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The Endotracheal tube is intended for oral or nasal intubation and for airway management.

The Reinforced Endotracheal tube is intended for airway management by oral or nasal intubation of the trachea during anesthesia. It is a device inserted into the trachea through the mouth or nose to facilitate breathing and it may be used where the patient's neck is likely to be moved of flexed or the prone position so that a non-reinforced tracheal tube might become kinked.

The Endotracheal tubes are used for oral or nasal intubation and for airway management, which are mainly for patients that require repeated anesthesia, artificial ventilation and assisted breathing. The Endotracheal tube is available in cuffed and uncuffed variants. The cuff is intended to provide a seal against the trachea, ensuring that inspiratory and expiratory gasses are routed through the tube and not allowed to escape to the patient's upper airway. The structure of Cuffed Endotracheal tube contains a main tube (patient end, machine end and murphy eye), cuff, and inflating system (including inflating tube, valve and pilot balloon). The uncuffed Endotracheal tube contains main tube (patient end, shaft and machine end). All variants have a Murphy eye. The products are primarily made from polyvinyl chloride (PVC) materials. The Endotracheal tubes are available in a number of sizes: the nominal inside diameter of uncuffed Endotracheal tubes are from 2.0mm to 10.0mm; the nominal inside diameter of cuffed Endotracheal tubes are from 2.5mm to 10.0mm. The Endotracheal tubes are disposable and are supplied sterile. The contact time should be no more than 30 days.

The reinforced Endotracheal tubes are a tracheal tube with additional metal wire spiral reinforcement to provide kink-resistance. The products are always used during operations where a high degree of flexibility is required from the tube. The reinforced Endotracheal tubes are also available in cuffed and uncuffed variants, and nominal inside diameter of both the uncuffed and cuffed reinforced Endotracheal tubes are from 3.0mm to 9.0mm. The only difference between reinforced Endotracheal tubes and Endotracheal tubes is the metal wire spiral inside the tube, which is made by 304 stainless steel and used for reinforcement that maintains the patency of the lumen.

The provided document describes the acceptance criteria and the study conducted for the Endotracheal Tube and Reinforced Endotracheal Tube manufactured by Zhanjiang Star Enterprise Co., Ltd. This is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving novel effectiveness.

Here's the breakdown of the information requested:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the devices are based on compliance with international standards, primarily ISO 5361: 2012 for performance and ISO 10993-1 (and #G95-1) for biocompatibility. The reported device performance is that the "endotracheal tubes meet the requirement of ISO 5361" and that "all of the results meet the acceptance criteria" for shelf-life testing. The devices also passed various biocompatibility tests.

Table of Acceptance Criteria and Reported Device Performance:

1. Size designation
2. Dimensions (ID, OD, connectors, machine and patient ends, opening)
3. Tracheal tube bevel (angle, free from sharp edges)
4. Tracheal tubes cuffs (tube collapse, free of sharp edges)
5. Inflating system for cuffs (OD, angle, pilot balloon)
6. Curvature of the tube (radius, maintain intended shape)
7. Kink resistance
8. Additional requirement for Murphy eye
9. Sterility assurance
10. Marking | "The results showed that the endotracheal tubes meet the requirement of ISO 5361."
    "The testing results demonstrate that the proposed devices meet the requirements of the standards listed above." (Referencing ISO 5361:2012 for the proposed device and ISO 5361:1999 for the predicate for reinforced ETT) |
    | Biocompatibility | #G95-1 and ISO 10993-1 - covering tests such as:
11. In Vitro Cytotoxicity
12. Skin Sensitization
13. Oral mucosa Irritation
14. Oral mucosa Prolonged Irritation
15. Genotoxicity Test
16. Implantation Test
17. Acute Systemic Toxicity Test
18. Subchronic Systemic Toxicity Test
19. Endotoxin Test
20. Pyrogen
21. EO and ECH Residual Test
22. DEHP Residual Test | "The proposed device is considered as external communicating device in contact with tissue less than 30 days, and evaluation was conducted in accordance with #G95-1 and ISO 10993-1,...There is no additional risk for the proposed products when compared with the predicate devices. The Biocompatibility testing show below: [list of all tests mentioned as passed]" |
    | Shelf Life | Package integrity and physical performance after accelerated aging | "all of the results meet the acceptance criteria. Therefore, the product has a shelf life of 5 years was proved." |
    | Sterilization | ISO 11135-1:2007 (Ethylene oxide sterilization) - covering:
    Sterilization validation, bioburden test, product sterility test, Biological Indicators (BI) sterility test | "The sterilization validation was conducted according to ISO 11135-1:2007... The sterilization validation, bioburden test, product sterility test, and Biological Indicators (BI) sterility test were conducted." (Implies successful completion and meeting of criteria) |

Breakdown of Study Information:

2. Sample size used for the test set and the data provenance:

• The document primarily describes non-clinical performance testing, which involves testing device samples against specified technical standards and biocompatibility requirements. It does not refer to a "test set" in the context of a clinical study or expert review of data from patients.
• Data Provenance: The tests (physical performance, biocompatibility, shelf-life, sterilization) were performed on samples of the manufactured devices. The origin of the data is from these laboratory evaluations and not from patient data from a specific country or retrospective/prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable to the type of studies described. The "ground truth" for these tests is defined by the requirements of the international standards (e.g., ISO 5361, ISO 10993). Experts are typically involved in setting these standards and conducting the laboratory tests, but there's no mention of a specific ground truth established by a panel of experts for a clinical test set in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not applicable. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations to resolve discrepancies among multiple expert readers. This document describes laboratory and bench testing against pre-defined technical standards.

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:

• No, an MRMC comparative effectiveness study was not done. This document is for an endotracheal tube, a physical medical device, not an AI or diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• No, a standalone algorithm performance study was not done. This product is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For performance testing (ISO 5361), the ground truth is defined by the specifications and measurement tolerances provided within the ISO standard. This involves objective physical measurements and functional evaluations.
• For biocompatibility testing (ISO 10993), the ground truth is established by biological test methods and criteria outlined in the standard, which assess the device's interaction with biological systems through various assays (cytotoxicity, irritation, sensitization, etc.).
• For shelf-life and sterilization testing, the ground truth is based on pre-established quality parameters and microbial inactivation levels as defined by the relevant standards (e.g., ISO 11135-1).

8. The sample size for the training set:

• Not applicable. This submission is for a physical medical device, not a machine learning or AI algorithm, 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 for an AI/ML algorithm.

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The PVC Urinary Catheter is launched for clean intermittent catheterization (CIC) treatment. It is intended for use in the drainage of fluid from the urinary tract. It is indicated for use in male, female, and pediatric patients 2-12 years old.

The Silicone Urinary Catheter is intended to be placed in the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.

The Latex Urinary Catheter is intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Neleton catheters are launched for clean internittent catheterization (CIC). Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder irrigation. It is indicated for use in male, female, and pediatric patients 2-12 years old.

Disposable urinary catheter is a kind of disposable product which is used for draining the bladder, for temporary or short term. Based on the materials, the disposable urinary catheter includes PVC Urinary Catheter, Silicone Urinary Catheter and Latex Urinary Catheter.

PVC Urinary Catheter only has nelaton type structure, which is made of PVC and is intended for draining the bladder for short term. PVC Urinary Catheter consists of drainage funnel, drainage lumen, eyelets and tip. It is supplied in French size ranging from 8 to 20F. The catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.

Silicone Urinary Catheter is made of pure silicone. It is intended to be placed in the bladder, through the urethra, to drain urine into a collection device and has two-way type and three-way type. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eyes, balloon, inflating connector and valve. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.

Latex Foley Catheter is made of nature latex, which has nelaton type, two-way type and three-type.

The nelaton Latex Urinary Catheter is intended for draining the bladder for short term and consists of drainage funnel, drainage lumen, eyelets and tip. The nelaton catheters come in sizes from 12Fr-20Fr for adults and 8Fr-10Fr for pediatrics 2-12 years old.

The two-way type and three-way type are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. The two-way type consists of funnel, drainage lumen, drainage eyes, balloon, inflating connector and valve. The three-way type consists of Funnel, Drainage lumen, Injection connector, injection lumen, drainage eye. Both of them are supplied in French size ranging from 8 to 24F. The catheters come in sizes from 12Fr-24Fr for adults and 8Fr-10Fr for pediatrics 2 -12 years old.

This document describes a 510(k) premarket notification for Disposable Urinary Catheters (PVC, Silicone, and Latex). It focuses on demonstrating substantial equivalence to predicate devices, rather than a de novo evaluation of clinical effectiveness with an AI component. Therefore, much of the requested information regarding AI-specific studies (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) is not applicable or present in this document.

Here's an analysis of the provided information, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting specified performance standards. The reported device performance is that the device "Passed" all tests against these requirements.

2. Sample size used for the test set and the data provenance

This document describes non-clinical "bench testing" and "biocompatibility tests" performed in accordance with standards like EN 1616, ASTM F623, and ISO 10993. These types of tests do not typically involve patient-specific data or test sets in the context of AI. The sample sizes for these bench tests are not specified in this document, nor is the data provenance in terms of country of origin or retrospective/prospective status as it would be for a clinical study. The device manufacturer is Zhanjiang Star Enterprise Co., Ltd based in China.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a non-clinical, bench testing submission. No "ground truth" established by experts in a clinical context (e.g., radiologists) is mentioned or required for this type of submission.

4. Adjudication method for the test set

Not applicable. There are no clinical test sets or expert evaluations requiring adjudication in this submission.

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 urinary catheter, not an AI-powered diagnostic or assistive technology. No MRMC studies were conducted or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device (urinary catheter) and does not involve an algorithm or AI.

7. The type of ground truth used

For the performance tests, the "ground truth" is defined by the technical specifications and requirements outlined in the referenced international standards (e.g., EN 1616, ASTM F623). For biocompatibility, the "ground truth" is adherence to the criteria set forth in the ISO 10993 series of standards. This is not clinical "ground truth" such as pathology or outcomes data.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore, no training set.

9. How the ground truth for the training set was established

Not applicable. No training set exists for this device.

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