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 Predicate Device, 510(k) Number: K111034, cleared on July14, 2011 consists of a plastic syringe filled with 0.9% Sodium Chloride Solution that is terminally sterilized. The predicate syringe is fluid path sterile with a Sterility Assurance Level (SAL) of 10⁻⁶. This is a single use device packaged in a dust cover.

The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.9% Sodium Chloride Solution that is terminally sterilized. The modified device has a sterile exterior in addition to the sterility of the fluid, fluid path and the exterior of the device. The package that maintains the sterility of the modified device has a Sterility Assurance Level (SAL) is 10⁻⁶. This is a single use device.

Technical Data: The technical characteristics of the syringe for the modified device do not differ from those of the currently marketed predicate device. These syringes have the same design, the same functional characteristics, and have the same intended use. The proposed modification involves a change in packaging from the dust cover with a sterile barrier package for use in a sterile field. All other aspects of the syringe design remain the same.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "0.9% Sodium Chloride Flush Syringe". It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The 510(k) is for a physical medical device (saline flush syringe), not an AI/ML software device. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, training/test sets, and MRMC studies are not applicable to the provided text.

The "study" mentioned here is a series of non-clinical verification tests for the physical changes to the syringe (specifically, the sterile packaging).

Here's how I can address the prompts based only on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative format for device performance as one would expect for an AI/ML device. Instead, it refers to:

Aspect	Acceptance Criteria (Implicit from "equivalent manner", "consistent performance")	Reported Device Performance
Sterility	Sterility Assurance Level (SAL) of 10⁻⁶	Modified device achieves SAL of 10⁻⁶ (fluid path, fluid, exterior).
Physical Design	Same design as predicate device	Modified device has the same design as the predicate with sterile barrier packaging.
Functional Characteristics	Consistent functional performance as predicate device	Non-clinical verification testing found equivalent performance for the modified device.
Material Selections	Same material selections as predicate device	Modified device has the same material selections as the predicate.
Intended Use	Same intended use as predicate device	Modified device has the same intended use.
Chemical-Physical Properties	Equivalent chemical-physical properties to predicate device	Non-clinical verification testing verified equivalent performance.
Package Validation	Package maintains sterility and performs equivalently to predicate	Package validation studies verified equivalent performance.

Explanation: The "acceptance criteria" here are largely implied by the concept of "substantial equivalence" to the predicate device. The goal was to demonstrate that modifications (specifically to the sterile packaging) did not negatively impact the safety or effectiveness of the device, making it perform in an "equivalent manner."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document mentions "non-clinical verification testing" which included "chemical-physical, functional, and package validation studies" but does not detail the sample sizes for these tests.
Data Provenance: Not specified, but these would be laboratory test results related to the physical syringe and its packaging, likely conducted by the manufacturer (AMUSA) or a contracted lab. The manufacturer's address is Nashville, TN, USA. These tests are prospective in the sense that they were conducted for the purpose of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This pertains to a physical medical device. Ground truth as typically understood for AI/ML algorithms (e.g., diagnostic labels) is not relevant here. The "ground truth" for the tests would be the established performance characteristics for medical devices (e.g., SAL for sterility, validated functional tests).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This pertains to a physical medical device. Adjudication methods are typically for resolving discrepancies in expert interpretations, which is not relevant here.

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 physical medical device, not an AI/ML system, so no MRMC study would be performed.

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

Not applicable. This is a physical medical device; there is no algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this physical device would be derived from standardized testing protocols and specifications for medical devices, specifically related to sterility, material properties, functional performance (e.g., fluid delivery), and package integrity. These are objective measures, not expert consensus or pathology in the AI/ML sense.

8. The sample size for the training set

Not applicable. This is a physical medical device; there is no training set for an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable. There is no training set for an AI/ML algorithm.

Summary

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510(k) Summary

510(k) Summary of Safety and Effectiveness

As required by 809.92(a)(2).

special 510 (k) Premarket notification number: KL20 836

JUL 12 2012

Submitter and Owner of the 510(k)

AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: 615-833-2633 Fax: 615-831-1817

Official Correspondent

Karen Thomison Director of Quality Assurance AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: 615-833-2633 Fax: 615-831-1817

Date of Preparation 3/13/12

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

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510(k) Summary

Classification Panel

General Hospital

Classification Product Code

NGT

INDICATIONS FOR USE

INDIOATHONO FOR OOE intended use. 0.3% Odding Online Plaalling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

DEVICE DESCRIPTION:

The Predicate Device, 510(k) Number: K111034, cleared on July14, 2011 consists of a plastic rre Predicate Device, o ro(ty Namber. It Frob Solution that is terminally sterilized. The predicate synige is fluid path sterile with a Sterlity Assurance Level (SAL) of 10°. This is a single use device packaged in a dust cover.

The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.99% The Modified Device, the Subject of this of (1)) otterilized. The modified device has a sterile outlum Onlon of the sterility of the fluid, fluid path and the exterior of the device. The package that maintains the sterily of the package is not open and aseptic techniques modified device out bo acounte Level (SAL) is 10 - This is a single use device.

Technical Data: The technical characteristics of the syringe for the modified device do not r ecoffnour Duta. The confined characted device. These syringes have the same design, the differ from those of the ouriently manietics, and have the same intended use. The proposed Same innualhemal selemans, and hostitution the dust cover with a stelle barrier modification involves a change in pastialistics for use in a sterile field. All other aspects of the syringe design remain the same.

Substantial Equivalence: Non-clinical verification testing for the proposed change involved Shemical-physical, functional, and package validation studies. The result of testing conducted verifies that the change in sterile packaging of the modified device performed in an equivalent venties that the change in Steme packaging of the used as intended. Other manner to the products as not special 510(k)s submitted with similar changes.

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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 stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

Ms. Karen Thomison Director of Quality and Regulatory Affairs AMUSA 5209 Linbar Drive, Suite 640 Nashville, Tennessee 37211

JUL 12 2012

Re: K120836

Trade/Device Name: 0.9% Sodium Chloride Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: June 11, 2012 Received: June 13, 2012

Dear Ms. Thomison:

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 (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely vours,

FR Bisley
Turkett MD

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

Indications for Use Statement

510(k) Number (if known):

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)

Rohit Gangulin
(Division Sign-Off) 7/12/12

Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K120836

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).