(273 days)
SPECATH® Central Venous Catheters are intended for the purpose of providing short term access (less than 30 days) to the vascular system for the infusion of fluids, monitoring of pressures, and/or sampling of blood.
SPECATH® catheters are polyurethane, radiopaque single or multiple (up to 4) lumen catheters. The size of catheters are from 4 French through 12 French and lengths 10 cm through 30 cm. Each lumen extends from the vicinity of the distal tip to the main (bifurcation or junction) hub, where it branches into dedicated extension lines. The extension line hubs are labeled to provide positive identification of the lumen size and location. The catheter body has depth markings, measured in cm from the catheter tips. The extension line marked "distal" is used for device placement using a guide wire and then to infuse fluids. The distal tip is soft to minimize patient trauma during insertion. The device is radiopaque to allow verification of location in the patient. Central venous catheters are inserted into a large vein and threaded into the central venous system. To reduce the chance of complications, the central venous catheter tip should be placed in the superior vena cava above its junction with the right atrium with the distal catheter parallel to the vessel wall. For reference. the distal tip should be positioned at a level above either the azvaos vein or the carina of the trachea whichever is better visualized. The accessories described below will be included in the SPECATH® Central Venous Catheter Kits. Guidewires: The quidewire is used for quiding the catheter through the venous a. system to the desired catheter placement location. According to the different sizes of the catheters, varying size quidewire will be included in the kit: Diameters are 0.018", 0.035"; Lengths are 450mm (45cm), 500 mm (50cm), 700mm (70cm), 1500mm (150 cm), b. Vessel Dialators: Dialators are used to enlarge the introducer path of the catheter. According to the size of the catheter, there will be a corresponding dialator with different size and effective lengths. C. Introducer: The introducer is used for entrance and tunneling into the skin and vascular system for the purpose of catheter placement. According to the size of the catheter, the following introducers will be included: 18 Ga, 70 mm; 19 Ga, 45 mm; 20 Ga, 45 mm. ರ. Syringe: A 5 ml. Svringe manufactured by Becton Dickinson and used to infuse fluids into the catheter will be included in the kit. Injection Caps: The injection cap is connected to the female luer hubs of the e. extension tubes.
The provided text describes a 510(k) submission for the SPECATH® Central Venous Catheter Kits. This is a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than a study evaluating the performance of a device against specific acceptance criteria in a clinical or standalone setting.
Therefore, many of the requested details, such as acceptance criteria, reported device performance, sample size for test sets, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and details about training sets, are not applicable or available in this type of submission.
Instead, the submission focuses on non-clinical tests to support the substantial equivalence claim.
Here's a breakdown of the information provided that relates to your request:
1. A table of acceptance criteria and the reported device performance
The document lists various non-clinical tests performed, implying that the device met certain internal specifications or industry standards for these tests to claim substantial equivalence. However, the specific acceptance criteria (e.g., "flow rate must be > X ml/min") and the reported device performance results (e.g., "flow rate was Y ml/min") are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Surface acceptability | (Not specified) |
| Size conformance | (Not specified) |
| Distance Markings accuracy | (Not specified) |
| Lumen Markings clarity | (Not specified) |
| Primary Volume Test results | (Not specified) |
| Break Force strength | (Not specified) |
| Flow Rate conformity | (Not specified) |
| Burst Pressure Test results | (Not specified) |
| Leakage absence | (Not specified) |
| Tensile Strength Test results | (Not specified) |
| Radio-detectability | (Not specified) |
| Hub Liquid Leakage absence | (Not specified) |
| Hub Air Leakage absence | (Not specified) |
| Hub Separation Force strength | (Not specified) |
| Hub Stress Cracking resistance | (Not specified) |
| Label Information accuracy | (Not specified) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "Testing to Support Substantial Equivalence included" a list of non-clinical tests. These are typically bench tests or in-vitro tests, so the concept of "test set" in the context of patient data is not applicable here.
- Data Provenance: Not applicable. These are non-clinical, bench-top tests, not human data. The manufacturing company is Special Medical Co. Ltd. from Guangdong, China.
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. Ground truth from experts is relevant for clinical studies or studies involving human judgment (e.g., image interpretation). These are non-clinical, quantifiable tests where "ground truth" would be established by the physical properties of the device and testing equipment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to adjudication for human-interpreted data or clinical outcomes.
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 is a non-clinical submission for a medical device (catheter kit), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is implied to be the physical and chemical specifications of the device material and design, as measured and verified against established engineering and safety standards.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
§ 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).