Praxiject 0.9% NaCl

K171109 · Medxl, Inc. · NGT · Dec 21, 2017 · General Hospital

Device Facts

• Record ID: K171109
• Device Name: Praxiject 0.9% NaCl
• Applicant: Medxl, Inc.
• Product Code: NGT · General Hospital
• Decision Date: Dec 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.

Device Story

Praxiject™ 0.9% NaCl is a single-use, prefilled plastic piston syringe containing 0.9% Sodium Chloride Injection, USP. Device features Luer lock connection and non-vented tip cap. Available in various fill volumes (3 mL, 5 mL, 10 mL) within 5 cc or 10 cc syringe barrels. Terminally sterilized via gamma irradiation. Used in clinical settings by healthcare professionals to flush vascular access devices; maintains patency of IV catheters and tubing. Syringe barrel/plunger constructed of polypropylene; plunger stopper of bromobutyl rubber. Device is packaged in a plastic peel pouch. Clinical benefit includes standardized, sterile delivery of saline for catheter maintenance, reducing risk of contamination during flushing procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including USP 39-NF34 solution compliance, ISO 7886-1 syringe performance, and comprehensive biocompatibility testing (ISO 10993-1, -4, -5, -10, -11, -18). Testing confirmed non-hemolytic, non-cytotoxic, non-sensitizing, and non-irritant properties. Particulate matter and bacterial endotoxins met USP <788>, <85>, and <161> requirements. Shelf life validated per ISO 11607-1.

Technological Characteristics

Single-use plastic piston syringe; barrel/plunger: polypropylene; plunger: bromobutyl rubber; tip cap: ABS. Luer lock connection. Sterilization: gamma radiation (10-6 SAL). Standards: ISO 7886-1 (syringe performance), ISO 10993 series (biocompatibility), ISO 11607-1 (packaging), USP <788> (particulates), USP <85>/<161> (endotoxins).

Indications for Use

Indicated for flushing vascular access devices in patients requiring intravenous catheter maintenance. Suitable for use on a sterile field.

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

• Excelsior Saline Pre-filled Syringe(s) in Sterile Field Packaging (K082837)

Submission Summary (Full Text)

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December 21, 2017

MedXL Inc. Premala Premanathan Regulatory Affairs Associate Contact Address

Re: K171109

Trade/Device Name: Praxiject™ 0.9% NaCl Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: November 28, 2017 Received: November 30, 2017

Dear Premala Premanathan:

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.

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 of medical device-related adverse events) (21 CFR 803); 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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)

Device Name

Praxiject™ 0.9% NaCl

Indications for Use (Describe)

The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> <path d="M2,2 L14,14 M14,2 L2,14" stroke="black" stroke-width="2"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-family: Arial, sans-serif;"> <svg height="16" width="16"> <rect fill="white" height="16" stroke="black" stroke-width="1" width="16" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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December 20, 2017

| Trade Name: | Praxiject™ 0.9% NaCl |
|-------------------------|-----------------------------------------------------------------------------------------------------------|
| Common Name: | Saline Flush Syringe |
| Classification Name: | Saline, Vascular Access Flush |
| Product Code: | NGT |
| Regulation: | 21 CFR §880.5200 |
| Regulatory Class: | Class II |
| Submitter/Manufacturer: | MedXL Inc. |
| Address: | 285 Av Labrosse<br>Pointe Claire, Quebec H9R 1A3, Canada<br>Tel: [phone] Fax: [phone] |
| Contact: | Premala Premanathan, Regulatory Affairs Associate |

This 510(k) Summary has been prepared in accordance with 21 CFR §807.92.

## Predicate Device

K082837, Excelsior Saline Pre-filled Syringe(s) in Sterile Field Packaging - Excelsior Medical Corp.

## Device Description

The Praxiject™ 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled fill volume with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. Each prefilled syringe is individually packaged in a plastic peel pouch and terminally sterilized by gamma irradiation.

### Intended Use / Indications for Use

The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.

### Comparison of Technological Characteristics

The Praxiject™ 0.9% NaCl prefilled syringe is substantially equivalent to the predicate device in fundamental technology, product design and materials, operating principles, and performance characteristics for the intended use. The differences between the two devices have been addressed by material and device component qualification, process and packaging validation, and finished product release testing in conformance with recognized consensus standards.

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| Device<br>Characteristic | Predicate Device (K082837) | Praxiject™ 0.9% NaCl |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Excelsior Sterile Field Saline Flush<br>Syringe(s) are intended for use in<br>flushing IV catheters and IV tubing. | The Praxiject™ 0.9% NaCl prefilled<br>syringe with 0.9% Sodium Chloride<br>Injection, USP, is intended only for<br>flushing vascular access devices.<br>May be placed on a sterile field. |
| Design | Prefilled plastic piston syringe with<br>Luer lock connection fitting and<br>non-vented, female Luer lock tip cap | Prefilled plastic piston syringe with<br>Luer lock connection fitting and<br>non-vented, female Luer lock tip cap. |
| Syringe Size and<br>Fill Volumes | 10 mL in 10 cc syringe | 3 mL in 5 cc syringe<br>5 mL in 5 cc syringe<br>3 mL in 10 cc syringe<br>5 mL in 10 cc syringe<br>10 mL in 10 cc syringe |
| Fill Volume<br>Graduations | On syringe label | On syringe label |
| Syringe Content | 0.9% Sodium Chloride Injection, USP | 0.9% Sodium Chloride Injection, USP |
| Labeled<br>Non-pyrogenic | Yes | Yes |
| Single Use Only | Yes | Yes |
| Sterile | Yes | Yes |
| Use on Sterile Field | Yes | Yes |
| Sterilization<br>Method | Terminally sterilized by<br>steam, 10-6 SAL | Terminally sterilized by<br>gamma radiation, 10-6 SAL |
| Shelf Life | 2 years | 2 years |
| Syringe Material | - Barrel and Plunger: Polypropylene<br>- Plunger: Isoprene rubber (Not made<br>with natural rubber latex)<br>- Tip Cap: Polypropylene with white<br>colorant | - Barrel and Plunger: Polypropylene<br>- Plunger: Bromobutyl rubber (Not<br>made with natural rubber latex)<br>- Tip Cap: ABS with white colorant |
| Syringe Packaging | Plastic peel pouch (printed on one<br>side, clear on the other) | Plastic peel pouch (printed on one<br>side, clear on the other) |
| Content of Syringe<br>Package | One or two syringes per pouch | One syringe per pouch |

A side-by-side comparison of key device characteristics is presented in the following table.

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## Summary of Non-Clinical Testing

The design and manufacturing of Praxiject™ 0.9% NaCl prefilled syringes are subject to verification and validation testing in conformance with regulatory guidance and recognized consensus standards.

| Device / Performance<br>Characteristic | Performance Standard | Results |
|-------------------------------------------|----------------------------------------------------|-----------------------------------------------|
| Solution | Sodium Chloride Injection,<br>USP 39-NF34 | Conforms |
| Plastic syringe | ISO 7886-1, 0 mL average syringe<br>induced reflux | Conforms |
| Biocompatibility | ISO 10993-1 | N/A |
| - Hemolysis | ISO 10993-4 (ASTM F756) | Non-hemolytic |
| - Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| - Sensitization | ISO 10993-10 | Non-sensitizer |
| - Irritation/Intracutaneous<br>reactivity | ISO 10993-10 | Non-irritant |
| - Acute system toxicity | ISO 10993-11 | No systemic toxicity |
| - Material—mediated<br>pyrogenity | ISO 10993-11 (USP <151>) | No material mediated<br>response observed |
| - Bacterial Endotoxins | USP <85> and USP <161><br>(≤ 0.5 EU/mL) | Conforms |
| - Chemical<br>characterization | ISO 10993-18 | Acceptable<br>extractables/leachables profile |
| - Particulate matter | USP <788> | Conforms |

The shelf life of the final finished sterilized device was evaluated using the recognized consensus standard on the requirements for materials, sterile barrier systems and packaging systems for terminally sterilized medical devices (ISO 11607-1).

## Substantial Equivalence Conclusion

The results of the above described non-clinical testing demonstrate that the Praxiject™ 0.9% NaCl prefilled syringe fulfills the established performance criteria and it is substantially equivalent to the predicate device.