Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock 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's Heparin Lock Flush, USP devices are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The products contain a solution of heparin sodium, USP and 0.9% sodium chloride, USP. The solution is delivered through the luer lock of a venous access device to maintain catheter patency (lock catheters) between treatments. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling, total parenteral nutrition, or hemodialysis.

AI/ML Overview

This document does not contain information about acceptance criteria and device performance in the context of a study. The provided text is a 510(k) summary for the Heparin Lock Flush, USP, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a specific study with performance metrics against pre-defined acceptance criteria.

The 510(k) summary outlines the following:

Device Description: The Heparin Lock Flush, USP
Intended Use/Indications for Use: Flushing of IV catheters and IV tubing for maintaining patency.
Technological Characteristics: A comparison table with predicate devices (K061497 and K023740) highlighting similarities in solution, concentrations, single-use nature, sterility, barrel material, plunger rod material, piston, tip cap material, tip cap colorants, and packaging.
Purpose of Submission: To add alternate suppliers of the heparin sodium (USP) raw material.
Non-Clinical Testing: A list of studies performed or relied upon:
- Raw material qualification
- Biocompatibility (ISO 10993-1)
- Stability Studies
- Sterilization validation (ISO 17665-1 and -2)
- Extractables/Leachables
- Testing of final product to Heparin Lock Flush Solution USP Monograph
Conclusion: The change in heparin source is supported by the cited studies, and no new questions of safety and effectiveness are raised, leading to the conclusion of substantial equivalence.

The document does NOT include the following information, which would be necessary to answer the prompt:

A table of acceptance criteria and reported device performance.
Sample sizes used for any test set or data provenance.
Number and qualifications of experts for ground truth.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness study results.
Standalone (algorithm only) performance.
Type of ground truth used.
Sample size for training set.
How ground truth for the training set was established.

This is expected as 510(k) submissions for devices like a Heparin Lock Flush typically rely on demonstrating equivalence to existing devices through material characterization, manufacturing controls, and non-clinical testing rather than clinical performance studies with specific acceptance criteria as one might see for an AI/ML diagnostic device.

Summary

{0}------------------------------------------------

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

November 14, 2014

Excelsior Medical Corporation Mr. John Linfante Vice President RA/QA 1933 Heck Avenue Neptune, NJ 07753

Re: K133446

Trade/Device Name: Heparin Lock Flush, USP Regulation Number: 21 CFR 880.5200 Regulation Name: Heparin, Vascular Access Flush Regulatory Class: II Product Code: NZW Dated: October 16, 2014 Received: October 16, 2014

Dear Mr. Linfante

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.

{1}------------------------------------------------

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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K133446

Device Name

Heparin Lock Flush, USP

Indications for Use (Describe)

Heparin Lock Flush, USP is supplied as:

· 3 USP Units per 3 mL (1 USP unit per mL); 3 mL volume in a 10 mL syringe
· 6 USP Units per 3 mL (2 USP unit per mL); 3 mL volume in a 10 mL syringe
· 30 USP Units per 3 mL (10 USP unit per mL); 3 mL volume in a 10 mL syringe
· 50 USP Units per 5 mL (10 USP unit per mL); 5 mL volume in a 10 mL syringe
· 300 USP Units per 3 mL (100 USP unit per mL); 3 mL volume in a 10 mL syringe
· 500 USP Units per 5 mL (100 USP unit per mL); 5 mL volume in a 10 mL syringe

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Manufacturer Name:	Excelsior Medical Corporation
Address:	1933 Heck AvenueNeptune, NJ 07753
Contact Name:	John Linfante
Title:	Vice President RA/QA
Phone Number:	732-643-6088
Fax Number:	732-776-7600
Date Prepared:	October 16, 2014

510(k) Summary

Device Proprietary Name:	Heparin Lock Flush, USP
Device Common or Usual Name:	Heparin Lock Flush, USP
Classification Name:	Heparin, Vascular Access Flush
Classification Code:	NZW
Regulation Number:	21 CFR Part 880.5200
Device Classification:	II

Predicate Devices:

Substantial equivalence is claimed to the following devices as related to intended use, design, and material characteristics:

. Syrex Pre-Filled Syringe, 10 U/mL & 100 U/mL, Excelsior Medical Corporation, K023740
. Syrex Heparin Lock Flush Syringe, 1 U/mL & 2 U/mL, Excelsior Medical Corporation, K061497

Description of the Device

Heparin Lock Flush, USP is available as follows:

. Heparin Lock Flush, USP, 3 USP Units per 3 mL (1 USP unit per mL); 3 mL volume in a 10 mL syringe
Heparin Lock Flush, USP, 6 USP Units per 3 mL (2 USP unit per mL); 3 mL volume ● in a 10 mL syringe

{4}------------------------------------------------

Heparin Lock Flush, USP, 30 USP Units per 3 mL (10 USP unit per mL); 3 mL volume in a 10 mL syringe
Heparin Lock Flush, USP, 50 USP Units per 5 mL (10 USP unit per mL); 5 mL volume in a 10 mL syringe
Heparin Lock Flush, USP, 300 USP Units per 3 mL (100 USP unit per mL); 3 mL ● volume in a 10 mL syringe
Heparin Lock Flush, USP, 500 USP Units per 5 mL (100 USP unit per mL); 5 mL volume in a 10 mL syringe

The product is intended for use with commercially available valves and catheters fitted with a standard mating luer lock or luer taper.

Intended Use/Indications for Use

Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Flush, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Technological Characteristics

The heparin lock/flush syringes subject to this filing have been previously cleared by FDA under K023740 and K061497. A comparison of the products is provided in the table below.

510(k) Number		K061497	K023740
Device Name	Heparin Lock Flush,USP	Syrex Heparin LockFlush Syringes	Syrex Pre-FilledSyringe
Manufacturer	Excelsior Medical Corporation
Intended Use	Flushing of IVcatheters and IVtubing only. Solutionis intended formaintenance ofpatency ofintravenous injectiondevices. Prior to andafter administrationof intermittentmedication, entirelyflush the intravenousinjection device(catheter and or	Excelsior MedicalHeparin Lock FlushSolutions (1 Unit/mLand 2 Units/mL) areindicated for use inmaintaining patencyof vascular accessdevices designed forintermittent orinfusion therapy.Prior to and afteradministration ofintermittentmedication, entirely	Flushing of IVcatheters and IVtubing only. Prior toand afteradministration ofintermittentmedication, entirelyflush the catheterand/or tubing withHeparin Lock FlushSolution, either USP10 Units/mL, or USP100 Units/mL. Usein accordance with
	tubing) with HeparinLock Flush, USP.Use in accordancewith any warning orprecautionsappropriate tomedication beingadministered. Thisdevice is not to beused for anti-coagulant therapy.	flush the vascularaccess device withHeparin Lock FlushSolution, USP. Usein accordance withany warning orprecautionsappropriate tomedication beingadministered. Thisdevice is not to beused for anti-coagulant therapy	any warning orprecautionsappropriate tomedication beingadministered. Thisdevice is not to beused for anti-coagulant therapy.Protect from freezingand avoid excessiveheat. Store at 25°C(77°F); excursionspermitted to 15°-30°C (59°-86°F).
Solution	Heparin Lock FlushSolution, USP (0.9%Sodium ChlorideInjection, USP)	Heparin Lock FlushSolution, USP (0.9%Sodium ChlorideInjection, USP)	Heparin Lock FlushSolution, USP (0.9%Sodium ChlorideInjection, USP)
Concentrations	1 U/mL2 U/mL10 U/mL100 U/mL	1 U/mL2 U/mLN/AN/A	N/AN/A10 U/mL100 U/mL
Single UseDevice	Yes	Yes	Yes
Sterility	Terminally sterilizedvia steam; SAL 10-6	Terminally sterilizedvia steam; SAL 10-6	Terminally sterilizedvia steam; SAL 10-6
BarrelMaterial	Polypropylene andsilicone lubricant	Polypropylene andsilicone lubricant	Polypropylene
Plunger RodMaterial	Medical gradepolypropylene	Medical gradepolypropylene	Medical gradepolypropylene
Piston	Synthetic isoprenerubber	Synthetic isoprenerubber	Synthetic isoprenerubber
Tip Cap	Medical gradepolypropylene andTPE plus colorant	Medical gradepolypropylene andTPE plus colorant	Medical gradepolypropylene andTPE plus colorant
Tip CapColorants	1 U/mL - Green2 U/mL - Lavender10 U/mL - Blue100 U/mL - Yellow	1 U/mL - Green2 U/mL - Lavender	10 U/mL - Blue100 U/mL - Yellow
Packaging	Tamper evident over-wrap	Tamper evident over-wrap	Tamper evident over-wrap

{5}------------------------------------------------

As seen above there are no significant differences between the subject and predicate devices. The purpose of this submission is to add alternate suppliers of the heparin sodium (USP) raw material for all of Excelsior Medical's heparin products.

{6}------------------------------------------------

Non-Clinical Testing

The following studies have been performed or are being relied upon to support the safety and effectiveness of the product:

Raw material qualification ●
Biocompatibility (ISO 10993-1) ●
Stability Studies ●
Sterilization validation (ISO 17665-1 and -2) ●
Extractables/Leachables
Testing of final product to Heparin Lock Flush Solution USP Monograph

Conclusion

As noted above, the only change to the Heparin Lock Flush, USP products as cleared in K023749 and K061497 is the source of heparin. This change is supported by the studies cited above, and results of the testing show that there are no new questions of safety and effectiveness. Therefore, it is concluded that the product is as safe and as effective for use, and is substantially equivalent to the identified predicate devices.

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).