(303 days)
POLYPERF® / POLYPERF® Safe connecting lines are indicated for the administration into or withdrawal of fluids from implanted ports. POLYPERF® Safe is designed to help protect against exposure to blood caused by accidental needle stick injuries.
POLYPERF®: Connection lines with Huber needle. Curved needle with luer lock and clamp with and without injection site.
POLYPERF® Safe: Safety Huber needle with connecting line. Prevention of ABE. Easy to perform positive Pressure.
Here's an analysis of the provided 510(k) summary regarding the POLYPERF® / POLYPERF® Safe device, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) summary, which often provides a high-level overview of performance data rather than a detailed study report. As such, some specific details commonly found in clinical trial reports (like exact statistical acceptance criteria values, full study designs, or detailed expert qualifications) are not fully elaborated in this type of document.
POLYPERF® / POLYPERF® Safe Device Performance Summary
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials must be biocompatible for their intended use (implied, as this is standard for medical devices with blood contact). | Performance data included with submission indicated "✓ Biocompatibility." |
| Safety and Functionality | The device must function safely and as intended (implied, encompassing aspects like fluid administration/withdrawal, connection integrity, etc.). | Performance data included with submission indicated "✓ Safety and functionality testing." For POLYPERF® Safe, this also implicitly includes the ability to prevent accidental needle stick injuries. |
| Clinical Handiness & Safety | POLYPERF® Safe must be clinically handy and safe to use, specifically in preventing accidental needle stick injuries. | Performance data included with submission indicated "✓ Clinical evaluation of the handiness and the safety of use of Polyperf® safe." The conclusion states that "Performance data demonstrates safety, effectiveness and substantial equivalence." This implies the device met the criteria for handiness and safety. |
| Substantial Equivalence | POLYPERF® / POLYPERF® Safe must be substantially equivalent to its predicate devices concerning intended use and technological characteristics. | "POLYPERF® / POLYPERF® Safe connecting lines are substantially equivalent to their predicate devices in term of intended use and technological characteristics (materials, design and functionality)." |
| Prevention of ABE (implied for POLYPERF® Safe) | The device should effectively prevent "accidental needle stick injuries." | POLYPERF® Safe is "designed to help protect against exposure to blood caused by accidental needle stick injuries." The positive clinical evaluation implies it fulfills this design intent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the "Clinical evaluation of the handiness and the safety of use of Polyperf® safe." It simply states that such an evaluation was performed.
- Data Provenance: Not explicitly stated. Given the submitter is a French company (Laboratoire PEROUSE, France), it is plausible that some of the data, especially the "clinical evaluation," originated in France or Europe. The document does not specify if the studies were retrospective or prospective, but clinical evaluations are typically prospective to assess "handiness and safety of use." The biocompatibility and safety/functionality testing are likely laboratory-based.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- The document mentions a "Clinical evaluation" for POLYPERF® Safe but does not specify the number or qualifications of experts (e.g., radiologists, nurses, physicians) involved in this evaluation or in establishing any ground truth. For a device like an intravascular administration set, the "experts" would likely be healthcare professionals who routinely use such devices.
4. Adjudication Method for the Test Set
- The document does not describe any adjudication method used for the "Clinical evaluation" or any other performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices, where multiple readers interpret cases with and without AI assistance. The POLYPERF® device is an intravascular administration set, and its evaluation revolves around its physical properties, functionality, biocompatibility, and user-friendliness, not diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
- N/A. The POLYPERF® / POLYPERF® Safe device is a physical medical device (an intravascular administration set and a safety Huber needle), not an algorithm or AI software. Therefore, the concept of a "standalone" algorithmic performance study is not applicable. The "safety and functionality testing" might be considered a standalone physical device assessment.
7. The Type of Ground Truth Used
- For Biocompatibility: Ground truth would be based on established international standards (e.g., ISO 10993 series) and laboratory test results demonstrating the materials do not elicit adverse biological responses.
- For Safety and Functionality Testing: Ground truth would be based on predefined engineering specifications, performance metrics (e.g., flow rate, connection integrity, tensile strength, leak tests), and the device's ability to perform its intended functions without failure.
- For Clinical Evaluation of Handiness and Safety of Use (for POLYPERF® Safe): Ground truth would be established through direct observation, user feedback, and potentially incident tracking (e.g., actual vs. prevented needle stick injuries). This typically involves subjective and objective assessments by healthcare professionals.
- For Substantial Equivalence: Ground truth is the characteristics of the legally marketed predicate devices (GRIPPER PLUS NEEDLE -DELTEC, INC - K021999 and GRIPPER NEEDLE - DELTEC, INC - K896346).
8. The Sample Size for the Training Set
- N/A. The POLYPERF® / POLYPERF® Safe device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The development and testing would involve prototypes and manufacturing batches, but not a data training set.
9. How the Ground Truth for the Training Set was Established
- N/A. As above, the concept of a training set and its ground truth is not applicable to this type of device. The development process would involve iterative design, manufacturing, and testing based on engineering principles and regulatory standards.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.