For the flushing and assessing the patency of indwelling catheters and venipuncture devices which are designed for intermittent injection therapy, blood sampling, or fluid and nutritional therapy.

Device Description

The proposed Flush Syringe pre-filled with 0.9% Sodium Chloride will be composed of a medical grade plastic syringe and 0.9% Sodium Chloride for the purpose of flushing and assessing the patency of indwelling catheters and venipuncture devices

AI/ML Overview

This document is a 510(k) Premarket Notification for a Flush Syringe with 0.9% Sodium Chloride. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the provided text, the device in question is a medical device (a pre-filled syringe with saline), not an AI/ML powered device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., accuracy, sensitivity, specificity, F1 score) are not applicable here.

The document discusses "substantial equivalence" based on technological characteristics and intended use, comparing the new device to existing predicate devices. The "study" here refers to the documentation and testing performed to demonstrate that the new device is as safe and effective as the predicate devices, rather than a performance study of an algorithm.

Here's a breakdown of the information relevant to a non-AI/ML medical device submission, structured to answer your questions as much as possible given the context:

1. Table of Acceptance Criteria and Reported Device Performance

For non-AI/ML medical devices like this flush syringe, "acceptance criteria" and "device performance" are typically related to:

Physical and chemical characteristics: Sterility, composition of saline, syringe materials, plunger function, integrity.
Functional performance: Ability to flush and assess patency without leakage or material incompatibility.
Biocompatibility: Materials used are safe for medical contact.

The document does not explicitly list a table of acceptance criteria with specific quantitative targets and results for the flush syringe's performance attributes in the provided sections. Instead, it relies on demonstrating substantial equivalence to predicate devices.

What is implied:

Acceptance Criteria Category	Implicit Criterion (based on substantial equivalence)	Reported Device Performance (implied)
Intended Use	Same as predicate devices	"To flush or assess the patency of indwelling catheters and venipuncture devices" - Met
Technological Characteristics	Similar to predicate devices	"Technology and operating principles are the same for both devices." - Met
Material/Design (Differences)	Differences (sterilization, plunger tip) do not raise new safety/effectiveness questions	Information provided in 510(k) "supports claim for substantial equivalence." - Met
Sterility	Must be sterile (implied for medical device)	New sterilization method used, assumed to meet sterility standards (details not provided here) - Met
Functionality (e.g., no leaks)	Perform effectively without unintended side effects	Not explicitly detailed here, but presumed to be equivalent to predicates - Met

The 510(k) process is about demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against novel, pre-defined quantitative metrics similar to those for AI models. The "study" is the entire 510(k) submission itself, which provides data and justification for substantial equivalence.

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

This information is not provided in the given text. For a physical device like a syringe, "test set" would refer to the number of syringes subjected to various physical, chemical, and sterility tests. The provenance (country of origin, retrospective/prospective) of such test data is also not specified, though it would typically be derived from manufacturer-conducted studies.

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 to this type of device submission. "Ground truth" established by experts is primarily relevant to diagnostic or interpretative AI/ML systems where human judgment is being replicated or assisted. For a flush syringe, the "ground truth" is typically defined by objective physical, chemical, and biological tests (e.g., pH readings, bacterial cultures, material compatibility tests) against established engineering and medical standards.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of device submission. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human experts when establishing ground truth for diagnostic decisions, which is not the case for a physical medical device like a flush syringe.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. These studies are typically performed for diagnostic imaging devices or software where multiple readers (e.g., radiologists) interpret cases (e.g., medical images) to assess the impact of a new technology (e.g., AI assistance) on their diagnostic performance. This is not relevant for a pre-filled saline syringe.

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

No, a standalone performance study was not done. This concept refers to the performance of an AI algorithm independent of human interaction. Since the device is a physical syringe and not an AI algorithm, this question is not applicable.

7. The Type of Ground Truth Used

As discussed in point 3, the concept of "ground truth" in the AI/ML sense is not applicable. For this device, "ground truth" would be established through:

Objective physical and chemical tests: Ensuring the 0.9% Sodium Chloride solution is accurate, maintaining pH, integrity of the syringe components, ease of plunger movement, etc.
Sterility testing: Ensuring the product is sterile.
Biocompatibility testing: Ensuring the materials are safe for patient contact.
Functional testing: Ensuring the syringe can effectively flush without leakage or particulate generation.
Compliance with recognized standards: Adherence to ISO standards, USP monographs, etc.

The document implicitly refers to these types of "truths" by stating the device has "similarities" in technology and operating principles to predicate devices and that differences "do not raise new questions of safety or effectiveness."

8. The Sample Size for the Training Set

Not applicable. This device does not use an AI/ML algorithm that requires a "training set."

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

Not applicable. As there is no AI/ML training set, there is no ground truth to establish for it in this context.

Summary

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Contidential

March 2009

K0908882

Original 510(k) Premarket Notification Flush Syringe with 0.9% Sodium Chloride

510(k) SUMMARY 5

APR 2 3 2010

Phone: (224)212-4898 Hospira, Inc. 5.1 Submitted by: D-389 Bldg. H2 Fax: (224) 212-5401 275 N. Field Drive Lake Forest, IL 60045
Contact: Keith Dunn
March 25, 2009 5.2 Date Prepared:
Vascular Access Flush, Intravascular, 5.3 Name/Classification Saline, Catheter, Class 2, 80-NGT of Device:

0.9% Sodium Chloride Flush Syringe 5.4 Trade Name of Proposed Device:

5.5 Predicate Devices:

Device Name	510(k) Number
Modification to Syringe Pre-filled with 0.9% Sodium Chloride	K001616
Syringe Pre-filled with 0.9% Sodium Chloride	K953805
Modification to Monoject Pre-Fill 0.9% Sodium Chloride	K032438

5.6 Proposed Device Description:

5.7 Statement of Intended Use:

For the flushing and assessing the patency of indwelling catheters and venipuncture devices which are designed for intermittent injection therapy, blood sampling, or fluid and nutritional therapy.

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510(k) SUMMARY (continued) ട്

5.8 Summary of Technological Characteristics of New Device Compared to Predicate Devices:

The Flush Syringe pre-filled with 0.9% Sodium Chloride as described in this submission is substantially equivalent to the predicate Flush Syringe pre-filled with 0.9% Sodium Chloride with respect to the following characteristics:

5.8.1 Similarities:

Both devices are intended to be used to flush or assess the patency of . indwelling catheters and venipuncture devices
The technology and operating principles are the same for both devices .
. The fill size of the syringe

5.8.2 Differences:

The sterilization method .
The plunger tip material and shape .

The claim for substantial equivalence is supported by the information provided in this 510(k) submission.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes extending upwards and a ribbon-like shape below.

Public Health Service

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

Mr. Keith Dunn Manager Hospira, Incorporated 275 North Field Drive, D-389, Building, H2 Lake Forest, Illinois 60045

APR 2 3 2010

Re: K090882

Trade/Device Name: Flush Syringe Filled with 0.9% Sodium Chloride Regulation Number: 21 CFR 880.5200 Regulation Name: Saline, Vascular Access Flush Regulatory Class: II Product Code: NGT Dated: April 12, 2010 Received: April 13, 2010

Dear Mr. Dunn:

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. Dunn

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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Slladthones
Anthony Watson, B.S., M.S., M.B.A.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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March 2009

Indications for Use

510(k) Number (if known)

Device Name: Flush Syringe filled with 0.9% Sodium Chloride

List Numbers/Descriptions: 1078-10 30 x 10mL single use syringes, 1078-20 100 x 10mL single use syringes, 1078-25 30 x 5mL single use syringes, 1078-35 100 x 5mL single use syringes, 1078-23 30 x 3mL single use syringes, and 1078-33 100 x 3mL single use syringes.

Indications for Use:

For the flushing and assessing the patency of indwelling catheters and venipuncture devices which are designed for intermittent injection therapy, blood sampling, or fluid and nutritional therapy.

Prescription Use X (Part 21 CFR 801 Subpart D) ANDIOR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Susan Tipton

Division of Anesthesiology, General Hosp Infection Control, Dental Device

510(k) Number: K090857

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).