(183 days)
Tracheostomy tubes are intended for use in providing direct tracheal access for airway management.
The document describes several types of Silicone Tracheostomy Tubes: Silicone Foam Cuff Tracheostomy Tubes, Silicone Cuffless Neonatal and Pediatric Tracheostomy Tubes, Silicone Cuffless Adult Tracheostomy Tubes, and Silicone Air Cuff and Air Cuff Adjustable Neck Flange Tracheostomy Tubes. These devices are made of silicone, are radiopaque, and are white or clear in color. They include a 15mm connector and an obturator. The packaging is a PETG Tray with Tyvek Lid or a Tyvek Pouch, and they are packaged with accessories including Twill Tape and a Disconnect Wedge. Sterilization is by ETO. Labels contain product information such as name, style, size, part number, ID, OD, length, lot number, manufacturer's name, quantity, sterilization method, and expiration date. The devices comply with ASTM F 1666-95 and ASTM F 1627-95 standards.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Arcadia Medical Tracheostomy Tubes.
Important Note: The provided text is a 510(k) Summary, which is a premarket notification to the FDA. It demonstrates substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a full-fledged clinical study in the way a new, high-risk device might. The "study" here is primarily a comparison to the predicate device and adherence to industry standards, along with standard manufacturing quality controls.
Acceptance Criteria and Device Performance
The acceptance criteria for the Arcadia Medical Tracheostomy Tubes are implicitly defined by their substantial equivalence to the Bivona Medical Technologies predicate devices and compliance with relevant ASTM standards. The "reported device performance" is essentially the device's characteristics matching or being comparable to the predicate and meeting standard specifications.
Table of Acceptance Criteria and Reported Device Performance
| Characteristic / Acceptance Criteria | Arcadia Medical Performance (Meets Acceptance Criteria) |
|---|---|
| Common to all Tracheostomy Tubes: | |
| Material: Silicone | Yes |
| Radiopaque | Yes |
| Color: White (or Clear for Adjustable Neck Flange) | Yes |
| 15mm Connector | Yes |
| Obturator | Yes |
| Packaging: PETG Tray with Tyvek Lid (or Tyvek Pouch for Adjustable) | Yes |
| Accessories: Twill Tape and Disconnect Wedge | Yes |
| Sterilization Method: ETO | Yes |
| Label Information: Product Name, Style, Size, Part Number, ID, OD, | Yes |
| Length, Lot Number, Manufacturer, Quantity, Sterile-ETO, Expiration | |
| Adult Cuffless Tracheostomy Tubes: | |
| Size Range: 6.0mm, 7.0mm, 8.0mm, 9.0mm, 9.5mm | Yes (matches 5 sizes of predicate, predicate has 6) |
| Length: 6.0=51mm, 7.0=67mm, 8.0=78mm, 9.0=91mm, 9.5=95mm | Yes (compared against predicate lengths) |
| Neck Flange with OD/ID, Name & Model Type | Yes |
| Cuff Style: Cuffless | Yes |
| Complies with ASTM F 1666-95 (Adult Tracheostomy Tubes) | Yes |
| Pediatric Cuffless Tracheostomy Tubes: | |
| Size Range: 2.5mm, 3.0mm, 3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm (7 Sizes) | Yes |
| Lengths provided (e.g., 2.5=38mm to 5.5=46mm) | Yes (compared against predicate lengths) |
| Neck Flange with OD/ID, Name & Model Type | Yes |
| Wire Reinforced | Yes |
| Cuff Style: Cuffless | Yes |
| Complies with ASTM F 1627-95 (Pediatric Tracheostomy Tubes) | Yes |
| Neonatal Cuffless Tracheostomy Tubes: | |
| Size Range: 2.5mm, 3.0mm, 3.5mm, 4.0mm (4 Sizes) | Yes |
| Lengths provided (e.g., 2.5=30mm to 4.0=36mm) | Yes (compared against predicate lengths) |
| Neck Flange with OD/ID, Name & Model Type | Yes |
| Wire Reinforced | Yes |
| Cuff Style: Cuffless | Yes |
| Complies with ASTM F 1627-95 (Pediatric Tracheostomy Tubes) | Yes |
| Adult Foam Cuff Tracheostomy Tubes: | |
| Size Range: 6.0mm, 7.0mm, 8.0mm, 9.0mm, 9.5mm | Yes (matches 5 sizes of predicate, predicate has 6) |
| Lengths provided (e.g., 6.0=51mm to 9.5=95mm) | Yes (compared against predicate lengths) |
| Neck Flange with OD/ID, Name & Model Type | Yes |
| Cuff Style: Foam Cuff with Pilot Port and attached plug | Yes |
| Complies with ASTM F 1666-95 (Adult Tracheostomy Tubes) | Yes |
| Adult Air Cuff Tracheostomy Tubes: | |
| Size Range: 6.0mm, 7.0mm, 8.0mm, 9.0mm, 9.5mm | Yes (matches 5 sizes of predicate, predicate has 6) |
| Lengths provided (e.g., 6.0=51mm to 9.5=95mm) | Yes (compared against predicate lengths) |
| Neck Flange with OD/ID, Name & Model Type | Yes |
| Cuff Style: Air Cuff with Pilot Balloon, Inflation Valve, Inflation | Yes |
| Line | |
| Complies with ASTM F 1666-95 (Adult Tracheostomy Tubes) | Yes |
| Adult Air Cuff Adjustable Neck Flange Tracheostomy Tubes: | |
| Size Range: 6.0mm, 7.0mm, 8.0mm, 9.0mm (4 Sizes) | Yes |
| Usable Length: 6.0=110mm, 7.0=120mm, 8.0=130mm, 9.0=140mm | Yes |
| Adjustable Neck Flange with OD/ID, Name & Model Type | Yes |
| Wire Reinforced | Yes |
| Color: Clear | Yes |
| Cuff Style: Air Cuff with Pilot Balloon, Inflation Valve, Inflation | Yes |
| Line | |
| Above the Cuff Access Port for Suctioning and Vocalization | Yes (Predicate "Not Available on this Model") |
| Introducer/Obturator | Yes |
| Complies with ASTM F 1666-95 (Adult Tracheostomy Tubes) | Yes |
Study Details to Prove Acceptance Criteria
The provided text is a 510(k) summary, which focuses on demonstrating "substantial equivalence" of the new device to a predicate device already on the market. It does not describe a clinical study in the traditional sense with a "test set" of patients, ground truth experts, or an AI algorithm. Instead, the "study" is a comparison of technical characteristics and compliance with recognized standards.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable in the context of a 510(k) substantial equivalence comparison based on technical characteristics. The "test" is a comparison to the predicate device's specifications and ASTM standards.
- Data Provenance: The data is a comparison of specifications of the Arcadia Medical device against the Bivona Medical Technologies predicate device and relevant ASTM standards. This is a technical comparison, not patient data. It is inherently "prospective" in the sense that the new device's specifications are established. Country of origin for data is not explicitly stated beyond Arcadia Medical being in Schaumburg, IL, USA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth for a device's technical specifications is established through engineering design, testing, and compliance with industry standards, not typically by expert consensus in the way clinical images would be. The "experts" are the engineers and quality assurance personnel at Arcadia Medical and the standards bodies (ASTM) who defined the specifications.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This is a comparison of technical specifications to a predicate device and industry standards, not a judgment of clinical data.
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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:
- MRMC Study: No, an MRMC study was not done. This device is a physical medical device (tracheostomy tube), not an AI algorithm for diagnostic imaging.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No, this device is a physical medical device, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The "ground truth" for this submission are the established technical specifications of the predicate device (Bivona Medical Technologies tracheostomy tubes) and the requirements outlined in relevant ASTM International standards (ASTM F 1666-95 for Adult Tracheostomy Tubes and ASTM F 1627-95 for Pediatric Tracheostomy Tubes). This is a specification-based ground truth or standard compliance ground truth.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This is not an AI algorithm that requires a training set. The development of the device would involve engineering design, prototyping, and testing, but these are not referred to as "training sets" in this context.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no "training set" for physical device development in the AI sense. The design and manufacturing processes are guided by the "ground truth" of the predicate device's successful performance and adherence to established industry standards for safety and efficacy.
§ 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.