(54 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of a spring-loaded autoinjector, with no mention of AI or ML technologies.
No.
The device is an autoinjector used to deliver a drug product; it does not directly treat or diagnose a disease.
No
Explanation: The device is an autoinjector designed for the subcutaneous injection of medication. It is a delivery system for self-injection, not a device used to diagnose a medical condition.
No
The device description clearly states it is a "reusable, spring-loaded injection device" consisting of "two subassemblies" and describes mechanical actions like "needle penetration, injection and needle cover," indicating it is a physical hardware device.
Based on the provided information, the GripMate™ autoinjector is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The GripMate™ autoinjector is a device used to deliver a drug (glatiramer acetate) subcutaneously into the patient's body. It is an injection device, not a diagnostic tool that analyzes biological samples.
The description clearly states its purpose is for "subcutaneous injection of Sun Pharma's glatiramer acetate". This is a drug delivery function, not an in vitro diagnostic function.
N/A
Intended Use / Indications for Use
The GripMate™ autoinjector is intended for use with Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes (a 1 mL BD Hypak Biotech glass syringe, containing a ½'' fixed needle of 29G, and drug product solutions with a viscosity between 1.7 and 2.3 mPas). The GripMate™ autoinjector is a reusable injection device for patients with multiple sclerosis age 18 and older for the subcutaneous injection of Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes.
Product codes (comma separated list FDA assigned to the subject device)
KZH
Device Description
The GripMate™ is a non-sterile, reusable, spring-loaded injection device. The device consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection. The device does not have any fluid path and does not have any contained within the syringe. The user has the option to adjust the needle extension using the device Needle Hider Feature. Injection occurs upon the activation of a trigger button which drives the syringe in a three-step sequence which includes needle penetration, injection and needle cover. Once the injection is completed the device provides visual indication to confirm that the full drug dose has been delivered.
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
18 and older
Intended User / Care Setting
patients with multiple sclerosis / At home, for single patient use only
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)
Functional Testing:
Conducted in accordance with ISO 11608-1, ISO 11608-5, and FDA guidance "Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products".
Tests included: Verification of dose accuracy, Injection time, Needle extension, Safety features, Indicators features, Force required to actuate the injector, Force required to operate the Needle Shield Remover, Force required to override the safety mechanism, Force required to load the pre-filled syringe, Torque required to assemble/disassemble the injector, Torque required to operate Needle Hider Front Adjuster, Load testing on individual device components.
Environmental Conditions Testing:
Conducted according to ASTM D4169 and ISO 11608-1.
Results: Device performance and reliability are not affected by specified environmental conditions during storage, use, or transportation.
Shelf Life and In-Use Life Testing:
Conducted according to ISO 11608-1 and ASTM F 1980.
Method: Accelerated stability studies and use life testing. Verified with a real-time protocol. Device operated 1.5 times its expected actuations during planned use life.
Results: Supports an in-use life claim of two years after first use.
Tested solutions: glatiramer acetate 20 mg, glatiramer acetate 40 mg, clexane forte, and 34% sucrose solution.
Biocompatibility Testing:
Performed according to ISO 10993-1 by a certified testing laboratory.
Results: Biocompatibility was concluded based on interpretation of biological evaluation data and overall biological safety assessment.
Human Factors Testing:
Evaluated in a simulated use Human Factors study in accordance with AAMI / ANSI HE75 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices".
Results: Use-related risks are adequately mitigated by the device design and labeling.
Summary: The GripMate™ was found to perform similarly to the predicate device.
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.
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
§ 880.6920 Syringe needle introducer.
(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 2, 2024
Synthon Hispania S.L. % Rebecca (Becky) Welton Senior Consultant, RA Lachman Consultant Services, Inc. 1600 Stewart Avenue, Suite 604 Westbury, New York 11590
Re: K243232
Trade/Device Name: GripMate Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe needle introducer Regulatory Class: Class II Product Code: KZH Dated: October 9, 2024 Received: October 9, 2024
Dear Rebecca (Becky) Welton:
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) K243232
Device Name GripMate™
Indications for Use (Describe)
The GripMate™ autoinjector is intended for use with Sun Pharma's glatiramer acetate 20 mg/mL prefilled syringes (a 1 mL BD Hypak Biotech glass syringe, containing a ½2ª fixed needle of 29G, and drug product solutions with a viscosity between 1.7 and 2.3 mPas). The GripMate™ autoinjector is a reusable injection device for patients with multiple sclerosis age 18 and older for the subcutaneous injection of Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
K243232 510(k) SUMMARY
APPLICANT
Synthon Hispania S.L. Calle Castello 1 Poligono Las Salinas Sant Boi de Llobregat, Barcelona, 08830 Spain
Contact Person: Mrs. Ana Miralles Telephone: +34936401516 Email: ana.miralles@synthon.com Date Prepared: November 21, 2024
CORRESPONDENT
Lachman Consultant Services, Inc. 1600 Stewart Avenue, Suite 604 Westbury NY 11590 United States
Contact Person: Rebecca (Becky) Welton Alternate Contact Person: Jennifer Leaming Telephone: 516-222-6222 Email: LCSReg(@lachmanconsultants.com
DEVICE NAME
Name: GripMate™ Common name: Syringe needle introducer Classification name: Introducer, Syringe Needle Regulation number: 880.6920 Product codes(s): KZH
LEGALLY MARKETED PREDICATE DEVICES
Device name: Lobster Auto-Injector 510(k) number: K124026 Product codes(s): KZH
5
DEVICE DESCRIPTION SUMMARY
The GripMate™ is a non-sterile, reusable, spring-loaded injection device. The device consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self-injection. The device does not have any fluid path and does not have any contained within the syringe. The user has the option to adjust the needle extension using the device Needle Hider Feature. Injection occurs upon the activation of a trigger button which drives the syringe in a three-step sequence which includes needle penetration, injection and needle cover. Once the injection is completed the device provides visual indication to confirm that the full drug dose has been delivered.
INTENDED USE / INDICATIONS FOR USE
The GripMate™ autoinjector is intended for use with Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes (a 1 mL BD Hypak Biotech glass syringe, containing a ½'' fixed needle of 29G, and drug product solutions with a viscosity between 1.7 and 2.3 mPas). The GripMate™ autoinjector is a reusable injection device for patients with multiple sclerosis age 18 and older for the subcutaneous injection of Sun Pharma's glatiramer acetate 20 mg/mL and 40 mg/mL prefilled syringes.
INDICATIONS FOR USE COMPARISON
GripMate™ autoinjector has a similar intended use and the same principle of operation as the Lobster autoinjector.
TECHNOLOGICAL COMPARISON
The GripMate™ autoinjector is substantially equivalent to the predicate device. Both devices are designed for selfadministered subcutaneous injection of FDA-approved drugs, using a spring-loaded powered mechanism. They share many of the same features such as spring-loaded powered mechanisms, biocompatibility, and usability characteristics. The primary differences lie in the specific applications and injection depth settings; the GripMate™ is tailored for Sun Pharma's glatiramer acetate, includes two viewing windows for better visual feedback, and has audio feedback for injection, enhancements that improve user usability and interaction. The GripMate™ has two injection depth settings (6 and 8 mm), whereas the predicate device has injection depth settings of 4, 6, 8 and 10 mm.
Additionally, both devices conform to ISO 13485 standards and have the same classification under 21 CFR § 880.6920. The GripMate™ slight differences and additional features such as audio feedback are considered are aimed at enhancing usability without altering the fundamental technology or principles of operation. These updates ensure that the GripMate™ provides improved user feedback and ease of use while maintaining the core functionalities and safety measures of the predicate Lobster device.
| Specification/
Characteristic | Predicate Device
Lobster | Candidate Device
GripMate™ | Comparison |
|----------------------------------|-------------------------------------|-------------------------------------|-------------------------------------------------------------------------------------|
| Manufacturer | Sandoz Inc. | Synthon | Substantially equivalent
(SE)
Manufacturers QMS
operate under
ISO 13485 |
| 510(k) | K124026 | K243232 | n/a |
| Product code | KZH
Syringe needle
introducer | KZH
Syringe needle
introducer | Identical |
| Regulation
number | 21 CFR § 880.6920 | 21 CFR § 880.6920 | Identical |
| Classification
panel | General Hospital (80) | General Hospital (80) | Identical |
6
| Over-the-
Counter (OTC)
and/or
Prescription (Rx Only) | Rx only and Over the
Counter | Rx only | SE
Validated via human
Factors |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For a self-administered
subcutaneous injection
of FDA approved drugs | For a self-administered
subcutaneous injection of
Sun Pharma's glatiramer
acetate 20 mg/mL and 40
mg/mL prefilled syringes | SE
Scope is for self-
administration of a
specific FDA approved
product |
| Indications for use | The Lobster device is
intended for use with a
1mL glass syringe,
containing a fixed needle
of 27G to 29G gauge,
and drug product
solutions with a
viscosity between 1 and
4 mPas. The Lobster
auto-injector is a
reusable injection device
for the subcutaneous
injection of FDA
approved drugs. | The GripMate™
autoinjector is intended
for use with Sun
Pharma's glatiramer
acetate 20 mg/mL and 40
mg/mL prefilled syringes
(a 1 mL BD Hypak
Biotech glass syringe,
containing a ½" fixed
needle of 29G, and drug
product solutions with a
viscosity between 1.7 and
2.3 mPas). The
GripMate™ autoinjector
is a reusable injection
device for patients with
multiple sclerosis age 18
and older for the
subcutaneous injection of
Sun Pharma's glatiramer
acetate 20 mg/mL and 40
mg/mL prefilled
syringes. | SE
Scope is for self-
administration of a
specific FDA approved
product |
| Fundamental scientific
technology | Handheld self-injection
system | Handheld self-injection
system | Identical |
| Principle of operation | Spring-loaded powered
mechanism is used to
insert a hypodermic
needle attached to a pre-
filled syringe through the
patient's skin and to
inject the drug | Spring-loaded powered
mechanism is used to
insert a hypodermic
needle attached to a pre-
filled syringe through the
patient's skin and to
inject the drug | Identical |
| Environment of use | At home,
for single patient use
only | At home,
for single patient use only | Identical |
| Device type | Hand-held, non-sterile,
reusable | Hand-held, non-sterile,
reusable | Identical |
| Syringe type | Glass, pre-filled | Glass, pre-filled | Identical |
| Syringe size | 1.0 ml | 1.0 ml | Identical |
| Fixed or removable needle | Fixed needle | Fixed needle | Identical |
| Dose system | One injection per syringe | One injection per syringe | Identical |
| End of dose indication | Visual | Visual | Identical |
| Trigger
button for firing | Yes | Yes | Identical |
| Fixed dose | Yes | Yes | Identical |
| Needle hidden before
injection | Yes | Yes | Identical |
| | | | |
| Safety lock to prevent
accidental activation | Yes | Yes | Identical |
| Needle shield removal | Yes | Yes | Identical |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 | Identical |
| Overall device length,(mm) | 226.0 | 224.0 | SE |
| Overall device width- at
widest point (mm) | 31.0 | 34.0 | Validated via human
Factors |
| Needle extension
penetration | Variable, 4-10 mm | Variable, 6-8 mm | SE
To mitigate the risk of
inadequate injection the
4 and 10 mm setting
were not incorporated in
the candidate device.
Verified through design
verification. |
| Injection time as indicated
in labeling | 80 | n/a |
| Syringe loading
force (N) | Unknown | ≤ 27.1 | n/a |
| Needle shield
remover force (N) | Unknown | ≤ 35 | n/a |
7
PERFORMANCE DATA / NONCLINICAL TESTING
Design verification and performance testing have been conducted to verify GripMate™ meets design specifications and performs as intended.
Functional Testing
Functional evaluation was conducted in accordance with the FDA recognized International Standards ISO 11608-1 "Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems", ISO11608-5 "Needle-Based Injection Systems for Medical Use - Requirements and Test
8
Methods - Part 5: Automated functions" and the recommendations included in the FDA guidance document, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products". Per standard requirements an environmental testing (e.g., temperature cycling, drop testing etc.) preceded the functional testing of the GripMate™.
Testing to assess the functionality of GripMate™ included:
- Verification of dose accuracy ●
- . Iniection time
- Needle extension
- . Safety features
- Indicators features .
Testing to assess the mechanical specifications of GripMate™ included:
- Force required to actuate the injector ●
- Force required to operate the Needle Shield Remover ●
- Force required to override the safety mechanism ●
- Force required to load the pre-filled syringe
- Torque required to assemble/disassemble the injector
- Torque required to operate Needle Hider Front Adjuster .
- . Load testing on individual device components
Environmental Conditions Testing
The environmental conditions and packaging integrity evaluation for GripMate™ was conducted by a certified testing laboratory in accordance with the recognized by the FDA ASTM D4169 "Standard Practice for Performance Testing of Shipping Containers and Systems" and in-house in accordance with the International Standard ISO 11608-1 "Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems". The outcome of the testing demonstrates that the candidate device performance and reliability is not affected by the environmental conditions specified by the standards at the time of storage, use testing or during transportation.
Shelf Life and In-Use Life Testing
Candidate device shelf life and in-use life evaluation was conducted in accordance with the ISO 11608-1 "Needlebased injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems" and ASTM F 1980 "Standard Guide For Accelerated Aging of Sterile Barrier Systems For Medical Devices". Shelflife and in-use life claims were established per outcome of the accelerated stability studies and use life testing. A real-time protocol was evaluated to assure on-going stability. The use life of the device was simulated by operating the device 1.5 times its expected number of actuations during the device's planned use life and taking into consideration the intended use of device as described in the device Instructions for Use. The successful completion of functionality and reliability testing of the device supports in-use life claim of two years after first use.
In the non-clinical bench testing the following solutions were tested: glatiramer acetate 20 mg, glatiramer acetate 40 mg, clexane forte and 34 % sucrose solution.
Biocompatibility Testing
GripMate™ safety with regard to the biocompatibility was concluded based on the interpretation of biological evaluation data and overall biological safety assessment. The biocompatibility testing was performed by a certified testing laboratory in accordance with FDA recognized International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process."
Human Factors Testing
The GripMate™ design and Instructions for Use (IFU) were evaluated in a simulated use Human Factors study in accordance with AAMI / ANSI HE75, Human Factors Engineering - Design Of Medical Devices and the recommendations included in the FDA guidance document, "Applying Human Factors and Usability Engineering to Medical Devices". The study demonstrates that the use-related risks are adequately mitigated by the design and labelling of the device.
Summary
Based on the performance data, the GripMate™ was found to perform similarly to the predicate device.
9
CONCLUSION
The GripMate™ is substantially equivalent to the predicate device.