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.

Device Description

The Predicate Device, 510(k) Number: K111034, AMUSA consists of a plastic syringe filled with 0.9% Sodium Chloride Flush Solution that is terminally sterilized. The predicate device filud path of 10 Section Onlonde Hush Oolution that is terminally sterlized. This is a single use device.

The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.9% Sodium Chlerida Fluch Calification that the United on the Sodium Chloride Flush Solution that is terminally sterilized. The modified device fluid path sterile has a Sterility Assurance Level (SAL) of 108. This is a single use device.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "0.9% Sodium Chloride Flush Syringe". However, it is not a study report for an AI/ML powered device, but rather a submission for a standard medical device that has undergone a change in component supplier.

Therefore, the information requested regarding acceptance criteria and studies for an AI/ML device (e.g., performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth establishment) is not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device for a physical product by verifying technical characteristics and conducting non-clinical testing.

Here's what can be extracted from the provided text, adapted to the context of a traditional medical device submission:

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

Since this is a Class II medical device being evaluated for substantial equivalence after a component supplier change, the acceptance criteria are not in terms of AI performance metrics, but rather in terms of demonstrating that the modified device is as safe and effective as the predicate device.

Acceptance Criteria Category	Description	Reported Device Performance
Design	The modified device should have the same design as the currently marketed predicate device.	"The technical characteristics for the modified device do not differ from those of the currently marketed device. These devices have the same design..."
Fundamental Science	The modified device should have the same fundamental scientific characteristics as the predicate device.	"...the same fundamental scientific characteristics..."
Labeling	The modified device should have the same label as the predicate device.	"...the same label..."
Intended Use	The modified device should have the same intended use as the predicate device.	"...have the same intended 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.")
Sterility Assurance Level (SAL)	The modified device's fluid path must maintain a sterile SAL of 10⁻⁶. (While not explicitly stated as an "acceptance criteria" here, it's a critical safety parameter for terminally sterilized devices and the text mentions it for the modified device).	The modified device fluid path sterile has a Sterility Assurance Level (SAL) of 10⁻⁶. (The predicate device is also "terminally sterilized" implicitly suggesting a similar SAL).
"Substantial Equivalence"	Non-clinical verification testing must demonstrate that the modified device performs in an equivalent manner to the predicate device and is safe and effective when used as intended, covering chemical-physical, functional, and product stability aspects.	"Non-clinical verification testing for the proposed change involved chemical-physical, functional, and product stability testing. The results of testing conducted verifies the modified terminally sterilized syringe performed in an equivalent manner to the predicate terminally sterilized syringe and is safe and effective when used as intended." (Specific quantitative results for these tests are not provided in this summary but were presumably submitted to the FDA.)

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify exact sample sizes for the "chemical-physical, functional, and product stability testing." It only mentions that these tests were conducted.
Data Provenance: Not explicitly stated, however, the testing would have been conducted by the manufacturer, AMUSA, or a qualified contract lab under their direction, as part of the regulatory submission process in the United States. It is "prospective" to the decision of equivalence, meaning it was performed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable here. Ground truth in the context of this device relates to established engineering and quality standards for medical devices (e.g., sterility, material compatibility, functional performance). The "experts" would be the engineers, scientists, and quality assurance personnel performing and interpreting the non-clinical tests, and the FDA reviewers evaluating the submission. Their qualifications are assumed to be appropriate for their roles.

4. Adjudication method for the test set:

Not applicable in the context of ground truth for an AI/ML device. The "adjudication" for this type of device is the FDA's regulatory review process, where they evaluate the submitted data against regulatory requirements and accepted standards.

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 device is not an AI/ML product and does not involve human readers interpreting data with or without AI assistance.

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

Not applicable. This device is not an AI/ML algorithm.

7. The type of ground truth used:

The "ground truth" for this device is based on established engineering principles, material science, microbiology (for sterility), and functional performance standards relevant to sterile, single-use medical devices. It would involve objective measurements from the chemical-physical, functional, and product stability tests.

8. The sample size for the training set:

Not applicable. This device does not involve a training set as it's not an AI/ML model.

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

Not applicable.

Summary

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510(k) Summary

113555

JAN 3 0 2012

510(k) Summary of Safety and Effectiveness

As required by 809.92(a)(2).

SPECIAL 510 (k) PREMARKET NOTIFICATION NUMBER:

Submitter and Owner of the 510(k)

AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: 615-833-2633 Fax: 615-332-9945

Official Correspondent

Karen Thomison Director of Quality Assurance AMUSA 5209 Linbar Dr., Suite 640 Nashville, TN 37211 Phone: 615-833-2633 Fax: 615-332-9945

Date of Preparation

November 1, 2011

510(k) Application Number TBD

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

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

DEVICE DESCRIPTION:

The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.9%
Sodium Chlerida Fluch Calification that the United on the Sodium Chloride Flush Solution that is terminally sterilized. The modified device fluid path sterile has a Sterility Assurance Level (SAL) of 108. This is a single use device.

TECHNICAL DATA: The technical characteristics for the modified device do not differ from those of the currently marketed device. These devices have the same design, the same fundamental scientific characteristics, the same label have the same intended use. The proposed modification involves a change in the syringe component supplier.

Substantial Equivalence: Non-clinical verification testing for the proposed change involved chemical-physical, functional, and product stability testing. The results of testing conducted verifies the modified terminally sterilized syringe performed in an equivalent manner to the predicate terminally sterilized syringe and is safe and effective when used as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The logo is black and white.

Public Health Service

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

JAN 3 0 2012

AM USA C/O Karen Thomison Director of Quality Assurance 5209 Linbar Drive, Suite 640 Nashville, Tennessee 37211

Re: K113555

Trade/Device Name: AM USA 0.9% Sodium Chloride Flush Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Saline, Vascular Access Flush Regulatory Class: II Product Code: NGT Dated: January 18, 2012 Received: January 19, 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 Eederal Register.

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Page 2 - Ms. Thomison

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Anthony J. Watson

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

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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 manufacture 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)

Rhd C. Chym 1/25/12

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K113555 510(k) Number:

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).