(106 days)
For vascular access devices flushing only. Sterile fluid path only. Not for use on a sterile field.
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.
The provided text is a 510(k) Pre-market Notification for a medical device called Praxiject™ SP 0.9% NaCl, a prefilled saline flush syringe. The document describes the device, its intended use, comparison to a predicate device, and non-clinical testing performed to demonstrate substantial equivalence. It explicitly states that "Clinical testing was not required for device evaluation."
Therefore, based on the information provided, it's not possible to answer questions related to clinical studies, human reader performance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth for a test set or training set in the context of an AI/algorithm-driven device. This document describes a medical device, not an AI/ML algorithm.
However, I can extract information related to the acceptance criteria and the non-clinical study that proves the device meets those criteria, as detailed in the "Summary of Non-Clinical Testing" section.
Here's the breakdown of the acceptance criteria and reported device performance from the non-clinical testing:
Acceptance Criteria and Reported Device Performance (Non-Clinical Testing)
1. A table of acceptance criteria and the reported device performance
The document provides a table outlining performance characteristics, the applicable performance standards, and the acceptance criteria. It then states, "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." This implies that the device successfully met all listed acceptance criteria through this testing, although specific "reported device performance" values are not explicitly given in the table beyond the acceptance limits.
| Performance Characteristic | Performance Standard | Acceptance Criteria |
|---|---|---|
| 0.9% Sodium Chloride Solution | ||
| Assay | USP Sodium Chloride Injection | 0.855 – 0.945% (w/v) |
| Identification | USP <191> Sodium and Chloride | Meets USP requirements |
| pH | USP <791> | 4.5 – 7.0 |
| Bacterial Endotoxins | USP <85>, USP <161> | ≤ 0.5 USP EU/mL |
| Particulate Matter | USP <788> | Particles ≥ 10 µm: ≤ 6000/syringe;Particles ≥ 25 µm: ≤ 600/syringe |
| Elemental Impurities | USP <232> and USP <233> | Arsenic: ≤ 1.5 µg/gCadmium: ≤ 0.2 µg/gLead: ≤ 0.5 µg/gMercury: ≤ 0.3 µg/g |
| Iron | USP <241> | ≤ 2 ppm |
| Appearance | USP <790> / Visual inspection | Clear and colorless.Free of foreign solid particles. |
| Volume | ISO 7886-1, USP <1151> | 10.0 - 11.0 mL |
| Sterility | USP <71> | Sterile solution |
| Sterilization Method Validation | ISO 11137-1, ISO 11137-2, USP <61>(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 maintainedfor 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 devicespecifications; Label integrity; Syringe andtip cap seal integrity (no damage, noleakage 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 sealintegrity (no damage, no leakage pastpiston 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 ofexternal communicating devices intendedfor indirect blood path contact with limitedduration |
| Chemical Characterization (Extractables/Leachables) | ISO 10993-18, ISO 10993-17USP <467> | 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 <151>) | Non-pyrogenic |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for each non-clinical test beyond implication from standard compliance. These tests are typically conducted on batches of manufactured devices following established quality control procedures. Given the manufacturing details, data provenance would be MedXL Inc., Canada. The testing is prospective in nature, as it's part of the pre-market validation for the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/ML device requiring human expert annotation or ground truth establishment in the traditional sense. The "ground truth" for non-clinical testing of a physical medical device refers to the objective, measurable properties and performance standards themselves, verified by laboratory testing protocols and validated analytical methods (e.g., chemical assays, sterility tests, physical integrity tests).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study involving subjective human interpretation or multi-reader scenarios. The testing involves objective, measurable criteria.
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. The device is a prefilled saline flush syringe, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The "device" itself is a physical medical product, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For non-clinical testing of this device, the "ground truth" is defined by established consensus standards and pharmacopeial specifications (e.g., USP standards, ISO standards) for chemical composition, sterility, physical integrity, and biological safety. These are objective, measurable parameters.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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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"
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(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
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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
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.
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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. LabrossePointe Claire, Quebec H9R 1A3, CanadaTel: (+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.
| DeviceCharacteristic | Predicate DevicePraxiject™ 0.9% NaCl(K231754) | Subject DevicePraxiject™ SP0.9% NaCl | Comparison Analysis |
|---|---|---|---|
| Indicationsfor Use | The Praxiject™ 0.9% NaClprefilled syringe with 0.9%Sodium Chloride Injection, USP,is intended only for flushingvascular access devices. May beplaced on a sterile field. | For vascular access devicesflushing only. Sterile fluid pathonly. Not for use on a sterilefield. | Same indications for use andintended use with explicit labelingto indicate that the subject device isdesigned to maintain a sterile fluidpath only and it is not suitable foruse on a sterile field. |
| Syringe Design | Prefilled plastic piston syringewith Luer lock connection fittingand non-vented, female Luerlock tip cap | Prefilled plastic piston syringewith Luer lock connectionfitting and non-vented, femaleLuer slip tip cap | Different. Luer slip tip cap designand syringe form factor differences.Devices meet the same safety andperformance standards. |
| 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 syringe20 mL in 20 cc syringe | 10 mL in 10 cc syringe | Different. The subject device issupplied only in one syringe sizeand fill volume, within the rangeoffered with the predicate device. |
| Fill VolumeGraduations | On syringe label | On syringe label | Identical. |
| Syringe Content(normal saline) | 0.9% Sodium Chloride Injection,USP | 0.9% Sodium ChlorideInjection, USP | Identical. |
| Non-pyrogenic | Yes | Yes | Identical. |
| Single Use Only | Yes | Yes | Identical. |
| Sterile Device | Yes | Sterile Fluid Path Only | Different. The difference in useenvironment is addressed bylabeling and distinct packaging. |
| SterilizationMethod | Terminally sterilized by gammaradiation,10-6 SAL | Terminally sterilized by gammaradiation,10-6 SAL | Identical. Validated sterilizationprocess. |
| Shelf Life | 2 years | 1 year | Different: Devices meet the samefunctional, biological safety andstability standards. |
| Syringe Material | Barrel and Plunger:PolypropylenePiston: Bromobutyl rubber (Notmade with natural rubber latex)Tip Cap: ABS with whitecolorant | Barrel and Plunger:PolypropylenePiston: Bromobutyl rubber (Notmade with natural rubber latex)Tip Cap: Polypropylene &Thermoplastic elastomer withwhite colorant | Identical barrel, plunger and pistonmaterial.Different tip cap material.Devices meet the same biologicalsafety and stability standards. |
| DeviceCharacteristic | Predicate DevicePraxiject™ 0.9% NaCl(K231754) | Subject DevicePraxiject™ SP0.9% NaCl | Comparison Analysis |
| SyringePackaging | Sterile Barrier: Plastic heat-sealed peel pouch (printed onone side, clear on the other) –all sizes and fill volumes; ORAluminum foil heat-sealedpouch (printed on one side) –10 mL in 10 cc syringe | Dust Cover: Clear plastic heat-sealed flow-wrapped pouch(printed one side with: “Do NotPlace Syringe On SterileField”) | Different.The subject device meets applicableconsensus standards for package anddevice integrity to the point of care. |
| Content ofSyringe Package | One syringe per pouch | One syringe per pouch | Identical. |
| Dispensing Caseand Sterilization/Shipping CartonConfiguration | 60 syringes (20cc), 100 syringes(10 cc), or 120 syringes (5cc) percase / 6 cases per shipping carton– all sizes and fill volumes inplastic peel pouch OR115 syringes per double bag / 4double bags per shipping carton– only 10mL in 10cc syringe inaluminum foil pouch | 30 syringes (10 cc) percosmetic box;6 cosmetic boxes per shippingcarton | Different.The sterilization process wasrevalidated for the packaging of thesubject devices.Current consensus standards wereapplied for package and deviceintegrity 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.
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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%SodiumChlorideSolution | Assay | USP Sodium Chloride Injection | 0.855 – 0.945% (w/v) |
| Identification | USP <191> Sodium and Chloride | Meets USP requirements | |
| pH | USP <791> | 4.5 – 7.0 | |
| BacterialEndotoxins | USP <85>, USP <161> | ≤ 0.5 USP EU/mL | |
| ParticulateMatter | USP <788> | Particles ≥ 10 µm: ≤ 6000/syringe;Particles ≥ 25 µm: ≤ 600/syringe | |
| ElementalImpurities | USP <232> and USP <233> | Arsenic: ≤ 1.5 µg/gCadmium: ≤ 0.2 µg/gLead: ≤ 0.5 µg/gMercury: ≤ 0.3 µg/g | |
| Iron | USP <241> | ≤ 2 ppm | |
| Appearance | USP <790> / Visual inspection | Clear and colorless.Free of foreign solid particles. | |
| Volume | ISO 7886-1, USP <1151> | 10.0 - 11.0 mL | |
| Performance Characteristic | Performance Standard | Acceptance Criteria | |
| Sterility | USP <71> | Sterile solution | |
| Sterilization MethodValidation | ISO 11137-1, ISO 11137-2, USP <61>(Terminal sterilization by gamma radiation) | SAL 10-6 | |
| Shelf-life (Stability) | FDA Guidance: Shelf Life of MedicalDevices (1991); FDA Guidance: Q1DBracketing and Matrixing Designs forStability Testing of New Drug Substancesand Products (2003) | Device specifications must be maintainedfor the labeled shelf life | |
| Syringe Design andContainer closure integrity | ISO 7886-1, ISO 80369-7 / ISO 594-1 andISO 594-2 (Adapted solution leakage test) | Conformity to standards and devicespecifications; Label integrity; Syringe andtip cap seal integrity (no damage, noleakage 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 sealintegrity (no damage, no leakage pastpiston and tip cap.) | |
| Biological Safety Evaluation | ISO 10993-1, FDA Guidance: Use ofInternational Standard ISO 10993-1,Biological evaluation of medical devicesPart 1: Evaluation and testing within a riskmanagement process (2020) | Compliant process for the evaluation ofexternal communicating devices intendedfor indirect blood path contact with limitedduration | |
| Chemical Characterization(Extractables/Leachables) | ISO 10993-18, ISO 10993-17USP <467> | 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 <151>) | 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".
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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.
§ 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).