The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for use in maintaining the patency of vascular access devices (VAD's)

10 usp units/mL and 100 usp units/mL in 3ml fill in 3ml syringe with 10ml diameter and 5ml fill in 5ml syringe with 10ml diameter

Device Description

The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe uses a single use disposable Hypodermic syringe, identical to the Predicate Device (K003553), filled with USP Heparin Lock Flush Solution. The Modified Device has a sterile fluid path with an SAL of 10°.

The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe has been modified to achieve terminal sterilization (SAL of 1066) via steam autoclave.

The Modified Device is manufactured of similiar materials and has the same intended use as the Predicate Devices.

AI/ML Overview

This submission (K090680) describes a medical device, the Heparin Lock Flush Solution, USP - BD PosiFlush™ Heparin Lock Flush Syringe. It is important to note that this is a physical medical device (a pre-filled syringe with heparin solution) and not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML systems (such as sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment methods for observational data) are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to previously approved predicate devices based on design verification tests for safety and effectiveness of the physical product, its materials, intended use, and manufacturing process.

Here's the information parsed from the provided text, adapted for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device submission focused on substantial equivalence, the "acceptance criteria" are implied by the performance of the predicate device and the design verification tests. The "reported device performance" refers to the results of these tests and the overall assessment of equivalence.

Acceptance Criterion (Implied)	Reported Device Performance
Intended Use Equivalence: Maintain patency of vascular access devices (VAD's) for specific concentrations and fill volumes.	The Modified Device has the same intended use as the Predicate Devices: "maintaining the patency of vascular access devices (VADs)" with specified concentrations (10 usp units/mL and 100 usp units/mL) and fill volumes (3ml in 3ml syringe, 5ml in 5ml syringe).
Material Equivalence: Manufactured from similar materials to predicate.	The Modified Device is "manufactured of similar materials" to the Predicate Devices.
Sterility Assurance Level (SAL): Achieves terminal sterilization at SAL of 10⁻⁶.	The Modified Device has been modified to achieve terminal sterilization (SAL of 10⁻⁶) via steam autoclave. The predicate device K003553 also uses a hypodermic syringe with a sterile fluid path with an SAL of 10⁻⁶ (stated for the predicate in section 4, though the modified device's SAL is confirmed in section 6).
Safety and Effectiveness Equivalence relative to predicate devices.	"Design Verification tests were performed based on the risk analysis performed and results of these tests demonstrate that the Heparin Lock Flush Solution, USP - BD PosiFlush™ Heparin Lock Flush Syringe performed in an equivalent manner to the predicate devices and is safe and effective when used as intended."

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

Sample Size: The document does not specify a numerical sample size for "design verification tests." These tests are typically laboratory-based and may involve multiple units of the device to confirm manufacturing quality, material compatibility, and performance characteristics (e.g., flow rate, integrity, sterility).
Data Provenance: The data would be derived from internal testing conducted by Becton, Dickinson and Company. It is "prospective" in the sense that the tests were performed specifically for this 510(k) submission on the newly designed/modified device. The country of origin of the data is the USA (where BD Medical Surgical is located).

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

This concept is not directly applicable to this type of device submission. The "ground truth" for a physical device like a pre-filled syringe is established through objective engineering and chemical testing standards, manufacturing processes, and regulatory requirements (e.g., USP monographs for the heparin solution, ISO standards for syringes, sterility testing protocols). Experts would be involved in designing and executing these tests, and interpreting the results against established standards, rather than establishing a "ground truth" through consensus on observational data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers interpreting subjective data (e.g., medical images). For physical device testing, the results are typically objective measurements against a defined standard.

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 device, not an AI/ML system.

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

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device would be a combination of:

Established Standards: USP (United States Pharmacopeia) monographs for Heparin Lock Flush Solution, standards for syringe manufacturing, and sterility testing protocols.
Predicate Device Performance: The performance characteristics and safety profile of the legally marketed predicate devices (K011967, K003553, K013556) serve as a de facto "ground truth" for what is considered safe and effective in this device class.
Risk Analysis: A documented risk analysis would have guided the design verification tests to ensure all potential risks were mitigated and tested.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML system, so there is no "training set."

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

Not applicable.

Summary

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K090680

510(K) Summary of Safety and Effectiveness

Submitted By: 1.

John Roberts Regulatory Affairs Specialist

JUN 10 2009

BD Medical Surgical 1 Becton Drive Franklin Lakes, NJ 07417

Tel: 201 847 5473 201 847 5307 Fax:

2. Device Name:

Trade Name: Heparin Lock Flush Solution, USP -BD PosiFlushTM Heparin Lock Flush Syringe

Heparin Lock Flush Syringe Common Name:

Classification Name: Heparin, Vascular Access Flush

3. Predicate Device:

Trade Name:	BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, USP syringe
Manufacturer:	Becton, Dickinson and Company
510(k) Number:	K011967
Trade Name:	0.9% Sodium Chloride Injection, USP – BD Pre-Filled Flush Syringe
Manufacturer:	Becton, Dickinson and Company
510(k) Number:	K003553
Trade Name:	Monoject Prefill Heparin Lock Flush Syringe
Manufacturer:	Tyco Healthcare
510(k) Number:	K013556

Device Description: 4.

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Intended Use: ડાં

The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for use in maintaining the patency of vascular access devices (VAD's)

10 usp units/mL and 100 usp units/mL in 3ml fill in 3ml syringe with 10ml diameter and 5ml fill in 5ml syringe with 10ml diameter .

Technological Characteristics: 6.

The Modified Device is manufactured of similiar materials and has the same intended use as the Predicate Devices.

7. Performance:

Design Verification tests were performed based on the risk analysis performed and results of these tests demonstrate that the Heparin Lock Flush Solution, USP - BD PosiFlush™ Heparin Lock Flush Syringe performed in an equivalent manner to the predicate devices and is safe and effective when used as intended.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John Roberts Regulatory Affairs Specialist Becton Dickinson and Company BD Medical Surgical -1 Becton Drive MC237 Franklin Lakes, New Jersey 07417

JUN 1 0 2009

Re: K090680

Trade/Device Name: Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe

Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NZW Dated: May 12, 2009 Received: May 13, 2009

Dear Mr. Roberts:

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.

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. Roberts

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Anthony V. Winter for
Susan Runner, D.D.S., M.A.

Acting 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 Statement

510(k) Number (if known): K090680

Device Name:

Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe

Indications for Use:

The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for use in maintaining the patency of vascular access devices (VAD's)

10 usp units/mL and 100 usp units/mL in 3ml fill in 3ml syringe with 10ml diameter and 5ml fill in 5ml syringe with 10ml diameter

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

Page 01

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

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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).