HEPARIN LOCK FLUSH SYRINGE

K032417 · Am2 Pat, Inc. · FOZ · Dec 23, 2003 · General Hospital

Device Facts

• Record ID: K032417
• Device Name: HEPARIN LOCK FLUSH SYRINGE
• Applicant: Am2 Pat, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Dec 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Device is a sterile, single-use, pre-filled piston-type syringe containing 10 or 100 USP u/ml Heparin Lock Flush Solution. Components include a polypropylene barrel, polypropylene plunger, polyisoprene seal, and luer lock adapter or blunt tip cannula. Used in clinical settings to flush intravenous administration sets and indwelling intravascular access devices. Operated manually by healthcare professionals. Device maintains patency of access devices by preventing occlusion. Benefits include sterile, ready-to-use delivery of heparin solution, reducing preparation time and potential for contamination.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including stability testing, container/closure suitability, and material biocompatibility testing per USP Class VI and ISO 10993 standards.

Technological Characteristics

Polypropylene barrel, plunger, and luer lock adapter; polyisoprene seal. Sterile, single-use, manual piston-type syringe. Pre-filled with 10 or 100 USP u/ml Heparin Lock Flush Solution. Materials meet USP Class VI and ISO 10993 Part 1 requirements. Aseptic manufacturing process.

Indications for Use

Indicated for flushing compatible intravenous administration sets and indwelling intravenous access devices in patients requiring such maintenance.

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

• Saline IV Flush Syringe (K002142)
• BD PosiFlushTM Heparin Lock Flush Syringe (K011967)
• Heparin Lock Flush Syringe (K003245)
• Heparin IV Flush Syringe (K020996)

Submission Summary (Full Text)

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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: [phone] [phone] 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 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.

#### 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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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 [phone]. 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 [phone] or [phone] 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