(13 days)
For short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
The proposed PICC has similar technological characteristics as the predicate devices. lt is a flexible catheter with proximally located luer lock adapter(s) with a pressure activated safety valve, extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL) and effective (usable) length of 55 cm. The radiopaque catheter is marked with depth indicators along its length. The lumens are differentiated by proximally located colored hubs that indicate lumen size. Maximum power injection flow rates are indicated on the luer adapter(s). The proposed PICC may be provided as a stand alone device or in kits with other legally marketed products as a convenience to the user to accommodate their particular needs.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
It appears that the provided FDA 510(k) summary (K091261 for Navilyst Medical's PICC) does not contain the detailed information required to fully answer all aspects of your request regarding acceptance criteria and a specific study's results.
The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and general performance testing. It does not present a specific clinical study with detailed performance metrics against predefined acceptance criteria in the format you've requested.
However, I can extract what is available and highlight where information is missing based on your prompt.
Analysis of K091261 for Acceptance Criteria and Study Information
Summary of Findings:
The 510(k) submission primarily relies on in-vitro testing and biocompatibility assessments to demonstrate substantial equivalence, rather than a clinical study with detailed performance outcomes against specific, quantitative acceptance criteria. Therefore, most of the requested fields cannot be filled directly from the provided text.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Expected/Implied) | Reported Device Performance (from K091261) |
|---|---|---|
| Mechanical Performance | Adherence to ISO 10555-3 standards for intravascular catheters. | "in-vitro testing in accordance with ISO 10555-3" (Pass/Fail implied, but no specific values or thresholds reported). |
| Power Injection | Maintenance of integrity and specified flow rates during high-pressure injection. | "high pressure injection flow rates" (Pass/Fail implied, indicating the device can withstand and facilitate power injection as indicated, but no specific flow rates or pressure limits are reported here). |
| Valve Integrity | Functionality and sealing capabilities of the pressure-activated safety valve. | "valve integrity testing" (Pass/Fail implied, but no specific leak rates or pressure limits reported here). |
| Biocompatibility | Compliance with ISO 10993-1 for biological evaluation of medical devices. | "biocompatibility evaluation in accordance with ISO 10993-1" (Pass/Fail implied, but no specific test results or cytotoxicity/sensitization levels reported). |
| Clinical Efficacy/Safety | Not explicitly defined in the document for a new device study. | Not applicable in this context; not a clinical trial. |
Missing Information/Why it Can't be Fully Addressed from provided text:
The provided text only lists the types of performance testing conducted (ISO 10555-3, high pressure injection, valve integrity, biocompatibility). It does not:
- Specify quantitative acceptance criteria for each test (e.g., "tensile strength must be >X N," "flow rate must be >Y mL/s at Z psi").
- Report specific performance values or statistical outcomes from these tests.
- Describe a clinical study with patient outcomes.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions in-vitro testing but does not provide the number of units tested.
- Data Provenance: In-vitro laboratory testing. The country of origin for the lab testing is not specified but would typically be conducted at the manufacturer's R&D facilities or a contract lab. This is not clinical data (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable. This information is relevant for studies involving human interpretation (e.g., imaging, diagnostics). The tests described are in-vitro physical and material tests, not expert-adjudicated clinical data.
4. Adjudication Method for the Test Set
- Not applicable. See point 3. Testing involves objective measurements against established engineering standards, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not done. This device is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers. The submission does not describe any clinical study, let alone an MRMC study.
- Effect Size of Human Readers (with/without AI): Not applicable.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
- For the in-vitro tests: The "ground truth" is defined by established engineering standards (e.g., ISO 10555-3) and internal design specifications for mechanical, flow, and biocompatibility properties. It is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
- Not applicable. This concept typically applies to machine learning algorithms. The development of a physical medical device involves design, prototyping, and in-vitro testing, but not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
Conclusion:
The provided 510(k) summary for K091261 demonstrates substantial equivalence through a comparison of technological characteristics with predicate devices and compliance with relevant in-vitro and biocompatibility standards. It does not present a clinical study with detailed performance metrics against quantitative acceptance criteria in the manner you've outlined for AI or diagnostic devices.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”