Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)

K243149 · Congruence Medical Solutions, LLC · QLY · Dec 20, 2024 · General Hospital

Device Facts

• Record ID: K243149
• Device Name: Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)
• Applicant: Congruence Medical Solutions, LLC
• Product Code: QLY · General Hospital
• Decision Date: Dec 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Microliter Dosing Syringe is intended to inject fluid into, or withdraw fluid from the body. The Microliter Dosing Syringe is indicated for intravitreal use.

Device Story

The Microliter Dosing Syringe is a single-use, manually operated piston syringe designed for intravitreal fluid aspiration or injection. It consists of a cyclic olefin polymer barrel, a plunger rod subassembly (polycarbonate/PET with glass fiber and stainless steel), a chlorinated butyl rubber plunger stopper with fluoropolymer coating, and a matching tip cap. The device is provided sterile via e-beam irradiation. It is intended for use by healthcare professionals in clinical settings. By manually manipulating the plunger, the clinician aspirates or injects precise microliter volumes of fluid. The device facilitates ophthalmic procedures by providing a controlled delivery mechanism for intravitreal medications, potentially improving dosing accuracy and patient outcomes during ocular treatments.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included ISO 7886-1 (cleanliness, acidity/alkalinity, extractable metals, graduation tolerance, dead space, leakage, plunger force, stopper fit), USP <788>/<789> (particulate matter), and USP <85> (endotoxins). Biocompatibility testing per ISO 10993-1 included cytotoxicity, sensitization, ocular/intravitreal irritation, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, and hemolysis. Results demonstrated the device is biocompatible, non-pyrogenic, non-hemolytic, and meets all performance requirements.

Technological Characteristics

Manual piston syringe; 0.35mL volume; cyclic olefin polymer barrel; plunger rod (polycarbonate/PET/stainless steel); chlorinated butyl rubber stopper/tip cap with fluoropolymer coating; e-beam sterilization (SAL 10^-6); Luer lock connector. Tested per ISO 7886-1, ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-23, ASTM F756, USP <788>, USP <789>, and USP <85>.

Indications for Use

Indicated for intravitreal use for 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

• StaClear Syringe (K200242)

Submission Summary (Full Text)

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December 20, 2024

Congruence Medical Solutions, LLC Gautam Shetty Founder, CEO 3000 Falls Road Suite 200A Baltimore, Maryland 21211

Re: K243149

Trade/Device Name: Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: QLY, FMF Dated: December 7, 2024 Received: December 9, 2024

Dear Gautam Shetty:

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 (OS) 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 ([e-mail]) or phone [phone] 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) K243149

Device Name

Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models)

Indications for Use (Describe)

The Microliter Dosing Syringe is intended to inject fluid into, or withdraw fluid from the body. The Microliter Dosing Syringe is indicated for intravitreal use.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## K243149 510(k) Summary

Image /page/4/Picture/1 description: The image contains the logo for Congruence Medical Solutions, LLC. The logo features a stylized triangle shape at the top, with the word "CONGRUENCE" in a bold, sans-serif font below it. Underneath the word "CONGRUENCE", the text "MEDICAL SOLUTIONS, LLC" is written in a smaller font size.

| 510(k) Number | K243149 | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Preparation Date | December 20, 2024 | |
| Submitter | Congruence Medical Solutions, LLC<br>3000 Falls Road<br>Suite 200A<br>Baltimore, MD 21211<br>Email: [e-mail]<br>Phone: [phone] | |
| Primary Contact | Gautam Shetty, PhD<br>Founder, CEO<br>Congruence Medical Solutions, LLC<br>3000 Falls Road<br>Suite 200A<br>Baltimore, MD 21211 | |
| Subject Device | Trade Name | Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100<br>microliter models) |
| | Common name | Ophthalmic Syringe,<br>Piston syringe |
| | Regulation name | Syringe, Piston |
| | Regulation number | 21 CFR 880.5860 |
| | Device Class | Class II |
| | Product Codes | QLY, FMF |
| | Regulation Medical Specialty | General Hospital |
| | 510(k) Review Panel | General Hospital |
| Intended<br>Use/Indications for<br>Use | The Microliter Dosing Syringe is intended to inject fluid into, or withdraw fluid from the body.<br>The Microliter Dosing Syringe is indicated for intravitreal use. | |
| Device Description | The Microliter Dosing Syringe is a single-use, piston syringe-based device consisting of a<br>syringe barrel, plunger stopper, syringe tip cap and incorporates a plunger rod subassembly. It is<br>intended for use by healthcare professionals for general purpose fluid aspiration/injection. Its<br>operation is manual. The Microliter Dosing Syringe is single use only, non-toxic, non-pyrogenic<br>and sterilized by e-beam irradiation. The Microliter Dosing Syringe is suitable for ophthalmic<br>use. | |
| Predicate Device | Trade Name | StaClear Syringe |
| | Applicant | TriboFilm Research, Inc. |
| | 510(k) Number | K200242 |
| | Clearance Date | July 27, 2020 |
| | 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 |
| Mechanism of<br>Action | Manual operation | |

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Image /page/5/Picture/0 description: The image shows the logo for Congruence Medical Solutions, LLC. The logo features a stylized triangle above the company name. The triangle is divided into two sections, one dark blue and one light blue, with an orange circle in the center. The text "CONGRUENCE" is in a dark blue sans-serif font, and "MEDICAL SOLUTIONS, LLC" is in a smaller font below it.

| Technological<br>Characteristics | The technological characteristics of the subject device are substantially equivalent to the<br>predicate device with only minor differences observed in the device materials, syringe volume,<br>connector type, biocompatibility tests completed, and performance testing completed.<br>Biocompatibility testing and other non-clinical testing demonstrate these differences do not<br>raise questions of safety and effectiveness when compared to the predicate device. Refer to Table<br>1 below for a comparison of<br>technological characteristics between the subject and predicate devices. | | | | |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | Table 1: Comparison of Technological Characteristics | | | | |
| | Characteristic | Subject Device<br>Microliter<br>Dosing Syringe | Predicate<br>Device<br>StaClear<br>Syringe<br>(K200242) | Associated<br>Standard,<br>Testing | Comment |
| | Device Name | Microliter Dosing<br>Syringe | StaClear<br>Syringe | - | - |
| | Applicant | Congruence<br>Medical<br>Solutions, LLC | TriboFilm<br>Research, Inc. | - | - |
| | 510(k)<br>Number | K243149 | K200242 | - | - |
| | Intended Use | The Microliter<br>Dosing Syringe is<br>intended to inject<br>fluid into, or<br>withdraw fluid<br>from the body. | The StaClear<br>Syringe is<br>intended to<br>inject fluids<br>into, or<br>withdraw<br>fluids from,<br>the body. | Performance<br>and<br>Biocompatibility<br>testing results<br>provided herein<br>support the<br>safety and<br>effectiveness of<br>the device as<br>compared to the<br>predicate. | Identical |
| | Indications for<br>Use | The Microliter<br>Dosing Syringe is<br>indicated for<br>intravitreal use. | The StaClear<br>Syringe is<br>indicated for<br>intravitreal<br>use. | ISO 10993-23,<br>Intravitreal<br>Injection<br>Irritation<br>Testing, USP<br><788>, USP<br><789> | Identical |
| | Mechanism of<br>Action | Manual | Manual | ISO 7886-1 | Identical |
| | Sterilization<br>Information | Provided Sterile,<br>single-use<br>Sterilization<br>Method: Electron-<br>beam irradiation | Provided<br>Sterile, single-<br>use<br>Sterilization<br>Method:<br>Ethylene<br>Oxide | ISO 11137-1,<br>ISO 11137-2,<br>ISO 11737-1,<br>ISO 11737-2,<br>TIR13004 | Different |
| | Sterility<br>Assurance<br>Level (SAL) | 10-6 | 10-6 | ISO 11137-1,<br>ISO 11137-2,<br>ISO 11737-1,<br>ISO 11737-2,<br>TIR13004 | Identical |
| Shelf Life | 2 years | 1 year | ASTM F1980-21, ISO 7886-1, USP <71> | Different | |
| Device Materials | Barrel - Cyclic olefin polymer<br>Plunger Rod subassembly – Polycarbonate with glass fiber, Polyethylene terephthalate with glass fiber, stainless steel<br>Plunger stopper – chlorinated butyl rubber with fluoropolymer coating<br>Tip Cap – Chlorobutyl rubber with fluoropolymer coating | Barrel - Polypropylene<br>Plunger - Polyethylene<br>Plunger Stopper - Polyisoprene (Nipol IR2200, Zeon Chemicals)<br>Needle – ASTM 304 Stainless Steel<br>Needle Shield - Polyethylene<br>Plunger Cap - Polyethylene<br>Barrel Lubricant - Silicone Oil, crosslinked with inert argon gas plasma | ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-23, ASTM F756 | Different | |
| Syringe Volume | 0.35mL | 0.25mL | ISO 7886-1 | Different | |
| Target Dose Volume | $\pm$ 3µL (95% Confidence Level for all models) | Unknown | ISO 7886-1 | Different | |
| Connector Type | Luer lock | Pre-attached needle | ISO 7886-1, ISO 80369-7 | Different | |
| Cytotoxicity | No evidence of causing cell lysis or toxicity | No evidence of causing cell lysis or toxicity | ISO 10993-5 | Identical | |
| Sensitization | No skin sensitization | No skin sensitization | ISO 10993-10 | Identical | |
| Irritation or Intracutaneous Reactivity | Intracutaneous Reactivity: No intracutaneous reactivity | Intracutaneous Reactivity: No intracutaneous reactivity | ISO 10993-23 | Identical | |
| | Irritation, Ocular: Not considered irritants to the ocular tissue | Irritation, Ocular: Not considered irritants to the ocular tissue | ISO 10993-23, Annex D | Identical | |
| | Irritation, Intravitreal Injection: Not considered cause intravitreal irritation | Irritation, Intravitreal Injection: Not considered cause intravitreal irritation | Intravitreal Injection<br>Irritation testing | Identical | |
| Acute<br>Systemic<br>Toxicity | No evidence of<br>system toxicity | No evidence<br>of system<br>toxicity | ISO 10993-11 | Identical | |
| Pyrogenicity | Not pyrogenic | Not pyrogenic | ISO 10993-11 | Identical | |
| Hemolysis | Not hemolytic | Not hemolytic | ASTM F756,<br>ISO 10993-4 | Identical | |
| Particulate<br>Testing | Conforms to USP<br><788> and USP<br><789><br>requirements | Conforms to<br>USP <788><br>and USP<br><789><br>requirements | USP <788>,<br>USP <789> | Identical | |
| Endotoxin<br>Testing | ≤ 0.2 EU/device<br>or ≤ 0.2 EU/mL | Unknown.<br>The K200242<br>510(k)<br>Summary did<br>not contain<br>information<br>about<br>endotoxin<br>testing | USP <85> | No data<br>available for<br>predicate | |

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Image /page/6/Picture/0 description: The image shows the logo for Congruence Medical Solutions, LLC. The logo features a stylized triangle shape at the top, with the left side in dark blue and the right side in light blue. There is a small orange circle in the center of the triangle. Below the triangle is the word "CONGRUENCE" in a dark blue sans-serif font, and below that is the text "MEDICAL SOLUTIONS, LLC" in a smaller font.

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Image /page/7/Picture/0 description: The image shows the logo for Congruence Medical Solutions, LLC. The logo features a stylized triangle divided into two sections, one dark blue and one light blue, with a small orange circle in the center. Below the triangle is the word "CONGRUENCE" in dark blue, and below that is the text "MEDICAL SOLUTIONS, LLC" in a smaller font.

Substantial Equivalence Discussion:

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

- The intended use is equivalent to the predicate device.
- The technological characteristics of the subject device are substantially equivalent to the . predicate device with only minor differences; these minor differences do not introduce or increase safety risk.
- . Congruence completed performance testing according to the ISO 7886-1 standard and USP <789> for subvisible particulate testing. The Microliter Dosing Syringe met the applicable requirements of ISO 7886-1 and USP <789>. These standards were also used by the predicate device TriboFilm StaClear. In addition, endotoxin testing according to USP <85> was performed with the Microliter Dosing Syringe to establish conformance to the limits recommended for ophthalmic devices in FDA guidance. The Microliter Dosing Syringe test results demonstrate its performance characteristics are substantially equivalent to the predicate device. Refer to the Non-clinical Testing section below for a list of performance testing completed.
- . Biocompatibility testing was conducted in accordance with ISO 10993-1:2018 to demonstrate that the Microliter Dosing Syringe is as safe and effective as the legally marketed predicate device, and that any minor differences in technological characteristics do not raise questions of safety and effectiveness as compared to the predicate device (K200242). Refer to the Biocompatibility Testing section below for a list of the biocompatibility testing completed.
- . The differences between the predicate device (K200242) and the subject device for device volume, device materials, syringe volume and shelf-life do not introduce new or different questions of safety and effectiveness when compared to the predicate device based on successful completion of biocompatibility testing, non-clinical testing and performance testing conducted to support substantial equivalence.
- Adequate performance testing has been completed to support that the differences in connector types do not raise new or different questions of safety and effectiveness between the subject device and the predicate device. Substantial equivalence is also claimed despite difference in sterilization method (electron beam irradiation for Microliter Dosing Syringe compared to ethylene oxide sterilization for predicate device (K200242)), based on having an identical Sterility Assurance Level (SAL) of 10-6 and based on successful completion of biocompatibility testing, non-clinical testing and performance testing conducted with devices treated with electron beam irradiation.

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Image /page/8/Picture/0 description: The image is a logo for Congruence Medical Solutions, LLC. The logo features a stylized triangle shape at the top, with the left side in a dark blue color and the right side in a lighter blue color. There is a small orange circle in the center of the triangle. Below the triangle is the word "CONGRUENCE" in a dark blue sans-serif font, and below that is the text "MEDICAL SOLUTIONS, LLC" in a smaller font.

| Non-clinical testing | Bench testing was performed to demonstrate the subject device is as safe and effective as the<br>predicate device. The following tests were completed: |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | ISO 7886-1 Cleanliness Acidity and Alkalinity Extractable Metals Tolerance on Graduations Dead Space Air and Liquid Leakage Past Plunger Plunger Force Fit of Stopper Particulate Testing: USP <788> Particulate Matter in Injections USP <789> Particulate Matter in Ophthalmic Solutions Endotoxin Testing: USP <85> Bacterial Endotoxins Test |
| Non-clinical Testing<br>(Biocompatibility) | A chemical characterization of the device was done to evaluate the subacute/subchronic and<br>genotoxicity endpoints. The toxicological risk assessment demonstrated an acceptable level of<br>risk of systemic exposure to the extractable compounds when classifying the Microliter Dosing<br>Syringe as externally communicating device with prolonged contact (>24 hours to 30 days) with<br>patient tissue contact through the injectable fluid.<br>The following biological safety tests were also completed: 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 or toxicity, was not considered<br>a sensitizer, was not considered an irritant to the ocular tissue of the rabbit, was not considered<br>inflammatory to intraocular tissues of the rabbit, did not show evidence of erythema and edema,<br>did not show evidence of mortality or systemic toxicity, was not considered pyrogenic, and was<br>not considered hemolytic. Therefore, this biological safety testing demonstrates the subject<br>device is biocompatible for its intended use. |
| Clinical Testing | Not applicable - "N/A" |
| Conclusion | In conclusion, the Microliter Dosing Syringe is biocompatible for its intended use, demonstrates<br>equivalent performance as the predicate device, and conforms to limits for endotoxins in single-<br>use ophthalmic devices recommended in FDA guidance. |
| | The suitability of the device for intravitreal injection was evaluated through biocompatibility,<br>intravitreal injection irritation testing, particulate and endotoxin testing. |
| | Test results confirm that the differences between the predicate and the subject device do not raise<br>new questions of safety or effectiveness, supporting conclusion of substantial equivalence. |
| | The Microliter Dosing Syringe is substantially equivalent to the predicate device - StaClear<br>Syringe (K200242) with respect to the intended use, target populations, treatment method, and<br>technological characteristics. |