(106 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a prefilled syringe, with no mention of AI or ML.
No
The device is described as a prefilled syringe containing normal saline for flushing vascular access devices, not for therapeutic intervention in the body.
No
This device is a prefilled syringe containing sterile saline for flushing vascular access devices, not for diagnosing medical conditions.
No
The device description clearly describes a physical prefilled syringe containing saline solution, 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 "For vascular access devices flushing only." This describes a procedure performed on a patient's vascular access device, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The device is a prefilled syringe containing saline solution. This is a medical device used for flushing, not a reagent or instrument used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for flushing a medical device.
N/A
Intended Use / Indications for Use
For vascular access devices flushing only. Sterile fluid path only. Not for use on a sterile field.
Product codes
NGT
Device Description
The Praxiject™ SP 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled volume of 10mL with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. The Praxiject™ SP 0.9% NaCl prefilled syringe is designed to maintain a sterile fluid path only and is individually packaged in a clear flexible plastic film, flow-wrapped heatsealed pouch that functions only as a protective barrier (dust cover). The device is 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)
The design and manufacturing of the Praxiject™ SP 0.9% NaCl prefilled syringe is subject to risk assessment per ISO 14971 and verification and validation testing in conformance with regulatory guidance and consensus standards applicable to this device type. Non-clinical testing included evaluation of the 0.9% Sodium Chloride Solution (Assay, Identification, pH, Bacterial Endotoxins, Particulate Matter, Elemental Impurities, Iron, Appearance, Volume), Sterility, Sterilization Method Validation, Shelf-life (Stability), Syringe Design and Container closure integrity, Package integrity, Biological Safety Evaluation, Chemical Characterization (Extractables/Leachables), Cytotoxicity, Sensitization, Irritation, Hemolysis, Acute Systemic Toxicity, and Pyrogenicity. Clinical testing was not required for device evaluation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
February 27, 2024
MedXL Inc. Faiza Benazza Regulatory Affairs Specialist 285 Avenue Labrosse Pointe-Claire, QC H9R 1A3 Canada
Re: K233623
Trade/Device Name: Praxiject™ SP 0.9% NaCl Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: January 31, 2024 Received: January 31, 2024
Dear Faiza Benazza:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233623
Device Name Praxiject™ SP 0.9% NaCl
Indications for Use (Describe)
For vascular access devices flushing only. Sterile fluid path only. Not for use on a sterile field.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for MEDXL. The letters "MED" are in blue, and the letters "XL" are in red. To the right of the letters is a red line that resembles a heartbeat.
..............................................................................................................................................................................
510(k) Summary - K233623
February 23, 2024
| Device Trade Name: | Praxiject™ SP 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. |
| 285 Av. Labrosse | |
| Pointe Claire, Quebec H9R 1A3, Canada | |
| Tel: (+1) 514.693.3150 Fax: (+1) 514.695.1511 | |
| Regulatory Contact: | Faiza Benazza, Regulatory Affairs Specialist |
Predicate Device
| Device Trade Name: | Praxiject™ 0.9% NaCl |
|---|---|
| 510(k) Number: | K231754 |
| Classification: | Class II, 21 CFR §880.5200, Saline, Vascular Access Flush |
| Product Code: | NGT |
Device Description
The Praxiject™ SP 0.9% NaCl prefilled syringe is a single use plastic piston syringe with a Luer lock connection fitting, prefilled to labeled volume of 10mL with 0.9% Sodium Chloride Injection, USP, with no preservatives (normal saline), and capped with a plastic tip cap. The Praxiject™ SP 0.9% NaCl prefilled syringe is designed to maintain a sterile fluid path only and is individually packaged in a clear flexible plastic film, flow-wrapped heatsealed pouch that functions only as a protective barrier (dust cover). The device is terminally sterilized by gamma irradiation.
Intended Use / Indications for Use
For vascular access devices flushing only. Sterile fluid path only. Not for use on a sterile field.
Comparison of Technological Characteristics
The Praxiject™ SP 0.9% NaCl prefilled syringe is similar to the predicate device in intended use, indications for use, fundamental technology, operating principles, and performance characteristics. Technological differences in tip cap design and in syringe form and packaging of the Praxiject™ SP 0.9% NaCl that is supplied with a sterile fluid path only have been addressed by labeling and conformity to consensus standards. A side-by-side comparison of key device characteristics is presented in the following table:
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Image /page/5/Picture/0 description: The image shows the logo for MEDXL. The letters "MED" are in blue, and the letters "XL" are in red. To the right of the letters is a red line that resembles an EKG readout.
| Device
Characteristic | Predicate Device
Praxiject™ 0.9% NaCl
(K231754) | Subject Device
Praxiject™ SP
0.9% NaCl | Comparison Analysis |
|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | For vascular access devices
flushing only. Sterile fluid path
only. Not for use on a sterile
field. | Same indications for use and
intended use with explicit labeling
to indicate that the subject device is
designed to maintain a sterile fluid
path only and it is not suitable for
use on a sterile field. |
| Syringe 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 slip tip cap | Different. Luer slip tip cap design
and syringe form factor differences.
Devices meet the same safety and
performance standards. |
| 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
20 mL in 20 cc syringe | 10 mL in 10 cc syringe | Different. The subject device is
supplied only in one syringe size
and fill volume, within the range
offered with the predicate device. |
| Fill Volume
Graduations | On syringe label | On syringe label | Identical. |
| Syringe Content
(normal saline) | 0.9% Sodium Chloride Injection,
USP | 0.9% Sodium Chloride
Injection, USP | Identical. |
| Non-pyrogenic | Yes | Yes | Identical. |
| Single Use Only | Yes | Yes | Identical. |
| Sterile Device | Yes | Sterile Fluid Path Only | Different. The difference in use
environment is addressed by
labeling and distinct packaging. |
| Sterilization
Method | Terminally sterilized by gamma
radiation,
10-6 SAL | Terminally sterilized by gamma
radiation,
10-6 SAL | Identical. Validated sterilization
process. |
| Shelf Life | 2 years | 1 year | Different: Devices meet the same
functional, biological safety and
stability standards. |
| Syringe Material | Barrel and Plunger:
Polypropylene
Piston: Bromobutyl rubber (Not
made with natural rubber latex)
Tip Cap: ABS with white
colorant | Barrel and Plunger:
Polypropylene
Piston: Bromobutyl rubber (Not
made with natural rubber latex)
Tip Cap: Polypropylene &
Thermoplastic elastomer with
white colorant | Identical barrel, plunger and piston
material.
Different tip cap material.
Devices meet the same biological
safety and stability standards. |
| Device
Characteristic | Predicate Device
Praxiject™ 0.9% NaCl
(K231754) | Subject Device
Praxiject™ SP
0.9% NaCl | Comparison Analysis |
| Syringe
Packaging | Sterile Barrier: Plastic heat-
sealed peel pouch (printed on
one side, clear on the other) –
all sizes and fill volumes; OR
Aluminum foil heat-sealed
pouch (printed on one side) –
10 mL in 10 cc syringe | Dust Cover: Clear plastic heat-
sealed flow-wrapped pouch
(printed one side with: “Do Not
Place Syringe On Sterile
Field”) | Different.
The subject device meets applicable
consensus standards for package and
device integrity to the point of care. |
| Content of
Syringe Package | One syringe per pouch | One syringe per pouch | Identical. |
| Dispensing Case
and Sterilization/
Shipping Carton
Configuration | 60 syringes (20cc), 100 syringes
(10 cc), or 120 syringes (5cc) per
case / 6 cases per shipping carton
– all sizes and fill volumes in
plastic peel pouch OR
115 syringes per double bag / 4
double bags per shipping carton
– only 10mL in 10cc syringe in
aluminum foil pouch | 30 syringes (10 cc) per
cosmetic box;
6 cosmetic boxes per shipping
carton | Different.
The sterilization process was
revalidated for the packaging of the
subject devices.
Current consensus standards were
applied for package and device
integrity to the point of care. |
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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, going through the "X" in XL. To the right of the "XL" is a red line that resembles an EKG.
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Summary of Non-Clinical Testing
The design and manufacturing of the Praxiject™ SP 0.9% NaCl prefilled syringe is subject to risk assessment per ISO 14971 and verification and validation testing in conformance with regulatory guidance and consensus standards applicable to this device type:
| Performance Characteristic | Performance Standard | Acceptance Criteria | |
|---|---|---|---|
| 0.9% | |||
| Sodium | |||
| Chloride | |||
| Solution | Assay | USP Sodium Chloride Injection | 0.855 – 0.945% (w/v) |
| Identification | USP Sodium and Chloride | Meets USP requirements | |
| pH | USP | 4.5 – 7.0 | |
| Bacterial | |||
| Endotoxins | USP , USP | ≤ 0.5 USP EU/mL | |
| Particulate | |||
| Matter | USP | Particles ≥ 10 µm: ≤ 6000/syringe; | |
| Particles ≥ 25 µm: ≤ 600/syringe | |||
| Elemental | |||
| Impurities | USP and USP | Arsenic: ≤ 1.5 µg/g | |
| Cadmium: ≤ 0.2 µg/g | |||
| Lead: ≤ 0.5 µg/g | |||
| Mercury: ≤ 0.3 µg/g | |||
| Iron | USP | ≤ 2 ppm | |
| Appearance | USP / Visual inspection | Clear and colorless. | |
| Free of foreign solid particles. | |||
| Volume | ISO 7886-1, USP | 10.0 - 11.0 mL | |
| Performance Characteristic | Performance Standard | Acceptance Criteria | |
| Sterility | USP | Sterile solution | |
| Sterilization Method | |||
| Validation | ISO 11137-1, ISO 11137-2, USP | ||
| (Terminal sterilization by gamma radiation) | SAL 10-6 | ||
| Shelf-life (Stability) | 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 | |||
| Syringe Design and | |||
| Container closure integrity | ISO 7886-1, ISO 80369-7 / ISO 594-1 and | ||
| ISO 594-2 (Adapted solution leakage test) | Conformity to standards and device | ||
| specifications; Label integrity; Syringe and | |||
| tip cap seal integrity (no damage, no | |||
| leakage past piston and tip cap.) | |||
| Package integrity | ISO 11607-1, ISO 11607-2, ASTM F1980, | ||
| ASTM D4169, ISO 7886-1 and ISO 594-2 | |||
| (Syringe and tip cap integrity verification) | No structural damage to shipping carton; | ||
| Label integrity; Syringe and tip cap seal | |||
| integrity (no damage, no leakage past | |||
| piston and tip cap.) | |||
| Biological Safety 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 for the evaluation of | ||
| 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 logo is in two colors, blue and red. The letters "MED" are in blue, and the letters "XL" are in red. There is a red line going through the middle of the letters "MEDXL", and there is a red heartbeat symbol to the right of the letters "XL".
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Summary of Clinical Testing
Clinical testing was not required for device evaluation.
Conclusion
The conclusions drawn from the non-clinical testing demonstrate that the Praxiject™ SP 0.9% NaCl prefilled syringe is as safe, as effective, and performs as well as or better than the legally marketed predicate device.