Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) are indicated for use in maintaining patnecy of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy

Device Description

Excelsior Medical Heparin Lock Flush Syringes are polypropylene latex-free syringes which contains a labeled volume of a sterile, non-pyrogenic solution of Heparin Lock Flush Solution, USP derived from porcine intestinal mucosa in 0.9 sodium chloride USP with a pH range of 5.0 - 7.5.

AI/ML Overview

This is a 510(k) summary for a medical device: Excelsior Medical Heparin Lock Flush Syringes. The document focuses on establishing substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria in the typical clinical study format.

Therefore, many of the requested sections about clinical study details (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training data) cannot be fully answered from the provided text.

Here is an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The document states that the device was tested according to "specifications documented in Design Verification Testing Reports and independent laboratory testing." It concludes that the device "functioned as intended and met all pass criteria as expected." However, the specific acceptance criteria and the detailed performance results are not provided in this 510(k) summary. The summary focuses on comparing the new device's characteristics to its predicate devices to establish substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (e.g., Sterility, pH Range, Heparin Concentration)	Reported Device Performance
Not explicitly detailed in this summary document. The document refers to "specifications documented in Design Verification Testing Reports and independent laboratory testing."	"functioned as intended and met all pass criteria as expected."

Study Information:

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "Design Verification Testing Reports and independent laboratory testing" but does not provide details on sample sizes for these tests.
- Data Provenance: Not specified, but likely from laboratory testing (e.g., sterility, chemical analysis, functional tests) rather than human clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable or not provided. This type of detail is typically associated with clinical studies involving interpretation (e.g., imaging devices), not physical device performance testing for a syringe and its contents. The ground truth would be established by validated analytical methods, not expert consensus.
Adjudication method for the test set:
- This information is not applicable or not provided. Adjudication methods like "2+1" or "3+1" are used in clinical studies where human interpretation of results is involved (e.g., radiologists reading scans). This document describes performance testing for a physical device, where results are typically objective measurements.
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:
- No, an MRMC study was not done. This type of study is relevant for diagnostic devices, especially those using AI, that assist human readers in interpreting clinical data. This device is a pre-filled syringe, not a diagnostic tool assisted by AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This section is for AI/algorithm-based devices. The Excelsior Medical Heparin Lock Flush Syringe is a physical medical device.
The type of ground truth used:
- Laboratory Testing Parameters/Specifications: The ground truth for this device's performance would be established by predefined quality and functional specifications (e.g., sterility, pH range of the solution, heparin concentration, syringe integrity, flush volume). These are determined through established scientific and manufacturing standards for medical devices and pharmaceuticals.
The sample size for the training set:
- Not applicable. This pertains to AI/machine learning models. For a physical device, there isn't a "training set" in the AI sense.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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K061497

p. 1 of 3

510(k) SUMMARY

Excelsior Medical Heparin Lock Flush Syringes (1 Unit per ml and 2 Units per ml)

FEB 2 3 2007

This 510(k) summary is provided as part of the Premarket Notification for Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml)

Submitter: Excelsior Medical 1933 Heck Ave. Neptune, New Jersey 07753 Phone: +1-732-776-6079 Facsimile: +1-732776-7600

Contact Person: John J. Talarico

Date Prepared: February 21, 2007

Name of Device: Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml)
Common or Usual Name: Heparin Lock Flush Syringe

Classification Name: Intravascular Catheter 21 CFR 880 5200

Predicate Devices:

Medefil 1 U/ml Flush Syringe Hospital filled 1 U/ml Flush Syringe

Intended Use / Indications for Use

A. Intended Use

The Excelsior Medical Heparin Lock Flush Syringes are intended for use in flushing IV catheters and IV tubing.

B. Indications for Use

To maintain patency of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Excelsior Medical Heparin Lock Flush Syringes (1U/ml & 2U/ml) 510k K061497

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C. Contraindications

Heparin Lock Flush Solution, USP should not be used in patients with thrombocytopenia or with an uncontrollable active bleeding state. Heparin Lock Flush Solution USP for IV flush should not be used for anticoagulant therapy. Heparin Lock Flush Solution USP is not for use in patients with documented hypersensitivity to heparin or pork products.

Technological Characteristics

Heparin is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1)a-L-iduronic acid 2 sulfate, (2)2-deoxy-2sulfamino-a-D-glucose, 6 -sulfate, (3)ß-D-glucuronic acid, (4)2-acetamido-2-deoxy- a-D-glucose, and (5) a -L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)>(1)>(4)>(3)>(5),are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions.

The Excelsior Medical Heparin Lock Flush is designed to be injected into a vascular access device. The appropriate concentration of Heparin Lock Flush Solution USP should be based on current practice standards and institutional policies and procedures.

Performance Data

The Excelsior Medical Heparin Lock Flush Syringes are tested according to the specifications documented in Design Verification Testing Reports and independent laboratory testing. In all instances, the Excelsior Medical Heparin Lock Flush Syringes functioned as intended and met all pass criteria as expected.

Substantial Equivalence

The Excelsior Medical Heparin Lock Flush Syringes are as safe and effective as the Medefil's 1 U/ml Flush Syringe and Hospital pharmacy filled 1 U/ml Flush Syringes. The Excelsior Medical Heparin Lock Flush Syringes have the same

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061497 2.38

intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Excelsior Medical Heparin Lock Flush Syringes and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrates that the Excelsior Medical Heparin Lock Flush Syringes are as safe and effective as the Medefil's 1 U/ml Flush Syringe and Hospital pharmacy filled 1 U/ml Flush Syringe. Thus, the Excelsior Medical Heparin Lock Flush Syringes are substantially equivalent to the predicate devices in construction, materials, and intended use.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John J. Talarico Vice President & Regulatory Affairs Excelsior Medical Corporation 1933 Heck Avenue Neptune, New Jersey 07753

FEB 2 3 2007

Re: K061497

Trade/Device Name: Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NZW Dated: December 15, 2006 Received: January 31, 2007

Dear Mr. Talarico:

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. Talarico

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 (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. .

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours.

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 Statement

510(k) Number (if known): K061497

Device Name: Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml)

Indications For Use: Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) are indicated for use in maintaining patnecy of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

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

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

Shida P. Maybey, Ph Concurrence of CDRH, Office of Device Evaluation (ODE)

12-11-22 23:11

K64/447

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).