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510(k) Data Aggregation
(305 days)
HENAN TUOREN MEDICAL DEVICE CO., LTD
The Endobronchial Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia.
The Endobronchial Tube is made of Polyvinylchloride and is available in sizes 26fr to 41fr. They are designated as double lumen tube with 2 cuffs and separate 15mm connectors for isolating and ventilating one lung during surgical procedures. The tubes contain an x-ray opaque line that runs through the tube making them detectable by x-ray. Environments of use: Hospital-OR and ICU
The provided text describes the 510(k) submission for the "Endobronchial Tube" by Henan Tuoren Medical Device Co., Ltd. and its substantial equivalence to a predicate device (Well LEAD Endobronchial Tubes, K092886). The evaluation primarily relies on non-clinical testing (bench testing and biocompatibility assessments) to demonstrate that the proposed device meets established standards and performs comparably to the predicate.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a detailed table of performance testing for the Endobronchial Tube.
| Type of Bench Test | Referenced Standard | Acceptable Criteria | Reported Device Performance (Pass/fail) |
|---|---|---|---|
| Cuff diameter | ISO 5361: 2012 | The maximum cuff diameter shall be within ± 0.5mm of the nominal value when tested according to ISO 5361 Annex B. | Pass |
| Cuffed tube collapse test | ISO 5361: 2012 | The steel ball shall pass freely through the tube when tested according to ISO 5361 Annex C. | Pass |
| Cuff herniation test | ISO 5361: 2012 | No part of the inflated cuff shall reach beyond the nearest edge of the bevel when tested according to ISO 5361 Annex D. | Pass |
| Seal testing | ISO 5361: 2012 | The leakage limit is ≤2.0ml/h at cuff pressures not to exceed 2.7 kPa (27 cmH2O) when tested according to ISO 5361 Annex G. | Pass |
| Sealing of cuff inflating system | Not explicitly referenced | No air leakage happens under the condition of continuous 3kPa positive pressure imposition for 10 seconds. | Pass |
| Sealing of connector assembly | Not explicitly referenced | No air leakage happens on any joints under the condition of continuous 6kPa gas pressure imposition to lumen of main tube (shaft) for 60 seconds. | Pass |
| Inflating tube (outside diameter) | ISO 5361: 2012 | The inflating tube shall have an outside diameter of not more than 3.0mm. | Pass |
| Inflating tube (angle) | ISO 5361: 2012 | The angle between the inflating tube and the Endobronchial tube at the point of separation shall not exceed 45°. | Pass |
| Kink resistance test | ISO 5361: 2012 | The steel ball shall pass freely through the lumen of the tube when tested according to ISO 5361 Annex H. | Pass |
| Gauging of One Way Valve | ISO 594/1 1986 | The plane of the maximum diameter at the opening of the female conical fitting of One Way Valve lie between the two limit planes of the gauge. | Pass |
| Liquid leakage of One Way Valve | ISO 594/1 1986 | No leakage sufficient to form a falling drop of water. | Pass |
| Air leakage of One Way Valve | ISO 594/1 1986 | Continued formation of air bubbles not be evident. | Pass |
| Separation force of One Way Valve | ISO 594/1 1986 | The conical fitting under test remain attached to the test fixture. | Pass |
| Stress cracking (One Way Valve) | ISO 594/1 1986 | There shall be no evidence of stress cracking of the conical fitting. | Pass |
| Security of construction of suction catheter | ISO 8836-2007 | The force required to detach any component permanently attached to the shaft shall be not less than that specified in standard. | Pass |
| Shaft resistant to negative pressure (suction catheter) | ISO 8836-2007 | A vacuum source at 40kPa below ambient pressure for 15s at a temperature of 23°C ±2°C with the patient end occluded, the shaft shall not collapse. | Pass |
| 15mm connector | ISO5356-1: 2004 | Comply with the ISO5356-1: 2004. | Pass |
| Burst Testing (Cuff burst) | Not explicitly referenced | The volume of injected gas when cuff bursting happens is larger than 40ml during inflation of endobronchial tube. | Pass |
| Burst Testing (Bursting between cuff and main tube) | Not explicitly referenced | There should be no fracture on junctions while inflated 30kpa gas. | Pass |
| Bond Strength | Not explicitly referenced | The joints of endobronchial tube should be firm bonding. When an axial force of 50±5N is applied at 50±5mm/min, the testing portion (between connector and...) [The sentence is cut off here, but "Pass" is indicated] | Pass |
| Air flow resistance | Not explicitly referenced | Pressure increment should no more than 0.2Kpa/h when testing the endobronchial tube under the specified flow rate (3, 6, 9L/min). | Pass |
| Radiopaque test | Not explicitly referenced | When exposing the Endobronchial tube with the low dose rays, the X-ray machine should have film development. | Pass |
| Endotoxin test | USP36_NF31 | 0.25EU/ml, 20EU/Device. | Pass |
| In vitro cytotoxicity | ISO10993-5:2009 | No potential toxicity to L-929 cells under specified test conditions (using MTT method MEM extract and MTT method MEM with 10% FBS extract). | Pass |
| Skin sensitization Test (Guinea Pig) | ISO10993-10:2010 | No significant evidence of causing skin sensitization in the guinea pig under specified test conditions (using 0.9% sodium chloride injection extract and sesame oil extract). | Pass |
| Oral Mucosa Irritation test | ISO10993-10:2010 | No significant evidence of causing oral irritation in the hamster under specified test conditions (using 0.9% sodium chloride extract and sesame oil extract). | Pass |
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 the exact sample size for the mechanical performance tests, biocompatibility tests, or endotoxin tests. It mentions "non-clinical testing was performed" and provides "Test result" for each criterion. The data provenance is not explicitly stated in terms of country of origin for the testing, but the manufacturer is Henan Tuoren Medical Device Co., Ltd, China. The testing described is clearly prospective for the device being submitted, as it was performed to demonstrate compliance with standards.
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 product is a medical device (Endobronchial Tube, Class II), not an AI or imaging diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or clinical diagnosis is not applicable here. The "ground truth" for this device's performance is established by adherence to engineering and biocompatibility standards and quantified through objective physical and chemical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or subjective adjudication. The tests involve objective measurements against predefined criteria in recognized standards (e.g., ISO).
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 not an AI diagnostic device. No MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device. The performance is assessed based on the physical properties and biological compatibility of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance assessment is primarily defined by:
- Engineering Standards: Specific requirements and limits outlined in international standards like ISO 5361, ISO 594/1, ISO 8836, and ISO 5356-1.
- Biocompatibility Standards: Criteria for no toxicity, sensitization, or irritation as per ISO 10993 series.
- Safety Standards: Endotoxin limits as per USP.
These standards provide objective, measurable criteria which serve as the ground truth against which the device's performance is evaluated.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of data for an algorithm.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for it. The standards mentioned in point 7 serve as the universally accepted benchmarks for this type of device.
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