(162 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a prefilled syringe and its contents, with no mention of AI or ML technologies.
No.
The device is intended only for flushing vascular access devices, which is a maintenance activity rather than a therapeutic treatment for a medical condition.
No
Explanation: The device is described as a prefilled syringe intended only for flushing vascular access devices. Its function is to clear or maintain the patency of vascular lines, not to diagnose a medical condition.
No
The device description clearly outlines a physical syringe prefilled with a solution, which is a hardware component, not solely 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 direct interaction with a medical device within the body (or connected to the body), not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a prefilled syringe containing saline solution. This is a delivery system for a substance used for flushing, not a reagent or instrument used to analyze a biological sample.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as:
- Reagents for detecting specific analytes.
- Instruments for analyzing biological samples (blood, urine, tissue, etc.).
- Assays or tests for diagnosing diseases or conditions.
The device's function is to physically flush a vascular access device, which is a therapeutic or procedural action, not a diagnostic test.
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™ 0.9% NaCl prefilled syringe is a single use plastic piston syringe 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. Each prefilled syringe is individually packaged in a heat-sealed pouch and 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:
- Visual inspection of pouch seals per ASTM F1886
- Purpose: To verify pouch seal integrity
- Acceptance Criteria: No visible unsealed areas, channels/pathway across width of seal, tears/holes: Reject on detection*; Undersealed areas, oversealed areas (hard/brittle seal), narrow seals (thinning along length of seal): non defective seal width should be greater than 67% of nominal seal width*
- Results: Conforms
- Bubble emission test of pouch per ASTM D3078
- Purpose: To verify the integrity of the product packaging (pouch)
- Acceptance Criteria: No leaks (no bubbles emitted upon immersion, no fluid inside the package)
- Results: Conforms
- Visual inspection of prefilled syringe for damage
- Purpose: To ensure the prefilled syringe is not damaged in a way that would prevent its use
- Acceptance Criteria: No critical damage (consistent with instructions for use); no leaks
- Results: Conforms
- Test for liquid leakage and resistance of luer lock fitting
- Purpose: To ensure the prefilled syringe is adequately sealed
- Acceptance Criteria: No leaks; no cracks
- Results: Conforms
- Test for integrity of printed label per ASTM F2250
- Purpose: To verify the integrity of the printed information is adequate for the intended use environment
- Acceptance Criteria: Print must remain defined and legible, color must not lighten, ink must not run (Slight smudging of ink or transfer to swab is allowable)
- Results: Conforms
- Test of formulation per Sodium Chloride Injection USP monograph:
- Purpose: To verify formulation of the Sodium Chloride solution meets the USP requirements
- Tests and Acceptance Criteria:
- Assay of Sodium Chloride (per USP monograph): 0.855 to 0.945% NaCl
- pH per USP: 4.5 to 7.0
- Identification of Sodium and Chloride per USP : Successful identification
- Particulate matter per USP : ≥ 10μm: ≤ 6000 part/syringe; ≥ 25μm: ≤ 600 part/syringe
- Bacterial Endotoxins per USP : ≤ 0.5 EU/mL
- Elemental Impurities (Heavy Metals) per USP/ (Class I elements): Arsenic: ≤ 1.5μg/g; Cadmium: ≤ 0.2μg/g; Mercury: ≤ 0.3μg/g; Lead: ≤ 0.5μg/g
- Iron per USP : ≤ 2ppm
- Results: Conforms (for all individual tests)
- Distribution cycle (Transport) Validation per ASTM D4169, Distribution Cycle 13
- Purpose: To ensure the packaging maintains product integrity under anticipated shipping and handling conditions
- Acceptance Criteria: Packaging and syringe integrity per ISO 11607-1
- Results: Conforms
- Sterilization Validation
- Purpose: To establish the minimum irradiation dose required to render the product sterile
- Acceptance Criteria: 10-6 SAL per ISO 11137-2
- Results: Conforms
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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 13, 2020
MedXL Inc. Premala Premanathan Regulatory Affairs Associate 285 Av Labrosse Pointe-Claire, H9R 1A3 Ca
Re: K192414
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: January 16, 2020 Received: January 21, 2020
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. 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 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
1
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 (QS) 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.
Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
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) |
|---|
| 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 "D" in MED, going through the "XL" and ending in a heartbeat-like pattern.
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
510(k) Summary K192414
February 3, 2020
| 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) 514.695.7474 Fax: (+1) 514.695.1511 | |
| Regulatory Contact: | Premala Premanathan, Regulatory Affairs Associate |
Predicate Device
| Device Trade Name: | Praxiject™ 0.9% NaCl |
|---|---|
| 510(k) Number: | K171109 |
| Classification: | Class II, 21 CFR §880.5200, Saline, Vascular Access Flush |
| Product Code: | NGT |
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 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 heat-sealed pouch and terminally sterilized by gamma irradiation.
Device Modification
The reason for this submission is the extension to the Praxiject™ 0.9% NaCl prefilled syringe line to include an additional 10 mL prefilled syringe model individually packaged in an aluminum foil pouch (as compared to the plastic peel pouch used for the predicate device models). The subject device model is distributed in four double bags with 115 syringes per double bags (as compared to six cases with 100 syringes (10 cc) or 120 syringes (5 cc) per case of the predicate device models) within a standard size shipping carton.
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.
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Image /page/4/Picture/0 description: The image shows the logo for MEDXL in blue and red. The MED is in blue, and the XL is in red. There is a red line going through the middle of the letters, and the line extends to the right of the XL in a wave pattern.
..............................................................................................................................................................................
Technological Characteristics Comparison Table
Shown below is a side-by-side comparison of key device characteristics between the subject device and the predicate device.
| Device
Characteristic | Predicate Device
Praxiject™ 0.9% NaCl (K171109) | Subject Device
Praxiject™ 0.9% NaCl (K192414) | 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. | 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. | 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 | Identical |
| Fill Volume
Graduations | On syringe label | On syringe label | Identical |
| Syringe Content | 0.9% Sodium Chloride Injection, USP | 0.9% Sodium Chloride Injection, USP | Identical |
| Labeled Non-
pyrogenic | Yes | Yes | Identical |
| Single Use Only | Yes | Yes | Identical |
| Sterile | Yes | Yes | Identical |
| Use on Sterile Field | Yes | Yes | Identical |
| Sterilization Method | Terminally sterilized by gamma
radiation, 10-6 SAL | Terminally sterilized by gamma
radiation, 10-6 SAL | Identical |
| Shelf Life | 2 years | 2 years | Identical |
| 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: ABS with white colorant | Identical |
| Device
Characteristic | Predicate Device
Praxiject™ 0.9% NaCl (K171109) | Subject Device
Praxiject™ 0.9% NaCl (K192414) | Comparison |
| Syringe Packaging | Plastic peel pouch (printed on one
side, clear on the other) - all sizes and
fill volumes | Plastic peel pouch (printed on one
side, clear on the other) - all sizes and
fill volumes
OR
Aluminum foil pouch (printed on one
side) – 10 mL in 10 cc syringe | Different |
| Content of Syringe
Package | One syringe per pouch | One syringe per pouch | Identical |
| Shipping Package
Configuration | 100 syringes (10 cc) or 120 syringes
(5cc) per case / 6 cases per shipping
carton – all sizes and fill volumes | 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 -
10 mL in 10 cc syringe in aluminum
foil pouch | Different |
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Image /page/5/Picture/0 description: The image shows the logo for MEDXL. The logo is in blue and red. The letters MED are in blue, and the letters XL are in red. There is a red line that extends from the top of the E to the top of the X, and a red line that extends from the bottom of the X to the right, forming a heart rate line.
The subject device, Praxiject™ 0.9% NaCl prefilled syringe, compares identical to the predicate device in intended use, indications for use, fundamental technology, product design, operating principles, and performance characteristics. The only difference between the subject device and the predicate device is in the primary protective packaging and shipping package configuration of the additional 10 mL prefilled syringe model.
Summary of Non-Clinical Testing
Shown below is a summary of the non-clinical testing that was performed with the subject device. The testing below was performed to demonstrate that the subject device meets the identified standards for this device type.
| Test Methodology / Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Visual inspection of pouch seals per | |||
| ASTM F1886 | To verify pouch seal | ||
| integrity | No visible unsealed areas, | ||
| channels/pathway across width | |||
| of seal, tears/holes: Reject on | |||
| detection* | Conforms | ||
| Undersealed areas, oversealed | |||
| areas (hard/brittle seal), narrow | |||
| seals (thinning along length of | |||
| seal): non defective seal width | |||
| should be greater than 67% of | |||
| nominal seal width* | Conforms | ||
| Bubble emission test of pouch per | |||
| ASTM D3078 | To verify the integrity of | ||
| the product packaging | |||
| (pouch) | No leaks (no bubbles emitted | ||
| upon immersion, no fluid | |||
| inside the package) | Conforms | ||
| Test Methodology / Standard | Purpose | Acceptance Criteria | Results |
| Visual inspection of prefilled syringe | |||
| for damage | To ensure the prefilled | ||
| syringe is not damaged in | |||
| a way that would prevent | |||
| its use | No critical damage (consistent | ||
| with instructions for use); no | |||
| leaks | Conforms | ||
| Test for liquid leakage and resistance | |||
| of luer lock fitting | To ensure the prefilled | ||
| syringe is adequately | |||
| sealed | No leaks; no cracks | Conforms | |
| Test for integrity of printed label per | |||
| ASTM F2250 | To verify the integrity of | ||
| the printed information is | |||
| adequate for the intended | |||
| use environment | Print must remain defined and | ||
| legible, color must not lighten, | |||
| ink must not run | |||
| (Slight smudging of ink or | |||
| transfer to swab is allowable) | Conforms | ||
| Test of formulation per Sodium | |||
| Chloride Injection USP monograph: |
- Assay of Sodium Chloride (per
USP monograph) - pH per USP
- Identification of Sodium and
Chloride per USP - Particulate matter per USP
- Bacterial Endotoxins per USP
- Elemental Impurities (Heavy
Metals) per USP/
(Class I elements) - Iron per USP | To verify formulation of
the Sodium Chloride
solution meets the USP
requirements | See below for individual test
acceptance criteria:
0.855 to 0.945% NaCl
4.5 to 7.0
Successful identification
≥ 10μm: ≤ 6000 part/syringe
≥ 25μm: ≤ 600 part/syringe
≤ 0.5 EU/mL
Arsenic: ≤ 1.5μg/g
Cadmium: ≤ 0.2μg/g
Mercury: ≤ 0.3μg/g
Lead: ≤ 0.5μg/g
Iron: ≤ 2ppm | Conforms
(See below)
Conforms
Conforms
Conforms
Conforms
Conforms
Conforms |
| Distribution cycle (Transport)
Validation per ASTM D4169,
Distribution Cycle 13 | To ensure the packaging
maintains product
integrity under anticipated
shipping and handling
conditions | Packaging and syringe integrity
per ISO 11607-1 | Conforms |
| Sterilization Validation | To establish the minimum
irradiation dose required
to render the product
sterile | 10-6 SAL per ISO 11137-2 | Conforms |
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Image /page/6/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. A red line goes through the middle of the letters "EDX", and a red heartbeat line is to the right of the letters "XL".
MedXL inc. | 285 Labrosse, Pointe-Claire (Qc), Canada, H9R1A3 T : +1 514.695.7474 | F : +1 514.695.1511 | www.medxl.com
Conclusion
The conclusions drawn from the nonclinical testing for the subject device, Praxiject™ 0.9% NaCl prefilled syringe, demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.