The NavaClick Injection System is intended for injection of fluids into the body. It is specifically indicated for injection of botulinum neurotoxin, consistent with the neurotoxin's approved labeling.

Device Description

The NavaClick Injector is a manually-operated, 1 mL piston syringe consisting of a calibrated, hollow barrel with a standard luer-lock connector into which is inserted a closely-fitted, ratcheted, moveable plunger. The syringe is printed with a graduated scale (1 mL volume), and has audible and tactile feedback upon delivery of each 0.02 mL fluid. The syringe has been designed to enhance the efficiency and precision of neurotoxin injections.

The syringe has been packaged with other components for convenience. The NavaClick Injection System is a kit containing the NavaClick Injectors (syringes), needles, and a vial adapter for delivery of neurotoxin per the labeled indication.

The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for the NavaClick Injection System, which is a medical device classified as a piston syringe.

The document does not describe acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an AI/ML-driven medical device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Merit Syringe K171362) through performance testing against recognized standards, biocompatibility testing, and sterility/shelf-life testing.

The questions in the prompt (regarding sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details, etc.) are highly relevant to the evaluation of AI/ML devices, particularly those involving image analysis or diagnostic support. However, these concepts are not applicable to the NavaClick Injection System as described in this 510(k) summary because:

The NavaClick Injection System is a physical medical device (a syringe), not an AI/ML-driven software device. Its functionality is mechanical (injecting fluids) and does not involve AI or machine learning algorithms for diagnosis, prediction, or image interpretation.
The "study" described is a series of engineering and biological tests, not a clinical study involving the interpretation of data by AI or humans.
"Acceptance criteria" are presented in terms of compliance with recognized international standards (ISO, ASTM, USP), not performance metrics like accuracy, sensitivity, or specificity as would be expected for an AI/ML diagnostic tool.

Therefore, I cannot populate the requested table or answer most of the questions using the provided text, as the context of the prompt (AI/ML device evaluation) does not align with the nature of the device (a mechanical syringe) described in the input.

I can, however, extract information about the types of tests conducted and the standards they adhere to, which serve as "acceptance criteria" for this specific type of piston syringe.

Here's a summary of the compliance and testing information available in the document, framed as close as possible to the prompt's request but acknowledging the different device type:

Device Name: NavaClick Injection System
Device Type: Piston Syringe (mechanical medical device)
Regulatory Pathway: 510(k) Premarket Notification (demonstrating substantial equivalence to a predicate device)

Reason why the prompt's questions are not directly applicable: The NavaClick Injection System is a physical, mechanical device (a syringe) and not an AI/ML-driven software device. Therefore, concepts like "AI assistance," "human readers," "ground truth establishment by experts for image interpretation," "training sets," or "MRMC studies" are not relevant to its regulatory submission. The "acceptance criteria" for this device are primarily based on engineering performance standards, biocompatibility, and sterility.

1. A table of "Acceptance Criteria" (Compliance with Standards) and Reported Device Performance:

"Acceptance Criteria" (Standard Compliance)	Reported Device Performance (Summary)
Performance Testing
ISO 7886-1:2017	Components tested and demonstrated conformance.
ISO 80369-7:2021	Components tested and demonstrated conformance.
ISO 7864:2016	Components tested and demonstrated conformance.
Biocompatibility Testing
ISO 10993-1:2018 (overall guidance)	Testing conducted per various parts of ISO 10993 (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemolysis, Material Mediated Pyrogenicity). No deviations noted. Results support biocompatibility and safety.
USP <788> (Particulate matter)	Evaluation of particulate in the fluid path conducted. Although no specific USP specifications for devices, by comparison, kit components met the specification for small volume parenteral fluids.
Sterility & Shelf Life
ISO 11137-1:2006/Amd 2:2019	Acceptable test results from sterilization validation demonstrated ability of electron beam process to consistently yield a Sterility Assurance Level (SAL) of 10^-6. No deviations noted.
ISO 11137-2:2013	Acceptable test results from sterilization validation. No deviations noted.
ISO 11137-3:2017	Acceptable test results from sterilization validation. No deviations noted.
AAMI TIR29:2012 (R2017)	Sterilization and endotoxin testing completed in accordance. No deviations noted.
USP <85> (Bacterial Endotoxin Test)	Sterilization and endotoxin testing completed in accordance. No deviations noted.
ASTM F1980-21 (Accelerated Aging)	Accelerated stability testing demonstrates sterility and performance for a 1-year shelf-life. Product performance testing of each component conducted according to relevant ISO standards and functional performance testing as a kit.
ASTM F1886 (Visual inspection)	Package (sterile barrier) testing performed after accelerated aging & simulated environmental/distribution conditioning. No deviations noted.
ASTM 2096-11 (Bubble Leak Test)	Package (sterile barrier) testing performed after accelerated aging & simulated environmental/distribution conditioning. No deviations noted.
ASTM F88/F88M-21 (Seal Strength)	Package (sterile barrier) testing performed after accelerated aging & simulated environmental/distribution conditioning. No deviations noted.

2. Sample size used for the test set and the data provenance:

The document does not specify exact sample sizes for each test (e.g., number of syringes tested for flow rate, number of samples for biocompatibility).
Data provenance is implicitly "Lineage Biomedical" (the manufacturer) and conducted by their testing partners or internal labs as part of the device development and validation. The data is for a physical device and is based on prospective testing/validation conducted specifically for this 510(k) submission. Country of origin for data is not explicitly stated but would typically be the location of the testing facilities (likely within the US or compliant international labs).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. "Ground truth" in the context of expert consensus for AI/ML evaluation is not relevant here. Device performance is measured against established engineering and biological standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This concept applies to human-in-the-loop or expert review processes, not the physical testing of a syringe against engineering standards.

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:

Not applicable. This is not an AI/ML device, and no human reader studies (MRMC or otherwise) are relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device does not have an "algorithm" in the sense of AI/ML.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is adherence to defined parameters within recognized international standards (e.g., ISO, ASTM, USP) for piston syringes, biocompatibility, and sterilization. This is a technical/engineering ground truth, not a diagnostic one.

8. The sample size for the training set:

Not applicable. No "training set" in the context of AI/ML.

9. How the ground truth for the training set was established:

Not applicable. No "training set" or "ground truth" in the context of AI/ML.

In conclusion: The provided document is a regulatory submission for a physical medical device (syringe) and details its compliance with established engineering and biological standards to demonstrate substantial equivalence, rather than a clinical study evaluating an AI/ML-driven medical device. Therefore, most of the prompt's specific questions regarding AI/ML evaluation criteria are not applicable to this content.

Summary

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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 seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

November 30, 2023

Bradley Pliskow Director of R&D and Operations 620 NW Dixie Hwy Stuart, Florida 34994

Re: K231877

Trade/Device Name: NavaClick Injection System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI, LHI Dated: September 22, 2023 Received: November 3, 2023

Dear Bradley Pliskow:

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.

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 mediation-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).

Juliane C. Lessard -S Sincerely,

Juliane C. Lessard, Ph.D. 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

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Indications for Use

Submission Number (if known)

K231877

Device Name

NavaClick Injection System

Indications for Use (Describe)

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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K231877 510(k) Summary

SUBMITTED BY:

Company Name:	Lineage Biomedical.
Address:	620 NW Dixie HwyStuart, FL 34994
Telephone:	1-772-539-9749
Fax:	N/A

CONTACT PERSON:	Bradley Pliskow
DATE PREPARED:	Nov 27, 2023
TRADE NAME:	NavaClick Injection System
COMMON and CLASSIFICATION NAME:	Piston Syringe
CLASSIFICATION REG/PANEL:	21 CFR 880.5860/ General and Plastic Surgery
PROCODE:	FMF

PREDICATE DEVICE:

Merit Syringe K171362

DEVICE DESCRIPTION:

The product is sterile, single use only, non-pyrogenic and sterilized by electron beam radiation.

INDICATIONS FOR USE/INTENDED USE:

The NavaClick Injection System is intended for injection of fluids into the body and is specifically indicated for injection of botulinum neurotoxin, consistent with the neurotoxin's approved labeling.

The general intended use for injection of fluids into the body is identical to that of the predicate device; however, the subject device is not intended for withdrawal of fluids from the body. I In addition, the subject device is specifically used to inject botulinum neurotoxin per the neurotoxin product's intended use. This difference does not alter the general intended use of the subject

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device for injection of fluids which is identical to a section of the predicate device's intended use statement and covered in 21 CFR 880.5860.

COMPARISON of TECHNOLOGICAL CHARACTERISTICS:

Results from testing based on "Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes" April 1993, support substantial equivalence of the NavaClick Injector to the predicate Merit Syringe cleared under K171362.

Attribute	NavaClick InjectionSystem (Syringe)	Predicate Device:Merit Syringe K171362	Analysis
Manufacturer	Lineage Biomedical	Merit Medical Systems
Design	Piston Syringe	Piston Syringe	Same
Device Class	II	II	Same
Procode	FMF	FMF	Same
Syringe Type	Piston Syringe	Piston Syringe	Same
Intended Use	Intended to inject fluids intothe body and is specificallyindicated for injection ofbotulinum neurotoxinconsistent with theneurotoxin's approvedlabeling	Used to inject fluids into, orwithdraw fluids from, thebody	DifferentThe general intended usefor injection of fluids is thesame for both the subjectand predicate device and iscovered in 21 CFR880.5860 (piston syringe).No new questions of safetyor effectiveness.
Principle ofOperations	Manually operated byadvancing and withdrawingthe plunger within the barrel	Manually operated byadvancing and withdrawingthe plunger within the barrel	Same
Specific DrugUse	Neurotoxin	Not specified	DifferentInjection of botulinum toxin(neurotoxin) is typicallyachieved using anyconventional piston syringe;a specific delivery device isnot required or identified inpublished prescribinginformation for commonbotulinum toxin drugs.Therefore, no newquestions of safety oreffectiveness for use of theNavaClick piston syringe fordelivery of neurotoxin.
Design	Standard piston syringeconstruction. The deviceuses a two-piece moldedratcheted plunger. Fittingoffered with male luer lockconnector.	Standard three-piece pistonsyringe. The device uses asingle-piece moldedratcheted plunger. Fittingoffered with male luer lockconnector	DifferentThe subject device has afree mode (plungeroperates freely with nofeedback), and a feedbackmode (ratchet provides
Attribute	NavaClick InjectionSystem (Syringe)	Predicate Device:Merit Syringe K171362	Analysis
Materials	The barrel is constructedusing polypropylene, theplunger from polypropylene,and the seal frompolyisoprene	The barrel is constructedusing polypropylene, theplunger from polypropylene,and the seal from silicone.	DifferentBoth polyisoprene andsilicone are commonly usedplunger seal materials.Testing confirmsperformance andbiocompatibility of subjectdevice. No new questionsof safety or effectiveness.
OperationalVolume	Operational Volume of 1 mL	Operational volume of 10mL	DifferentUse of a plunger within thesyringe barrel to move fluidinto and out of the syringefor operation of the syringeis the same for bothdevices. No new questionsof safety or effectiveness.
Graduation	Printed with accurategraduation lines that arecompliant with ISO 7886-1	Printed with accurategraduation lines that arecompliant with ISO 7886-1	DifferentThe subject device has agraduation scale division of0.1 mL and sub-division of0.01 mL. Although volumeincrements for thegraduation scale aredifferent, graduation forboth the subject andpredicate is in compliantwith ISO 7886-1. No newquestions of safety oreffectiveness.
BarrelTransparency	Clear as required by ISO7886-1	Clear as required by ISO7886-1	Same
Biocompatibility	Per ISO 10993-1	Per ISO 10993-1	Same
PerformanceTesting	ISO 7886-1ISO 80369-7	ISO 7886-1ISO 594-2 (withdrawn)	Same
Re-use	Single use only	Single use only	Same
Sterilization	Electron Beam	Ethylene Oxide	Different
Attribute	NavaClick InjectionSystem (Syringe)	Predicate Device:Merit Syringe K171362	Analysis
			Both the subject andpredicate devices aresterilized using well-established methods.Electron Beam sterilizationof the subject device iscompliant with ISO 11137-1, ISO 11137-2 and ISO11137-3. No new questionsof safety or effectiveness.
Accessories	Packaged as a kit	Not a kit configuration	DifferentThe NavaClick syringe ispackaged with needles anda vial adapter forconvenience of the user.The kit components arepreviously 510k cleareddevices to be utilized perthe cleared indications. Nonew questions of safety ofeffectiveness.

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The NavaClick Injector has the same intended use, materials of construction, and principle of operations as the predicate device. There are minor differences between the subject and predicate devices. Although they are both 3-part piston syringes consisting of a barrel, plunger and tip, the Nava device also has grips to enhance control. Both devices have ratcheted plungers; however, the mechanism to produce an audible clicking and tactile feedback is different. The Nava device allows the feedback mechanism to engage by twisting the thumb rest 90 degrees. These differences are not significant with regard to the function of the syringe to inject fluids; these minor differences do not raise different questions of safety and effectiveness.

Performance Testing

The NavaClick Injection System components described in this summary have been tested and demonstrated to be in conformance with the following FDA recognized standards:

. ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications • - Part 7: Connectors for intravascular or hypodermic applications
. ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods

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Biocompatibility Testing

Biocompatibility testing of the predicate device was conducted per ISO 10993-1:2018 and the risk-based approach outlined in FDA quidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Sep 4, 2020. Based on the standard, the kit components were defined as externally communicating, limited exposure and either blood path indirect (syringe and adapter) or circulating blood (needle). The following testing was conducted on all kit components and no deviations were noted.

. Cytotoxicity (ISO 10993-5:2009 "Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity")
Sensitization (ISO 10993-10:2021 "Biological evaluation of medical device Part 10: . Tests for skin sensitization")
Irritation (ISO 10993-23:2021 "Biological evaluation of medical device – Part 23: Test for irritation")
. Acute Systemic Toxicity (ISO 10993-11:2017 "Biological evaluation of medical device -Part 11: Tests for systemic toxicity")
Hemolysis (ISO 10993-4:2017 "Biological evaluation of medical device – Part 4: Selection of tests for interactions with blood")
Material Mediated Pyrogenicity (ISO 10993-11:2017 "Biological evaluation of medical . device - Part 11: Tests for systemic toxicity")

Evaluation of particulate in the fluid path per USP <788> has been conducted on the NavaClick Injection System. Although there are no USP specifications for particulate matter found in or on medical devices, by comparison, the kit components met the specification for small volume parenteral fluids.

Results from the biocompatibility testing support the biocompatibility and safety of the subject device.

Sterility and Shelf Life

The sterilization method for the NavaClick Injection System is electron beam irradiation with a sterilization dose minimum of 25kGy. Acceptable test results from the sterilization validation demonstrated the ability of the electron beam process to consistently vield a sterility assurance level (SAL) of 10° for the NavaClick Injection System. Sterilization and endotoxin testing was completed in accordance with the following standards. No deviations were noted.

ISO 11137-1: 2006/Amd 2:2019 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2: 2013 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose

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ISO 11137-3:2017 Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
AAMI TIR29:2012 (R2017) Guide For Process Characterization And Control In Radiation Sterilization Of Medical Devices
USP <85> Bacterial Endotoxin Test ●

Accelerated stability testing demonstrates the sterility and performance of the device to support the shelf-life of 1 year.

Product stability testing of the NavaClick Injection System was conducted after accelerated aging per ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. Product performance testing of each component was conducted according to the relevant ISO standard as well as functional performance testing as a kit.

Package (sterile barrier) testing was performed on the subject device after accelerated aging per ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices. Package testing was also performed after simulated environmental conditioning (ASTM D4332-22) and distribution (ASTM D4169-22). Sterile barrier integrity testing was completed in accordance with the following standards. No deviations were noted.

Visual inspection (ASTM F1886)
Bubble Leak Test (ASTM 2096-11) ●
Seal Strength (ASTM F88/F88M-21)

Conclusion

Based on the intended use, technological characteristics, performance testing, and biocompatibility studies, the NavaClick Injection System meets the requirements that are considered essential for its intended use. The technological differences between the predicate (K171362) Merit Syringe and the subject device do not raise any new questions of safety or effectiveness. The NavaClick Injection System is considered substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).