(25 days)
Indicated for use in vascular access to intravenously administer nutrients, fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring.
The Spectrum Five Lumen Central Venous Catheter Set is a central venous catheter designed to intravenously administer nutrients, fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring through the vasculature. The Spectrum Five Lumen Central Venous Catheter will be 10 Fr. available in lengths of 15, 20, 25, and 30 cm. The Spectrum Five Lumen Catheter will be impregnated with an average of 683.3 ug/cm minocycline and 564.1 ug/cm rifampin. This device will be supplied sterile and is intended for one-time use.
Here's an analysis of the provided text regarding the Cook Incorporated Spectrum® Five Lumen Central Venous Catheter, formatted to answer your questions where information is available.
It's important to note that this document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to existing predicate devices rather than providing a detailed clinical study report typically found for a novel AI/software device. Therefore, many of your questions related to AI performance metrics, ground truth, and expert evaluation will not be applicable.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Testing | (Explicit criteria not stated in the summary, but implied to meet industry standards for catheter integrity under tension.) | The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter. |
| Shaft Flexibility Testing | (Explicit criteria not stated in the summary, but implied to meet industry standards for catheter flexibility.) | The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter. |
| Shaft Flexural Fatigue Tolerance Testing | (Explicit criteria not stated in the summary, but implied to meet industry standards for catheter durability under repeated flexing.) | The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter. |
| Gravity Flow Rate Testing | (Explicit criteria not stated in the summary, but implied to meet clinically relevant flow rates for intravenous administration.) | The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter. |
| Air Leakage Testing | (Explicit criteria not stated in the summary, but implied to demonstrate absence of air leaks.) | The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter. |
| Collapsibility under Vacuum Testing | (Explicit criteria not stated in the summary, but implied to demonstrate resistance to collapse under vacuum conditions.) | The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter. |
| Liquid Leakage Testing | (Explicit criteria not stated in the summary, but implied to demonstrate absence of liquid leaks.) | The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter. |
| Burst Pressure Testing | (Explicit criteria not stated in the summary, but implied to demonstrate integrity under high-pressure conditions.) | The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter. |
| Biocompatibility Testing | (Implied to meet ISO 10993 standards and other relevant biocompatibility requirements.) | The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter. |
| Tensile Testing after Aging | (Implied to meet tensile strength requirements after simulated aging to ensure long-term integrity.) | The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter. |
| Amount of Minocycline and Rifampin Impregnated | (Explicitly states an average concentration of 683.3 ug/cm minocycline and 564.1 ug/cm rifampin to indicate consistency of impregnation.) | Average of 683.3 ug/cm minocycline and 564.1 ug/cm rifampin. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for these engineering and material tests, nor does it detail data provenance. These are typically bench and lab tests, not clinical studies with human subjects.
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)
- This question is not applicable. The device validation involves engineering and material testing, not interpretation of data requiring expert consensus or ground truth in the way an AI/diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are relevant for diagnostic interpretations, not for physical material and performance tests of a catheter.
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
- This question is not applicable. The device is a physical medical device (central venous catheter), not an AI/software diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This question is not applicable in the context of diagnostic "ground truth." The "ground truth" for this device's performance would be the physical properties and functional specifications of the catheter itself, verified through standardized testing methods, not a clinical diagnosis.
8. The sample size for the training set
- This question is not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established
- This question is not applicable. This is not an AI/machine learning device.
Summary of the Study (Device Verification/Validation):
The "study" described in this 510(k) summary is a series of in-vitro, bench-top engineering, and material tests designed to assure the reliable design and performance of the Cook Incorporated Spectrum® Five Lumen Central Venous Catheter. These tests are standard for evaluating the physical, chemical, and mechanical properties of medical devices like catheters. The purpose is to demonstrate that the device meets predetermined specifications for safety and effectiveness, and is substantially equivalent to legally marketed predicate devices. The document explicitly states that "The results of these tests provide reasonable assurance that the device conforms to the requirements necessary for its use as a central venous catheter."
§ 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).