The DEVICE, the subject of this 510(k), Normal Saline I. V. Flush Syringes (0.9% Sodium Chloride Injection, USP) will be terminally sterilized as compared to its predicate device which was aseptically filled. The DEVICE will be marketed in various sizes and fill volumes similar to its predicate device.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "MEDEFIL'S NORMAL SALINE I. V. FLUSH SYRINGE". It focuses on establishing substantial equivalence to a predicate device, primarily due to a change in the sterilization process and polypropylene material.

Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a diagnostic AI device would. This is not a study or performance report for an AI device.

Instead, it's a regulatory submission demonstrating that the modified device (now terminally sterilized) is as safe and effective as its previously cleared version, which was aseptically filled. The "performance standard" mentioned refers to general regulatory standards, not specific performance metrics for an AI algorithm.

To directly answer your request based on the type of document provided, which is a 510(k) summary for a physical medical device (flush syringe), not an AI diagnostic tool:

Since the provided document is a 510(k) summary for a physical medical device (Normal Saline I.V. Flush Syringe) and not an AI diagnostic device, the requested information about acceptance criteria, study details, and AI-specific metrics (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or present in this document.

The document states:

"No performance standard(s) applicable to this device has been promulgated under Section 514 of the Food, Drug, and Cosmetic Act."
The device "shall be pyrogen free per the LAL test method for bacterial endotoxin." This is a quality control test, not a performance study in the context of diagnostic accuracy.

The submission aims to demonstrate "substantial equivalence" of the new manufacturing process and material to the previously cleared predicate device (Medefil, Inc. Normal Saline I. V. Flush Syringe K020999), not to prove performance against specific diagnostic accuracy criteria through a study.

Therefore, the specific elements you've asked for (such as a table of acceptance criteria vs. device performance, sample sizes for test/training sets, details on expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not included within this type of regulatory submission for this particular device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for MEDEFIL, INC. The logo consists of the company name in bold, uppercase letters, with a thick black line above the name. Below the name is a stylized lowercase "m" inside of a circle, with a small dot above the "m". There is also a handwritten number "K091583" at the top of the image.

JAN 2 8 2010

"Continuous improvement today for the challenges of tomorrow

510(k) Summary

MEDEFIL'S NORMAL SALINE I. V. FLUSH SYRINGE

JANUARY 27, 2010

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

Reason for 510(k): Introduction of a terminally sterilized product
Name of Device:

Classification Name Common Name Proprietary Name

Catheter Intravascular, Small Volume 0.9% Sodium Chloride Injection, USP. Medefil's Normal Saline I. V. Flush Svringe

1. Classification:
  Name/Class Panel Product Code 21 CFR 880.5200 Class II General Hospital NGT
1. Establishment Registration Number:

Submitter's Name and Address: 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.

1423982

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Image /page/1/Picture/0 description: The image shows the logo for MEDEFIL, INC. The logo features the company name in bold, uppercase letters above a stylized lowercase "m" inside a circle. There is a black bar above the company name.

"Continuous improvement today for the challenges of tomorrow

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1. Device Description and Indicated Use:
  The DEVICE, the subject of this 510(k), Normal Saline I. V. Flush Syringes (0.9% Sodium Chloride Injection, USP) will be terminally sterilized as compared to its predicate device which was aseptically filled. The DEVICE will be marketed in various sizes and fill volumes similar to its predicate device.

Same intended use as the Predicate Device

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

1. Packaging:

Same packaging as the Predicate Device

The DEVICE provided is individually packaged in a plastic pouch (dust cover).

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

1. Substantial Equivalence:
  The Normal Saline Flush Syringe DEVICE is substantially equivalent to the legally marketed predicate device listed below:

Medefil, Inc. Normal Saline I. V. Flush Syringe (K020999)

The proposed modification involves change in the polypropylene and sterilization process.

END OF SUMMARY

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 that resembles a person embracing or supporting another, with flowing lines suggesting movement or support.

Public Health Service

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

JAN 2 8 2910

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

Re: K091583 Trade/Device Name: Normal Saline I.V. Flush Syringe Regulation Number: 21CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT 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.

Th for

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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Indications for Use

510(k) Number (if known): K091583

Device Name:

NORMAL SALINE I. V. FLUSH SYRINGE

Model Number	Concentration	Fill Volume
MIS-1121	9 mg/mL	1 mL fill in 6 mL Syringe
MIS-1122	9 mg/mL	2 mL fill in 6 mL Syringe
MIS-1152	9 mg/mL	2.5 mL fill in 6 mL Syringe
MIS-1123	9 mg/mL	3 mL fill in 6 mL Syringe .
MIS-1125	9 mg/mL	5 mL fill in 6 mL Syringe
MIS-1133	9 mg/mL	3 mL fill in 12 mL Syringe
MIS-1135	9 mg/mL	5 mL fill in 12 mL Syringe
MIS-1130	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)

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

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

15 X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elaine S. Mushaul fu EFC

(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).