The Mallya 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 two parts to be assembled onto a pen injector. The Mallya base part (about 6 x 3 x 2 cm) which clips around the body of the injection pen and the Mallya button (about 2.5 x Ø2 cm) that slips over the injection pen button. A USB cable, necessary to charge the MALLYA device, and a reset key are also provided in the package.

AI/ML Overview

This is a description of the Mallya Injection Pen Adapter, K222689. The document is for a 510(k) premarket notification, indicating it's a medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Electromagnetic Compatibility and Electrical Safety	IEC 60601-1 and appropriate collateral requirements (IEC 60601-2 and IEC 60601-1-11)	Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion.
Performance (Bench Testing)	ISO 11608-1 (as a guide)	Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion, and specific sub-criteria are listed below.
Performance (Dose Accuracy)	Dose accuracy of pen is not affected by Mallya	Implied successful completion as "Dose accuracy of Mallya dose recording has been assessed and verified during Design Verification." and listed as part of performance data.
Performance (Recording and Transmission Accuracy)	Recording and transmission Accuracy	Implied successful completion as "Dose accuracy of Mallya dose recording has been assessed and verified during Design Verification." and listed as part of performance data.
Performance (Dose Prime Differentiation)	Dose Prime Differentiation	Listed as part of performance data, implying successful evaluation.
Performance (Complete Dose Notification)	Complete Dose Notification	Listed as part of performance data, implying successful evaluation.
Performance (Incomplete Injection Identification)	Incomplete Injection Identification	Listed as part of performance data, implying successful evaluation.
Performance (Physical Interaction with pen)	Force to mount, maintain, and remove Mallya	Listed as part of performance data, implying successful evaluation.
Biocompatibility	ISO 10993-1 and FDA guidance; permanent contact with intact skin	Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion.
Lifetime	Operational/Function for 2 years (Use Lifetime) following storage for up to two years (Shelf Life)	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).
Cybersecurity	Cybersecurity Testing and Software Verification and Validation per FDA Guidelines	Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion.
Human Factors	HF Validation per FDA guidance	Not explicitly stated "met," but implied to have been conducted as "Data on the following testing were generated verifying the design of the device." This implies successful completion.

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

The document does not specify the exact sample size used for the test set (e.g., number of injections, number of devices tested). It mentions "Bench testing on performance, using ISO 11608-1 as a guide" and "Design Verification." It does not provide information on the country of origin of the data or whether the data was retrospective or prospective.

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

This document does not provide details on the number of experts or their qualifications for establishing ground truth for the test set. The tests appear to be primarily engineering and performance-based (bench testing, dose accuracy assessments) rather than involving subjective expert interpretation of medical images or conditions.

4. Adjudication method for the test set

The document does not discuss any adjudication method (e.g., 2+1, 3+1). The nature of the tests (bench testing, electrical safety, lifetime, etc.) suggests objective measurements rather than subjective assessments requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Mallya Injection Pen Adapter is a device that captures and transmits dosing information; it is not an AI-powered diagnostic or assistive tool for human readers interpreting medical cases. Therefore, the concept of improving human readers with AI assistance does not apply to this device.

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

The device itself is a standalone mechanism for capturing and transmitting data from an injection pen. Its performance (e.g., dose recording accuracy, transmission accuracy) would inherently be "standalone" in the sense that the device performs these functions automatically without direct human intervention in the data capture and transmission process itself. However, it requires a human to operate the injection pen. The specific "standalone" performance details (like sensitivity, specificity, accuracy metrics typically associated with algorithms) are not presented in this summary beyond general statements of accuracy.

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

The type of ground truth for most of the performance tests would be objective physical measurements or established engineering standards. For example:

Dose accuracy: The ground truth would be the actual dose dialed and delivered by the injection pen, measured precisely using calibrated equipment.
Recording and transmission accuracy: The ground truth would be the known, actual dose input/occurrence, compared to what the Mallya device records and transmits.
Electrical safety/EMC: Ground truth is defined by compliance with the referenced IEC standards.
Lifetime: Ground truth is reaching or exceeding the specified operational and shelf life under test conditions.

8. The sample size for the training set

The document does not mention any "training set." This type of device does not typically involve machine learning or AI models that require training data in the conventional sense. Its functionality is based on sensing physical rotation and transmitting data, rather than learning patterns from a dataset.

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

As there is no mention of a training set or machine learning components, this question is not applicable.

Summary

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December 5, 2022

Biocorp Production % Lee Leichter President P/L Biomedical 5800 West State Road 80 - Lot 219 Labelle, Florida 33935

Re: K222689

Trade/Device Name: Mallya Injection Pen Adapter (Mallya® for Solostar®) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QOG Dated: August 29, 2022 Received: September 6, 2022

Dear Lee Leichter:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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,

Alan M.
Stevens -S3

CAPT Alan M. 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)

K222689

Device Name

Mallya Injection Pen Adapter

Indications for Use (Describe)

The Mallya 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.

MALLYA MODEL	INSULIN BRAND NAME	MOLECULE NAME	MOLECULE CONCENTRATION
Mallya 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	100 IU/mL+33 mcg/mL

Type of Use (Select one or both, as applicable)
-------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

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

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BIOCORP 510 (k)

Mallya Injection Pen Adapter

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Summary of Safety and Effectiveness (510(k) Summary)

1. Prepared Bv: Alexia Garin 2. Date Prepared: Dec 5, 2022 Mallya Injection Pen Adapter (Mallya® for Solostar®) 3. Trade/Proprietary Name: 4. Common/Usual Name: Injection Data Capture Device 5. Classification Name: Piston Syringe 21 CFR 880.5860 Product Code: QOG 6. Predicate Device: K160629, Companion Medical, InPen 7. Manufacturing Site: Biocorp Production
  France
1. Registration Number:
1. Substantial Equivalence: The Mallya device is substantially equivalent to the InPen (K160629). The InPen is classified as a Piston Syringe and indicated for the delivery Humalog and Novolog. Although the InPen is a full reusable Injection Pen, it contains electronics, a non-replaceable battery and a Bluetooth radio that facilitates capture and transmission of dosing information to a standalone software device. This function is the functionality added by the Mallya as an accessory to SoloStar® injection pens that are not so equipped.

ZI Lavaur La Béchade 63500 Issoire -

1. Technological Characteristics: The Mallya Injection Pen Adapter has the same technological characteristics as the predicate device to capture and transmit dosing information. The information is captured through a translation of the rotation of the dosing knob of the pen into a value indicating the dose increment dialed. The Mallya senses the proximity of the dose knob at the end of the delivery to indicate that the dose has been completed. Both the Mallya and the predicate device use Low Energy Bluetooth (BLE) communication technology and protocol to pair and transmit the information to a mobile device with a compatible app.
1. Physical description: The device is made of two parts to be assembled onto a pen injector. The Mallya base part (about 6 x 3 x 2 cm) which clips around the body of the injection pen and the Mallya button (about 2.5 x Ø2 cm) that slips over the injection pen button. A USB cable, necessary to charge the MALLYA device, and a reset key are also provided in the package.
1. Mallya device is compatible with the SoloStar® injection pens available on the US market such as the insulin brand names, molecules and associated concentrations listed in the table below:

MALLYA MODEL	INSULIN BRAND NAME	MOLECULE NAME	MOLECULECONCENTRATION
	Lantus		100 IU/mL
Mallya designed forSoloStar® SANOFIinjection pen	Toujeo	GLARGINE	300 IU/mL
	Admelog	LISPRO	100 IU/mL
	Apidra	GLULISINE	100 IU/mL
	Soliqua 100/33	GLARGINE ANDLIXISENATIDE	100 IU/mL+33 mcg/mL

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COMPARISONS TO PREDICATE DEVICE

Attribute	Subject Device	Predicate	Discussion/Comments
DeviceName	Mallya	InPen(data capture andtransmission technologyonly)	The InPen functions as a pen injector inaddition to capturing andcommunicating information. The Mallyaworks only as a data capture andtransmission device accessory toapproved pen injectors
	Information Capture and Transmission Technology
510(k)Number	N/A	K160629	N/A
DeviceClassification	Class 2 - QOG	Class 2 - FMF	The InPen is classified as a PistonSyringe and not the new Procode ofInjection Data Capture Device. Both arewithin the same classification
Indication forUse	Indicated for the capture andwireless transmission ofdosing information fromcompatible reusable anddisposable pen injectors.	The InPen is a home-usereusable pen injector forsingle-patient use	The InPen is indicated for use as aninjection pen and dose calculator, butdoes not have a specific indication foruse related to information capture andtransmission
Single patientUse	Yes	Yes	Same
Intended Use	Intended to be used bypatients in the same useenvironment as theircompatible injection pen.	Intended to be used bypeople with diabetes age 12and older for the self-injection of a desired doseof insulin.	The InPen is intended to deliver insulinwhereas the Mallya will work with anycompatible injection pen for which it islabeled.
Prescriptionuse	No	Yes	injection pens are for use byprescription only, but a separateprescription is not required for theMallya
User Group	User of Compatible InjectionPens; includes diabetespatients	Diabetes patients treatedwith multiple daily insulininjection (MDI) therapy	Same
UserFeedback	Electronic - LED (light) andAudible (Beeps)	Mechanical - Audible andtactile clicks per increment	Feedback to user is for injection penfunction
WirelessConnectivity	Bluetooth Low Energy (BLE)	Bluetooth Low Energy(BLE)	Same
Control orimpactDrugdelivery	No	No	Same, the information recording andtransmission function does not impactdrug delivery
Software	Yes	Yes	The recording and transmission ofinformation is controlled by software
Fluid PathwayContact	None	None	Same
DoseRecorded	Calculated based on doseset	Calculated based on doseset	Same
InformationTransmitted	Dialed dose, and time anddate of injection	Dialed dose, and time anddate of injection	Same
Mechanism forRecording	Sense dose dialed throughrotation of dosing mechanism	Sense dose dialed throughrotation of dosing mechanism	Although the technology is different(magnet vs. electronic rotational)
Attribute	Subject Device	Predicate	Discussion/Comments
dose dialed	during dose setting	during dose setting	encoder), both use the rotation of thedose knob during dose setting todetermine the dose that has beendialed. Accuracy of Mallya doserecording has been assessed andverified during Design Verification.,
DifferentiatesPrime vs. Dose	Yes	Yes	Same
Battery	Non-Replaceable;Rechargeable	Non-Replaceable; Non-Rechargeable	The InPen cannot be recharged.
Lifetime	2 years of use	1 year of use	The Mallya can be used for up to twoyears

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14. Performance Data

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

Electromagnetic Compatibility and Electrical Safety IEC 60601-1 and appropriate ● collateral requirements from IEC 60601-2 and IEC 60601-1-11
Bench testing on performance, using ISO 11608-1 as a quide. ●
- Dose accuracy of pen is not affected by Mallya .
- . Recording and transmission Accuracy
- . Dose Prime Differentiation
- . Complete Dose Notification
- . Incomplete Iniection Identification
- Physical Interaction with pen, including force to mount, maintain and remove Mallya
Biocompatibility ISO 10993-1 and FDA guidance; 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).
Cybersecurity Testing and Software Verification and Validation per FDA Guidelines ●
Human Factors HF Validation per FDA guidance ●

15. Conclusion

The data presented supports that the Mallya is substantially equivalent to the predicate for specific indications and technological characteristics of the predicate device with regards to the data recording and transmission.

16. 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).