StaClear Syringe

K200242 · Tribofilm Research, Inc. · QLY · Jul 27, 2020 · General Hospital

Device Facts

• Record ID: K200242
• Device Name: StaClear Syringe
• Applicant: Tribofilm Research, Inc.
• Product Code: QLY · General Hospital
• Decision Date: Jul 27, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

StaClear Syringe is a single-use, manual piston syringe; 0.25 mL graduated barrel; 31-gauge needle permanently attached. Used by healthcare professionals for general fluid aspiration/injection, specifically intravitreal procedures. Device components: polypropylene barrel, polyethylene plunger/cap/shield, polyisoprene stopper, ASTM 304 stainless steel needle, silicone oil lubricant crosslinked with inert argon gas plasma. Sterilized by ethylene oxide. Manual operation; no electronic or software components. Provides precise fluid delivery for ophthalmic applications; biocompatibility and particulate testing confirm suitability for intraocular use.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including performance testing (ISO 7886-1, ISO 7864, ISO 9626), particulate testing (USP <788>, USP <789>), and comprehensive biocompatibility testing (ISO 10993 series, ASTM F756).

Technological Characteristics

Materials: Polypropylene barrel, polyethylene plunger/cap/shield, polyisoprene stopper, ASTM 304 stainless steel needle, silicone oil lubricant (argon gas plasma crosslinked). 0.25 mL volume. 31G needle, 5/16 in length. Manual operation. Sterilization: Ethylene oxide (SAL 10^-6). Standards: ISO 7886-1, ISO 7864, ISO 9626, ISO 10993, USP <788>, USP <789>, ASTM F756.

Indications for Use

Indicated for intravitreal use in patients requiring fluid injection into or withdrawal from the body.

Regulatory Classification

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.

Predicate Devices

• Sterile Single-use Syringe with Needle (K163161)

Reference Devices

• BD Insulin Syringe (K024112)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>625 Hutton Street, Suite 105<br>Raleigh, NC 27606<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Primary Contact | Jackson Thornton, PhD<br>Director of Research<br>TriboFilm Research, Inc.<br>625 Hutton Street, Suite 105<br>Raleigh, NC 27606 | |
| Subject Device | Trade Name | StaClear Syringe |
| | Common Name | Ophthalmic Syringe;<br>Syringe, Piston;<br>Needle, Hypodermic, Single<br>Lumen |
| | Regulation Name | Piston syringe;<br>Hypodermic single lumen needle |
| | Regulation Numbers | 21 CFR 880.5860;<br>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 /<br>Indications for<br>Use | The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use. | |
| Device<br>Description | 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 Medical<br>Equipment 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;<br>Needle, Hypodermic, Single<br>Lumen |
| | Regulation Name | Piston syringe;<br>Hypodermic single lumen needle |
| | Regulation Numbers | 21 CFR 880.5860;<br>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. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

| Characteristic | Subject Device | Predicate Device | Associated<br>Testing<br>Standard |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | StaClear Syringe | Sterile Single-Use<br>Syringe with Needle | - |
| Applicant | TriboFilm<br>Research, Inc. | JiangXi HongDa<br>Medical Equipment<br>Group Ltd. | - |
| 510(k) Number | K200242 | K163161 | - |
| Intended Use | The StaClear<br>Syringe is intended<br>to inject fluids into.<br>or withdraw fluids<br>from, the body. | Identical | All listed<br>Performance and<br>Biocompatibility<br>testing listing<br>within this 510(k)<br>Summary support<br>the safety and<br>effectiveness of<br>the device as<br>compared to the<br>predicate. |
| Indications for<br>Use | The StaClear<br>Syringe is<br>indicated for<br>intravitreal use. | Equivalent, the<br>predicate device does<br>not identify specific<br>indications for use. | ISO 10993-15,<br>Intravitreal<br>Injection<br>Irritation testing,<br>USP <788>, USP<br><789> |
| Mechanism of<br>Action | Manual | Identical | ISO 7886-1 |
| Sterilization<br>information | Provided Sterile,<br>single-use<br>Sterilization<br>Method: Ethylene<br>Oxide<br>SAL: 10-6 | Identical | ISO 10993-7,<br>ISO 14937, TIR<br>56, ISO 11135,<br>ISO 11737-1,<br>ISO 11737-2 |
| Shelf Life | 1 year | Unknown<br>The predicate device's<br>shelf life is unknown.<br>This information is not<br>provided in the<br>K163161 510(k) | ASTM F1980-16,<br>ISO 7886-1, ISO<br>7864, USP <71> |
| Device Materials | Barrel -<br>Polypropylene<br>Plunger -<br>Polyethylene<br>Plunger Stopper -<br>Polyisoprene<br>(Nipol IR2200,<br>Zeon Chemicals)<br>Needle - ASTM<br>304 Stainless Steel<br>Needle Shield -<br>Polyethylene<br>Plunger Cap -<br>Polyethylene<br>Barrel Lubricant -<br>Silicone Oil,<br>crosslinked with<br>inert argon gas<br>plasma | Equivalent. Both the<br>subject and predicate<br>devices use stainless<br>steel for the needles.<br>Both the subject and<br>predicate devices use<br>polypropylene and<br>polyisoprene for the<br>syringes.<br>The predicate device<br>additionally uses<br>polyethylene for the<br>syringe's plunger,<br>needle shield, and<br>plunger cap. These<br>components are non-<br>patient contacting.<br>The subject device<br>uses a silicone oil<br>crosslinked with inert<br>argon gas plasma for<br>the lubricant. The<br>predicate device uses<br>standard silicone oil as<br>the lubricant. | ISO 10993-1,<br>ISO 10993-2,<br>ISO 10993-4,<br>ISO 10993-5,<br>ISO 10993-10,<br>ISO 10993-11,<br>ISO 10993-12,<br>ISO 10993-17,<br>ISO 10993-18,<br>ASTM F756 |
| Syringe Volume | 0.25 mL | Equivalent. The<br>subject device's 0.25<br>mL syringe volume is<br>smaller than the<br>predicate device's<br>syringe volume range<br>of 1 mL to 60 mL. | ISO 7886-1 |
| Connector Type | Attached needle | Equivalent. The<br>subject device has the<br>needle permanently<br>attached to the syringe<br>body whereas the<br>predicate uses a luer<br>slip and luer lock<br>connector. | ISO 7886-1, ISO<br>7864, ISO 9626 |
| Needle Gauge | 31 G | Equivalent. The<br>subject device's 31G<br>needle is smaller than<br>the predicate device's<br>needle range of 18G to<br>30G. | ISO 7864 and<br>ISO 9626 |
| Needle Length | 5/16 in. | Equivalent. The<br>subject device's 5/16<br>in. needle length is<br>shorter than the<br>predicate device's<br>needle length range of<br>1/8 in. to 1 1/8 in. | ISO 7864 and<br>ISO 9626 |
| Cytotoxicity | | | |
| Cytotoxicity | No evidence of causing cell lysis or toxicity | Identical | ISO 10993-5 |
| Sensitization | No skin sensitization | Identical | ISO 10993-10 |
| Irritation or<br>Intracutaneous<br>Reactivity | Intracutaneous<br>Reactivity: No<br>intracutaneous<br>reactivity | Identical | ISO 10993-15,<br>Intravitreal<br>Injection<br>Irritation testing |
| Irritation or<br>Intracutaneous<br>Reactivity | Irritation, Ocular:<br>Not considered<br>irritants to the<br>ocular tissue<br>Irritation,<br>Intravitreal<br>Injection: Not<br>considered<br>inflammatory to<br>intraocular tissues | N/A. Ocular Irritation<br>and Intravitreal<br>Injection Irritation<br>testing not performed<br>on predicated device. | ISO 10993-15,<br>Intravitreal<br>Injection<br>Irritation testing |
| Acute Systemic<br>Toxicity | No mortality or<br>evidence of<br>systemic toxicity | Identical | ISO 10993-11 |
| Pyrogenicity | Not pyrogenic | Identical | ISO 10993-11 |
| Hemolysis | Not hemolytic | Identical | ASTM F756, ISO<br>10993-4 |

### 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-Clinical<br>Testing<br>(Biocompatibility<br>) | StaClear Syringe is classified as an externally communicating device with<br>prolonged (> 24 hours to 30 days) tissue contact. TriboFilm completed the<br>following biological safety tests:<br>• Chemical Characterization<br>• Cytotoxicity<br>• Sensitization<br>• Irritation, Ocular<br>• Irritation, Intravitreal Injection<br>• Intracutaneous Reactivity<br>• Acute Systemic Toxicity<br>• Pyrogenicity<br>• Hemolysis |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The test article extract did not show evidence of causing cell lysis or<br>toxicity, was not considered a sensitizer, was not considered an irritant to<br>the ocular tissue of the rabbit, was not considered inflammatory to<br>intraocular tissues of the rabbit, did not show evidence of erythema and<br>edema, did not show evidence of mortality or systemic toxicity, was not<br>considered pyrogenic, and was not considered hemolytic. A chemical<br>characterization of the device was done to evaluate the subacute/subchronic<br>and genotoxicity endpoints. The toxicological risk assessment<br>demonstrated an acceptable level of risk of systemic exposure to the<br>extractable compounds. Therefore, this biological safety testing<br>demonstrates 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,<br>demonstrates equivalent performance as the predicate device, and<br>demonstrates better performance than the reference device. TriboFilm<br>Research, Inc. respectfully requests FDA clearance to legally market the<br>StaClear Syringe in the U.S.<br><br>The modifications to design, dimensions, and materials met the<br>requirements of the standards. The suitability of the device for intravitreal<br>injections was evaluated through biocompatibility and particulate testing.<br><br>The differences between the predicate and the subject device do not raise<br>any new or different questions of safety or effectiveness. The StaClear<br>Syringe is substantially equivalent to the Sterile Single-use Syringe with<br>Needle cleared under K163161 with respect to the intended use, target<br>populations, treatment method, and technological characteristics. |