K Number

Device Name

Mallya Injection Pen Adapter (Mallya® for Solostar®)

Manufacturer

Biocorp Production

Date Cleared

2022-12-05

(90 days)

Product Code

QOG

Regulation Number

880.5860

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K160629

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device that captures and transmits data, but there is no mention of AI or ML being used for analysis, interpretation, or any other function. The performance studies focus on accuracy of data capture and transmission, not on algorithmic performance.

Therapeutic

No
The Mallya Injection Pen Adapter is indicated for the capture and wireless transmission of dosing information from compatible pen injectors, and it does not directly administer or influence a therapeutic intervention. Its function is to provide data, not therapy.

Diagnostic

The device description clearly states its purpose is for "capture and wireless transmission of dosing information from compatible reusable and disposable pen injectors," not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly states it is made of two physical parts that assemble onto a pen injector and includes a USB cable and reset key, indicating it is a hardware device with software components. The performance studies also include testing related to physical interaction, electrical safety, and biocompatibility, which are characteristic of hardware devices.

IVD (In Vitro Diagnostic)

Based on the provided information, the Mallya Injection Pen Adapter is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to capture and transmit dosing information from injection pens. This is related to drug delivery and patient management, not the diagnosis of a disease or condition using in vitro methods (testing samples like blood, urine, etc.).
Device Description: The device is an adapter that attaches to an injection pen. It doesn't involve any reagents, test strips, or other components typically associated with IVD testing.
Lack of IVD-Specific Information: The document does not mention any aspects related to in vitro testing, such as sample types, analytical methods, or diagnostic results.
Focus on Performance: The performance studies described focus on the device's ability to accurately record and transmit dosing information, its physical interaction with the pen, and its safety and reliability. These are not the types of performance metrics typically evaluated for IVDs (e.g., sensitivity, specificity, accuracy in detecting analytes).

In summary, the Mallya Injection Pen Adapter is a device designed to enhance the functionality of an injection pen by providing data capture and transmission capabilities. It does not perform any diagnostic testing on biological samples, which is the core function of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 for Solostar® SANOFI injection 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 AND LIXISENATIDE	100 IU/mL +33 mcg/mL

Product codes (comma separated list FDA assigned to the subject device)

QOG

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

User of Compatible Injection Pens; includes diabetes patients

Intended User / Care Setting

Intended to be used by patients in the same use environment as their compatible injection pen.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 ●

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160629

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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

Indications for Use

510(k) Number (if known)

K222689

Device Name

Mallya Injection Pen Adapter

Indications for Use (Describe)

MALLYA MODEL	INSULIN BRAND NAME	MOLECULE NAME	MOLECULE CONCENTRATION
Mallya designed for
Solostar® SANOFI
injection 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 AND
LIXISENATIDE	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

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 | MOLECULE
CONCENTRATION |
|----------------------------------------------------------|--------------------|------------------------------|---------------------------|
| | Lantus | | 100 IU/mL |
| Mallya designed for
SoloStar® SANOFI
injection pen | Toujeo | GLARGINE | 300 IU/mL |
| | Admelog | LISPRO | 100 IU/mL |
| | Apidra | GLULISINE | 100 IU/mL |
| | Soliqua 100/33 | GLARGINE AND
LIXISENATIDE | 100 IU/mL
+33 mcg/mL |

COMPARISONS TO PREDICATE DEVICE

Attribute	Subject Device	Predicate	Discussion/Comments
Device
Name	Mallya	InPen
(data capture and
transmission technology
only)	The InPen functions as a pen injector in
addition to capturing and
communicating information. The Mallya
works only as a data capture and
transmission device accessory to
approved pen injectors
	Information Capture and Transmission Technology
510(k)
Number	N/A	K160629	N/A
Device
Classification	Class 2 - QOG	Class 2 - FMF	The InPen is classified as a Piston
Syringe and not the new Procode of
Injection Data Capture Device. Both are
within the same classification
Indication for
Use	Indicated for the capture and
wireless transmission of
dosing information from
compatible reusable and
disposable pen injectors.	The InPen is a home-use
reusable pen injector for
single-patient use	The InPen is indicated for use as an
injection pen and dose calculator, but
does not have a specific indication for
use related to information capture and
transmission
Single patient
Use	Yes	Yes	Same
Intended Use	Intended to be used by
patients in the same use
environment as their
compatible injection pen.	Intended to be used by
people with diabetes age 12
and older for the self-
injection of a desired dose
of insulin.	The InPen is intended to deliver insulin
whereas the Mallya will work with any
compatible injection pen for which it is
labeled.
Prescription
use	No	Yes	injection pens are for use by
prescription only, but a separate
prescription is not required for the
Mallya
User Group	User of Compatible Injection
Pens; includes diabetes
patients	Diabetes patients treated
with multiple daily insulin
injection (MDI) therapy	Same
User
Feedback	Electronic - LED (light) and
Audible (Beeps)	Mechanical - Audible and
tactile clicks per increment	Feedback to user is for injection pen
function
Wireless
Connectivity	Bluetooth Low Energy (BLE)	Bluetooth Low Energy
(BLE)	Same
Control or
impact
Drug
delivery	No	No	Same, the information recording and
transmission function does not impact
drug delivery
Software	Yes	Yes	The recording and transmission of
information is controlled by software
Fluid Pathway
Contact	None	None	Same
Dose
Recorded	Calculated based on dose
set	Calculated based on dose
set	Same
Information
Transmitted	Dialed dose, and time and
date of injection	Dialed dose, and time and
date of injection	Same
Mechanism for
Recording	Sense dose dialed through
rotation of dosing mechanism	Sense dose dialed through
rotation 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 the
dose knob during dose setting to
determine the dose that has been
dialed. Accuracy of Mallya dose
recording has been assessed and
verified during Design Verification.,
Differentiates
Prime 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 two
years

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