HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710

K092938 · App Pharmaceuticals, LLC · NZW · Jun 18, 2010 · General Hospital

Device Facts

• Record ID: K092938
• Device Name: HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710
• Applicant: App Pharmaceuticals, LLC
• Product Code: NZW · General Hospital
• Decision Date: Jun 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Indications for Use

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 Story

Heparin Lock Flush Solution, USP is a sterile, preservative-free anticoagulant solution supplied in 3 cc polypropylene vials. It is used by clinicians to flush indwelling venipuncture devices to maintain patency between intermittent injections, infusions, or blood sampling. The solution prevents clot formation within the catheter lumen. The device is a pharmaceutical-grade liquid; it does not involve electronic processing, algorithms, or software. It is intended for prescription use in clinical settings.

Clinical Evidence

Bench testing only. Biocompatibility demonstrated via MEM Elution cytotoxicity testing (USP/ISO compliant) and hemolysis testing (ASTM Direct Contact Method). Leachable analysis for TMTBB in polypropylene vials performed via HPLC; results confirmed TMTBB was not detected following sterilization or over shelf life.

Technological Characteristics

Preservative-free Heparin Lock Flush Solution, USP. Concentrations: 10 USP Units/mL and 100 USP Units/mL. Fill volume: 1 mL. Packaging: 3 cc polypropylene vials. Sterilization: Terminal sterilization. Biocompatibility: Non-cytotoxic, non-hemolytic.

Indications for Use

Indicated for maintaining patency of indwelling venipuncture devices used for intermittent injection, infusion therapy, or blood sampling in patients requiring such vascular access.

Regulatory Classification

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.

Predicate Devices

• 10 & 100 USP Units/mL Heparin (K001795)

Submission Summary (Full Text)

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K0929438
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# 510(K) SUMMARY
(as required by 807.92(c))

| | JUN 1 8 2010 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Correspondent | Arthur Ward<br>Regulatory and Marketing Services<br>962 Allegro Ln<br>Apollo Beach, FL 33572<br>[phone]<br>[e-mail] / [e-mail] |
| Submitter of 510(k): | APP Pharmaceuticals, LLC<br>1501 East Woodfield Rd, Suite 300 East<br>Schaumburg, IL 60173<br>USA<br>Phone: [phone]<br>Fax: [phone] |
| 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 code<br>505701 (10 USP units/mL) and product code<br>504901 (100 USP Units/mL), is intended to<br>maintain patency of an indwelling venipuncture<br>device designed for intermittent injection or<br>infusion therapy or blood sampling. |
| Device Description: | The Heparin Lock Flush Solution, USP product<br>code 505701 comes in concentration of 10 USP<br>Units/mL, and in strengths of 10 USP units. The<br>Heparin Lock Flush Solution, USP product code<br>504901 comes in concentration of 100 USP<br>Units/mL, and in strength of 100 USP units. These<br>two product codes are packaged in 3 cc plastic vials |

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K092938
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#### 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.

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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.

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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.

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#### 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 [phone] or [phone] 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

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## 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