The concerned Mallya Injection Pen Adapter, also called Mallyaº, is a smart sensor composed of a button to be assembled onto a pen injector by covering the injection pen button. It is designed to be mounted on specific Novo Nordisk® PDS290 platform injection pens. A USB cable, necessary to charge the Mallya® device is also provided in the package.

AI/ML Overview

The given text is a 510(k) Premarket Notification from the FDA for a medical device called the "MallyaD injection pen adapter (MallyaD)". It details the device's indications for use, technological characteristics, and a comparison to a predicate device. While it mentions various tests and guidelines, it does not contain the specific information required to fully answer your request regarding the acceptance criteria and the study that proves the device meets them in the context of an AI/ML medical device.

The "MallyaD" device, as described, appears to be an adapter that records and transmits dosing information from an injection pen. It's a hardware device with associated software, but there is no explicit mention of it being an AI-powered medical device or using machine learning. The "Software controlled" attribute in the table refers to its internal operation rather than AI/ML algorithms.

Therefore, many of your requested points, which are highly relevant for AI/ML device studies, are not present in this document. For example, there's no mention of:

A table of acceptance criteria for AI model performance (e.g., sensitivity, specificity, AUC).
Sample sizes for a test set in the context of an AI model's performance on medical images or other data types.
Data provenance for an AI test set.
Number of experts, their qualifications, or adjudication methods for establishing ground truth for an AI model.
Multi-Reader Multi-Case (MRMC) studies for AI assistance.
Standalone performance for an AI algorithm.
Type of ground truth for AI model training or testing (e.g., pathology, outcomes data).
Sample size or ground truth establishment for an AI training set.

The document primarily focuses on the substantial equivalence to a predicate device based on its intended use, technological characteristics (e.g., BLE communication), and physical attributes, along with general performance tests like dose accuracy, biocompatibility, electrical safety, and cybersecurity. The "Dose accuracy: 99% of the recorded doses match the dialed doses with a margin of error of +/- 1 increment" is a performance claim, but it's for the device's basic function, not an AI/ML model's diagnostic or predictive performance.

In summary, based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria as if it were an AI/ML medical device because the document describes a hardware device with embedded software for data capture and transmission, not an AI/ML algorithm or model for diagnostic or predictive purposes.

Summary

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March 27, 2025

Image /page/0/Picture/1 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.

BioCorp Production Alexia Garin QARA Director ZI de Lavaur La Bechade Issoire, 63500 France

Re: K250555

Trade/Device Name: MallyaD injection pen adapter (MallyaD) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QOG Dated: February 18, 2025 Received: February 25, 2025

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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).

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Sincerely,

Shruti N. Mistry -S

Shruti Mistry 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) K250555

Device Name MallyaD injection pen adapter (MallyaD)

Indications for Use (Describe)

The MallyaD Injection Pen Adapter is indicated for the capture and wireless transmission of compatible reusable and disposable pen injectors.

The Novo Nordisk PDS290 Injection pens compatible for diabetes treatment are:

insulin degludec molecule (Tresiba U-100 FlexTouch and Tresiba U-200 FlexTouch)
insulin aspart molecule (Fiasp FlexTouch)
insulin degludec and liraglutide molecules (Xultophy)

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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Image /page/4/Picture/0 description: The image shows the logo for Biocorp, a Novo Nordisk company. The logo is in a dark gray color and features the word "BIOCORP" in a bold, sans-serif font. The two O's in the word are interlocked, creating a visual link. Below the word "BIOCORP" is the text "a novo nordisk company" in a smaller font size.

MALLYAP

510(k) Summary - K250555

1 SUBMITTER
Applicant:	Biocorp ProductionZI Lavaur La Béchade63500 Issoire - France
Prepared By:Date Prepared:	Alexia GarinMarch 26, 2025
2 DEVICE
Trade/Proprietary Name:Common/Usual Name:Classification Name:Product Code:Class:	MallyaD Injection Pen Adapter (MallyaD)Injection Data Capture Device21 CFR §880.5860 Piston SyringeQOGII

3 PREDICATE DEVICE

K231820, Biocorp Production, SoloSmart Injection Pen Adapter (SoloSmart®).

4 SUBSTANTIAL EQUIVALENCE

The Mallyaº Injection Pen Adapter device is substantially equivalent to the SoloSmart® (K231820). The device has the same indication for use, intended use and same fundamental scientific technology.

4.1 DEVICE DESCRIPTION

4.2 TECHNOLOGICAL CHARACTERISTICS

The Mallya® 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 Mallyaº 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.

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Image /page/5/Picture/0 description: The image shows the logo for BICORP, a Novo Nordisk company. The logo is in a dark gray color and features the word "BICORP" in a bold, sans-serif font. The two O's in the word are interlocked. Below the word "BICORP" is the text "a novo nordisk company" in a smaller, lighter font.

4.3 INDICATIONS FOR USE

The Mallyaº is indicated for the capture and wireless transmission of dosing information of compatible reusable and disposable pen injectors.

The Novo Nordisk PDS290 Injection pens compatible for diabetes treatment are:

insulin degludec molecule (Tresiba U-100 FlexTouch and Tresiba U-200 FlexTouch)
insulin aspart molecule (Fiasp FlexTouch)
insulin degludec and liraglutide molecules (Xultophy)

4.4 DEVICE 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 25.8 mm diameter and 40.1 mm height. A USB cable, necessary to charge the Mallya® device is also provided in the package.

Attribute	Subject Device	Predicate device
Device Name/Brandname	MallyaD Injection Pen AdapterMallyaD	SoloSmart Injection Pen AdapterSoloSmart
		Data Capture and Transmission Technology
510(k) Number	K250555	K231820
Attribute	Subject Device	Predicate device	Discussion/Comments
Classification-Product Code	Class 2 - QOG	Class 2 - QOG	Same
Indication forUse	The MallyaD Injection Pen Adapter isindicated for the capture and wirelesstransmission of dosing information ofcompatible reusable and disposablepen injectors.The Novo Nordisk PDS290 Injectionpens compatible for diabetestreatment are:- insulin degludec molecule (TresibaU-100 FlexTouch and Tresiba U-200FlexTouch)- insulin aspart molecule (FiaspFlexTouch)- insulin degludec and liraglutidemolecules (Xultophy)	The SoloSmart Injection Pen Adapter isindicated for the capture and wirelesstransmission of dosing informationfrom compatible reusable anddisposable pen injectors.The following Injection pens arecompatible:DEVICE MODELNAME INSULINBRAND NAME MOLECULE NAME MOLECULECONCENTRATION SoloSmart®designed forSoloStar®SANOFI injectionpen LantusToujeoAdmelogApidraSoliqua 100/33 GLARGINEGLARGINELISPROGLULISINEGLARGINE ANDLIXISENATIDE 100 IU/mL300 IU/mL100 IU/mL100 IU/mL100 IU/mL+33 mcg/mL		Similar indicationfor use,compatibility withdifferentmanufacturerinjection pen forsame therapeuticarea. Verificationtests conductedwith compatiblepen.
Type of pens	The following Novo Nordisk PDS290pen platform are compatible:Tresiba® U-100 FlexTouch® andTresiba® U-200 FlexTouch®, Fiasp®FlexTouch®,Xultophy®	The following Sanofi SoloStar® Injectionpens are compatible: LantusToujeo Toujeo Max ApridaSoliqua 100/33	Compatible with adifferent penplatform: NovoNordisk PDS290.Verification testsconducted with thecompatible pen.

4.5 SUBSTANTIAL EQUIVALENCE DISCUSSION

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Image /page/6/Picture/0 description: The image shows the logo for Biocorp, a Novo Nordisk company. The logo is in a dark gray color and features the word "BIOCORP" in a bold, sans-serif font. The two O's in the word are linked together, creating a visual element that resembles a chain or connection. Below the word "BIOCORP" is the text "a novo nordisk company" in a smaller font.

MALLYAº

Attribute	Subject Device	Predicate device
Single patientUse	Yes	Yes	Same
ReusableDevice	Yes	Yes	Same
Intended Use	Intended to be used by patients in thesame use environment as theircompatible injection pen.	Intended to be used by patients in thesame use environment as theircompatible injection pen.	Same
Prescriptionuse	No	No	Same
User Group	User of Compatible Injection Pens;includes patients or patientrelatives/caregiver	User of Compatible Injection Pens;includes patients or patientrelatives/caregiver
User Feedback	Electronic - LED (light)	Electronic - LED (light)	Same type ofcoloured lightindication adaptedto pen mechanicalbehaviour.Softwareverification testsconducted with thecompatible pen.
WirelessConnectivity	Bluetooth Low Energy (BLE)	Bluetooth Low Energy (BLE)	Same connectivityBLE protocol
Control orimpact Drugdelivery	No	No	Same
Fluid PathwayContact	None	None	Same
Softwarecontrolled	Yes	Yes	Same
Dose Recorded	Calculated based on dose incrementset	Calculated based on dose delivered	Change frompredicate adaptedto pen mechanicalbehaviour.
InformationTransmitted	Dialed dose increment, and time anddate of injection	Delivered dose, and time and date ofinjection	Dose recordingaccuracyverification testsconducted with thecompatible pen.
Mechanism forRecording dosedialed	Sense dose increment dialed throughmovement and rotation of dosingmechanism during dose setting	Sense dose increment deliveredthrough rotation of dosing mechanismduring dose administration
DifferentiatesPrime vs. Dose	Yes	Yes	Same
Battery	Non-Replaceable; Rechargeable	Non-Replaceable; Rechargeable	Same
Lifetime	Up to 3 years of use frommanufacturing date	Up to 3 years of use frommanufacturing date	Same

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Image /page/7/Picture/0 description: The image shows the logo for BICORP, a Novo Nordisk company. The logo is in a dark gray color and features the word "BICORP" in a bold, sans-serif font. The two O's in the word are designed to look like interlocking links of a chain. Below the word "BICORP" is the text "a novo nordisk company" in a smaller, sans-serif font.

MALLYAP

5 SIGNIFICANT PERFORMANCE CHARACTERISTICS

5.1 PERFORMANCE CLAIMS

Mallyaº claims are based on the reported dose accuracy:

Device accuracy: 99% of the recorded doses match the dialed doses with a margin of error of +/- 1 increment.

5.2 SUPPORTING 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 Mallya® ●
- . Recording and transmission Accuracy
- . Dose Prime Differentiation
- . Complete Dose Notification
- Incomplete Injection Identification
- Physical Interaction with pen, including force to mount, maintain and remove Mallya®
Biocompatibility –FDA guidance; permanent contact with intact skin based on ● ISO10993-1.
Lifetime The product met test criteria to verify it will operate/function before the ● expiration date of 3 years including storage and Use Lifetime.
Electrical safety, EMC and Radiocommunication per FDA Guidelines based on ● 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

5.3 HUMAN FACTOR VALIDATION

Biocorp performed a HF impact assessment for performance and safety validation to confirm the usability of the device form factor and associated instructions for use per FDA guidance.

6 CONCLUSION

Biocorp as concluded that the evidence documented during design control activities supports that the Mallya® Injection Pen Adapter (Mallyaº), is substantially equivalent to the predicate for specific indications and technological characteristics of the predicate device with regards to the data recording and transmission.

7 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).