Heparin Lock Flush Solution, USP product code 505701 (10 USP units/mL) and product code 504901 (100 USP Units/mL), is intended to maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.

Device Description

The Heparin Lock Flush Solution, USP product code 505701 comes in concentration of 10 USP Units/mL, and in strengths of 10 USP units. The Heparin Lock Flush Solution, USP product code 504901 comes in concentration of 100 USP Units/mL, and in strength of 100 USP units. These two product codes are packaged in 3 cc plastic vials.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, Heparin Lock Flush Solution USP. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials as one might see for novel AI software. Therefore, the questions related to AI-specific study designs, reader performance, and ground truth establishment in a diagnostic context are not directly applicable.

Instead, the "acceptance criteria" here relate to demonstrating biocompatibility and stability, and the "study" involves laboratory testing.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was tested for)	Reported Device Performance (Test Results)
Biocompatibility
Cytotoxicity (MEM Elution test)	Sample met USP and ISO requirements; found to be non-cytotoxic.
Hemolysis (ASTM Hemolysis Direct Contact)	Samples were found to be non-hemolytic.
Chemical Stability/Leachables
Presence of TMTBB (HPLC limit test)	TMTBB was not detected after sterilization or over the shelf life.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a number of "patients" or "cases" but rather samples of the Heparin Lock Flush Solution, USP. For the biocompatibility tests (cytotoxicity, hemolysis) and the leachable test, specific quantities of the product were used. The document does not specify the exact number of solution samples tested, but it refers to "the sample" for cytotoxicity and "the samples" for hemolysis.
Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective medical data. These were laboratory tests performed on the manufactured product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for these types of tests is established by adherence to recognized laboratory standards (USP, ISO, ASTM) and analytical methods, not by expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set:

Not applicable. The tests performed are objective laboratory measurements with pass/fail criteria based on established scientific standards, not subjective interpretations requiring adjudication.

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:

No. This is a medical device (a pharmaceutical solution), not an AI diagnostic tool. Therefore, MRMC studies and AI-specific effectiveness measures are not relevant or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a pharmaceutical solution, not an algorithm.

7. The type of ground truth used:

Biocompatibility: Established by adherence to industry standards (USP, ISO, ASTM) for cytotoxicity and hemolysis. The "ground truth" is that the material must meet the specified safe limits as defined by these standards.
Chemical Stability/Leachables: Established using a scientifically validated analytical method (HPLC limit test) to detect the presence of a specific compound (TMTBB). The "ground truth" is the verifiable absence (below detection limits) of the leachable.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable. (See #8)

Summary

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

K0929438
p 1 of 3

510(K) SUMMARY

(as required by 807.92(c))

	JUN 1 8 2010
Regulatory Correspondent	Arthur WardRegulatory and Marketing Services962 Allegro LnApollo Beach, FL 33572(813) 645-2855award@ajwtech.com / Awconsltng@aol.com
Submitter of 510(k):	APP Pharmaceuticals, LLC1501 East Woodfield Rd, Suite 300 EastSchaumburg, IL 60173USAPhone: (847) 330-3898Fax: (847) 413-8570
Contact Person:	Aditi Dron
Date of Summary:	June 18, 2010
Trade/Proprietary Name:	Heparin Lock Flush Solution USP
Classification Name:	Heparin, vascular access flush
Product Code:	NZW
Intended Use:	Heparin Lock Flush Solution, USP product code505701 (10 USP units/mL) and product code504901 (100 USP Units/mL), is intended tomaintain patency of an indwelling venipuncturedevice designed for intermittent injection orinfusion therapy or blood sampling.
Device Description:	The Heparin Lock Flush Solution, USP productcode 505701 comes in concentration of 10 USPUnits/mL, and in strengths of 10 USP units. TheHeparin Lock Flush Solution, USP product code504901 comes in concentration of 100 USPUnits/mL, and in strength of 100 USP units. Thesetwo product codes are packaged in 3 cc plastic vials

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

K092938
p2df3

Technological Characteristics:

Heparin Lock Flush Solution, USP, product codes 505701 (10 USP Units/mL, preservative-free, 1 mL fill volume) and 504901 (100 USP Units/mL, preservative-free, 1 mL fill volume) are single dose preservative free presentations of Heparin Lock Flush Solution, USP. They differ from the other FDA-approved product codes (504401, 504411, 504501, and 504505) since these are preserved with methylparaben and propylparaben. Another existing product code (1710) is also preservative free but it has a larger fill volume of 10 mL per vial.

K001795 - 10 & 100 USP Units/mL Heparin

Vascular Access Flush Device

Predicate Device:

Substantial Equivelance:

APP claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K001795. APP claims this equivalence because the proposed devices have an equivalent intended use, manufacturing materials, operating principles and physical operational specifications as compared to the predicate devices. The similarities and differences between the proposed and predicate devices have been identified and explained in the comparison matrix which has been included in Section 9 of this submission. These differences have no effect on safety and effectiveness.

Test Summary:

APP has performed cytotoxicity and hemolysis tests to demonstrate the biocompatibility of the final finished sterilized Heparin Lock Flush Solutions, USP. A MEM Elution test to determine the cytotoxicity of extractable substances was performed. The test results demonstrate that the sample met USP and ISO requirements. Therefore, the sample was found to be non-cytotoxic. The hemolysis test was conducted in accordance with US FDA regulations per 21 CFR Part 58 utilizing the ASTM Hemolysis (Direct Contact) Method.

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

K692938 p 30 3

The samples of Heparin Lock Flush Solution, USP were found to be non-hemolytic. APP has also developed a test method to detect the presence of a potential leachable from the polypropylene vials into the Heparin Lock Flush Solution, USP. The potential leachable is 1,3,5-trimethyl-2,4,6-tris(3,5di-tert-butyl-4-hydroxybenzyl) benzene (TMTBB). This compound has been identified by the resin manufacturer as a compound present in their resin material used to produce the vial used for the Heparin Lock Flush Solution, USP. APP analyzed freshly prepared samples as well as stability samples of Heparin Lock Flush Solution, USP using a high performance liquid chromatography (HPLC) limit test method for the determination of TMTBB. The results demonstrated that TMTBB is not detected in Heparin Lock Flush Solution, USP following sterilization or over the shelf life of the solution.

Test Conclusion:

The biocompatibility of Heparin Lock Flush Solution, USP following sterilization has been tested using cytotoxicity and hemolysis testing. Furthermore, potential leachables from the polypropylene vials into the Heparin Lock Flush Solution, USP have also been studied. The results of these studies indicate that APP's Heparin Lock Flush Solution, USP product codes 504901 and 505701 are non-cytotoxic, non-hemolytic, and free from leachables. Therefore, we consider the devices to be substantially equivalent.

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

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing its wings or body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

APP Pharmaceuticals, LLC C/O Mr. Arthur Ward Regulatory and Marketing Services 962 Allegro Lane Apollo Beach, Florida 33572

JUN 1 8 2010

Re: K092938

Trade/Device Name: Heparin Lock Flush Solution USP, Models 504901 and 505701 Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NZW Dated: May 19, 2010 Received: May 20, 2010

Dear Mr. Ward:

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.

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

Page 2-Mr. Ward

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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Susan Romero

Anthony D. Watson, B.S., M.S., M.B.A. Director

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

Enclosure

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

Indications for Use

510(k) Number (if known): K092938

Device Name: Heparin Lock Flush Solution

Indications for Use:

Heparin Lock Flush Solution, USP product code 505701 (10 Units/mL) and product code 504901 (100 USP Units/mL) is intended to maintain patency of an indwelling venipuncture device designed for intermittent injection or infusion therapy or blood sampling.

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

-(Division-Sign=Off)_

Division of Anesthesiology, General Hospital Concurrence of CDRH, Office of Device Ey (Alexandar Control Dental Devices

510(k) Number: JK 092938

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).