Excelsior Medical Corporation's 0.9% Sodium Chloride Injection. USP prefilled syringe products are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The saline solution is delivered through the luer lock of a venous access device to maintain catheter patency via hydraulic displacement. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling. total parenteral nutrition, or hemodialysis.

0.9% Sodium Chloride Injection, USP, prefilled syringes are available as follows:

2.5 mL in 3 mL Syringe
3 mL in 10 mL Syringe
5 mL in 10 mL Syringe
10 mL in 10 mL Syringe
The product is intended for use with commercially available valves and catheters fitted with a standard mating luer lock or luer taper.

AI/ML Overview

The provided text does not describe an acceptance criteria or a study proving that a device meets the acceptance criteria for a medical device that utilizes artificial intelligence (AI). The document is a 510(k) premarket notification for a 0.9% Sodium Chloride Injection, USP (a saline vascular access flush). This is a physical, sterile medical product, not an AI-driven device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI device cannot be extracted from this document.

The document discusses non-clinical testing performed for the saline solution and prefilled syringes, which includes:

Raw material qualification
Stability Studies
Sterilization validation
Extractables/Leachables

These tests are standard for a sterile drug product/device combination and are not related to AI performance. Biocompatibility testing was deemed not required because the products were considered the same as predicate devices, except for the source of the sodium chloride raw material.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

December 12, 2014

Excelsior Medical Corporation Mr. John Linfante Vice President RA/QA 1933 Heck Avenue Neptune, NJ 07753

Re: K142620

Trade/Device Name: 0.9% Sodium Chloride Injection, USP Regulation Number: 21 CFR 880.5200 Regulation Name: Saline, Vascular Access Flush Regulatory Class: II Product Code: NGT Dated: September 15, 2014 Received: September 16, 2014

Dear Mr. Linfante

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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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) K142620

Device Name

0.9% Sodium Chloride Injection, USP

(2.5 mL in 3 mL Syringe, 3 mL in 10 mL Syringe, 5 mL in 10 mL Syringe, 10 mL in 10 mL Syringe)

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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Manufacturer Name:	Excelsior Medical Corporation
Address:	1933 Heck AvenueNeptune, NJ 07753
Contact Name:	John Linfante
Title:	Vice President RA/QA
Phone Number:	732-643-6088
Fax Number:	732-776-7600
Date Prepared:	September 15, 2014

510(k) Summary

Device Proprietary Name:	0.9% Sodium Chloride Injection, USP
Device Common or Usual Name:	Saline, Vascular Access Flush
Classification Name:	Saline, Vascular Access Flush
Classification Code:	NGT
Regulation Number:	21 CFR Part 880.5200
Device Classification	II

Predicate Devices:

Substantial equivalence is claimed to the following devices as related to intended use, design, and material characteristics:

Excelsior Disposable Syringe W/Normal Saline (0.9% Sodium Chloride), Excelsior ● Medical Corp., K962938
. Sterile Field Saline Flush Syringe(s), Excelsior Medical Corporation, K082837

Description of the Device

0.9% Sodium Chloride Injection, USP, prefilled syringes are available as follows:

2.5 mL in 3 mL Syringe
3 mL in 10 mL Syringe ●
5 mL in 10 mL Syringe ●

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10 mL in 10 mL Syringe ●
The product is intended for use with commercially available valves and catheters fitted with a standard mating luer lock or luer taper.

Intended Use/Indications for Use

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

Technological Characteristics

The 0.9% Sodium Chloride Injection, USP syringes subject to this filing were previously cleared by FDA under K962938. The use of alternate syringes, application of syringe labels on nonprinted barrels, and sterilization via steam were cleared under K082837 for Excelsion's Sterile Field Flush saline syringes.

A comparison of the products is provided in the table below.

Intended use	Saline Flush Syringe(Subject Device)	Sterile Field SalineFlush Syringe(s)K082837	Excelsior DisposableSyringe W/ NormalSalineK962938
	Flushing of IVcatheters and IVtubing only	Flushing IV cathetersand IV tubing	Flushing IV cathetersand IV tubing
Components	• Barrel – Medicalgrade polypropyleneand silicone lubricant• Plunger - Medicalgrade polypropylene• Piston - Latex freeisoprene rubber• Tip Cap – Medicalgrade polypropyleneand TPE pluscolorant	• Barrel – Medicalgrade polypropyleneand silicone lubricant• Plunger - Medicalgrade polypropylene• Piston - Latex freeisoprene rubber• Tip Cap – Medicalgrade polypropyleneand TPE pluscolorant	• Barrel – Medicalgrade polypropyleneand silicone lubricant• Plunger - Medicalgrade polypropylene• Piston - Latex freeisoprene rubber• Tip Cap – Medicalgrade polypropyleneand TPE pluscolorant
Solution	0.9% Sodium ChlorideInjection, USP	0.9% Sodium ChlorideInjection, USP	0.9% Sodium ChlorideInjection, USP
Max. Filllevel	10 mL	10 mL	10 mL
Sterility	Terminally sterilized bysteam 10-6 SAI	Terminally sterilized bysteam 10-6 SAL	Terminally sterilized bygamma

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Shelf Life	Intended 2 years	2 years	2 years
SyringeBarrel	Not printedSyringe Label contains:• Graduation marks• Lot Number• Expiry Date	Not printedSyringe Label contains:• Graduation marks• Lot Number• Expiry Date	Pre-printed syringe barrel

There are no differences between the subject and predicate device with respect to intended use or technology. The subject device is the exact same device as the predicate device cleared under K962938 with the following exceptions:

Introduction of alternate sources of syringes ●
Introduction of alternate source of saline
Gradation markings applied via label
Sterilization method is steam ●

These differences are addressed via material qualification, process validation, and finished product release testing. In addition, Excelsior Medical has undertaken performance testing to support that the use of an alternate source of saline does not alter the safety and effectiveness of the product.

Non-Clinical Testing

The following studies have been performed or are being relied upon to support the safety and effectiveness of the product:

Raw material qualification
Stability Studies ●
Sterilization validation
Extractables/Leachables

Biocompatibility testing on the subject device is not required as the products are exactly the same as the predicate devices with the exception of the source of the sodium chloride raw material.

Conclusion

Based on the analysis presented above and the results of the performance testing, the subject device is as safe and effective as the predicate device. No new or different questions of safety and effectiveness than the predicate device are raised by the changes.

Therefore, it is concluded that the product is substantially equivalent to the identified predicate devices.

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).