The DEVICE, the subject of this 510 (k), MEDEFLUSH™ Normal Saline I. V. Flush Syringe - Sterile Field Ready (0.9% Sodium Chloride Flush Syringe, USP) will be sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, inspected, plunger rod inserted, labeled and then pouched in steam sterilizable paper pouch prior to terminally sterilization as compared to its predicate device which is sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, steam sterilized and then inspected, plunger rod inserted and labeled prior to packaging. The DEVICE will be marketed in various sizes and fill volumes similar to its predicate device.

AI/ML Overview

The provided text is a 510(k) summary for the MEDEFLUSH™ Normal Saline I. V. Flush Syringe - Sterile Field Ready. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria and performance data for the device itself in terms of clinical outcomes or diagnostic accuracy.

Therefore, many of the requested categories for device evaluation (such as sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, etc.) are not applicable to this type of regulatory submission, as it does not involve an AI/ML-based diagnostic or prognostic device requiring such studies.

The acceptance criteria for this type of device are primarily related to its physical and chemical properties, manufacturing processes, and sterility, ensuring it functions as intended and is safe for use. The "study" proving it meets acceptance criteria is primarily an equivalence comparison to a legally marketed predicate device, coupled with quality control measures for manufacturing and sterilization.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance/Comparison
Intended Use	Same intended use as the Predicate Device: To maintain patency of in-dwelling intravenous vascular access devices (IVAD).
Device Description	Similar to predicate: Sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, plunger rod inserted, labeled. Marketed in various sizes and fill volumes (1mL-10mL fill in 6mL or 12mL syringes).
Sterility	Terminal sterilization after packaging in a steam sterilizable paper pouch, compared to predicate's sterilization before packaging. This is the key modification to achieve "Sterile Field Ready" status. Implicitly, sterility must meet established standards, although the specific standard is not detailed beyond "steam sterilizable paper pouch."
Pyrogen-free	The device shall be pyrogen free per the LAL test method for bacterial endotoxin. (This is a performance requirement, implying the device must pass this test.)
Packaging	Same packaging as the Predicate Device, individually packaged in a steam sterilizable paper pouch. The modification directly relates to the packaging and sterilization sequence.
Substantial Equivalence to Predicate Device	The core "performance" is its demonstration of substantial equivalence to Medefil, Inc. Normal Saline I. V. Flush Syringe (K091583). The proposed modification is specifically articulated: "making Normal Saline I. V. Flush Syringe ready for usage in Sterile Field." This implies that all other aspects (material, safety, efficacy for intended use) are equivalent to the predicate.
Material/Composition (0.9% Sodium Chloride, USP)	Implicitly meets USP standards, as it states "0.9% Sodium Chloride Flush Syringe, USP."

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

This is not applicable for this type of 510(k) submission. There is no specific "test set" in the context of diagnostic performance or clinical trials. The submission relies on demonstrating substantial equivalence to a predicate device already on the market and adherence to manufacturing and sterility standards.

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

This is not applicable. Ground truth establishment by experts is relevant for diagnostic devices that interpret data (e.g., medical images). This product is a medical device for flushing IV lines.

4. Adjudication Method for the Test Set

This is not applicable.

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

This is not applicable. This device is not an AI/ML-based diagnostic tool.

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

This is not applicable.

7. The Type of Ground Truth Used

This is not applicable in the context of diagnostic accuracy. The "ground truth" for this device relates to:

Established physical/chemical properties: 0.9% Sodium Chloride solution meeting USP standards.
Sterility: Demonstrated through validated sterilization processes (e.g., steam sterilization cycle validation) and LAL testing for endotoxins.
Functional equivalence: Comparison to the predicate device for its ability to maintain patency of IVADs, implying that its design and basic function are proven.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable.

Summary

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Medefil, Inc April, 2012

MEDEFLUSH™ Normal Saline I. V. Flush Syringe - Sterile Field Ready [DEVICE] Attachment 7 - 510 (k) Summary

510(k) Summary

SEP 20 2012

MEDEFLUSH™ Normal Saline I. V. Flush Syringe – Sterile Field Ready April 12, 2012

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 Sterile Field Ready Normal Saline I. V. Flush Syringe

Catheter Intravascular, Small Volume

0.9% Sodium Chloride Flush Syringe

MEDEFLUSHTM Normal Saline I. V.

Flush Syringe - Sterile Field Ready

Name of Device:

Classification Name Common Name

Proprietary Name

Classification: 3.
Name/Class Panel Product Code

21 CFR 880.5200 Class II General Hospital NGT

Establishment Registration Number: 4.

Submitter's Name and Address: ನ .

1423982

USP.

Medefil, Inc. 250 Windy Point Drive Glendale Heights, Illinois 60139

Manufacturing and sterilization facilities: Medefil, Inc. 6. 250 Windy Point Drive Glendale Heights, Illinois 60139

Performance Standards:

No performance standard(s) applicable to this device has been promulgated under Section 514 of the Food, Drug, and Cosmetic Act.

Device Description and Indicated Use: 8.

The DEVICE, the subject of this 510 (k), MEDEFLUSH™ Normal Saline I. V. Flush Syringe - Sterile Field Ready (0.9% Sodium Chloride Flush Syringe, USP)

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will be sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, inspected, plunger rod inserted, labeled and then pouched in steam sterilizable paper pouch prior to terminally sterilization as compared to its predicate device which is sealed with tip cap, filled with 0.9% Sodium Chloride solution, sealed with plunger stopper, steam sterilized and then inspected, plunger rod inserted and labeled prior to packaging. The DEVICE will be marketed in various sizes and fill volumes similar to its predicate device.

Same intended use as the Predicate Device.

The DEVICE is used to maintain patency of in-dwelling intravenous vascular access devices (IVAD).

Packaging:

Same packaging as the Predicate Device

The DEVICE provided is individually packaged in a steam sterilizable paper pouch.

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

Substantial Equivalence: 10.

MEDEFLUSH™ Normal Saline I. V. Flush Syringe - Sterile Field Ready is substantially equivalent to the legally marketed predicate device listed below:

Medefil, Inc. Normal Saline I. V. Flush Syringe (K091583)

The proposed modification involves making Normal Saline I. V. Flush Syringe ready for usage in Sterile Field.

END OF SUMMARY

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wings.

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

Medefil, Incorporated C/O Mr. Pradeep Aggarwal President & CEO 250 Windy Point Drive Glendale Heights, Illinois 60139

SEP 20 2012

Re: K121262

Trade/Device Name: MEDEFLUSH™ Normal Saline I.V. Flush Syringe - Sterile Field Ready Regulation Number: 21 CFR 880.5200

Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: August 21, 2012 Received: August 22, 2012

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. 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.

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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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

For Dale Watkins

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

Enclosure

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Indications for Use

510(k) Number (if known):

MEDEFLUSH™ Normal Saline I. V. Flush Syringe - Sterile Field Ready Device Name:

Model Number	Concentration	Fill Volume
MIS-1171	9 mg/mL	1 mL fill in 6 mL Syringe
MIS-1172	9 mg/mL	2 mL fill in 6 mL Syringe
MIS-1177	9 mg/mL	2.5 mL fill in 6 mL Syringe
MIS-1173	9 mg/mL	3 mL fill in 6 mL Syringe
MIS-1175	9 mg/mL	5 mL fill in 6 mL Syringe
MIS-1183	9 mg/mL	3 mL fill in 12 mL Syringe
MIS-1185	9 mg/mL	5 mL fill in 12 mL Syringe
MIS-1180	9 mg/mL	10 mL fill in 12 mL Syringe

Indications For Use:

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

X Prescription Use (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)

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(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K 121262 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).