0.9% Sodium Chloride Injection, USP

K173348 · Medline Industries, Inc. · NGT · Jun 21, 2018 · General Hospital

Device Facts

• Record ID: K173348
• Device Name: 0.9% Sodium Chloride Injection, USP
• Applicant: Medline Industries, Inc.
• Product Code: NGT · General Hospital
• Decision Date: Jun 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.

Device Story

0.9% Sodium Chloride Injection, USP prefilled syringes; used for flushing IV catheters and IV tubing. Device consists of sterile saline solution in a prefilled syringe format. Used in clinical settings by healthcare professionals to maintain catheter patency. Simple mechanical delivery; no electronic components or software.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

0.9% Sodium Chloride solution, USP. Prefilled syringe form factor. Sterile, non-pyrogenic. No electronic components, software, or energy source.

Indications for Use

Indicated for flushing of IV catheters and IV tubing. Prescription use only.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue and white.

Medline Industries, Inc. Matt Clausen Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093

Re: K173348

Trade/Device Name: 0.9% Sodium Chloride Injection, USP Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: May 24, 2018 Received: May 29, 2018

Dear Matt Clausen:

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.

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K173348

#### Device Name 0.9% Sodium Chloride Injection, USP

Indications for Use (Describe)

0.9% Sodium Chloride Injection, USP prefilled syringes are intended for flushing of IV catheters and IV tubing only.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

scription 333 (Part 21, ST11-001 Subpart B)

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

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