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510(k) Data Aggregation
(231 days)
TRACOE silcosoft Tracheostomy Tube
The TRACOE silcosoft® tracheostomy tube is intended to provide direct airway access for a tracheotomized patient up to 29 days. It may be reprocessed for single patient use up to 7 times. Patient population: Neonates, infants, children, and adolescents.
TRACOE silcosoft® is a silicone tracheostomy tube, with wire reinforcement, that provides an artificial airway to the lower respiratory tract for neonates, infants, children, and adolescents.
The TRACOE silcosoft® includes a tracheostomy tube, an obturator, a fabric neck strap and a disconnection wedge which are supplied in a sterile blister pack. The silicone tracheostomy tube is radiopaque, available in different diameters and lengths, cuffed or uncuffed models, and includes a plastic or metal obturator. The appropriate diameter and length of the tube is determined by the physician.
For insertion, the neck is extended with the tracheostoma open and free of obstruction. The tracheostomy tube (with the obturator inside), is inserted directly into the tracheostoma until the neck plate is in contact with the skin surface. Once in place the obturator is removed and when applicable, the cuff is filled with sterile water. When the tracheostomy tube is in position, the device is secured with a neck strap.
The TRACOE silcosoft® is intended for single-patient use up to 29 days and may be reprocessed 7 times within this period. The device is applicable for mechanically ventilated or spontaneously breathing patients in hospitals, pre-hospital (EMS), extended care facilities, outpatient clinics, or home care and can be used by individuals trained in tracheostomy care.
The provided text describes the regulatory clearance (510(k)) for the TRACOE silcosoft® tracheostomy tube. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study for device acceptance criteria in the context of an AI/ML powered device.
Therefore, many of the requested fields regarding AI/ML-specific study information (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this traditional medical device submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in the format typically seen with performance metrics for an AI/ML algorithm. Instead, it demonstrates equivalency to a predicate device through a comparison of technical characteristics and non-clinical testing against recognized standards.
| Characteristic / Test | Acceptance Criteria (Implicit: Equivalent to predicate & relevant standards) | Reported Device Performance (TRACOE silcosoft®) |
|---|---|---|
| Intended Use | Provide direct airway access for a tracheostomized patient for up to 29 days. Reprocessable for single patient use. Patient population: neonates, infants, children, adolescents. | "The TRACOE silcosoft® tracheostomy tube is intended to provide direct airway access for a tracheotomized patient up to 29 days. It may be reprocessed for single patient use up to 7 times. Patient population: neonates, infants, children, and adolescents." - Matches intended use, with slight difference in reprocessing frequency. |
| Material | Silicone with wire reinforcement. | Silicone with wire reinforcement. |
| Radiopacity | Radiopaque, usable in x-ray, CT or MR imaging (MR Conditional). | Radiopaque, usable in x-ray, CT or MR imaging (MR Conditional). |
| Sterility & Use | Provided sterile and intended for single patient use. | Provided sterile and intended for single patient use. |
| Securement | Secured with a fabric tie/strap. | Secured with a fabric tie/strap. |
| Obturator | Includes an obturator to assist with insertion. | Includes an obturator to assist with insertion. |
| Flange, Cuff, Inflation System Material | Made of silicone. | Made of silicone. |
| Functional/Mechanical Testing (ISO 5366-3) | Conformance to ISO 5366-3 for pediatric tracheostomy tubes. | Successfully met product requirements and control measures. |
| Biocompatibility Testing (ISO 10993-1) | Conformance to ISO 10993-1 (biological risk assessment, chemical analysis, cytotoxicity, genotoxicity, intracutaneous reactivity, sensitization, acute toxicity). | Successfully met product requirements and control measures. |
| Sterilization, Reprocessing & Packaging Validation (ISO 11135-1, ISO 10993-7, ISO 17665-1, ISO 17665-2, ISO 11138-3) | Conformance to specified ISO standards for sterilization, reprocessing, and packaging. | Successfully met product requirements and control measures. |
| Comparison Testing to Predicate | Design, functionality, and performance comparable or superior to the predicate device. | "The successful results of the non-clinical testing demonstrated that TRACOE silcosoft® is substantially equivalent to the predicate device." |
| Reprocessing Allowed | Up to 10 times for adult sizes and up to 5 times for pediatric sizes (predicate). | Up to 7 times for single patient use. |
Differences Not Raising New Questions of Safety/Effectiveness:
- Patient population: Predicate offers adult sizes (larger diameters), while TRACOE silcosoft® is for neonates, infants, children, and adolescents. This difference is not considered to raise new safety/effectiveness concerns as the new device falls within a subset of the predicate's population.
- Reprocessing: Predicate allows 5 times for pediatric sizes, TRACOE silcosoft® allows 7 times. This change in reprocessing frequency for pediatric sizes is deemed not to raise different questions of safety and effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This was a non-clinical evaluation based on device testing and comparison to a predicate, not a study involving human data or an AI/ML algorithm's test set.
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. No ground truth based on expert review was established for a test set in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission was based on established engineering principles, recognized international standards for medical devices (e.g., ISO standards for tracheostomy tubes, biocompatibility, sterilization), and the performance of the legally marketed predicate device.
8. The sample size for the training set
Not applicable. No AI/ML model training was involved.
9. How the ground truth for the training set was established
Not applicable.
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