilly and Company · QOG · Sep 16, 2022 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG/K212217 ## Device Facts - **Applicant:** Eli Lilly and Company - **Product Code:** [QOG](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG.md) - **Decision Date:** Sep 16, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5860 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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. ## Device Story Tempo Smart Button is a reusable data transmitter that attaches to a disposable Tempo Pen; detects and stores insulin dose-related data; transfers data via Bluetooth to a compatible mobile application (e.g., myTempo App). Used by patients 18+ with diabetes in home environments. Mobile app displays insulin brand, dose amount, date, and time. Device assists patients in tracking insulin administration history; supports clinical decision-making by providing accurate dose logs to healthcare providers. Does not control dosing; does not contact drug. ## Clinical Evidence Bench testing only. Evaluated per ISO 10993-1 (biocompatibility), IEC 60601-1/1-2/1-11 (electrical safety/EMC), and ISO 11608-1 (dose accuracy). Software verification/validation performed per FDA guidance. Human factors validation study confirmed safe/effective use by intended population in simulated use scenarios. ## Technological Characteristics Reusable electronic module; attaches to Tempo Pen. Materials meet ISO 10993-1 for intact skin contact. Bluetooth connectivity. Non-rechargeable battery. Folded flex circuit architecture. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11. Software meets IEC 62304 requirements. ## Regulatory 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. ## Predicate Devices - InPen System ([K160629](/device/K160629.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. 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 {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, 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) 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary #### l. Submitter | Name and Address: | Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285 | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Marcia Arentz, MBA, MS-RA/QA, RAC
Senior Director Global Regulatory Affairs -
Drug Delivery & Digital Health
Mobile: (317) 864-4676
marcia.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 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. #### 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. {4}------------------------------------------------ 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 injector
electronic functionality
(predicate device, K160629) | Tempo Smart Button
(subject device) | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | Intended Use of Electronic
Functionality | Detect, store, and transfer insulin dose-
related data from the pen to a compatible
application | 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 attaches
needle to pen | User attaches module and attaches
needle to pen | | Classification | Class II - 21 CFR 880.5860 | Same | | Drug Contact | None | Same | | Biocompatibility defined
by ISO 10993-1 | Meets requirements
for intact skin contact | Same | | Dose Accuracy | Meets ISO 11608-1 requirements when
evaluated with compatible pre-filled
cartridges | Meets ISO 11608-1 requirements when
evaluated with compatible pens | | Reusable Device | Yes | Same | | Digital Dose Display | No | Same | | Electronically Controlled
Dosing | 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 Insulin
Identification | Insulin Identification manually selected
by user during setup and displayed on
mobile application during dosing | Insulin Identification detected by system
and displayed on mobile application | | Electronic Data for Dose
Information Capture | Nominal dose recorded | Dose-related data recorded; dose
information displayed on mobile
application | | Dose History | Full; Displayed on mobile application | Same | | Data Transfer | Bluetooth (proprietary profile) | Similar | {5}------------------------------------------------ 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 {6}------------------------------------------------ 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. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG/K212217](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/QOG/K212217) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com