MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY

K121262 · Medefil, Inc. · NGT · Sep 20, 2012 · General Hospital

Device Facts

• Record ID: K121262
• Device Name: MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
• Applicant: Medefil, Inc.
• Product Code: NGT · General Hospital
• Decision Date: Sep 20, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

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

Device Story

The MEDEFLUSH™ Normal Saline I.V. Flush Syringe is a pre-filled, sterile, single-use syringe containing 0.9% Sodium Chloride solution. It is designed for use in a sterile field to maintain the patency of in-dwelling intravenous vascular access devices (IVAD). The device consists of a syringe barrel filled with saline, sealed with a tip cap and plunger stopper. The primary modification from the predicate is the manufacturing process, which involves terminal sterilization of the fully assembled and pouched syringe, allowing for sterile field readiness. It is intended for use by healthcare professionals in clinical settings. The device provides a convenient, ready-to-use method for flushing IV lines, helping to prevent occlusion and maintain access for patient treatment.

Clinical Evidence

No clinical data. Bench testing only, including LAL testing for bacterial endotoxin to ensure the device is pyrogen-free.

Technological Characteristics

Pre-filled syringe containing 0.9% Sodium Chloride (USP). Components include syringe barrel, plunger stopper, and tip cap. Sterilization method: terminal steam sterilization of the pouched, fully assembled device. Packaging: steam-sterilizable paper pouch. Connectivity: None. Software: None.

Indications for Use

Indicated for maintaining the patency of in-dwelling intravenous vascular access devices (IVAD) in patients requiring intravenous therapy.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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

2. 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

7. 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).

9. 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 [phone] or [phone] 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: __