0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

Device Description

The new device, the subject of this 510(k), consists of a 20 mL, non-sterile plastic syringe filled with 20 mL of 0.9% Sodium Chloride Flush Solution USP that is terminally sterilized. The new devine is starle on the outside and has a sterile fluid path. The Sterility Assurance Level (SAL) is 10°. The syringe may be used on a sterile field if packaging is not damaged and aseptic technique is used. This is a ningle use device. The solution contains no preservatives, or antimicrobial agents. No plasticizers, additives, crosslink agents, reagents, colorants, inks, adhesives, surfactants, detergents, used during the manufacture of the syringes. The 20mL filled with 0.9% Sodium Chloride Flush Solution in a 20mL syringe is the only model which is subject to this 510(k). Other models previously cleared under 510K (K120836) consists of a non-sterile plastic 12 cc syringe filled with 3 mL, 5 mL, or 10 mL of 0.9% Sodium Chloride Flush Solution that is terminal sterilized.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "0.9% Sodium Chloride Flush Syringe". It's a submission to the FDA to demonstrate that the new device is substantially equivalent to a previously cleared predicate device.

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the way one might expect for a diagnostic or AI-driven device. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing various technical characteristics and outlining the types of tests performed.

However, based on the "Technological/Substantial Equivalence Comparison Table" (Page 5) and the accompanying text, we can infer some "acceptance criteria" through the lens of equivalence and the types of tests performed to ensure that equivalence is met.

Acceptance Criteria (Inferred from Equivalence and Testing)	Reported Device Performance (New Device)
Intended Use (Same as predicate)	"0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices." (Identical to predicate)
Design (Identical to predicate)	"New device has the same design as predicate."
Chemical Composition of Barrel (Same as predicate)	"Non-sterile Polypropylene PF-535 Resin" (Same as predicate)
Chemical Composition of Plunger (Same as predicate)	"Non-sterile Black Pharmaceutical Grade Rubber (Not made with Natural Rubber Latex)" (Same as predicate)
Chemical Composition Tip Cap (Same as predicate)	"Non-sterile Basell PF535 Polypropylene, Alpha Gray TPE G968B 4170" (Same as predicate)
Environment (Same as predicate)	"Positive Differential Controlled and Monitored" (Same as predicate)
Energy Source (Same as predicate)	"There is not an energy source. The device is operated mechanically." (Same as predicate)
Non-Pyrogenic (Same as predicate)	"Entire device is nonpyrogenic" (Same as predicate)
No Additives, Latex, or Preservatives (Same as predicate)	"No additives, natural rubber, or preservatives were used in the manufacture of the syringes." (Same as predicate)
Sterile Barrier Package (Same as predicate)	"Sterile barrier Pouch polypropylene film 3-6 mil" (Same as predicate)
Sterility Assurance Level (SAL) (Same as predicate: 10⁻⁶)	"10⁻⁶" (Same as predicate)
Sterility Labeling of Device (Same as predicate)	"Fluid path and outside of device are sterile." (Same as predicate)
Sterilization Method (Same as predicate: Gamma)	"Gamma" (Same as predicate)
Expiry Dating (Same as predicate: 2 years)	"2 years" (Same as predicate)
Filling Process (Same as predicate)	"The filling process occurs in a positive differential, monitored, and controlled environment. The solution is contained in a sterile closed system." (Same as predicate)
Bench and Stability Testing (Same tests as predicate, demonstrating equivalent performance)	"The same Bench and Stability tests were performed on the new device as the predicate device. Bench and Stability tests included: • Sterility • Pyrogen (LAL) analysis • pH • Water Loss • Iron • Heavy Metals • Sodium, Chloride • Particulate Matter" (Implied to have met predicate performance standards)

Key Differences and Specific Performance:

Size and Fill Volumes:
- Predicate: 3 mL/12 mL; 5 mL/12 mL, 10 mL/12 mL
- New Device: 20 mL/20 mL (This is the primary change in the new device, and verification testing was done to ensure equivalence despite this change).

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

This document is for a medical device (flush syringe), not a diagnostic algorithm or AI product. Therefore, the concepts of "test set," "training set," "data provenance," "country of origin," and "retrospective/prospective" studies as they apply to AI/software performance evaluation do not apply to this submission.

Instead,

The "test set" would be akin to the samples of the device itself that underwent various physical, chemical, and biological tests. The document doesn't specify the exact number of syringes tested for each benchmark, which is typical for a 510(k) summary (detailed test reports would be in the full submission, not the summary).
The "data provenance" is derived from the testing of the manufactured devices, following established quality control and testing protocols for medical devices.

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

Not applicable. This is not an AI/diagnostic device that relies on expert interpretation of data to establish ground truth. Device performance is measured against established scientific and engineering standards (e.g., sterility, pH, particulate matter).

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. This is not an AI/diagnostic device that relies on human adjudication of results.

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

Not applicable. This is a medical device (flush syringe), not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device (flush syringe), not an algorithm.

7. The Type of Ground Truth Used

For this medical device, the "ground truth" for its performance is established by:

Physical/Chemical Standards: Adherence to USP (United States Pharmacopeia) standards for sodium chloride solution, and specifications for materials (polypropylene, rubber, etc.).
Biological Standards: Sterility Assurance Level (SAL) of 10⁻⁶, non-pyrogenicity (LAL analysis).
Functional Standards: Performance during bench testing for water loss, particulate matter, etc., ensuring the syringe functions as intended.
Stability data: To confirm the product maintains its characteristics over its shelf life (2 years).

These are objective, measurable outcomes, not expert consensus or pathology reports.

8. The Sample Size for the Training Set

Not applicable as this is a medical device, not an AI/ML algorithm requiring a "training set."

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

Not applicable.

Summary

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Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.

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

August 13, 2014

AMUSA Mr. Alex Ferri VP/GM of Operations 5209 Linbar Dr. Suite 640 Nashville, TN 37211

Re: K133685

Trade/Device Name: 0.9% Sodium Chloride Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Device, Flush, Vascular Access Regulatory Class: II Product Code: NGT Dated: July 11, 2014 Received: July 15, 2014

Dear Mr. Ferri:

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. Ferri

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/Resourcesfor You/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mary S. Runner -
S

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

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Indications for Use

Indications for Use Statement

510(k) Number (if known): ¿ 33 685

Device Name: 0.9% Sodium Chloride Flush Syringe

Indications for Use:

"0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device".

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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20mL Sterile 510(K) Attachment_ Page Le of 68 AMUSA. Nashville, TN

510(k) Summary

Image /page/3/Picture/4 description: The image shows the logo for AMUSA, a manufacturing company that produces quality products for healthcare. The logo features a stylized American flag on the left, followed by the company name in bold, sans-serif font. The "A" in AMUSA is stylized with a star in the middle. Below the company name is the tagline "MANUFACTURING QUALITY PRODUCTS FOR HEALTHCARE" in a smaller font.

510(k) Summary

As required by 809.92(a) (2).

. . . . . . .

510 (k) PREMARKET NOTIFICATION NUMBER: K133685

Submitter and Owner of the 510(k)

AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: 615-833-2633 Fax: 615-425-2772

Official Correspondent

Alex Ferri VP/GM of Operations __________________________________________________________________________________________________________________________________________________________ AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: 615-833-2633 Fax: 615-425-2772

Date of Preparation: 5/15/14

510(k) Application Number

Trade/Proprietary Name

0.9% Sodium Chloride Flush Syringe Common Name/Usual Name Saline Flush Syringe Device Classification Name Device, Flush, Vascular Access Regulation Number 880.5200 Device Class Class II Device Classification Panel General Hospital Classification Product Code NGT

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20mL Sterile 510(k) Attachment AMUSA, Nashville,

THE PREDICATE DEVICE DESCRIPTION:

The Predicate Device, 510(k) Number: K120836 (AMUSA) consists of a non-sterile plastic 12 cc syringe filled with 3 mL, or 10 mL of 0.9% Sodium Chloride of a nor-selection that is terminally sterilized. The predicate device is sterile on the outside and has a sterile fluid path. The Sterility Assurance Level (SAL) is 10°. This is a single use device. The solution contains no preservatives, or antimicrobial agents. No plasticizers, additives, crosslink agents, reagents, or surfactants were used during the manufacture of the syringes. The syringe may be used on a sterile field if packaging is not damaged and aseptic technique is used.

Indications For Use:

Intended use: 0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Il se according to the recommendations of the manufacture for the appropriate device.

THE NEW DEVICE DESCRIPTION:

Indications For Use:

Intended use: 0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device.

TECHNILOGICAL/SUBSTANTIAL EQUIVALENCE SUMMARY: The technical

characteristics for the new device do not differ from those of the currently marketed device. These devices have the same design, the same fundamental scientific and chemical characteristics, the same labeling, and have the same intended use. The differences in the proposed new device are an increase in the size and fill volume of the syringe. All other aspects of the product design remain the same. This device is categorized in ISO 10993-1:2009 as "External communicating device – blood path, indirect per section 5.2.2(a). The device will have limited contact of less than or equal to 24 hours. All materials contact the fluid path and are treated as indirect patient contact. The syringe device is fabricated from the following raw materials:

. Polypropylene homopolymer pellets (PF535)
Dow Corning 360 Medical fluid .
West Pharmaceutical Rubber Plunger Tips .
. Tip Cap Non-sterile Basell PF535 Polypropylene, Alpha Gray TPE G968B 4170

No other materials including plasticizers, additives, crosslink agents, colorants, inks, adhesives, surfactants, detergents, etc., are used during the manufacture of the syringes. The device does not use an energy source.

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20mL Sterile 510(K) Attachment Page_ र of (o AMUSA. Nashville, TN

Technological/Substantial Equivalence Comparison Table:

Conclusion: The new device is identical to the predicate device in plastic materials composition, the form, and function (e.g. Flushing of vascular access devices). The two changes to the new device involve 1. Increase in syringe size from a 12 mL syringe to a 20 mL syringe and 2. Increase in the solution volume. Non-clinical verification testing for the proposed change involved chemical-physical, functional, and product stability testing. The results of testing conducted verify the new device performed in an equivalent manner to the predicate device. Therefore, the new device is substantially equivalent to the predicate device. Other companies have FDA 510(k) clearance for similar 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).

Technological/Substantial Equivalence Table
	Predicate Device	New Device
Intended Use	Intended use: 0.9% Sodium Chloride Flush Syringesare intended for use in flushing compatibleintravenous administration sets and indwellingintravenous access devices.	Intended use: 0.9% Sodium Chloride Flush Syringes are intended foruse in flushing compatible intravenous administration sets andindwelling intravenous access devices.
Design	Predicate device and new device have identicaldesign.	New device has the same design as predicate.
ChemicalCompositionof Barrel	Non-sterile Polypropylene PF-535 Resin	Non-sterile Polypropylene PF-535 Resin
ChemicalCompositionof Plunger	Non-sterile Black Pharmaceutical Grade Rubber (Notmade with Natural Rubber Latex)	Non-sterile Black Pharmaceutical Grade Rubber (Not made withNatural Rubber Latex)
ChemicalCompositionTip Cap	Non-sterile Basell PF535 Polypropylene, Alpha GrayTPE G968B 4170	Non-sterile Basell PF535 Polypropylene, Alpha Gray TPE G968B 4170
Environment	Positive DifferentialControlled and Monitored	Positive DifferentialControlled and Monitored
EnergySource	There is not an energy source. The device is operatedmechanically.	There is not an energy source. The device is operated mechanically.
Non-Pyrogenic	Entire device is nonpyrogenic	Entire device is nonpyrogenic
Non-PyrogenicAdditives,latex, orpreservatives	No additivies, natural rubber, or preservatives wereused in the manufacture of the syringes.	No additivies, natural rubber, or preservatives were used in themanufacture of the syringes.
SterileBarrierPackage	Sterile barrier Pouchpolypropylene film 3-6 mil	Sterile barrier Pouchpolypropylene film 3-6 mil
SterilityAssuranceLevel	10-6	10-6
SterilityLabeling ofDevice	Fluid path and outside of device are sterile.	Fluid path and outside of device are sterile.
SterilizationMethod	Gamma	Gamma
Expiry Dating	2 years	2 years
FillingProcess	The filling process occurs in a positive differential,monitored, and controlled environment. Thesolution is contained in a sterile closed system.	The filling process occurs in a positive differential, monitored, andcontrolled environment. The solution is contained in a sterile closedsystem.
EquivalentBench andStabilityTesting	The predicate device Bench and Stability testsincluded:• Sterility• Pyrogen (LAL) analysis• pH• Water Loss• Iron• Heavy Metals• Sodium, Chloride• Particulate Matter	The same Bench and Stability tests were performed on the newdevice as the predicate device. Bench and Stability tests included:• Sterility• Pyrogen (LAL) analysis• pH• Water Loss• Iron• Heavy Metals• Sodium, Chloride• Particulate Matter
Size and FillVolumes	3 mL/12 mL; 5 mL/12mL, 10 mL/12mL	20 mL/20 mL