(162 days)
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 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.
The provided text is a 510(k) summary for the Praxiject™ 0.9% NaCl prefilled syringe, a medical device. It describes the device, its intended use, and comparative non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's the information extracted from the document regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| 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. Undersealed areas, oversealed areas (hard/brittle seal), narrow seals: 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 |
| 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: | To verify formulation of the Sodium Chloride solution meets the USP requirements | Assay of Sodium Chloride: 0.855 to 0.945% NaCl | Conforms |
| - pH per USP <791> | pH: 4.5 to 7.0 | Conforms | |
| - Identification of Sodium and Chloride per USP <191> | Identification: Successful identification | Conforms | |
| - Particulate matter per USP <788> | Particulate matter: ≥ 10μm: ≤ 6000 part/syringe; ≥ 25μm: ≤ 600 part/syringe | Conforms | |
| - Bacterial Endotoxins per USP <85> | Bacterial Endotoxins: ≤ 0.5 EU/mL | Conforms | |
| - Elemental Impurities (Heavy Metals) per USP<232>/<233> (Class I elements) | Elemental Impurities: Arsenic: ≤ 1.5μg/g; Cadmium: ≤ 0.2μg/g; Mercury: ≤ 0.3μg/g; Lead: ≤ 0.5μg/g | Conforms | |
| - Iron per USP <24> | Iron: ≤ 2ppm | 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 |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each individual test. It lists "non-clinical testing" as the study type. The reference to standards like ASTM and USP monographs implies that the testing was performed on physical samples of the device and its packaging.
- Data Provenance: The tests are described as "non-clinical testing" performed by MedXL Inc. The country of origin of the data is not specifically stated, but the manufacturer's address is in Pointe-Claire, Quebec, Canada. The data is retrospective as it was performed prior to the submission of the 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The studies performed are non-clinical (physical and chemical tests) and do not involve human interpretation or the establishment of ground truth by experts in a clinical context. The "ground truth" is determined by the results of the standardized tests against their defined acceptance criteria.
4. Adjudication method for the test set:
Not applicable. This concept applies to studies involving human interpretation or subjective assessments, which is not the case for these non-clinical tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a non-clinical device (prefilled saline syringe) and does not involve AI assistance, human readers, or clinical effectiveness studies in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve algorithms or AI.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests is established by pre-defined, objective acceptance criteria derived from recognized industry standards (ASTM, ISO) and pharmaceutical monographs (USP). For example, the definition of an acceptable seal, specific chemical concentrations, or maximum particulate matter levels.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML device, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, this question is not relevant.
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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
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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
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Indications for Use
510(k) Number (if known)
Device Name Praxiject™ 0.9% NaCl
Indications for Use (Describe)
The Praxiject™ 0.9% NaCl prefilled syringe with 0.9% Sodium Chloride Injection, USP, is intended only for flushing vascular access devices. May be placed on a sterile field.
| Type of Use (Select one or both, as applicable) |
|---|
| 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.
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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.
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Technological Characteristics Comparison Table
Shown below is a side-by-side comparison of key device characteristics between the subject device and the predicate device.
| DeviceCharacteristic | Predicate DevicePraxiject™ 0.9% NaCl (K171109) | Subject DevicePraxiject™ 0.9% NaCl (K192414) | Comparison |
|---|---|---|---|
| Indications for Use | The Praxiject™ 0.9% NaCl prefilledsyringe with 0.9% Sodium ChlorideInjection, USP, is intended only forflushing vascular access devices.May be placed on a sterile field. | The Praxiject™ 0.9% NaCl prefilledsyringe with 0.9% Sodium ChlorideInjection, USP, is intended only forflushing vascular access devices.May be placed on a sterile field. | Identical |
| Design | Prefilled plastic piston syringe withLuer lock connection fitting and non-vented, female Luer lock tip cap. | Prefilled plastic piston syringe withLuer lock connection fitting and non-vented, female Luer lock tip cap. | Identical |
| Syringe Size andFill Volumes | 3 mL in 5 cc syringe5 mL in 5 cc syringe3 mL in 10 cc syringe5 mL in 10 cc syringe10 mL in 10 cc syringe | 3 mL in 5 cc syringe5 mL in 5 cc syringe3 mL in 10 cc syringe5 mL in 10 cc syringe10 mL in 10 cc syringe | Identical |
| Fill VolumeGraduations | 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 gammaradiation, 10-6 SAL | Terminally sterilized by gammaradiation, 10-6 SAL | Identical |
| Shelf Life | 2 years | 2 years | Identical |
| SyringeMaterial | Barrel and Plunger: PolypropylenePiston: Bromobutyl rubber(Not made with natural rubber latex)Tip Cap: ABS with white colorant | Barrel and Plunger: PolypropylenePiston: Bromobutyl rubber(Not made with natural rubber latex)Tip Cap: ABS with white colorant | Identical |
| DeviceCharacteristic | Predicate DevicePraxiject™ 0.9% NaCl (K171109) | Subject DevicePraxiject™ 0.9% NaCl (K192414) | Comparison |
| Syringe Packaging | Plastic peel pouch (printed on oneside, clear on the other) - all sizes andfill volumes | Plastic peel pouch (printed on oneside, clear on the other) - all sizes andfill volumesORAluminum foil pouch (printed on oneside) – 10 mL in 10 cc syringe | Different |
| Content of SyringePackage | One syringe per pouch | One syringe per pouch | Identical |
| Shipping PackageConfiguration | 100 syringes (10 cc) or 120 syringes(5cc) per case / 6 cases per shippingcarton – all sizes and fill volumes | 100 syringes (10 cc) or 120 syringes(5cc) per case / 6 cases per shippingcarton – all sizes and fill volumes inplastic peel pouchOR115 syringes per double bag /4 double bags per shipping carton -10 mL in 10 cc syringe in aluminumfoil 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 perASTM F1886 | To verify pouch sealintegrity | No visible unsealed areas,channels/pathway across widthof seal, tears/holes: Reject ondetection* | Conforms |
| Undersealed areas, oversealedareas (hard/brittle seal), narrowseals (thinning along length ofseal): non defective seal widthshould be greater than 67% ofnominal seal width* | Conforms | ||
| Bubble emission test of pouch perASTM D3078 | To verify the integrity ofthe product packaging(pouch) | No leaks (no bubbles emittedupon immersion, no fluidinside the package) | Conforms |
| Test Methodology / Standard | Purpose | Acceptance Criteria | Results |
| Visual inspection of prefilled syringefor damage | To ensure the prefilledsyringe is not damaged ina way that would preventits use | No critical damage (consistentwith instructions for use); noleaks | Conforms |
| Test for liquid leakage and resistanceof luer lock fitting | To ensure the prefilledsyringe is adequatelysealed | No leaks; no cracks | Conforms |
| Test for integrity of printed label perASTM F2250 | To verify the integrity ofthe printed information isadequate for the intendeduse environment | Print must remain defined andlegible, color must not lighten,ink must not run(Slight smudging of ink ortransfer to swab is allowable) | Conforms |
| Test of formulation per SodiumChloride Injection USP monograph:- Assay of Sodium Chloride (perUSP monograph)- pH per USP<791>- Identification of Sodium andChloride per USP <191>- Particulate matter per USP <788>- Bacterial Endotoxins per USP <85>- Elemental Impurities (HeavyMetals) per USP<232>/<233>(Class I elements)- Iron per USP <24> | To verify formulation ofthe Sodium Chloridesolution meets the USPrequirements | See below for individual testacceptance criteria:0.855 to 0.945% NaCl4.5 to 7.0Successful identification≥ 10μm: ≤ 6000 part/syringe≥ 25μm: ≤ 600 part/syringe≤ 0.5 EU/mLArsenic: ≤ 1.5μg/gCadmium: ≤ 0.2μg/gMercury: ≤ 0.3μg/gLead: ≤ 0.5μg/gIron: ≤ 2ppm | Conforms(See below)ConformsConformsConformsConformsConformsConforms |
| Distribution cycle (Transport)Validation per ASTM D4169,Distribution Cycle 13 | To ensure the packagingmaintains productintegrity under anticipatedshipping and handlingconditions | Packaging and syringe integrityper ISO 11607-1 | Conforms |
| Sterilization Validation | To establish the minimumirradiation dose requiredto render the productsterile | 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.
§ 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).