The Heparin I. V. Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic prefilled syringe. The DEVICE consists of a hypodermic syringe barrel, stopper plunger, plunger rod, luer lock (LL) tip cap and Heparin Lock Flush Solution, USP (1 Unit/mL or 10 Units/mL or 100 Units/mL in 0.9% Sodium Chloride), which meets the requirements set forth in the current USP Heparin Lock Flush Solution monograph. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in packaging. The hypodermic syringe is transparent. The barrel of the reservoir for the product and will be overfilled during manufacturing process. The plunger and plunger rod are the only two moving parts of the device. The flush solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip. The DEVICE will be filled using fully automated syringe filling machine utilizing non - sterile components. The components of the DEVICE (hypodermic syringe, tip cap and (Heparin Lock Flush Solution, USP) will be sterilized using steam in a terminal sterilizer after the syringe barrel is filled with Heparin Lock Flush Solution and sealed with Tip Cap and Plunger Stopper.

AI/ML Overview

The acceptance criteria and study information for Medefil's Heparin I.V. Flush Syringe are described below, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Reported Device Performance
Physical Integrity	Dimensional Requirements (Engineering Drawings)	The DEVICE meets the requirements set forth in the engineering drawings.
	Mechanical Performance	The DEVICE performed comparably to the substantially equivalent predicate device, not affecting safety or effectiveness.
	Seal Integrity (Dye Ingress Test)	Tested on terminally sterilized syringes (filled, sealed, steam sterilized). Specific results (e.g., pass/fail rates) are not provided, but the statement implies successful integrity.
	Seal Integrity (Microbial Ingress Test)	Performed by filling with Tryptic Soy Broth and using a vacuum method. Specific results are not provided, but the statement implies successful integrity.
Biocompatibility	Biological Reactivity (In Vitro and In Vivo)	The polypropylene used in the DEVICE was found to meet the requirements of a USP Class VI plastic.
	Cytotoxicity	Polypropylene and tip caps are not cytotoxic in nature.
Sterility	Pyrogenicity (LAL Test Method for Bacterial Endotoxin)	The DEVICE shall be pyrogen free. (Implied performance is that it meets this, as it supports the claim of increased sterility assurance with terminal sterilization).
Chemical Stability & Compatibility	Compatibility with Heparin Lock Flush Solution (USP Monograph)	Stability testing was performed on Heparin I.V. Flush Syringes after terminal sterilization, at accelerated and real-time temperatures. This demonstrated that the new syringe material and sterilization process are compatible with the USP Heparin Lock Flush Solution.
Clinical Safety	Hemolysis (for 100 Units/mL concentration)	Did not result in any hemolysis, as measured by quantitating free hemoglobin in plasma and LDH levels.
	Osmolality	No change in osmolality.
	Dilution of Heparin in Whole Blood Impact	The study showed that dilution of heparin in whole blood did not result in any measurable changes in various markers of hemolysis.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes used for each test. However, it indicates:

Test Sets: "The syringes tested were filled with product, sealed, steam sterilized... for dye leak testing. The microbial ingress testing was performed by filling with Tryptic Soy Broth..." and "The polypropylene was tested for Biological Reactivity Tests In Vitro and In Vivo." Also, "The stability testing was performed on Heparin I. V. Flush Syringes..." and "Heparin I. V. Flush Syringe, 100 Units/mL did not result in any hemloysis..."
Data Provenance: The studies were conducted by Medefil, Inc. and appear to be prospective in nature, as they involve testing of the device for its performance and safety characteristics. The document does not specify a country of origin for the data, but Medefil, Inc. is located in Glendale Heights, Illinois, USA, suggesting a domestic provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device submission. The tests performed are laboratory-based and analytical (physical, mechanical, chemical, biological reactivity, sterility, stability, clinical safety markers), not involving subjective interpretation by human experts to establish "ground truth" in the way a diagnostic imaging device might.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are analytical and objective, not requiring adjudication of human interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance, to assess the AI's impact on reader performance. This device is a pre-filled syringe (a medical device), not a diagnostic imaging AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, the studies performed for this device can be considered standalone performance assessments of the device itself (the pre-filled syringe) in meeting its design specifications and safety requirements. The device itself is not an algorithm, so "without human-in-the-loop performance" here means evaluating the physical, chemical, and biological properties of the syringe system.

7. Type of Ground Truth Used

The "ground truth" for the various tests was established by:

Engineering Drawings: For dimensional criteria.
Predicate Device Performance: For mechanical comparability.
Established Test Methods and Standards:
- Dye ingress test and microbial ingress test: For seal integrity.
- USP Class VI plastic requirements: For biocompatibility of polypropylene.
- LAL test method: For pyrogenicity.
- USP monograph Heparin Lock Flush Solution: For chemical stability and compatibility.
- Quantitation of free hemoglobin, LDH levels, and osmolality measurement: For clinical safety (hemolysis).

These are objective, quantifiable measures against predefined standards or comparators.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical device (pre-filled syringe), not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above; there is no "training set" for this type of device.

Summary

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FEB - 3 2010

Image /page/0/Picture/1 description: The image shows the logo for MEDEFIL, INC. Above the company name is a series of numbers, 100924491. Below the company name is a circular logo with a stylized lowercase "m" inside.

"Continuous improvement today for the challenges of tomorrow'

510(k) SUMMARY

MEDEFIL'S HEPARIN I. V. FLUSH SYRINGE

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

1. Reason for 510(k):	Introduction of a terminally sterilized product
2. Name of Device:
Classification Name	Catheter Intravascular, Small Volume
Common Name	Heparin I. V. Flush Syringe, USP.
Proprietary Name	Medefil's Heparin I. V. Flush Syringe 1 Unit/mL or 10 Units/mL or 100 Units/mL
3. Classification:
Name/Class	21 CFR 880.5200
Panel	Intravascular, Short Term / Class II General Hospital
Product Code	NZW
4. Date Summary was prepared:	February 1, 2010
5. Establishment Registration Number:	1423982
6. Submitter's Name and Address:	Medefil, Inc. 250 Windy Point Drive, Glendale Heights, Illinois 60139
7. Contact Person and telephone number:	Pradeep Aggarwal
Telephone:	(630) 682 - 4600
8. Manufacturing and sterilization facilities:	Medefil, Inc. 250 Windy Point Drive Glendale Heights, Illinois 60139

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Image /page/1/Picture/0 description: The image shows the logo for MEDEFIL, INC. The text "MEDEFIL, INC." is written in a bold, sans-serif font. Below the text is a circular logo with a stylized letter "m" inside. The logo has a textured, slightly distressed appearance.

"Continuous improvement today for the challenges of tomorrow'

Substantial Equivalence: 9.

The intended use and principal technological characteristics of the DEVICE are substantially equivalent to the legally marketed predicate device listed below:

Medefil, Inc. Heparin I. V. Flush Syringe (K020996)

10. Device Description:

ﺮ

1 mL fill in 6 mL Syringe LL 2 mL fill in 6 mL Syringe LL 2.5 ml fill in 6 ml Syringe LL 3 mL fill in 6 mL Syringe LL 3 mL fill in 12 mL Syringe LL 5 mL fill in 6 mL Syringe LL 5 mL fill in 12 mL Syringe LL 10 mL fill in 12 mL Syringe LL

The hypodermic syringe is transparent. The barrel of the reservoir for the product and will be overfilled during manufacturing process. The plunger and plunger rod are the only two moving parts of the device. The flush solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip.

The DEVICE will be filled using fully automated syringe filling machine utilizing non - sterile components. The components of the DEVICE (hypodermic syringe, tip cap and (Heparin Lock Flush Solution, USP) will be sterilized using steam in a terminal sterilizer after the syringe barrel is filled with Heparin Lock Flush Solution and sealed with Tip Cap and Plunger Stopper.

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Image /page/2/Picture/0 description: The image shows the logo for MEDEFIL, INC. The text "MEDEFIL, INC." is in bold, uppercase letters. Below the text is a circular logo with a stylized letter "m" inside. The letter "m" is also in bold and has a small circle above it.

"Continuous improvement today for " challenges of tomorrow

11. Intended Use:

Same Intended Use as the Predicate Device.

For use to maintain the patency of in-dwelling intravenous vascular access device (IVAD).

1. Packaging:
  The DEVICE provided is individually packaged in a plastic pouch (dust cover). There are thirty (30), sixty (60) or one hundred twenty (120) individually packaged DEVICES in a dispensing box. Nine hundred sixty syringes (thirty two boxes of 30's, or sixteen boxes of 60's or eight boxes of 120's) individually packed devices will be packed in a card board master carton.

The DEVICE shall be pyrogen free per the LAL test method for bacterial endotoxin.

1. Technological Characters:
  The Medefil's Heparin I. V. Flush Syringe Device is similar to the legally marketed predicate device except the differences are:
The DEVICE will be manufactured using terminal sterilization process using steam where as the a) predicate device was manufactured using aseptic technique. The DEVICE will be filled and sealed in syringe barrels and then it will be subjected to steam sterilization where as for the predicate device sterile solution was filled in pre sterilized syringe barrels and this leads to increased sterility assurance
moreased blommy assulanter, the polypropylene used in the DEVICE was changed to one b) which will be able to withstand steam sterilization where as the polypropylene used in the predicate device was only able to withstand Gamma Radiation.
Performance Data: 14.

Three types of tests - physical (dimensional), mechanical, and compatibility tests - were conducted. The dimensional and mechanical tests were conducted to demonstrate that the DEVICE meets the requirements set forth in the engineering drawings and that it performed comparably to the substantially equivalent device, thereby not affecting safety or effectiveness. These tests are done to assure the integrity of the container closure system. The terminally sterilized Heparin I. V. Flush Syringes were put through seal integrity tests (dye ingress test and microbial ingress test). The syringes tested were filled with product, sealed, steam sterilized using steam - air mixture (SAM) process, inspected, labeled and packaged for dye leak testing. The microbial ingress testing was performed by filling with Tryptic Soy Broth and tested for microbial ingress using vacuum method.

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Image /page/3/Picture/0 description: The image shows the logo for MEDEFIL, INC. The text is in a bold, sans-serif font. Below the text is a circular graphic with a stylized lowercase "m" inside. There is a small circle above the "m".

"Continuous improvement today for the challenges of tomorrow"

The polypropylene resin as well as various color tip caps in the DEVICE is intended for components destined for subsequent steam sterilization. The polypropylene was tested for Biological Reactivity Tests In Vitro and In Vivo. The polypropylene was found to meet the requirements of a USP Class VI plastic. Similarly polypropylene and tip caps are also not cytotoxic in nature.

The stability testing was performed on Heparin I. V. Flush Syringes after terminal sterilization, per USP monograph Heparin Lock Flush Solution, both at accelerated temperature and real time temperature to demonstrate that the new syringe material and the sterilization process is compatible with the USP Heparin Lock Flush Solution thereby supporting the claim that the change in fluid container material does not raise new types of safety and effectiveness questions

Clinical Data: 15.
Heparin I. V. Flush Syringe, 100 Units/mL did not result in any hemloysis as measured by quantitating free hemoglobin in plasma and LDH levels. Also there was no change in osmolality. The study showed that dilution of heparin in whole blood did not result in any measurable changes in various markers of hemolysis.
1. Conclusion:
  The DEVICE is safe and effective. The new characteristic does not affect safety and effectiveness of the DEVICE and the DEVICE is substantially equivalent to its legally marketed predicate device. The changes (change in polypropylene and terminal sterilization) do not affect the safety or effectiveness because the systems and processes have been validated and verified to yield a product that fits its intended use. The terminal sterilization process has decreased any risk for contamination as the sterile processes are enhanced. Biocompatibility of polypropylene is not a concern because it has been tested and it meets the requirements of USP Class VI plastic. The tests also show that the DEVICE is safe and effective, the new characteristics DO NOT adversely affect the safety and effectiveness of the DEVICE, and the DEVICE is substantially equivalent to its legally marketed predicate device.
1. Certification:
  I certify that, in my capacity as President & CEO of Medefil, Inc., I believe to the best of my knowledge that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.

Sincerely
Medefil, Inc.

Pradeep Aggarwal
President & CEO

250 WINDY POINT DRIVE, GLENDALE HEIGHTS, ILLINOIS 60139 • TEL: (630) 682-4600 • FAX: (630) 681-9100

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, curved shapes that resemble human figures or waves. The symbol is positioned to the right of the text, creating a balanced and recognizable emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

FEB - 3 2010

Mr. Pradeep Aggarwal President and Chief Executive Officer Medefil, Incorporated 250 Windy Point Drive Glendale Heights, Illinois 60139

Re: K092491

Trade/Device Name: Heparin I.V. Flush Syringe Regulation Number: 21CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NZW Dated: January 25, 2010 Received: January 26, 2010

. Dear Mr. Aggarwal:

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. 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.

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.

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Page 2- Mr. Aggarwal

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

in foc

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

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Medefil, Inc. January, 2010 Sterile Heparin 1. V. Flush Syringe [DEVICE] Indication for Use Statement

Indications for Use

510(k) Number (if known): K092491

HEPARIN I. V. FLUSH SYRINGE Device Name:

Products in 0.9% Sodium Chloride

Model Number	Concentration	Fill Volume	Model Number	Concentration	Fill Volume
MIH-4421	1 Unit/mL	1 mL in 6 mL Syringe	MIH-4422	1 Unit/mL	2 mL in 6 mL Syringe
MIH-4452	1 Unit/mL	2.5 mL in 6 mL Syr.	MIH-4423	1 Unit/mL	3 mL in 6 mL Syringe
MIH-4425	1 Unit/mL	5 mL in 6 mL Syringe	MIH-4433	1 Unit/mL	3 mL in 12 mL Syr.
MIH-4435	1 Unit/mL	5 mL in 12 mL Syr.	MIH-4430	1 Unit/mL	10 mL in 12 mL Syr.
MIH-2221	10 Units/mL	1 mL in 6 mL Syringe	MIH-2222	10 Units/mL	2 mL in 6 mL Syringe
MIH-2252	10 Units/mL	2.5 mL in 6 mL Syr.	MIH-2223	10 Units/mL	3 mL in 6 mL Syringe
MIH-2225	10 Units/mL	5 mL in 6 mL Syringe	MIH-2233	10 Units/mL	3 mL in 12 mL Syr.
MIH-2235	10 Units/mL	5 mL in 12 mL Syr.	MIH-2230	10 Units/mL	10 mL in 12 mL Syr.
MIH-3321	100 Units/mL	1 mL in 6 mL Syringe	MIH-3322	100 Units/mL	2 mL in 6 mL Syringe
MIH-3352	100 Units/mL	2.5 mL in 6 mL Syr.	MIH-3323	100 Units/mL	3 mL in 6 mL Syringe
MIH-3325	100 Units/mL	5 mL in 6 mL Syringe	MIH-3333	100 Units/mL	3 mL in 12 mL Syr.
MIH-3335	100 Units/mL	5 mL in 12 mL Syr.	MIH-3330	100 Units/mL	10 mL in 12 mL Syr.

Indications For Use:

FOR USE TO MAINTAIN THE PATENCY OF IN-DWELLING INTRAVENOUS VASCULAR ACCESS DEVICES (IVAD)

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth F. Laurie-Wells

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).