(159 days)
The primeMIDLINE™ Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling and power injection of contrast media. These catheters are indicated for patients older than 28 days and that weigh more than 10kg, with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The primeMIDLINE™ Catheters are suitable for use with power injectors.
The primeMIDLINE™ Catheters are a family of peripherally placed midline catheters designed to provide access to the vascular system. These catheters are offered in 3F, 4F and 5F Single Lumen and 5F Dual Lumen configurations with 20cm lengths. The catheter lumen is an open-ended design comprised of radiopaque polyurethane. Each primeMIDLINE™ Catheter is packaged sterile in a tray with the accessories necessary to establish short-term (less than 30 days) vascular access. The primeMIDLINE™ Catheters are suitable for use with power injectors.
The document provided describes the primeMIDLINE™ Catheters and their substantial equivalence to a predicate device, PowerMidline Catheters. It outlines verification testing performed to demonstrate that the device performs as intended and meets established acceptance criteria.
However, the document does not contain information about a study comparing the device's performance against specific acceptance criteria in the format requested. While it lists various performance testing categories, it does not provide:
- A table of specific quantitative acceptance criteria for each test (e.g., "Tensile Strength should be > X N") and the reported device performance against those criteria.
- Details on sample sizes for a "test set" in the context of device performance, data provenance, or the number/qualifications of experts for ground truth.
- Information on adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance, as these are typically relevant to AI/diagnostic imaging devices, not direct hardware performance.
- The type of ground truth used for performance validation.
- Training set sample size or how ground truth was established for a training set (again, this points more towards AI/ML studies).
Instead, the document states: "The subject devices met all predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This is a general statement that the device passed all tests, but without quantifying the criteria or the results.
Therefore, based on the provided text, I cannot complete the table or answer most of the requested questions because the specific data is not available.
Summary of available information:
- Device: primeMIDLINE™ Catheters
- Predicate Device: PowerMidline Catheters (K153393)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Visual Inspection | Met (Statement: "The subject devices met all predetermined acceptance criteria") |
| Dimensional Characteristics | Met (Statement: "...met all predetermined acceptance criteria") |
| Radiopacity | Met (Statement: "...met all predetermined acceptance criteria") |
| Catheter Collapse | Met (Statement: "...met all predetermined acceptance criteria") |
| Leak | Met (Statement: "...met all predetermined acceptance criteria") |
| Priming Volume | Met (Statement: "...met all predetermined acceptance criteria") |
| Flowrate: Gravity | Met (Statement: "...met all predetermined acceptance criteria") |
| Flowrate: Power Injection | Met (Statement: "...met all predetermined acceptance criteria") |
| Tensile Strength | Met (Statement: "...met all predetermined acceptance criteria") |
| Catheter Elongation | Met (Statement: "...met all predetermined acceptance criteria") |
| Lifecycle Performance | Met (Statement: "...met all predetermined acceptance criteria") |
| Static Burst Pressure | Met (Statement: "...met all predetermined acceptance criteria") |
| Suture Wing Integrity | Met (Statement: "...met all predetermined acceptance criteria") |
| Luer Testing | Met (Statement: "...met all predetermined acceptance criteria") |
| Biocompatibility Tests: | |
| Cytotoxicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Sensitization | Met (Statement: "...met all predetermined acceptance criteria") |
| Irritation/Intracutaneous Reactivity | Met (Statement: "...met all predetermined acceptance criteria") |
| Acute Systemic Toxicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Material Mediated Pyrogenicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Subacute/Subchronic Toxicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Genotoxicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Carcinogenicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Chronic Toxicity | Met (Statement: "...met all predetermined acceptance criteria") |
| Hemocompatibility | Met (Statement: "...met all predetermined acceptance criteria") |
| Implantation | Met (Statement: "...met all predetermined acceptance criteria") |
| Sterilization Validation: | |
| Sterilization Validation – Overkill Method | Met (Statement: "...met all predetermined acceptance criteria") |
| EO/ECH Residuals | Met (Statement: "...met all predetermined acceptance criteria") |
| Direct Product Sterility | Met (Statement: "...met all predetermined acceptance criteria") |
| Bioburden/Organism Characterization | Met (Statement: "...met all predetermined acceptance criteria") |
| Bacteriostasis Fungistasis Testing | Met (Statement: "...met all predetermined acceptance criteria") |
| Bacterial Endotoxins/Limulus Amebocyte Lysate | Met (Statement: "...met all predetermined acceptance criteria") |
Study Information (based on available text):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document states "design verification testing" was conducted but does not provide sample sizes for individual tests or data provenance.
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/Not specified. The testing described is performance testing of a physical device against standards, not expert-adjudicated diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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:
- No. This type of study is for diagnostic tools, typically AI-powered. The device is a physical catheter.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- "Predetermined acceptance criteria as defined in the referenced Standards, FDA Guidance Documents or PFM Medical, Inc. Internal Standards." This refers to objective measurements against established engineering and safety standards.
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.
§ 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).