(77 days)
To allow airflow over the vocal cords for speaking function. To be used with a standard 15 mm connection on tracheostomy tubes.
The Shikani speaking valve consists of a plastic housing with a captured ball that acts as a check valve. Once attached to the tracheostomy tube connector the speaking valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal cords which facilitates speech or phonation.
Acceptance Criteria and Device Performance for Shikani Speaking Valve
This report details the acceptance criteria and the study (or, in this case, comparison to a predicate device) that demonstrates the Shikani Speaking Valve meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a device that is essentially identical to a previously cleared predicate and is considered a line extension, the "acceptance criteria" are primarily established by the performance of the predicate device. The study performed is a demonstration of substantial equivalence based on identical design and performance parameters.
| Acceptance Criteria (based on Predicate) | Reported Device Performance (Shikani Speaking Valve) | Comment |
|---|---|---|
| Intended Use: Allow airflow over vocal cords for speaking function. | Allows airflow over vocal cords for speaking function. | Identical intended use. |
| Indications for Use: Allow airflow... with 15mm connection. | Allows airflow... with a standard 15 mm connection. | Identical indications for use, reflecting the predicate device's later line extension with 15mm connection. |
| Environment of Use: Hospital, Sub-acute, Home. | Hospital, Sub-acute Institutions, Home. | Identical. |
| Patient Population: Tracheostomy patients. | Tracheostomy patients. | Identical. |
| Contraindications: Not for use in-line with a ventilator. | Not for use with inflated tracheostomy tube cuff; Not for use with unconscious patients; Not for use with patients unable to exhale around the tube/cuff. | The proposed device includes additional contraindications considered appropriate for speaking valves in general, not due to new risk analysis of the device itself. |
| Standard 22/15mm Connections (per ISO 5356-1) | Yes - standard fitting to connect to breathing circuit and 15mm tracheostomy tube connector. | Identical. The device is confirmed to conform to ISO 5356-1. The manufacturer states "Conformance was not tested as the device is unchanged, but this standard is referenced." This implies previous testing or inherent design conformity. |
| Weight: 32 gm | 32 gm | Identical. |
| Valve type: Ball | Ball | Identical. |
| Attachment to tube: Attachment clip | Attachment clip | Identical. |
| Pressure drop: 1.3 cm H2O @ 30 lpm; 2.0 cm H₂O @ 40 lpm | 1.3 cm H2O @ 30 lpm; 2.0 cm H₂O @ 40 lpm | Identical. |
| Materials: Housing - Celcon C251-A Acetyl Copolymer; Ball - Nylon 6/6 Grade 2; Pin - 316 Stainless steel | Housing - Celcon C251-A Acetyl Copolymer; Ball - Nylon 6/6 Grade 2; Pin - 316 Stainless steel | Identical. |
| Biocompatibility: Passed ISO 10993 (for materials) | Materials passed ISO 10993 (as per predicate testing). | The proposed device uses identical materials, thus existing biocompatibility testing for the predicate applies. |
2. Sample Size Used for the Test Set and Data Provenance
This submission is for a device explicitly stated to be "the same device" as the legally marketed predicate (Shikani-French 15, which was a line extension of K982128). Therefore, there isn't a new "test set" in the traditional sense for evaluating AI/algorithm performance. The "test" is an assertion of identicality to the predicate device, which itself had performance testing.
- Sample Size for Test Set: Not applicable as a distinct new test set for the "proposed device" was not used. The performance claims rely on the predicate device's testing.
- Data Provenance: The original performance data for the predicate device (K982128) would have been generated during its initial clearance, likely from laboratory testing. Specific details on the country of origin or whether it was retrospective/prospective are not provided for the original K982128 submission in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a mechanical speaking valve, not an AI/imaging device requiring expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. This device is a mechanical speaking valve, not an AI/imaging device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a mechanical device, not an AI algorithm assisting human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a mechanical device, not an algorithm.
7. Type of Ground Truth Used
For the original predicate device (K982128), and by extension for this identical device, the "ground truth" for performance was based on physical measurements such as:
- Resistance to flow (pressure drop)
- Weight
- Material composition
- Biocompatibility test results (laboratory assays)
These are objective, quantifiable physical properties rather than expert consensus, pathology, or outcomes data typically associated with diagnostic or AI devices.
8. Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a mechanical device, not an AI algorithm.
§ 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.