(54 days)
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.
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.
The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the GripMate™ autoinjector.
Here's an analysis of the requested information:
1. Table of acceptance criteria and the reported device performance:
The document discusses various functional and mechanical tests. While it lists some quantitative specifications for the "Candidate Device GripMate™", it doesn't explicitly present acceptance criteria alongside the measured performance results in a formal table format. However, we can infer some criteria from the "Comparison" column and the descriptions of the tests.
| Acceptance Criteria (Inferred) | Reported Device Performance (GripMate™ Values) |
|---|---|
| Overall device length (mm) | 224.0 |
| Overall device width - at widest point (mm) | 34.0 |
| Needle extension penetration (mm) | Variable, 6-8 mm |
| Injection time as indicated in labeling | < 15 sec |
| Device state - visible feedback | Two viewing windows (Usability improvement) |
| Device state - audible feedback | Click at activation. Second click at injection completion. (Usability improvement) |
| Use-life | Two years after first use |
| Needle extension tolerance (mm) | ± 1.5 |
| Trigger button activation force (N) | 2-8 |
| Pre-injection pushing force (N) | 3-12 |
| Trigger button override force (N) | > 80 |
| Syringe loading force (N) | ≤ 27.1 |
| Needle shield remover force (N) | ≤ 35 |
| Biocompatibility | Conforms to ISO 10993 |
| Environmental Conditions | Performance and reliability not affected by specified environmental conditions |
| Shelf Life and In-Use Life | Established as per accelerated stability studies and use life testing (Real-time protocol for ongoing stability) |
| Functional Testing (Dose Accuracy, Injection Time, Needle Extension, Safety Features, Indicators) | Demonstrated to meet design specifications and perform as intended |
| Human Factors | Use-related risks adequately mitigated by design and labeling |
2. Sample size used for the test set and the data provenance:
The document broadly states "Design verification and performance testing have been conducted to verify GripMate™ meets design specifications and performs as intended" and lists various functional and mechanical tests. It does not provide specific sample sizes for any of the test sets.
Regarding data provenance:
- Country of origin of data: Not explicitly stated, but the applicant "Synthon Hispania S.L." is in Spain, and the correspondent "Lachman Consultant Services, Inc." is in the United States. Functional and biocompatibility testing was performed by "certified testing laboratories," implying external entities, but their location is not specified.
- Retrospective or prospective: The description of the studies ("Design verification and performance testing have been conducted") suggests these were prospective tests specifically performed to demonstrate the device's performance for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document describes "Human Factors Testing" which involved a "simulated use Human Factors study." While this implies user interaction and potentially expert evaluation, the number of experts and their specific qualifications are not provided. It's also not clear if "ground truth" in the traditional sense was established by experts for performance metrics (e.g., whether an injection was "successful"), or if it relied on objective measurements.
4. Adjudication method for the test set:
Not applicable or not explicitly stated for the described tests. The performance data seems to be based on direct measurements and observations from functional and mechanical tests rather than subjective human assessment requiring adjudication. For human factors testing, the adjudication method (if any) is not detailed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The GripMate™ is an autoinjector, a physical medical device, not an AI-powered diagnostic or decision support system. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. As mentioned above, this is a physical medical device, not an algorithm. Performance tests were conducted on the device itself.
7. The type of ground truth used:
For the functional and mechanical tests, the "ground truth" would be the objective physical measurements and observations of the device's operation against its design specifications and relevant ISO standards (e.g., measured injection time, force, needle extension, visual/audible indicators working as designed). For biocompatibility, it's conformance to ISO 10993. For human factors, it's the assessment of whether use-related risks are adequately mitigated. There is no mention of pathology or outcomes data as ground truth, as it is a device for drug delivery, not a diagnostic tool.
8. The sample size for the training set:
This is not applicable. The GripMate™ is a physical medical device for drug injection, not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for this device.
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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).
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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) 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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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
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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 DeviceLobster | Candidate DeviceGripMate™ | Comparison |
|---|---|---|---|
| Manufacturer | Sandoz Inc. | Synthon | Substantially equivalent(SE)Manufacturers QMSoperate underISO 13485 |
| 510(k) | K124026 | K243232 | n/a |
| Product code | KZHSyringe needleintroducer | KZHSyringe needleintroducer | Identical |
| Regulationnumber | 21 CFR § 880.6920 | 21 CFR § 880.6920 | Identical |
| Classificationpanel | General Hospital (80) | General Hospital (80) | Identical |
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| Over-the-Counter (OTC)and/orPrescription (Rx Only) | Rx only and Over theCounter | Rx only | SEValidated via humanFactors |
|---|---|---|---|
| Intended use | For a self-administeredsubcutaneous injectionof FDA approved drugs | For a self-administeredsubcutaneous injection ofSun Pharma's glatirameracetate 20 mg/mL and 40mg/mL prefilled syringes | SEScope is for self-administration of aspecific FDA approvedproduct |
| Indications for use | The Lobster device isintended for use with a1mL glass syringe,containing a fixed needleof 27G to 29G gauge,and drug productsolutions with aviscosity between 1 and4 mPas. The Lobsterauto-injector is areusable injection devicefor the subcutaneousinjection of FDAapproved drugs. | The GripMate™autoinjector is intendedfor use with SunPharma's glatirameracetate 20 mg/mL and 40mg/mL prefilled syringes(a 1 mL BD HypakBiotech glass syringe,containing a ½" fixedneedle of 29G, and drugproduct solutions with aviscosity between 1.7 and2.3 mPas). TheGripMate™ autoinjectoris a reusable injectiondevice for patients withmultiple sclerosis age 18and older for thesubcutaneous injection ofSun Pharma's glatirameracetate 20 mg/mL and 40mg/mL prefilledsyringes. | SEScope is for self-administration of aspecific FDA approvedproduct |
| Fundamental scientifictechnology | Handheld self-injectionsystem | Handheld self-injectionsystem | Identical |
| Principle of operation | Spring-loaded poweredmechanism is used toinsert a hypodermicneedle attached to a pre-filled syringe through thepatient's skin and toinject the drug | Spring-loaded poweredmechanism is used toinsert a hypodermicneedle attached to a pre-filled syringe through thepatient's skin and toinject the drug | Identical |
| Environment of use | At home,for single patient useonly | 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 |
| Triggerbutton for firing | Yes | Yes | Identical |
| Fixed dose | Yes | Yes | Identical |
| Needle hidden beforeinjection | Yes | Yes | Identical |
| Safety lock to preventaccidental 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- atwidest point (mm) | 31.0 | 34.0 | Validated via humanFactors |
| Needle extensionpenetration | Variable, 4-10 mm | Variable, 6-8 mm | SETo mitigate the risk ofinadequate injection the4 and 10 mm settingwere not incorporated inthe candidate device.Verified through designverification. |
| Injection time as indicatedin labeling | < 15 sec | < 15 sec | Identical |
| Device state-visible feedback | One viewing window | Two viewing windows | SETwo large feedbackwindows on thecandidate device isusability improvementwhich enables the userto see the injection statusfrom multiple angles.Validated via humanFactors |
| Device state-audible feedback | None | Click at activation.Second click at injectioncompletion. | SEAudio feedbacks featurefor candidate device isusability improvementwhich provides anaudible feedback to theuser about the injectioncompletion status. |
| Use-life | Two years after first use | Two years after first use | Identical |
| Needle extensiontolerance (mm) | Unknown | ± 1.5 | n/a |
| Trigger buttonactivation force (N) | Unknown | 2-8 | n/a |
| Pre-injectionpushing force (N) | Unknown | 3-12 | n/a |
| Trigger button overrideforce (N) | Unknown | > 80 | n/a |
| Syringe loadingforce (N) | Unknown | ≤ 27.1 | n/a |
| Needle shieldremover force (N) | Unknown | ≤ 35 | n/a |
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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
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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.
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CONCLUSION
The GripMate™ is substantially equivalent to the predicate device.
§ 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).