The SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.

Device Description

The device is made of a cap to be assembled onto a pen injector by covering the injection pen button. The overall device size is 21.4mm diameter & 23.3mm height. A USB cable, necessary to charge the SoloSmart® device is also provided in the package.

AI/ML Overview

The provided FDA 510(k) summary for the SoloSmart Injection Pen Adapter does not contain information related to a study proving the device meets acceptance criteria for an AI/ML-based medical device. This document describes a traditional medical device (an adapter for injection pens) and its substantial equivalence to a predicate device, focusing on its physical and functional characteristics, rather than AI performance.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.

The document discusses performance data related to the physical device and its ability to accurately record and transmit dosing information, but not the performance of an AI algorithm.

Here's a breakdown of what is in the provided text, and why it doesn't align with the request for AI/ML device performance:

Device Type: SoloSmart Injection Pen Adapter, a physical device that attaches to insulin pens to capture and transmit dosing data. It is not described as an AI/ML device.
Performance Data (Section 13): This section outlines "Bench testing on performance" for the physical adapter, including:
- Dose accuracy of pen not affected by SoloSmart®.
- Recording and transmission Accuracy.
- Dose Prime Differentiation.
- Complete Dose Notification.
- Incomplete Injection Identification.
- Physical Interaction with pen.
Other Testing: Biocompatibility, Lifetime, Electrical safety, EMC and Radiocommunication, Cybersecurity Testing and Software Verification and Validation. These are standard tests for medical devices, not specific to AI/ML performance.
Human Factor Validation (Section 14): Confirms usability of the device form factor and instructions for use.
Substantial Equivalence (Section 8 & 12): The core of the 510(k) submission is to demonstrate that the SoloSmart® is substantially equivalent to a legally marketed predicate device (Mallya Injection Pen Adapter). This comparison focuses on indications for use, intended use, fundamental scientific technology, and technological characteristics (e.g., Bluetooth Low Energy communication, mechanism for recording dose).

In summary, the provided text does not describe an AI/ML-based medical device or any studies related to its AI performance. Thus, it is impossible to extract the requested information regarding AI acceptance criteria and proof of meeting those criteria.

Summary

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January 12, 2024

Biocorp Production Alexia Garin Vice President & Regulatory Affairs Zi Lavaur -La Béchade Issoire, 63500, France

Re: K231820

Trade/Device Name: SoloSmart Injection Pen Adapter (SoloSmart®) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QOG Dated: December 20, 2023 Received: December 20, 2023

Dear Alexia Garin:

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, MS 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

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Indications for Use

510(k) Number (if known) K231820

Device Name

SoloSmart Injection Pen Adapter (SoloSmart®)

Indications for Use (Describe)

The SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors.

The following Injection pens are compatible:

DEVICE MODEL NAME	INSULIN BRAND NAME	MOLECULE NAME	MOLECULE CONCENTRATION
SoloSmartdesigned forSolostar® SANOFIInjection pen	Lantus	GLARGINE	100 IU/mL
	Toujeo		300 IU/mL
	Admelog	LISPRO	100 IU/mL
	Apidra	GLULISINE	100 IU/mL
	Soliqua 100/33	GLARGINE ANDLIXISENATIDE	100 IU/mL+33mcg/mL

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)

1. Prepared By: Alexia Garin

Date Prepared: December 20, 2023
1. Trade/Proprietary Name: SoloSmart Injection Pen Adapter (SoloSmart®)
1. Common/Usual Name: Iniection Data Capture Device Piston Syringe 5. Classification Name:
21 CFR 880.5860
1. Predicate Device: K222689, Biocorp Production, Mallya Injection Pen Adapter

Product Code: QOG

1. Biocorp Production Applicant: ZI Lavaur La Béchade 63500 Issoire - France
Substantial Equivalence: The SoloSmart® device is substantially equivalent to the Mallya 8. (K222689). The device has the same indication for use, intended use and same fundamental scientific technology.
1. Technological Characteristics: The Solosmart® Injection Pen Adapter has the same technological characteristics as the predicate device to capture and transmit dosing information. The information is captured through the rotation of the dosing button of the pen into a value indicating the dose increment injected. Both the SoloSmart® and the predicate device use same Low Energy Bluetooth (BLE) communication technology and same protocol to pair and transmit the information to a mobile device with a compatible app.
1. Physical description: The device is made of a cap to be assembled onto a pen injector by covering the injection pen button. The overall device size is 21.4mm diameter & 23.3mm height. A USB cable, necessary to charge the SoloSmart® device is also provided in the package.
1. Indications for Use: The SoloSmart Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors. The following Injection pens are compatible:

DEVICE MODEL	INSULIN BRANDNAME	MOLECULE NAME	MOLECULECONCENTRATION
SoloSmart®designed forSoloStar®SANOFIinjection pen	Lantus	GLARGINE	100 IU/mL
	Toujeo	GLARGINE	300 IU/mL
	Admelog	LISPRO	100 IU/mL
	Apidra	GLULISINE	100 IU/mL
	Soliqua 100/33	GLARGINE ANDLIXISENATIDE	GLARGINE ANDLIXISENATIDE

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12. Substantial Equivalence discussion:

Attribute	Subject Device	Predicate	Discussion/Comments
Device Name	SoloSmart®	Mallya	-
		Data Capture and Transmission Technology
510(k) Number	K231820	K222689	-
Device Classification	Class 2 - QOG	Class 2 - QOG
Indication for Use	Indicated for thecapture and wirelesstransmission of dosinginformation fromcompatible reusableand disposable peninjectors.	Indicated for thecapture and wirelesstransmission of dosinginformation fromcompatible reusableand disposable peninjectors.
Single patient Use	Yes	Yes
Reusable Device	Yes	Yes
Intended Use	Intended to be usedby patients in thesame useenvironment as theircompatible injectionpen.	Intended to be usedby patients in thesame useenvironment as theircompatible injectionpen.	same
Prescription use	No	No
User Group	User of CompatibleInjection Pens;includes diabetespatients	User of CompatibleInjection Pens;includes diabetespatients
User Feedback	Electronic - LED(light)	Electronic - LED(light) and Audible(Beeps)	Both provide visiblefeedback (light).Removal of audiblefeedback wasconfirmed asunnecessary in a HFValidation study
WirelessConnectivity	Bluetooth Low Energy(BLE)	Bluetooth Low Energy(BLE)	Same connectivity BLEprotocol
Control or impactDrug delivery	No	No
Fluid PathwayContact	None	None	same
Software controlled	Yes	Yes	same
Dose Recorded	Calculated based ondose set	Calculated based ondose set	Change from two-partto one part device
InformationTransmitted	Dialed dose, and timeand date of injection	Dialed dose, and timeand date of injection	necessitated andenabled changes to the
Mechanism forRecording dosedialed	Sense dose dialedthrough rotation ofdosing mechanismduring doseadministration	Sense dose dialedthrough rotation ofdosing mechanismduring dose setting	hardware and softwareto capture, record andtransmit the dosedelivered, rather than
Differentiates Primevs. Dose	Yes	Yes	only the dose that wasset (dialled).
Battery	Non-Replaceable;Rechargeable	Non-Replaceable;Rechargeable	Same type of batterywith same design inputspecification regardingbattery
Lifetime	Up to 3 years of usefrom manufacturingdate	2 years of use	Extended lifetime

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13. Performance Data

Data on the following testing were generated verifying the design of the device:

. Bench testing on performance, using ISO 11608-1 as a guide.
- Dose accuracy of pen is not affected by SoloSmart® .
- . Recording and transmission Accuracy
- Dose Prime Differentiation .
- . Complete Dose Notification
- . Incomplete Injection Identification
- Physical Interaction with pen, including force to mount, maintain and remove . SoloSmart®
Biocompatibility - ISO 10993-1 and FDA quidance; permanent contact with intact skin
Lifetime The product met test criteria to verify it will operate/function for 2 years (Use . Lifetime) following storage for up to two years (Shelf Life).
Electrical safety, EMC and Radiocommunication - IEC 60601-1 and appropriate collateral requirements from IEC 60601-2 and IEC 60601-1-11
Cybersecurity Testing and Software Verification and Validation per FDA Guidelines

14. Human factor validation

Biocorp performed a HF Validation study to confirm the usability of SoloSmart device form factor and associated instructions for use per FDA guidance.

15. Conclusion

Biocorp as concluded that the evidences documented during design control activities supports that the SoloSmart is substantially equivalent to the predicate for specific indications and technological characteristics of the predicate device with regards to the data recording and transmission.

1. Contact person: Alexia Garin, pms@biocorp.fr +33 473 557050

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).