The StaClear Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap. The needle is a 31-gauge needle, 5/16in in length, which is permanently attached to the syringe body. It is intended for use by health care professionals for general purpose fluid aspiration/injection. Its operation is manual. The StaClear syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear syringe is suitable for ophthalmic use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the StaClear Syringe, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Standard)	Reported Device Performance
Material/Physical Properties	Cleanliness	ISO 7886-1:2017, ISO 7864:2016, ISO 9626:2016	Met applicable requirements
	Acidity and Alkalinity	ISO 7886-1:2017, ISO 7864:2016, ISO 9626:2016	Met applicable requirements
	Extractable Metals	Exhaustive extraction, limits ≤ 0.2 µg/device (intraocular lenses)	Met applicable requirements
	Lubricant	ISO 7886-1:2017, ISO 7864:2016	Met applicable requirements
	Tolerance on Graduations	ISO 7886-1:2017	Met applicable requirements
	Stopper Detachment	ISO 7886-1:2017	Met applicable requirements
	Dead Space	ISO 7886-1:2017	Met applicable requirements
	Air and Liquid Leakage Past Plunger	ISO 7886-1:2017	Met applicable requirements
	Plunger Force	ISO 7886-1:2017	Met applicable requirements
	Fit of Stopper	ISO 7886-1:2017	Met applicable requirements
	Tolerance on Length (needle)	ISO 7864:2016	Met applicable requirements
	Tube Defects (needle)	ISO 7864:2016	Met applicable requirements
	Point Defects (needle)	ISO 7864:2016	Met applicable requirements
	Needle Penetration Force	ISO 7864:2016	Met applicable requirements
	Bond between Tube and Hub	ISO 7864:2016	Met applicable requirements
	Patency of Lumen	ISO 7864:2016	Met applicable requirements
	Materials (needle)	ISO 9626:2016	Met applicable requirements
	Surface Finish (needle)	ISO 9626:2016	Met applicable requirements
	Size designation (needle)	ISO 9626:2016	Met applicable requirements
	Dimensions (needle)	ISO 9626:2016	Met applicable requirements
	Stiffness (needle)	ISO 9626:2016	Met applicable requirements
	Resistance to Breakage (needle)	ISO 9626:2016	Met applicable requirements
	Resistance to Corrosion (needle)	ISO 9626:2016	Met applicable requirements
Particulate Matter	Particulate Matter in Injections	USP <788>	Met applicable requirements
	Particulate Matter in Ophthalmic Solutions	USP <789>	Met applicable requirements
Biocompatibility	Cytotoxicity (cell lysis/toxicity)	ISO 10993-5	No evidence of causing cell lysis or toxicity
	Sensitization (skin)	ISO 10993-10	Not considered a sensitizer
	Irritation, Ocular	ISO 10993-15	Not considered irritants to the ocular tissue of the rabbit
	Irritation, Intravitreal Injection	Intravitreal Injection Irritation testing	Not considered inflammatory to intraocular tissues of the rabbit
	Intracutaneous Reactivity	ISO 10993-15	No intracutaneous reactivity (no erythema and edema)
	Acute Systemic Toxicity	ISO 10993-11	No mortality or evidence of systemic toxicity
	Pyrogenicity	ISO 10993-11	Not considered pyrogenic
	Hemolysis	ASTM F756, ISO 10993-4	Not considered hemolytic
	Chemical Characterization / Toxicological Risk Assessment	ISO 10993-1, ISO 10993-2, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-17, ISO 10993-18	Acceptable level of risk of systemic exposure to extractable compounds

Study Information

The document describes non-clinical bench testing and biocompatibility testing. It does not describe a study comparing human readers with and without AI assistance, nor does it describe a standalone algorithm-only performance study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state numerical sample sizes for each test. For example, it lists "Cleanliness" as a test performed but does not quantify how many units were tested.
The data provenance is not specified beyond being "non-clinical bench testing" and "TriboFilm's design control system," implying internal testing by the manufacturer. No country of origin for test data is mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a medical product (syringe), and the evaluation involved bench testing and biocompatibility assessment, not interpretation of medical images or diagnostic tasks. As such, "ground truth" was established by adherence to recognized testing standards and methods, not expert consensus in a clinical diagnostic sense.

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

Not applicable for this type of device and testing. The tests performed are objective, quantitative measurements against established 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a syringe, not an AI-powered diagnostic tool.

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

No, a standalone algorithm-only performance study was not done. This device does not involve an algorithm.

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

The "ground truth" for evaluating the StaClear Syringe against its acceptance criteria was based on:
- International and National Standards: e.g., ISO 7886-1, ISO 7864, ISO 9626, ISO 10993 series, ASTM F756, USP <788>, USP <789>. These standards define acceptable performance limits and test methodologies.
- Objective Measurements: Laboratory and material testing results.
- Biological Endpoints: Observed responses in biocompatibility tests (e.g., absence of cell lysis, irritation, toxicity).

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, so there is no training set.

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

Not applicable. As there is no training set, this question is irrelevant.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

July 27, 2020

TriboFilm Research, Inc. % Beryl Jeanne Regulatory Consultant Namsa 400 Highway 169 South, Suite 500 Minneapolis, Minnesota 55426

Re: K200242

Trade/Device Name: StaClear Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QLY, FMF, FMF, FMI Dated: June 24, 2020 Received: June 25, 2020

Dear Beryl Jeanne:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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).

Sincerely,

For CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200242

Device Name StaClear Syringe

Indications for Use (Describe)

The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.

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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Image /page/3/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo consists of a stylized letter "T" with an orange ring around it, followed by the text "riboFilm" in blue. Below the text is "Research, Inc." also in blue.

K200242 510(k) Summary

510(k) Number	K200242
Preparation Date	June 21, 2020
Submitter	TriboFilm Research, Inc.625 Hutton Street, Suite 105Raleigh, NC 27606Phone: +1-919-838-2844Fax: +1-919-838-6787E-mail: info@tribofilmresearch.com
Primary Contact	Jackson Thornton, PhDDirector of ResearchTriboFilm Research, Inc.625 Hutton Street, Suite 105Raleigh, NC 27606
Subject Device	Trade Name	StaClear Syringe
	Common Name	Ophthalmic Syringe;Syringe, Piston;Needle, Hypodermic, SingleLumen
	Regulation Name	Piston syringe;Hypodermic single lumen needle
	Regulation Numbers	21 CFR 880.5860;21 CFR 880.5570
	Device Class	Class II
	Product Codes	QLY; FMF; FMI
	Regulation Medical Specialty	General Hospital
	510(k) Review Panel	General Hospital
Intended Use /Indications forUse	The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.
DeviceDescription	The StaClear Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap. The needle is a 31-gauge needle, 5/16in in length, which is permanently attached to the syringe body. It is intended for use by health care professionals for general purpose fluid aspiration/injection. Its operation is manual. The StaClear syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear syringe is suitable for ophthalmic use.
Predicate Device	Trade Name	Sterile Single-use Syringe with Needle
	Applicant	JiangXi HongDa MedicalEquipment Group Ltd.
	510(k) Number	K163161

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Image /page/4/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo consists of a stylized letter 'T' with an orange arc around it, followed by the text 'riboFilm' in blue. Below 'riboFilm' is the text 'Research, Inc.' also in blue.

	Clearance Date	March 20, 2017
	Common Name	Syringe, Piston;Needle, Hypodermic, SingleLumen
	Regulation Name	Piston syringe;Hypodermic single lumen needle
	Regulation Numbers	21 CFR 880.5860;21 CFR 880.5570
	Device Class	Class II
	Product Codes	FMF; FMI
	Regulation Medical Specialty	General Hospital
	510(k) Review Panel	General Hospital
Reference Device	Trade Name	BD Insulin Syringe
	Applicant	Becton, Dickinson & Company
	510(k) Number	K024112
	Clearance Date	01/09/2003
	Device	Syringe, Piston
	Regulation Numbers	21 CFR 880.5860
	Device Class	Class II
	Product Codes	FMF
	Regulation Medical Specialty	General Hospital
	510(k) Review Panel	General Hospital
Mechanism of Action	Manual operation

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Image /page/5/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo consists of a stylized letter "T" with an orange ring around it, followed by the text "riboFilm" in blue. Below the text is "Research, Inc." also in blue. The logo is clean and professional, suggesting a company involved in research and development.

Technological Characteristics	The technological characteristics of the subject device are substantially equivalent to the predicate device with only minor differences in the device materials, syringe volume, connector type, needle gauge, needle length, biocompatibility tests completed, and performance testing completed. Biocompatibility testing and performance testing demonstrate these differences do not raise questions of safety and effectiveness. Refer to Table 1 below for a comparison of technological characteristics between the subject and predicate devices.
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Technological Characteristics

The technological characteristics of the subject device are substantially equivalent to the predicate device with only minor differences in the device materials, syringe volume, connector type, needle gauge, needle length, biocompatibility tests completed, and performance testing completed. Biocompatibility testing and performance testing demonstrate these differences do not raise questions of safety and effectiveness. Refer to Table 1 below for a comparison of technological characteristics between the subject and predicate devices.

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Characteristic	Subject Device	Predicate Device	AssociatedTestingStandard
Device Name	StaClear Syringe	Sterile Single-UseSyringe with Needle	-
Applicant	TriboFilmResearch, Inc.	JiangXi HongDaMedical EquipmentGroup Ltd.	-
510(k) Number	K200242	K163161	-
Intended Use	The StaClearSyringe is intendedto inject fluids into.or withdraw fluidsfrom, the body.	Identical	All listedPerformance andBiocompatibilitytesting listingwithin this 510(k)Summary supportthe safety andeffectiveness ofthe device ascompared to thepredicate.
Indications forUse	The StaClearSyringe isindicated forintravitreal use.	Equivalent, thepredicate device doesnot identify specificindications for use.	ISO 10993-15,IntravitrealInjectionIrritation testing,USP <788>, USP<789>
Mechanism ofAction	Manual	Identical	ISO 7886-1
Sterilizationinformation	Provided Sterile,single-useSterilizationMethod: EthyleneOxideSAL: 10-6	Identical	ISO 10993-7,ISO 14937, TIR56, ISO 11135,ISO 11737-1,ISO 11737-2
Shelf Life	1 year	UnknownThe predicate device'sshelf life is unknown.This information is notprovided in theK163161 510(k)	ASTM F1980-16,ISO 7886-1, ISO7864, USP <71>
Device Materials	Barrel -PolypropylenePlunger -PolyethylenePlunger Stopper -Polyisoprene(Nipol IR2200,Zeon Chemicals)Needle - ASTM304 Stainless SteelNeedle Shield -PolyethylenePlunger Cap -PolyethyleneBarrel Lubricant -Silicone Oil,crosslinked withinert argon gasplasma	Equivalent. Both thesubject and predicatedevices use stainlesssteel for the needles.Both the subject andpredicate devices usepolypropylene andpolyisoprene for thesyringes.The predicate deviceadditionally usespolyethylene for thesyringe's plunger,needle shield, andplunger cap. Thesecomponents are non-patient contacting.The subject deviceuses a silicone oilcrosslinked with inertargon gas plasma forthe lubricant. Thepredicate device usesstandard silicone oil asthe lubricant.	ISO 10993-1,ISO 10993-2,ISO 10993-4,ISO 10993-5,ISO 10993-10,ISO 10993-11,ISO 10993-12,ISO 10993-17,ISO 10993-18,ASTM F756
Syringe Volume	0.25 mL	Equivalent. Thesubject device's 0.25mL syringe volume issmaller than thepredicate device'ssyringe volume rangeof 1 mL to 60 mL.	ISO 7886-1
Connector Type	Attached needle	Equivalent. Thesubject device has theneedle permanentlyattached to the syringebody whereas thepredicate uses a luerslip and luer lockconnector.	ISO 7886-1, ISO7864, ISO 9626
Needle Gauge	31 G	Equivalent. Thesubject device's 31Gneedle is smaller thanthe predicate device'sneedle range of 18G to30G.	ISO 7864 andISO 9626
Needle Length	5/16 in.	Equivalent. Thesubject device's 5/16in. needle length isshorter than thepredicate device'sneedle length range of1/8 in. to 1 1/8 in.	ISO 7864 andISO 9626
Cytotoxicity
Cytotoxicity	No evidence of causing cell lysis or toxicity	Identical	ISO 10993-5
Sensitization	No skin sensitization	Identical	ISO 10993-10
Irritation orIntracutaneousReactivity	IntracutaneousReactivity: Nointracutaneousreactivity	Identical	ISO 10993-15,IntravitrealInjectionIrritation testing
Irritation orIntracutaneousReactivity	Irritation, Ocular:Not consideredirritants to theocular tissueIrritation,IntravitrealInjection: Notconsideredinflammatory tointraocular tissues	N/A. Ocular Irritationand IntravitrealInjection Irritationtesting not performedon predicated device.	ISO 10993-15,IntravitrealInjectionIrritation testing
Acute SystemicToxicity	No mortality orevidence ofsystemic toxicity	Identical	ISO 10993-11
Pyrogenicity	Not pyrogenic	Identical	ISO 10993-11
Hemolysis	Not hemolytic	Identical	ASTM F756, ISO10993-4

Table 1: Comparison of Technological Characteristics

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Image /page/6/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo features a stylized "T" with an orange arc around it, followed by the text "riboFilm" in blue. Below that, the text "Research, Inc." is also written in blue.

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Image /page/7/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo features a stylized letter "T" with an orange ring around it, followed by the text "riboFilm" in blue. Below the text is the word "Research, Inc." also in blue. The logo is clean and professional, with a focus on the company's name and branding.

Substantial Equivalence Discussion:

The subject device is substantially equivalent to the predicate device when evaluating intended use and technological characteristics.

There are no differences between the subject device and the predicate device with respect to intended use.
The subject device is additionally indicated for intravitreal use. . This additional indication was evaluated through ocular and intravitreal injection irritation testing, demonstrating that the device is biocompatible for intravitreal use. This difference in indications for use between the subject and predicate device does not raise new or different questions of safety and effectiveness.
The technological characteristics of the subject device are substantially equivalent to the predicate device with only minor differences in the device materials, syringe volume, connector type, needle gauge, needle length.
. TriboFilm completed performance testing according to the following standards: ISO 7886-1, ISO 7864, and ISO 9626. The StaClear Syringe met the applicable requirements of all three standards. These three standards were utilized by predicate device JiangXi Sterile Single-use Syringe with Needle (K163161) to demonstrate performance. Additionally, TriboFilm completed particulate testing according to the following standards and

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Image /page/8/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo features a stylized letter "T" with an orange ring around it, followed by the text "riboFilm" in blue. Below "riboFilm" is the text "Research, Inc." also in blue.

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Image /page/9/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo consists of a stylized "T" with an orange circle around it, followed by the text "riboFilm" in blue. Below the text is the phrase "Research, Inc." also in blue.

Non-clinical Bench testing was performed to demonstrate the subject is as safe and Testing: effective as the proposed subject device. Performance testing was conducted according to TriboFilm's design control system. The following tests were completed: ISO 7886-1: 2017 ● Cleanliness Acidity and Alkalinity ● ● Extractable Metals (performed based on exhaustive extraction with limits set for intraocular lenses ≤ 0.2 µg/device) ● Lubricant ● Tolerance on Graduations Stopper Detachment ● Dead Space ● ● Air and Liquid Leakage Past Plunger ● Plunger Force Fit of Stopper ● ISO 7864: 2016 Cleanliness ● ● Acidity and Alkalinity ● Extractable Metals (performed based on exhaustive extraction with limits set for intraocular lenses ≤ 0.2 µg/device) ● Tolerance on Length ● Tube Defects ● Lubricant Point Defects ● Needle Penetration Force ● Bond between Tube and Hub ● . Patency of Lumen ISO 9626: 2016 Materials ● ● Surface Finish ● Cleanliness Acidity and Alkalinity ● ● Size designation Dimensions ● Stiffness ● ● Resistance to Breakage Resistance to Corrosion ● Particulate Testing USP <788> Particulate Matter in Injections ● USP <789> Particulate Matter in Ophthalmic Solutions ●

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Image /page/10/Picture/0 description: The image shows the logo for TriboFilm Research, Inc. The logo consists of a stylized letter "T" with an orange ring around it, followed by the text "riboFilm" in blue. Below the text is the phrase "Research, Inc." also in blue.

Non-ClinicalTesting(Biocompatibility)	StaClear Syringe is classified as an externally communicating device withprolonged (> 24 hours to 30 days) tissue contact. TriboFilm completed thefollowing biological safety tests:• Chemical Characterization• Cytotoxicity• Sensitization• Irritation, Ocular• Irritation, Intravitreal Injection• Intracutaneous Reactivity• Acute Systemic Toxicity• Pyrogenicity• Hemolysis
	The test article extract did not show evidence of causing cell lysis ortoxicity, was not considered a sensitizer, was not considered an irritant tothe ocular tissue of the rabbit, was not considered inflammatory tointraocular tissues of the rabbit, did not show evidence of erythema andedema, did not show evidence of mortality or systemic toxicity, was notconsidered pyrogenic, and was not considered hemolytic. A chemicalcharacterization of the device was done to evaluate the subacute/subchronicand genotoxicity endpoints. The toxicological risk assessmentdemonstrated an acceptable level of risk of systemic exposure to theextractable compounds. Therefore, this biological safety testingdemonstrates the subject device is biocompatible for its intended use.
Clinical Testing:	Not Applicable
Conclusion:	In conclusion, the StaClear Syringe is biocompatible for its intended use,demonstrates equivalent performance as the predicate device, anddemonstrates better performance than the reference device. TriboFilmResearch, Inc. respectfully requests FDA clearance to legally market theStaClear Syringe in the U.S.The modifications to design, dimensions, and materials met therequirements of the standards. The suitability of the device for intravitrealinjections was evaluated through biocompatibility and particulate testing.The differences between the predicate and the subject device do not raiseany new or different questions of safety or effectiveness. The StaClearSyringe is substantially equivalent to the Sterile Single-use Syringe withNeedle cleared under K163161 with respect to the intended use, targetpopulations, treatment method, and technological characteristics.

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).