(275 days)
The CATHTONG™ I PICC Catheter is intended for short or long-term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, power injection of contrast media, the administration of fluids, medications and nutrients, and allows for central venous pressure monitoring. The maximum recommended infusion rate is 1mL/sec for 3F and 3.5mL/sec for 4F single-lumen catheters. The maximum pressure of power injection with the CATHTONG™ I PICC Catheter may not exceed 325 psi. The CATHTONG™ I PICC Catheter is indicated for adult patients.
CATHTONG™ I PICC Catheters are radiopaque polyurethane-based peripherally inserted central venous catheters for short or long-term use. The CATHTONG™ I PICC Catheters are 55 cm in length with markings in 5 cm increments and available in 3 Fr and 4 Fr single lumen. The catheter is packaged as a kit with accessories necessary for implantation of a PICC catheter using a Seldinger or modified Seldinger technique.
The provided text is a 510(k) summary for the CATHTONG™ I PICC Catheter. It outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence. However, it does not describe an "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format of a clinical study assessing diagnostic performance as implied by the request (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size).
Instead, this document focuses on non-clinical testing to demonstrate the device's functional performance, safety, and biocompatibility compared to a predicate device. The acceptance criteria here are typically established by reference to a predicate device and relevant industry standards.
Here's an attempt to extract and reframe the information based on the provided document and the prompt's requirements, acknowledging the difference in the type of study presented:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CATHTONG™ I PICC Catheter are primarily defined by its substantial equivalence to the predicate device (NMI PICC IV, K140266) regarding its intended use, design, and performance characteristics, as well as by adherence to recognized industry standards for intravascular catheters. The document doesn't provide a direct table of numerical "acceptance criteria" and "reported performance" like a diagnostic device study would. Instead, it states that the non-clinical tests demonstrate the device meets "expected performance requirements."
Below is a table summarizing key performance characteristics and how they are addressed, based on the provided text's comparison to the predicate:
| Feature/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (CATHTONG™ I PICC Catheter) |
|---|---|---|
| Intended Use | Identical to predicate (NMI PICC IV) for central venous access. | Identical to predicate, including infusion, IV therapy, blood sampling, power injection, fluid/medication/nutrient administration, CVP monitoring for adult patients. |
| Maximum Flow Rate (Power Injection) | 3F SL: 1 mL/sec; 4F SL: 3.5 mL/sec (same as predicate) | 3F SL: 1 mL/sec; 4F SL: 3.5 mL/sec |
| Injection Pressure Limit Setting | 325 psi (same as predicate) | 325 psi |
| Catheter Material | Radiopaque polyurethane (same as predicate) | Radiopaque polyurethane (Carbothane) |
| Length | 55 cm (3F, 4F) (same as predicate) | 55 cm (3F, 4F) |
| # Lumens | Single lumen (explicit difference from predicate, but flow rates identical) | One (3F, 4F) |
| Catheter Design | Demonstrate equivalent performance despite design difference (standard vs. reverse tapered). | Standard tapered catheter. (Demonstrated to maintain identical maximum flow rates to predicate). |
| Sterilization Method | EO sterilization with acceptable low EO residues (same as predicate) | Provided sterile using EO sterilization method. |
| Biocompatibility | Compliance with ISO 10993 series for medical devices. | All specified biocompatibility tests (Cytotoxicity, Hemolysis, PTT, Systemic Toxicity, Irritation/Intracutaneous Reactivity, Sensitization, Implantation, Genotoxicity, Complement Activation) were performed and results are implied to be acceptable for substantial equivalence. |
| Mechanical Performance | Compliance with relevant ISO standards and predicate performance for: Flexural fatigue, peak tensile force, liquid/air leakage, flow rate, burst pressure, catheter collapse, radiopacity, gauging, separation force, unscrewing torque, ease of assembly, resistance to overriding, stress cracking. | Non-clinical tests listed for all these aspects were performed and demonstrate that the device "meets the expected performance requirements for a PICC device." |
| Regulatory Standards Compliance | Adherence to ISO 10551-1, ISO 10551-3, ISO 594-1, ISO 594-2, and FDA Guidance (1995). | The device was tested according to these standards, implying compliance, and deemed substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
The document specifies "Non-clinical Testing" including a list of tests. For these types of tests (e.g., mechanical, biocompatibility), the sample sizes are typically determined by relevant ISO standards or internal quality procedures. The document does not explicitly state the sample size for each non-clinical test performed on the device.
Regarding data provenance: These are laboratory tests performed on the device itself, not clinical data from patients. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" as applied to patient data are not directly relevant here. The tests are performed in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to the type of testing described. The "ground truth" for non-clinical performance and safety tests is established by:
- Industry standards: e.g., ISO 10551, ISO 594, ISO 10993 series. These standards define the acceptable methodologies and performance thresholds.
- Predicate device performance: The "ground truth" for substantial equivalence is that the new device performs at least as safely and effectively as the legally marketed predicate device.
- Regulatory requirements: FDA guidance documents.
These tests do not involve expert consensus on clinical images or patient outcomes.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. Adjudication methods are typically used in clinical studies to resolve discrepancies in expert interpretation of clinical data. The non-clinical tests described follow standardized protocols with objective measurements.
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 device is a physical medical device (PICC catheter), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
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 algorithm, so the concept of standalone algorithmic performance is not relevant.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:
- Compliance with recognized voluntary standards: As listed in the document (e.g., ISO 10551, ISO 10993 series). These standards define objective test methods and acceptable performance limits for various physical, mechanical, and biological properties.
- Comparative performance to the legally marketed predicate device: The new device must demonstrate that it is as safe and effective as the predicate, often by showing equivalent performance in relevant non-clinical tests.
- Established scientific principles: Underlying the safety and performance evaluation of medical devices.
No clinical "outcomes data" or "pathology" as ground truth is described in this non-clinical submission.
8. The Sample Size for the Training Set
Not applicable. There is no machine learning or AI algorithm involved, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.”