(262 days)
TRACOE® vario tracheostomy tubes are indicated for providing tracheal access for airway management especially to those patients with unusual anatomy or patients with thick necks. It may be used for up to 29 days.
TRACOE® vario Tracheostomy Tubes are suitable for adults and adolescents (12-21 years) where access to the airway via a tracheostoma is required. The flexible tracheostomy tubes are single patient use, individually packaged with an obturator and neckstrap and provided sterile.
The TRACOE® vario Tracheostomy Tubes have an adjustable neck flange with a locking mechanism that allows the length of the tube to be adapted to the anatomical requirements of the individual patient. In addition, the neck flange includes two flexible wings that allow the fastening of a strap around the patients neck for fixation of the tracheostomy tube. These wings can be turned together around the flange or rotated independently within a range of about 60° to 180°. These features are useful for patients with thick necks or with unusual anatomy. The TRACOE® vario Tracheostomy Tubes are available in different models: with or without a high-volume low-pressure cuff, with or without a subglottic suction line which is suitable for Above Cuff Vocalization, fenestrated tube, standard or extended lengths, different diameters, with or without a Minimally Traumatic Insertion System (P series) and can be used within an MR environment.
The TRACOE® vario Tracheostomy Tube is for prescription use only and is applicable for mechanically ventilated or self-breathing patients in hospital (EMS), extended care facilities, outpatient clinics and can be used by individuals trained in tracheostomy care.
This document describes the TRACOE® vario Tracheostomy Tube, a medical device. However, it does not include information about a study proving the device meets specific acceptance criteria in the manner requested (i.e., with a table of reported device performance, sample sizes for test/training sets, expert qualifications, etc.).
The document is a 510(k) summary for a premarket notification to the FDA. It declares the device, TRACOE® vario, to be substantially equivalent to a legally marketed predicate device (TRACOE medical GmbH's vario Tracheostomy Tubes, K051587). This means that the FDA determined the new device is as safe and effective as the predicate device, and it does not require a new Premarket Approval (PMA) application.
Instead of a study with acceptance criteria and measured performance, the document summarizes non-clinical testing and explicitly states "Clinical testing of the TRACOE® vario Tracheostomy Tube was not required to demonstrate substantial equivalence."
Therefore, I cannot provide the requested table and information about a study that proves the device meets acceptance criteria because such a study (with the specified details) is not present in the provided text.
The closest information available is a general statement about bench testing:
"The results of this testing confirm that the TRACOE® vario Tracheostomy Tubes perform as intended, the product information is complete and comprehensive, and the device meets the requirements."
And in the conclusion:
"The TRACOE® vario Tracheostomy Tube has passed all defined criteria. The device has performed as well as the predicate device and is therefore considered substantially equivalent to the cleared predicate device."
While these statements indicate that the device met certain requirements, the provided text does not define those "defined criteria" with specific performance metrics in a table. It also does not detail the methodology of "passing" these criteria as requested in your prompt (e.g., sample sizes, ground truth, expert opinions).
The document focuses on demonstrating substantial equivalence through:
- Comparison to a predicate device: The new device is a modification of an existing, cleared device (K051587). Key differences are listed, primarily adding new models (fenestrated, XL lengths, Minimally Traumatic Insertion System), an expanded intended use statement (29 days), and updated labeling for MR environment and Above Cuff Vocalization.
- Non-clinical testing: This primarily involves testing to recognized standards for:
- Sterilization and Cleaning (ISO 10993-7, ISO 11737-1, ISO 10993-5:2009)
- Shelf Life and Transport Testing (ASTM F 1980-16, ASTM 1886/F1886M, ASTM F1929-15, ASTM F2096-11, ASTM F88/88M, ISO 11607-1, ISO 18190, ISO 14644-1, ASTM D4169-16)
- Biocompatibility Testing (materials confirmed to be the same as legally US marketed devices, and clinical experience is also cited)
- Bench Testing (ISO 5366, ISO 5356-1, ASTM F640-12, ASTM F2052-15, ASTM F2213-17, ASTM F2119-07, ASTM F2182-11a, ASTM F2503-13). This includes functionality, radiopacity, and MRI compatibility.
Without the specific "acceptance criteria" and "reported device performance" in a quantitative table format mentioned in the prompt, along with the detailed study methodology (sample sizes, ground truth, experts), I cannot fulfill all parts of your request based solely on the provided text.
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.