(28 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™ 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.
The provided document is a 510(k) Pre-Market Notification for a medical device called Praxiject™ 0.9% NaCl, which is a prefilled saline flush syringe. The purpose of this notification is to demonstrate that the modified device is substantially equivalent to legally marketed predicate devices.
The document does not describe a study involving an AI/ML device, a "test set" of data, or "ground truth" as typically understood in the context of evaluating AI/ML performance. Instead, it details the analytical and performance testing conducted for a physical medical device to ensure its safety and effectiveness.
Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to this document as they are specific to AI/ML device evaluation.
However, I can extract information related to acceptance criteria and device performance based on the non-clinical testing summary.
1. A table of acceptance criteria and the reported device performance
The document provides a comprehensive table of "Device Specification," "Standard," and "Acceptance Criteria" under the "Summary of Non-Clinical Testing" section. The "reported device performance" is implicitly stated as meeting these acceptance criteria, as the conclusion states, "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." This implies all listed acceptance criteria were met.
Here is a summary of the acceptance criteria:
| Device Specification | Standard | Acceptance Criteria |
|---|---|---|
| Piston Syringe Testing (Each production lot) | ||
| Design and Performance Requirements | ISO 7886-1; ISO 80369-7 (ISO 594-1 and ISO 594-2) | Conformity to standards and device specifications |
| Finished Device Testing (Each production lot) | ||
| Appearance of Solution | USP <790> / Visual inspection | Clear and colorless; Free of visible foreign solid particles |
| Solution Volume | ISO 7886-1, USP <1151> | 3 mL in 5 cc syringe: 3.0–3.4 mL3 mL in 10 cc syringe: 3.0-3.6 mL5 mL in 5 cc syringe: 5.0-5.6 mL5 mL in 10 cc syringe: 5.0-6.0 mL10 mL in 10 cc syringe: 10.0–11.0 mL20 mL in 20 cc syringe: 20.0-22.0 mL |
| Assay | USP Sodium Chloride Injection | 0.855 - 0.945% (w/v) |
| Identification | USP <191> Sodium and Chloride | Meets USP requirements |
| 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 |
| pH | USP <791> | 4.5 - 7.0 |
| Elemental Impurities | USP <232> and USP <233> (Class I elements) | Arsenic: < 1.5 µg/gCadmium: < 0.2 µg/gLead: < 0.5 µg/gMercury: < 0.3 µg/g |
| Iron | USP <241> | ≤ 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 |
| Sterility and Shelf-life Testing (Design Verification and Validation) | ||
| Sterility of Solution and Syringe Exterior | USP <71> | Sterile |
| Sterilization Method Validation | ISO 11137-1, ISO 11137-2, USP <61> (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 <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)
This information is not provided in a way that is applicable to an AI/ML "test set." The document describes non-clinical testing of a physical device. While specific sample sizes and testing methodologies are implied by the listed standards (e.g., ISO, ASTM, USP), the exact sample sizes for each test are not explicitly enumerated in this summary. Data provenance, in terms of country of origin or retrospective/prospective collection, is not relevant for this type of device submission.
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. "Ground truth" and "experts" are terms used in the context of evaluating diagnostic AI/ML models. This document describes the physical and chemical testing of a medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This refers to methods for resolving discrepancies in expert interpretations, which is not relevant for physical device testing.
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 type of study specifically for evaluating AI/ML diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to the standalone performance of an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance is objective measurements against established international and USP standards for product quality, safety, and performance (e.g., pH, sterility, particle count, leakage, biocompatibility).
8. The sample size for the training set
Not applicable. This concept pertains to AI/ML model development.
9. How the ground truth for the training set was established
Not applicable. This concept pertains to AI/ML model development.
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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
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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
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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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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. LabrossePointe Claire, Quebec H9R 1A3, CanadaTel: (+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.
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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.
| DeviceCharacteristic | Primary Predicate DevicePraxiject™ 0.9% NaCl(K192414) | Reference DevicePraxiject™ 0.9% NaCl(K171109) | Subject DevicePraxiject™ 0.9% NaCl(K231754) | Comparison |
|---|---|---|---|---|
| Indicationsfor Use | The Praxiject™ 0.9% NaClprefilled syringe with 0.9%Sodium Chloride Injection,USP, is intended only forflushing vascular accessdevices. May be placed ona sterile field. | The Praxiject™ 0.9% NaClprefilled syringe with 0.9%Sodium Chloride Injection,USP, is intended only forflushing vascular accessdevices. May be placed ona sterile field. | The Praxiject™ 0.9% NaClprefilled syringe with 0.9%Sodium Chloride Injection,USP, is intended only forflushing vascular accessdevices. May be placed ona sterile field. | Identical |
| Design | Prefilled plastic pistonsyringe with Luer lockconnection fitting and non-vented, female Luer locktip cap. | Prefilled plastic pistonsyringe with Luer lockconnection fitting and non-vented, female Luer locktip cap | Prefilled plastic pistonsyringe with Luer lockconnection fitting and non-vented, female Luer locktip cap. | Identical |
| Syringe SizeandFill 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 | 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 | Different.New20mL/20ccmodelproduced tosame standard |
| Fill VolumeGraduations | On syringe label | On syringe label | On syringe label | Identical |
| DeviceCharacteristic | Primary Predicate DevicePraxiject™ 0.9% NaCl(K192414) | Reference DevicePraxiject™ 0.9% NaCl(K171109) | Subject DevicePraxiject™ 0.9% NaCl(K231754) | Comparison |
| SyringeContent | 0.9% Sodium ChlorideInjection USP | 0.9% Sodium ChlorideInjection USP | 0.9% Sodium ChlorideInjection USP | Same USPspecificationsbut producedby MedXL tocurrent qualitystandards |
| LabeledNon-pyrogenic | Yes; Bacterial Endotoxintesting per USP <85> and<161>: < 0.5 EU/mL | Yes; Bacterial Endotoxintesting per USP <85> and<161>: < 0.5 EU/mL | Yes; Bacterial Endotoxintesting per USP <85> and<161>: < 0.5 EU/mL | Identical |
| Single UseOnly | Yes | Yes | Yes | Identical |
| Sterile | Yes | Yes | Yes | Identical |
| SterilizationMethod | Terminally sterilized bygamma radiation, 10-6 SAL | Terminally sterilized bygamma radiation, 10-6 SAL | Terminally sterilized bygamma radiation, 10-6 SAL | Identical |
| Use on SterileField | Yes | Yes | Yes | Identical |
| Shelf Life | 2 years | 2 years | 2 years | Identical |
| SyringeMaterial | Barrel and Plunger:PolypropylenePiston: Bromobutyl rubber(Not made with naturalrubber latex)Tip Cap: ABS with whitecolorant | Barrel and Plunger:PolypropylenePiston: Bromobutyl rubber(Not made with naturalrubber latex)Tip Cap: ABS with whitecolorant | Barrel and Plunger:PolypropylenePiston: Bromobutyl rubber(Not made with naturalrubber latex)Tip Cap: ABS with whitecolorant | Identical |
| SyringePackaging | Plastic peel pouch (printedon one side, clear on theother) - all sizes and fillvolumesORAluminum foil pouch(printed on one side) - 10mL in 10 cc syringe | Plastic peel pouch (printedon one side, clear on theother) - all sizes and fillvolumes | Plastic peel pouch (printedon one side, clear on theother) - all sizes and fillvolumes; thicker plasticused for 20 mL/20ccprefilled syringe ORAluminum foil pouch(printed on one side) - 10mL in 10 cc syringe | Differentpouch materialthickness forthe 20mL/20ccmodel. Sameperformancespecifications |
| Content ofSyringe Package | One syringe per pouch | One syringe per pouch | One syringe per pouch | Identical |
| ShippingPackageConfiguration | 100 syringes (10 cc) or 120syringes (5cc) per case / 6cases per shipping carton -all sizes and fill volumes inplastic peel pouch | 100 syringes (10 cc) or 120syringes (5cc) per case / 6cases per shipping carton -all sizes and fill volumes inplastic peel pouch | 60 syringes (20cc), 100syringes (10 cc), or 120syringes (5cc) per case / 6cases per shipping carton -all sizes and fill volumes inplastic peel pouch | Differentpackagingquantity for20 mL/20ccmodel. |
| DeviceCharacteristic | Primary Predicate DevicePraxiject™ 0.9% NaCl(K192414) | Reference DevicePraxiject™ 0.9% NaCl(K171109) | Subject DevicePraxiject™ 0.9% NaCl(K231754) | Comparison |
| OR115 syringes per double bag | OR115 syringes per double | Sameperformancespecifications | ||
| / 4 double bags per shippingcarton - only 10 mL in 10cc syringe in aluminum foilpouch | bag / 4 double bags pershipping carton – only10mL in 10cc syringe inaluminum foil pouch | |||
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Image /page/5/Picture/0 description: The image shows the logo for MedXL. The logo has the company name in bold, blue letters, with the "X" and "L" in red. To the right of the logo is the company's contact information, including their address at 285 Labrosse, Pointe-Claire (Qc), Canada, H9R 1A3. The phone number is +1 514.695.7474, the fax number is +1 514.695.1511, and the website is www.medxl.com.
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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, through the "X" in XL, and then turns into a heartbeat line.
……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Summary of Non-Clinical Testing
The design and manufacturing of Praxiject™ 0.9% NaCl prefilled syringes are subject to verification and validation testing in conformance with regulatory guidance and recognized consensus standards. Below is a summary of the non-clinical testing and manufacturing controls that apply to this device modification.
| Device Specification | Standard | Acceptance Criteria |
|---|---|---|
| Piston Syringe Testing (Each production lot) | ||
| Design and PerformanceRequirements | ISO 7886-1; ISO 80369-7 (ISO 594-1and ISO 594-2) | Conformity to standards and devicespecifications |
| Finished Device Testing (Each production lot) | ||
| - Appearance of Solution | USP <790> / Visual inspection | Clear and colorless; Free of visibleforeign solid particles |
| - Solution Volume | ISO 7886-1, USP <1151> | 3 mL in 5 cc syringe: 3.0–3.4 mL3 mL in 10 cc syringe: 3.0-3.6 mL5 mL in 5 cc syringe: 5.0-5.6 mL5 mL in 10 cc syringe: 5.0-6.0 mL10 mL in 10 cc syringe: 10.0–11.0 mL20 mL in 20 cc syringe: 20.0-22.0 mL |
| - Assay | USP Sodium Chloride Injection | 0.855 - 0.945% (w/v) |
| - Identification | USP <191> Sodium and Chloride | Meets USP requirements |
| - 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 |
| - pH | USP <791> | 4.5 - 7.0 |
| - Elemental Impurities | USP <232> and USP <233>(Class I elements) | Arsenic: < 1.5 µg/gCadmium: < 0.2 µg/gLead: < 0.5 µg/gMercury: < 0.3 µg/g |
| - Iron | USP <241> | ≤ 2 ppm |
| - Syringe ClosureIntegrity | ISO 7886-1, ISO 594-2 (Adaptedsolution leakage test) | No damage, no leakage past piston andsyringe tip cap |
| - Pouch Integrity | ASTM D3078 (Vacuum bubbleemissions test) | No stream of bubbles; no leaks |
| Device Specification | Standard | Acceptance Criteria |
| Sterility and Shelf-life Testing (Design Verification and Validation) | ||
| Sterility of Solution andSyringe Exterior | USP <71> | Sterile |
| Sterilization MethodValidation | ISO 11137-1, ISO 11137-2, USP <61>(Terminal sterilization bygamma radiation) | SAL 10-6 |
| Shelf-life (Stability Study) | FDA Guidance: Shelf Life of MedicalDevices (1991); FDA Guidance: Q1DBracketing and Matrixing Designs forStability Testing of New DrugSubstances and Products (2003) | Device specifications must be maintainedfor 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 integrityverification); ASTM D3078 (Vacuumbubble emissions test); ISO 7886-1 andISO 594-2 (Syringe and tip cap integrityverification) | No structural damage to shipping carton;Pouch/seal integrity - No seal defects; nostream of bubbles and no leaks duringvacuum bubble emissions testing;Syringe integrity - No critical damage,no leaks past syringe cap or gasket;Luer lock (tip cap) connection - Nocracks, no leaks |
| Biocompatibility Testing (Design Verification and Validation) | ||
| Biological Evaluation | ISO 10993-1; FDA Guidance: Use ofInternational Standard ISO 10993-1,Biological evaluation of medical devicesPart 1: Evaluation and testing within arisk management process (2020) | Compliant process and evaluation forexternal communicating devices intendedfor indirect blood path contact withlimited duration |
| Chemical Characterization(Extractables/Leachables) | ISO 10993-18, ISO 10993-17USP <467> | Acceptable extractables/leachablesprofile; 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 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.
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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.
§ 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).