Praxiject™ 0.9% NaCl
Device Facts
| Record ID | K231754 |
|---|---|
| Device Name | Praxiject™ 0.9% NaCl |
| Applicant | Medxl, Inc. |
| Product Code | NGT · General Hospital |
| Decision Date | Jul 13, 2023 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 880.5200 |
| Device Class | Class 2 |
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.
Device Story
Praxiject™ 0.9% NaCl is a single-use, prefilled plastic piston syringe containing 0.9% Sodium Chloride Injection, USP (normal saline). The device features a Luer lock connection and is capped with a plastic tip cap. It is used in clinical settings to flush vascular access devices. The device is terminally sterilized by gamma irradiation. The modification adds a 20 mL fill volume model in a 20 cc syringe, packaged in a thicker heat-sealed peel pouch. The device is operated by healthcare professionals to maintain catheter patency. It does not involve electronic processing, software, or AI.
Clinical Evidence
No clinical data; bench testing only. Testing included verification of solution volume, assay, identification, bacterial endotoxins, particulate matter, pH, elemental impurities, iron content, syringe closure integrity, pouch integrity, sterility, shelf-life stability, distribution simulation, and comprehensive biocompatibility (cytotoxicity, sensitization, irritation, hemolysis, systemic toxicity, pyrogenicity).
Technological Characteristics
Materials: Polypropylene (barrel/plunger), Bromobutyl rubber (piston), ABS (tip cap). Principle: Manual hydraulic flushing. Energy: None. Dimensions: 3 mL to 20 mL fill volumes. Connectivity: None. Sterilization: Gamma radiation (SAL 10^-6). Software: None.
Indications for Use
Indicated for flushing vascular 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
- Praxiject™ 0.9% NaCl (K192414)
Reference Devices
- Praxiject™ 0.9% NaCl (K171109)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 13, 2023
MedXL Inc. Hina Saini Regulatory Affairs Specialist 285 Avenue Labrosse Pointe-Claire, QC H9R 1A3 Canada
Re: K231754
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: June 12, 2023 Received: June 15, 2023
Dear Hina Saini:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
K231754
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)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for MEDXL. The letters "MED" are in a dark blue color, while the "XL" is in red. A red line extends from the "X" in "XL" and forms a waveform pattern, resembling an electrocardiogram (ECG) or heart rate monitor display.
# 510(k) Summary
July 12, 2023
| Submission Number: | K231754 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Device 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 |
| Classification Panel: | General Hospital |
| Submitter/Manufacturer: | MedXL Inc.<br>285 Av. Labrosse<br>Pointe Claire, Quebec H9R 1A3, Canada<br>Tel: (+1) 514.693.3150 Fax: (+1) 514.695.1511 |
| Regulatory Contact: | Hina Saini, Regulatory Affairs Specialist |
Regulatory Contact:
#### Primary Predicate Device
| Device Trade Name: | Praxiject™ 0.9% NaCl |
|--------------------|-----------------------------------------------------------|
| 510(k) Number: | K192414 |
| Classification: | Class II, 21 CFR §880.5200, Saline, Vascular Access Flush |
| Product Code: | NGT |
#### Reference Device
| Device Trade Name: |
|--------------------|
| 510(k) Number: |
| Classification: |
| Product Code: |
Praxiject™ 0.9% NaCl K171109 Class II, 21 CFR §880.5200, Saline, Vascular Access Flush NGT
#### Device Description
The Praxiject™ family of 0.9% NaCl prefilled syringes marketed in the U.S.A. includes the following models: 37043US (3 mL/5 cc), 3704US (5 mL/5 cc), 37053US (3 mL/10 cc), 37055 US (5 mL/10 cc), 3705CUS (10 mL/10 cc), 3705-1US (10 mL/10 cc) and 3706US (20 mL/20 cc). These devices are single use plastic piston syringes with a Luer lock connection fitting, prefilled to labeled volume with 0.9% Sodium Chloride Injection USP, with no preservatives (normal saline), and capped with a plastic tip cap. Model 3705-1US (10 mL/10 cc) is individually packaged in a heat-sealed foil pouch, all other models are individually packaged in a heat-sealed peel pouch. All Praxiject™ 0.9% NaCl prefilled syringes are terminally sterilized by gamma irradiation.
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Image /page/4/Picture/0 description: The image shows the logo for MEDXL. The logo is split into two colors, with "MED" in a dark blue and "XL" in red. A red line extends from the "D" in MED, going through the "X" in XL, and then extending to the right in a wave pattern, resembling a heart rate monitor.
#### Device Modifications
MedXL has extended the Praxiject™ 0.9% NaCl prefilled syringe family to include an additional model with 20 mL fill volume in a 20 cc piston syringe (20 mL/20 cc) individually packaged in a thicker heatsealed peel pouch to account for the increased size and weight of the 20 mL/20 cc model is distributed in a standard size shipping carton containing 6 cases of 60 syringes each. The modified Praxiject™ 0.9% NaCl prefilled syringe family contains 0.9% Sodium Chloride Injection USP that is produced by MedXL to USP specifications and current recognized quality standards.
#### Intended Use / Indications for Use
The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing of vascular access devices. May be placed on a sterile field.
#### Comparison of Technological Characteristics Between the Subject Device and the Primary Predicate and Reference Devices
The modified Praxiject™ 0.9% NaCl prefilled syringe is identical to the primary predicate device and reference device in fundamental technology, product design and materials, operating principles, and performance characteristics for the intended use. The differences in technological characteristics have been addressed by material and device component qualification, biocompatibility studies, process and packaging validation, and finished product release testing in conformance with recognized consensus standards. A side-by-side comparison of device characteristics is presented in the following table.
| Device<br>Characteristic | Primary Predicate Device<br>Praxiject™ 0.9% NaCl<br>(K192414) | Reference Device<br>Praxiject™ 0.9% NaCl<br>(K171109) | Subject Device<br>Praxiject™ 0.9% NaCl<br>(K231754) | Comparison |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Praxiject™ 0.9% NaCl<br>prefilled syringe with 0.9%<br>Sodium Chloride Injection,<br>USP, is intended only for<br>flushing vascular access<br>devices. May be placed on<br>a sterile field. | The Praxiject™ 0.9% NaCl<br>prefilled syringe with 0.9%<br>Sodium Chloride Injection,<br>USP, is intended only for<br>flushing vascular access<br>devices. May be placed on<br>a sterile field. | The Praxiject™ 0.9% NaCl<br>prefilled syringe with 0.9%<br>Sodium Chloride Injection,<br>USP, is intended only for<br>flushing vascular access<br>devices. May be placed on<br>a sterile field. | Identical |
| Design | Prefilled plastic piston<br>syringe with Luer lock<br>connection fitting and non-<br>vented, female Luer lock<br>tip cap. | Prefilled plastic piston<br>syringe with Luer lock<br>connection fitting and non-<br>vented, female Luer lock<br>tip cap | Prefilled plastic piston<br>syringe with Luer lock<br>connection fitting and non-<br>vented, female Luer lock<br>tip cap. | Identical |
| Syringe Size<br>and<br>Fill Volumes | 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 | 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 | 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<br>20 mL in 20 cc syringe | Different.<br>New<br>20mL/20cc<br>model<br>produced to<br>same standard |
| Fill Volume<br>Graduations | On syringe label | On syringe label | On syringe label | Identical |
| Device<br>Characteristic | Primary Predicate Device<br>Praxiject™ 0.9% NaCl<br>(K192414) | Reference Device<br>Praxiject™ 0.9% NaCl<br>(K171109) | Subject Device<br>Praxiject™ 0.9% NaCl<br>(K231754) | Comparison |
| Syringe<br>Content | 0.9% Sodium Chloride<br>Injection USP | 0.9% Sodium Chloride<br>Injection USP | 0.9% Sodium Chloride<br>Injection USP | Same USP<br>specifications<br>but produced<br>by MedXL to<br>current quality<br>standards |
| Labeled<br>Non-pyrogenic | Yes; Bacterial Endotoxin<br>testing per USP <85> and<br><161>: < 0.5 EU/mL | Yes; Bacterial Endotoxin<br>testing per USP <85> and<br><161>: < 0.5 EU/mL | Yes; Bacterial Endotoxin<br>testing per USP <85> and<br><161>: < 0.5 EU/mL | Identical |
| Single Use<br>Only | Yes | Yes | Yes | Identical |
| Sterile | Yes | Yes | Yes | Identical |
| Sterilization<br>Method | Terminally sterilized by<br>gamma radiation, 10-6 SAL | Terminally sterilized by<br>gamma radiation, 10-6 SAL | Terminally sterilized by<br>gamma radiation, 10-6 SAL | Identical |
| Use on Sterile<br>Field | Yes | Yes | Yes | Identical |
| Shelf Life | 2 years | 2 years | 2 years | Identical |
| Syringe<br>Material | Barrel and Plunger:<br>Polypropylene<br>Piston: Bromobutyl rubber<br>(Not made with natural<br>rubber latex)<br>Tip Cap: ABS with white<br>colorant | Barrel and Plunger:<br>Polypropylene<br>Piston: Bromobutyl rubber<br>(Not made with natural<br>rubber latex)<br>Tip Cap: ABS with white<br>colorant | Barrel and Plunger:<br>Polypropylene<br>Piston: Bromobutyl rubber<br>(Not made with natural<br>rubber latex)<br>Tip Cap: ABS with white<br>colorant | Identical |
| Syringe<br>Packaging | Plastic peel pouch (printed<br>on one side, clear on the<br>other) - all sizes and fill<br>volumes<br>OR<br>Aluminum foil pouch<br>(printed on one side) - 10<br>mL in 10 cc syringe | Plastic peel pouch (printed<br>on one side, clear on the<br>other) - all sizes and fill<br>volumes | Plastic peel pouch (printed<br>on one side, clear on the<br>other) - all sizes and fill<br>volumes; thicker plastic<br>used for 20 mL/20cc<br>prefilled syringe OR<br>Aluminum foil pouch<br>(printed on one side) - 10<br>mL in 10 cc syringe | Different<br>pouch material<br>thickness for<br>the 20mL/20cc<br>model. Same<br>performance<br>specifications |
| Content of<br>Syringe Package | One syringe per pouch | One syringe per pouch | One syringe per pouch | Identical |
| Shipping<br>Package<br>Configuration | 100 syringes (10 cc) or 120<br>syringes (5cc) per case / 6<br>cases per shipping carton -<br>all sizes and fill volumes in<br>plastic peel pouch | 100 syringes (10 cc) or 120<br>syringes (5cc) per case / 6<br>cases per shipping carton -<br>all sizes and fill volumes in<br>plastic peel pouch | 60 syringes (20cc), 100<br>syringes (10 cc), or 120<br>syringes (5cc) per case / 6<br>cases per shipping carton -<br>all sizes and fill volumes in<br>plastic peel pouch | Different<br>packaging<br>quantity for<br>20 mL/20cc<br>model. |
| Device<br>Characteristic | Primary Predicate Device<br>Praxiject™ 0.9% NaCl<br>(K192414) | Reference Device<br>Praxiject™ 0.9% NaCl<br>(K171109) | Subject Device<br>Praxiject™ 0.9% NaCl<br>(K231754) | Comparison |
| | OR<br>115 syringes per double bag | | OR<br>115 syringes per double | Same<br>performance<br>specifications |
| | | | | |
| | / 4 double bags per shipping<br>carton - only 10 mL in 10<br>cc syringe in aluminum foil<br>pouch | | bag / 4 double bags per<br>shipping carton – only<br>10mL in 10cc syringe in<br>aluminum foil pouch | |
| | | | | |
| | | | | |
| | | | | |
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Image /page/5/Picture/0 description: The image shows the logo for MedXL. The logo has the company name in bold, blue letters, with the "X" and "L" in red. To the right of the logo is the company's contact information, including their address at 285 Labrosse, Pointe-Claire (Qc), Canada, H9R 1A3. The phone number is +1 514.695.7474, the fax number is +1 514.695.1511, and the website is www.medxl.com.
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Image /page/6/Picture/0 description: The image shows the logo for MEDXL. The letters "MED" are in a dark blue color, while the "XL" is in red. A red line extends from the "D" in MED, through the "X" in XL, and then turns into a heartbeat line.
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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. Below is a summary of the non-clinical testing and manufacturing controls that apply to this device modification.
| Device Specification | Standard | Acceptance Criteria |
|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Piston Syringe Testing (Each production lot) | | |
| Design and Performance<br>Requirements | ISO 7886-1; ISO 80369-7 (ISO 594-1<br>and ISO 594-2) | Conformity to standards and device<br>specifications |
| Finished Device Testing (Each production lot) | | |
| - Appearance of Solution | USP <790> / Visual inspection | Clear and colorless; Free of visible<br>foreign solid particles |
| - Solution Volume | ISO 7886-1, USP <1151> | 3 mL in 5 cc syringe: 3.0–3.4 mL<br>3 mL in 10 cc syringe: 3.0-3.6 mL<br>5 mL in 5 cc syringe: 5.0-5.6 mL<br>5 mL in 10 cc syringe: 5.0-6.0 mL<br>10 mL in 10 cc syringe: 10.0–11.0 mL<br>20 mL in 20 cc syringe: 20.0-22.0 mL |
| - Assay | USP Sodium Chloride Injection | 0.855 - 0.945% (w/v) |
| - Identification | USP <191> Sodium and Chloride | Meets USP requirements |
| - Bacterial Endotoxins | USP <85>, USP <161> | ≤ 0.5 USP EU/mL |
| - Particulate Matter | USP <788> | Particles ≥ 10 µm: ≤ 6000/syringe;<br>Particles ≥ 25 µm: ≤ 600/syringe |
| - pH | USP <791> | 4.5 - 7.0 |
| - Elemental Impurities | USP <232> and USP <233><br>(Class I elements) | Arsenic: < 1.5 µg/g<br>Cadmium: < 0.2 µg/g<br>Lead: < 0.5 µg/g<br>Mercury: < 0.3 µg/g |
| - Iron | USP <241> | ≤ 2 ppm |
| - Syringe Closure<br>Integrity | ISO 7886-1, ISO 594-2 (Adapted<br>solution leakage test) | No damage, no leakage past piston and<br>syringe tip cap |
| - Pouch Integrity | ASTM D3078 (Vacuum bubble<br>emissions test) | No stream of bubbles; no leaks |
| Device Specification | Standard | Acceptance Criteria |
| Sterility and Shelf-life Testing (Design Verification and Validation) | | |
| Sterility of Solution and<br>Syringe Exterior | USP <71> | Sterile |
| Sterilization Method<br>Validation | ISO 11137-1, ISO 11137-2, USP <61><br>(Terminal sterilization by<br>gamma radiation) | SAL 10-6 |
| Shelf-life (Stability Study) | FDA Guidance: Shelf Life of Medical<br>Devices (1991); FDA Guidance: Q1D<br>Bracketing and Matrixing Designs for<br>Stability Testing of New Drug<br>Substances and Products (2003) | Device specifications must be maintained<br>for the labeled shelf life |
| Distribution Simulation Testing (Design Verification and Validation) | | |
| Device & Package Integrity | ASTM D4169 (Distribution Cycle 13,<br>Assurance Level II); ISO 11607-1;<br>ASTM F1886 (Visual seal integrity<br>verification); ASTM D3078 (Vacuum<br>bubble emissions test); ISO 7886-1 and<br>ISO 594-2 (Syringe and tip cap integrity<br>verification) | No structural damage to shipping carton;<br>Pouch/seal integrity - No seal defects; no<br>stream of bubbles and no leaks during<br>vacuum bubble emissions testing;<br>Syringe integrity - No critical damage,<br>no leaks past syringe cap or gasket;<br>Luer lock (tip cap) connection - No<br>cracks, no leaks |
| Biocompatibility Testing (Design Verification and Validation) | | |
| Biological Evaluation | ISO 10993-1; FDA Guidance: Use of<br>International Standard ISO 10993-1,<br>Biological evaluation of medical devices<br>Part 1: Evaluation and testing within a<br>risk management process (2020) | Compliant process and evaluation for<br>external communicating devices intended<br>for indirect blood path contact with<br>limited duration |
| Chemical Characterization<br>(Extractables/Leachables) | ISO 10993-18, ISO 10993-17<br>USP <467> | Acceptable extractables/leachables<br>profile; Negligible risk of health hazard |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitizer |
| Irritation | ISO 10993-23 | Non-irritant |
| Hemolysis | ISO 10993-4 (ASTM F756) | Non-hemolytic |
| Acute Systemic Toxicity | ISO 10993-11 | Non-toxic |
| Pyrogenicity | ISO 10993-11 (USP <151>) | Non-pyrogenic |
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Image /page/7/Picture/0 description: The image shows the logo for MEDXL. The letters "MED" are in a dark blue, blocky font. The letters "XL" are in red, and a red line extends from the "X" to the right, forming a stylized heartbeat waveform. The logo is simple and modern, with a clear emphasis on the company name.
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#### Summary of Clinical Testing
Clinical testing was not required for this device modification.
### Conclusion
The conclusions drawn from the non-clinical testing demonstrate that the modified Praxiject™ 0.9% NaCl prefilled syringe, is as safe, as effective, and performs as well as or better than the legally marketed primary predicate device.
