(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 / Visual inspection | Clear and colorless; Free of visible foreign solid particles |
| Solution Volume | ISO 7886-1, USP | 3 mL in 5 cc syringe: 3.0–3.4 mL |
| 3 mL in 10 cc syringe: 3.0-3.6 mL | ||
| 5 mL in 5 cc syringe: 5.0-5.6 mL | ||
| 5 mL in 10 cc syringe: 5.0-6.0 mL | ||
| 10 mL in 10 cc syringe: 10.0–11.0 mL | ||
| 20 mL in 20 cc syringe: 20.0-22.0 mL | ||
| Assay | USP Sodium Chloride Injection | 0.855 - 0.945% (w/v) |
| Identification | USP Sodium and Chloride | Meets USP requirements |
| Bacterial Endotoxins | USP , USP | ≤ 0.5 USP EU/mL |
| Particulate Matter | USP | Particles ≥ 10 µm: ≤ 6000/syringe; |
| Particles ≥ 25 µm: ≤ 600/syringe | ||
| pH | USP | 4.5 - 7.0 |
| Elemental Impurities | USP and USP (Class I elements) | Arsenic: |
| 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 | Sterile |
| Sterilization Method Validation | ISO 11137-1, ISO 11137-2, USP (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 | Acceptable extractables/leachables profile; Negligible risk of health hazard |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitizer |
| Irritation | ISO 10993-23 | Non-irritant |
| Hemolysis | ISO 10993-4 (ASTM F756) | Non-hemolytic |
| Acute Systemic Toxicity | ISO 10993-11 | Non-toxic |
| Pyrogenicity | ISO 10993-11 (USP ) | Non-pyrogenic |
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.
§ 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).