Mallya Injection Pen Adapter (Mallya® for Solostar®)

K222689 · Biocorp Production · QOG · Dec 5, 2022 · General Hospital

Device Facts

• Record ID: K222689
• Device Name: Mallya Injection Pen Adapter (Mallya® for Solostar®)
• Applicant: Biocorp Production
• Product Code: QOG · General Hospital
• Decision Date: Dec 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

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.

Device Story

Mallya is an add-on accessory for SoloStar insulin pen injectors; clips onto pen body and button. Device senses rotation of pen's dosing knob to calculate dose increments; detects proximity of knob to confirm dose completion. Captures dialed dose, time, and date of injection. Uses Bluetooth Low Energy (BLE) to transmit data to a mobile device/app. Used by patients in home or clinical settings. Provides LED and audible feedback to user. Does not impact drug delivery mechanism. Benefits patient by automating logging of insulin injections, reducing manual entry errors, and improving adherence tracking.

Clinical Evidence

Bench testing only. No clinical data. Testing included dose accuracy, recording/transmission accuracy, prime differentiation, complete dose notification, incomplete injection identification, physical interaction forces, biocompatibility (ISO 10993-1), electromagnetic compatibility (IEC 60601-1), cybersecurity, and human factors validation.

Technological Characteristics

Two-part plastic assembly (base and button cap). Sensing via rotational tracking of pen dose knob. Connectivity: Bluetooth Low Energy (BLE). Power: Rechargeable battery (non-replaceable). Dimensions: Base ~6x3x2 cm, Button ~2.5x2 cm. Biocompatibility: ISO 10993-1 (permanent contact with intact skin). Software: Embedded firmware for data processing and transmission.

Indications for Use

Indicated for diabetes patients using compatible SoloStar injection pens (Lantus, Toujeo, Admelog, Apidra, Soliqua 100/33) to capture and wirelessly transmit insulin dosing information.

Regulatory Classification

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 (K160629)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## 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 for<br>Solostar® SANOFI<br>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<br>LIXISENATIDE | 100 IU/mL<br>+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)

## 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 [e-mail]

"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."

BIOCORP 510 (k)

Mallya Injection Pen Adapter

{3}------------------------------------------------

## 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

- 8. Registration Number:
- 9. 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 -

- 10. 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.
- 11. 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.
- 12. 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<br>CONCENTRATION |
|----------------------------------------------------------|--------------------|------------------------------|---------------------------|
| | Lantus | | 100 IU/mL |
| Mallya designed for<br>SoloStar® SANOFI<br>injection pen | Toujeo | GLARGINE | 300 IU/mL |
| | Admelog | LISPRO | 100 IU/mL |
| | Apidra | GLULISINE | 100 IU/mL |
| | Soliqua 100/33 | GLARGINE AND<br>LIXISENATIDE | 100 IU/mL<br>+33 mcg/mL |

{4}------------------------------------------------

# COMPARISONS TO PREDICATE DEVICE

| Attribute | Subject Device | Predicate | Discussion/Comments |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Name | Mallya | InPen<br>(data capture and<br>transmission technology<br>only) | The InPen functions as a pen injector in<br>addition to capturing and<br>communicating information. The Mallya<br>works only as a data capture and<br>transmission device accessory to<br>approved pen injectors |
| | Information Capture and Transmission Technology | | |
| 510(k)<br>Number | N/A | K160629 | N/A |
| Device<br>Classification | Class 2 - QOG | Class 2 - FMF | The InPen is classified as a Piston<br>Syringe and not the new Procode of<br>Injection Data Capture Device. Both are<br>within the same classification |
| Indication for<br>Use | Indicated for the capture and<br>wireless transmission of<br>dosing information from<br>compatible reusable and<br>disposable pen injectors. | The InPen is a home-use<br>reusable pen injector for<br>single-patient use | The InPen is indicated for use as an<br>injection pen and dose calculator, but<br>does not have a specific indication for<br>use related to information capture and<br>transmission |
| Single patient<br>Use | Yes | Yes | Same |
| Intended Use | Intended to be used by<br>patients in the same use<br>environment as their<br>compatible injection pen. | Intended to be used by<br>people with diabetes age 12<br>and older for the self-<br>injection of a desired dose<br>of insulin. | The InPen is intended to deliver insulin<br>whereas the Mallya will work with any<br>compatible injection pen for which it is<br>labeled. |
| Prescription<br>use | No | Yes | injection pens are for use by<br>prescription only, but a separate<br>prescription is not required for the<br>Mallya |
| User Group | User of Compatible Injection<br>Pens; includes diabetes<br>patients | Diabetes patients treated<br>with multiple daily insulin<br>injection (MDI) therapy | Same |
| User<br>Feedback | Electronic - LED (light) and<br>Audible (Beeps) | Mechanical - Audible and<br>tactile clicks per increment | Feedback to user is for injection pen<br>function |
| Wireless<br>Connectivity | Bluetooth Low Energy (BLE) | Bluetooth Low Energy<br>(BLE) | Same |
| Control or<br>impact<br>Drug<br>delivery | No | No | Same, the information recording and<br>transmission function does not impact<br>drug delivery |
| Software | Yes | Yes | The recording and transmission of<br>information is controlled by software |
| Fluid Pathway<br>Contact | None | None | Same |
| Dose<br>Recorded | Calculated based on dose<br>set | Calculated based on dose<br>set | Same |
| Information<br>Transmitted | Dialed dose, and time and<br>date of injection | Dialed dose, and time and<br>date of injection | Same |
| Mechanism for<br>Recording | Sense dose dialed through<br>rotation of dosing mechanism | Sense dose dialed through<br>rotation of dosing mechanism | Although the technology is different<br>(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<br>dose knob during dose setting to<br>determine the dose that has been<br>dialed. Accuracy of Mallya dose<br>recording has been assessed and<br>verified during Design Verification., |
| Differentiates<br>Prime vs. Dose | Yes | Yes | Same |
| Battery | Non-Replaceable;<br>Rechargeable | Non-Replaceable; Non-<br>Rechargeable | The InPen cannot be recharged. |
| Lifetime | 2 years of use | 1 year of use | The Mallya can be used for up to two<br>years |

{5}------------------------------------------------

#### 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, [e-mail] [phone]