The Heparin Lock Flush Syringe, 10 and 100 units/mL, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

Device Description

The proposed device is a sterile, single use, standard piston type syringe that is available in various fill volumes and syringe sizes containing either 10 or 100 USP u/ml Heparin Lock Flush Solution for anits Injection. The syringe uses a sterile, polypropylene luer lock fitting or blunt tip cannula. The piston syrings consists of a polypropylene barrel with a lucr lock adapter assembled with a polypropylene plunger and a polyisoprene seal. The dispensing end of the syringe is covered with a tip cap closure.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Heparin Lock Flush Syringe." This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove the device meets specific acceptance criteria related to its performance in a clinical or diagnostic context.

Therefore, the requested information, which is typically found in studies for AI/diagnostic devices (e.g., acceptance criteria tables, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance), is not available in this document.

Here's what the document does provide and why it doesn't fit the requested format:

Acceptance Criteria & Reported Performance: The document states that "Performance testing indicates that the proposed device meets all functional requirements and supports its suitability for use." However, it does not list specific acceptance criteria (e.g., a certain percentage of flushing success, a specific force required for plunger depression) nor does it provide a table of reported performance against these criteria. The emphasis is on material compliance and stability, not diagnostic or predictive performance.
Sample Size (Test Set) and Data Provenance: Not applicable. This device is a pre-filled syringe, not a diagnostic or AI device that would have a "test set" in the context of diagnostic accuracy.
Number of Experts/Qualifications & Adjudication Method: Not applicable. These relate to establishing ground truth for diagnostic accuracy, which is not relevant for a pre-filled syringe.
MRMC Comparative Effectiveness Study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which doesn't apply to a physical medical device like a syringe.
Standalone Performance: Not applicable. This refers to the algorithm's performance without human intervention, which is not relevant for a physical device.
Type of Ground Truth: Not applicable. Ground truth typically refers to a definitive diagnosis or outcome used to evaluate the accuracy of a diagnostic tool.
Sample Size (Training Set) & Ground Truth for Training Set: Not applicable. This device does not use a "training set" in the machine learning sense.

What the document does describe as proof of meeting requirements:

The "study" or evidence presented in this 510(k) is primarily focused on demonstrating that the Heparin Lock Flush Syringe is substantially equivalent to legally marketed predicate devices. This involves:

Comparison of Technological Characteristics:
- Same intended use
- All pre-filled with heparin lock flush solution, USP
- Single-use, disposable
- Sterile and pyrogen-free
- Manufactured using an aseptic process
- Available in similar syringe sizes and fill volumes
- Use polypropylene piston-type syringes
- Packaged in a wrapper or polybag and sealed
- Use manual energy
Non-Clinical Testing:
- Physical properties of materials tested by suppliers to meet USP Class VI plastic test requirements or ISO 10993 Part 1 (for fluid path components). This ensures biocompatibility and material safety.
- Materials in contact with the body found safe and effective (cleared through previous FDA submissions, e.g., EMT-Rx Syringe).
- Test data generated for stability and container/closure suitability. (Specific results or acceptance criteria for these tests are not detailed in this summary).
- Performance testing indicates the proposed device meets "all functional requirements" and supports its suitability for use. (Again, specific functional requirements and detailed results are not provided in this summary).

In summary, the "study" described is a non-clinical engineering and materials compliance assessment rather than a clinical or diagnostic performance study. The acceptance criteria are largely based on established material standards (USP Class VI, ISO 10993-1) and general functional suitability, for which specific quantitative data is not provided in this summary.

Summary

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DEC 2 3 2003

"510k Summary"

Preparation Date: July 20, 2003

AM2PAT, Inc. Submitter: 9400 Ransdell Road, Suite 10 Raleigh, NC 27603 Phone: (919) 552-9689 (919) 552-7400 Fax:

Contact: Dushyant Patel, President

Device Name: Heparin Lock Flush Syringe

Device Common/Usual Name: Heparin Lock Flush Solution, USP

Device Classification Name: Catheter, Intravascular, Therapeutic, Short Term Less Than 30 Days

Product Code: NGT – Device, Flush, Vascular Access

Substantially Equivalent Devices:

Company	Product/Device	510k Number
EMT-Rx	Saline IV Flush Syringe	K002142
Becton Dickinson	BD PosiFlushTM Heparin Lock Flush Syringe	K011967
Baxter Healthcare	Heparin Lock Flush Syringe	K003245
Medefil, Inc	Heparin IV Flush Syringe	K020996

Device Description:

The syringe uses a sterile, polypropylene luer lock fitting or blunt tip cannula. The piston syrings consists of a polypropylene barrel with a lucr lock adapter assembled with a polypropylene plunger and a polyisoprene seal. The dispensing end of the syringe is covered with a tip cap closure.

Intended Use:

The AM2PAT Heparin Lock Flush Syringe and its predicate products are intended for prescription use to flush compatible intravenous administration sets and indwelling intravascular access devices.

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Comparison to legally marketed devices:

The technological characteristics of the new device to legally marketed predicate devices are the same in that:

All devices have the same intended use All devices are pre-filled with a heparin lock flush solution, USP All are single use disposable products All are sterile and pryogen free All are manufactured using an aseptic process All are available in similar syringe sizes and fill volumes All use a polypropylene piston-type syringe All are packaged in a wrapper or polybag and sealed All use manual energy

Non-Clinical Testing:

The physical properties of the materials used to manufacture the Heparin Lock Flush Pre-Filled Syringe are tested by suppliers to ensure they meet either USP Class VI plastic test requirements or ISO 10993 Part 1 for all fluid path components. Materials that come into contact with the body have been tested and found to be safe and effective for their intended use. This information was submitted as part of 510 100and to be sure the EMT-Rx Syringe. These materials are widely used in similar, and other medical devices and have been cleared through FDA.

Test data have been generated for stability and containcr/closure suitability. Performance testing indicates that the proposed device meets all functional requirements and supports its suitability for use.

Conclusion:

The Heparin Lock Flush Pre-Filled Syringe is substantially cquivalent to the predicate devices cited with respect to indications for use, device design, matcrials, and labeling.

K032417

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three bars representing its wings, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, using black and white, and is designed to be easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2003

Mr. Dushvant Patel President AM2Pat, Incorporated 9400 Ransdell Road Raleigh, North Carolina 27603

Re: K032417

Trade/Device Name: Heparin Lock Flush Syringe - 10 and 100 units/mL Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 17, 2003 Received: December 18, 2003

Dear Mr. Patel:

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 such 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. Patel

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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

Applicant: AM2PAT

510(k) Number (if known): N/A K 032417

Device Name: Heparin Flush Syringe - 10 and 100 units/mL

Indications for Use: Lock

Leck The Heparin Flush Syringe, 10 and 100 units/mI. is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

Susanna F. Bassu D

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

510(k) Number: K032417

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

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Over-the-Counter Use

(Per 21CFR 801.109)

AM2PAT, Inc., Heparin Lock Flush Syringe 510k

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).