(30 days)
Not Found
No
The summary describes a smart sensor that captures and transmits data from injection pens, but there is no mention of AI or ML being used for data analysis, interpretation, or decision-making. The performance studies focus on accuracy of recording and transmission, not on algorithmic performance.
No.
Explanation: The device is a smart sensor that attaches to an injection pen to capture and transmit data, but it does not directly administer treatment or have a therapeutic effect itself. Its function is to monitor and record compatibility with existing therapeutic injection pens.
No
The device is an adapter for injection pens that records and transmits data about the injection process (e.g., dose accuracy, prime differentiation, complete dose notification), but it does not diagnose a medical condition or disease. It assists in monitoring medication delivery rather than determining a medical state.
No
The device description explicitly states it is a "smart sensor composed of a button to be assembled onto a pen injector" and includes a USB cable for charging, indicating it is a physical hardware device.
Based on the provided information, the MallyaD Injection Pen Adapter is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to capture and transmit data from injection pens used for diabetes treatment. This is related to drug delivery and patient monitoring, not the analysis of biological samples outside the body.
- Device Description: The device is an adapter that attaches to an injection pen to record and transmit data. It does not interact with biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing blood, urine, tissue, or any other biological specimen.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The MallyaD Injection Pen Adapter does not perform this function. It is a device that aids in the management of a condition (diabetes) by tracking medication delivery.
N/A
Intended Use / Indications for Use
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)
Product codes (comma separated list FDA assigned to the subject device)
QOG
Device Description
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.
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.
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
Not Found
Intended User / Care Setting
Intended to be used by patients in the same use environment as their compatible injection pen.
User of Compatible Injection Pens; includes patients or patient relatives/caregiver.
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)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Device accuracy: 99% of the recorded doses match the dialed doses with a margin of error of +/- 1 increment.
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.
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
§ 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).
0
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).
1
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).
2
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
3
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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4
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 Production |
| ZI Lavaur La Béchade | |
| 63500 Issoire - France | |
| Prepared By: | |
| Date Prepared: | Alexia Garin |
| March 26, 2025 | |
| 2 DEVICE | |
| Trade/Proprietary Name: | |
| Common/Usual Name: | |
| Classification Name: | |
| Product Code: | |
| Class: | MallyaD Injection Pen Adapter (MallyaD) |
| Injection Data Capture Device | |
| 21 CFR §880.5860 Piston Syringe | |
| QOG | |
| II |
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
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.
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.
5
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 Adapter | ||||||||||
| MallyaD | SoloSmart Injection Pen Adapter | ||||||||||
| SoloSmart | |||||||||||
| 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 for | |||||||||||
| Use | The MallyaD Injection Pen Adapter 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) | 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 SoloSmart®
designed for
SoloStar®
SANOFI injection
pen Lantus
Toujeo
Admelog
Apidra
Soliqua 100/33 GLARGINE
GLARGINE
LISPRO
GLULISINE
GLARGINE AND
LIXISENATIDE 100 IU/mL
300 IU/mL
100 IU/mL
100 IU/mL
100 IU/mL
+33 mcg/mL | | | | | | | | | Similar indication
for use,
compatibility with
different
manufacturer
injection pen for
same therapeutic
area. Verification
tests conducted
with compatible
pen. |
| Type of pens | The following Novo Nordisk PDS290
pen platform are compatible:
Tresiba® U-100 FlexTouch® and
Tresiba® U-200 FlexTouch®, Fiasp®
FlexTouch®,Xultophy® | The following Sanofi SoloStar® Injection
pens are compatible: Lantus
Toujeo Toujeo Max Aprida
Soliqua 100/33 | Compatible with a
different pen
platform: Novo
Nordisk PDS290.
Verification tests
conducted with the
compatible pen. | | | | | | | | |
4.5 SUBSTANTIAL EQUIVALENCE DISCUSSION
6
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 patient | |||
| Use | Yes | Yes | Same |
| Reusable | |||
| Device | 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 patients in the | ||
| same use environment as their | |||
| compatible injection pen. | Same | ||
| Prescription | |||
| use | No | No | Same |
| User Group | User of Compatible Injection Pens; | ||
| includes patients or patient | |||
| relatives/caregiver | User of Compatible Injection Pens; | ||
| includes patients or patient | |||
| relatives/caregiver | |||
| User Feedback | Electronic - LED (light) | Electronic - LED (light) | Same type of |
| coloured light | |||
| indication adapted | |||
| to pen mechanical | |||
| behaviour. | |||
| Software | |||
| verification tests | |||
| conducted with the | |||
| compatible pen. | |||
| Wireless | |||
| Connectivity | Bluetooth Low Energy (BLE) | Bluetooth Low Energy (BLE) | Same connectivity |
| BLE protocol | |||
| Control or | |||
| impact Drug | |||
| delivery | No | No | Same |
| Fluid Pathway | |||
| Contact | None | None | Same |
| Software | |||
| controlled | Yes | Yes | Same |
| Dose Recorded | Calculated based on dose increment | ||
| set | Calculated based on dose delivered | Change from | |
| predicate adapted | |||
| to pen mechanical | |||
| behaviour. | |||
| Information | |||
| Transmitted | Dialed dose increment, and time and | ||
| date of injection | Delivered dose, and time and date of | ||
| injection | Dose recording | ||
| accuracy | |||
| verification tests | |||
| conducted with the | |||
| compatible pen. | |||
| Mechanism for | |||
| Recording dose | |||
| dialed | Sense dose increment dialed through | ||
| movement and rotation of dosing | |||
| mechanism during dose setting | Sense dose increment delivered | ||
| through rotation of dosing mechanism | |||
| during dose administration | |||
| Differentiates | |||
| Prime vs. Dose | Yes | Yes | Same |
| Battery | Non-Replaceable; Rechargeable | Non-Replaceable; Rechargeable | Same |
| Lifetime | Up to 3 years of use from | ||
| manufacturing date | Up to 3 years of use from | ||
| manufacturing date | Same |
7
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