(28 days)
No
The device is a prefilled syringe for flushing vascular access devices and the description focuses on its physical characteristics, materials, and sterilization process. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is intended only for flushing vascular access devices, which is a maintenance task rather than a treatment of a disease or condition.
No
The device description clearly states its intended use is "only for flushing vascular access devices," which is a maintenance and procedural function, not diagnosis. Diagnostic devices are used to identify or determine the nature of a disease or condition.
No
The device description clearly describes a physical syringe prefilled with saline, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "only for flushing vascular access devices." This is a procedural use, not a diagnostic one. IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device is a prefilled syringe containing saline solution. This is a medical device used for a physical action (flushing), not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There are no reagents, test strips, or analytical components typically associated with IVDs.
The device is clearly a medical device used for a therapeutic or procedural purpose (flushing), not for in vitro diagnosis.
N/A
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.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was performed as summarized in the table:
- Piston Syringe Testing (Each production lot): Design and Performance Requirements. Standard: ISO 7886-1; ISO 80369-7 (ISO 594-1 and ISO 594-2). Acceptance Criteria: Conformity to standards and device specifications.
- Finished Device Testing (Each production lot): Appearance of Solution, Solution Volume, Assay, Identification, Bacterial Endotoxins, Particulate Matter, pH, Elemental Impurities, Iron, Syringe Closure Integrity, Pouch Integrity. Standards include USP , USP , USP Sodium Chloride Injection, USP , USP , USP , USP , USP , USP , USP , USP , ISO 7886-1, ISO 594-2, ASTM D3078. Acceptance Criteria are listed for each parameter, verifying compliance with USP limits, functional performance (no leaks, no damage), and specific volume ranges.
- Sterility and Shelf-life Testing (Design Verification and Validation): Sterility of Solution and Syringe Exterior, Sterilization Method Validation, Shelf-life (Stability Study). Standards include USP , ISO 11137-1, ISO 11137-2, USP , FDA Guidance: Shelf Life of Medical Devices (1991); FDA Guidance: Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products (2003). Acceptance Criteria: Sterile, SAL 10-6, device specifications maintained for the labeled shelf life.
- Distribution Simulation Testing (Design Verification and Validation): Device & Package Integrity. Standards include ASTM D4169 (Distribution Cycle 13, Assurance Level II); ISO 11607-1; ASTM F1886 (Visual seal integrity verification); ASTM D3078 (Vacuum bubble emissions test); ISO 7886-1 and ISO 594-2 (Syringe and tip cap integrity verification). Acceptance Criteria: No structural damage to shipping carton; Pouch/seal integrity - No seal defects, no stream of bubbles and no leaks during vacuum bubble emissions testing; Syringe integrity - No critical damage, no leaks past syringe cap or gasket; Luer lock (tip cap) connection - No cracks, no leaks.
- Biocompatibility Testing (Design Verification and Validation): Biological Evaluation, Chemical Characterization (Extractables/Leachables), Cytotoxicity, Sensitization, Irritation, Hemolysis, Acute Systemic Toxicity, Pyrogenicity. Standards include ISO 10993-1; FDA Guidance: Use of International Standard ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (2020); ISO 10993-18, ISO 10993-17, USP ; ISO 10993-5; ISO 10993-10; ISO 10993-23; ISO 10993-4 (ASTM F756); ISO 10993-11, ISO 10993-11 (USP ). Acceptance Criteria: Compliant process and evaluation for external communicating devices intended for indirect blood path contact with limited duration; Acceptable extractables/leachables profile; Negligible risk of health hazard; Non-cytotoxic; Non-sensitizer; Non-irritant; Non-hemolytic; Non-toxic; Non-pyrogenic.
Clinical testing was not required for this device modification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission 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)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
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. |
| 285 Av. Labrosse | |
| Pointe Claire, Quebec H9R 1A3, Canada | |
| 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.
4
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
Characteristic | Primary Predicate Device
Praxiject™ 0.9% NaCl
(K192414) | Reference Device
Praxiject™ 0.9% NaCl
(K171109) | Subject Device
Praxiject™ 0.9% NaCl
(K231754) | Comparison |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| 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. | 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. | 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. | Identical |
| Design | Prefilled plastic piston
syringe with Luer lock
connection fitting and non-
vented, female Luer lock
tip cap. | Prefilled plastic piston
syringe with Luer lock
connection fitting and non-
vented, female Luer lock
tip cap | Prefilled plastic piston
syringe with Luer lock
connection fitting and non-
vented, female Luer lock
tip cap. | Identical |
| Syringe Size
and
Fill Volumes | 3 mL in 5 cc syringe
5 mL in 5 cc syringe
3 mL in 10 cc syringe
5 mL in 10 cc syringe
10 mL in 10 cc syringe | 3 mL in 5 cc syringe
5 mL in 5 cc syringe
3 mL in 10 cc syringe
5 mL in 10 cc syringe
10 mL in 10 cc syringe | 3 mL in 5 cc syringe
5 mL in 5 cc syringe
3 mL in 10 cc syringe
5 mL in 10 cc syringe
10 mL in 10 cc syringe
20 mL in 20 cc syringe | Different.
New
20mL/20cc
model
produced to
same standard |
| Fill Volume
Graduations | On syringe label | On syringe label | On syringe label | Identical |
| Device
Characteristic | Primary Predicate Device
Praxiject™ 0.9% NaCl
(K192414) | Reference Device
Praxiject™ 0.9% NaCl
(K171109) | Subject Device
Praxiject™ 0.9% NaCl
(K231754) | Comparison |
| Syringe
Content | 0.9% Sodium Chloride
Injection USP | 0.9% Sodium Chloride
Injection USP | 0.9% Sodium Chloride
Injection USP | Same USP
specifications
but produced
by MedXL to
current quality
standards |
| Labeled
Non-pyrogenic | Yes; Bacterial Endotoxin
testing per USP and
: and
: and
: / Visual inspection | Clear and colorless; Free of visible
foreign solid particles |
| - Solution Volume | ISO 7886-1, USP | 3 mL in 5 cc syringe: 3.0–3.4 mL
3 mL in 10 cc syringe: 3.0-3.6 mL
5 mL in 5 cc syringe: 5.0-5.6 mL
5 mL in 10 cc syringe: 5.0-6.0 mL
10 mL in 10 cc syringe: 10.0–11.0 mL
20 mL in 20 cc syringe: 20.0-22.0 mL |
| - Assay | USP Sodium Chloride Injection | 0.855 - 0.945% (w/v) |
| - Identification | USP Sodium and Chloride | Meets USP requirements |
| - Bacterial Endotoxins | USP , USP | ≤ 0.5 USP EU/mL |
| - Particulate Matter | USP | Particles ≥ 10 µm: ≤ 6000/syringe;
Particles ≥ 25 µm: ≤ 600/syringe |
| - pH | USP | 4.5 - 7.0 |
| - Elemental Impurities | USP and USP
(Class I elements) | Arsenic: | ≤ 2 ppm |
| - Syringe Closure
Integrity | ISO 7886-1, ISO 594-2 (Adapted
solution leakage test) | No damage, no leakage past piston and
syringe tip cap |
| - Pouch Integrity | ASTM D3078 (Vacuum bubble
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
Syringe Exterior | USP | Sterile |
| Sterilization Method
Validation | ISO 11137-1, ISO 11137-2, USP
(Terminal sterilization by
gamma radiation) | SAL 10-6 |
| Shelf-life (Stability Study) | FDA Guidance: Shelf Life of Medical
Devices (1991); FDA Guidance: Q1D
Bracketing and Matrixing Designs for
Stability Testing of New Drug
Substances and Products (2003) | Device specifications must be maintained
for the labeled shelf life |
| Distribution Simulation Testing (Design Verification and Validation) | | |
| Device & Package Integrity | ASTM D4169 (Distribution Cycle 13,
Assurance Level II); ISO 11607-1;
ASTM F1886 (Visual seal integrity
verification); ASTM D3078 (Vacuum
bubble emissions test); ISO 7886-1 and
ISO 594-2 (Syringe and tip cap integrity
verification) | No structural damage to shipping carton;
Pouch/seal integrity - No seal defects; no
stream of bubbles and no leaks during
vacuum bubble emissions testing;
Syringe integrity - No critical damage,
no leaks past syringe cap or gasket;
Luer lock (tip cap) connection - No
cracks, no leaks |
| Biocompatibility Testing (Design Verification and Validation) | | |
| Biological Evaluation | ISO 10993-1; FDA Guidance: Use of
International Standard ISO 10993-1,
Biological evaluation of medical devices
Part 1: Evaluation and testing within a
risk management process (2020) | Compliant process and evaluation for
external communicating devices intended
for indirect blood path contact with
limited duration |
| Chemical Characterization
(Extractables/Leachables) | ISO 10993-18, ISO 10993-17
USP | Acceptable extractables/leachables
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 ) | 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.
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
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.