(280 days)
To monitor intra-cuff pressures of supraglottic airways.
The SureSeal™ supraglottic airway with attached Cuff Pilot ™ is indicated for use in achieving and maintaining control of the airway during routine anesthetic procedures on fasted patients and emergency procedures using either spontaneous or Positive Pressure Ventilation (PPV).
- An alternative to a face mask.
- . An airway device in routine anesthesia procedures.
- Securing the immediate airway in anticipated or unexpected difficult airway situations.
- Use in elective surgical procedures where tracheal intubation is not necessary.
- Establishing an immediate, clear airway during cardiopulmonary resuscitation (CPR) in the profoundly ● unconscious patient requiring artificial ventilation when tracheal intubation is not possible.
The Cuff Pilot™ is a simple device which allows the user to monitor the cuff pressure of supraglottic airways. It has been designed to display pressure ranges via color coded zones. The Cuff Pilot™ is designed with an internal bellows, is compressed as pressure increases and expands when intra-cuff pressure is less. There is an O-ring indicator that is on the bellows and this indicates the status of pressure within the define color coded pressure zones.
The SureSeal™ supraglottic airway is very similar in design, performance, indications for use, technology of operation, and materials to our LMA airways. It will have the Cuff Pilot™ attached and is considered MR Safe.
Let me break down the information from the provided text regarding the acceptance criteria and study for the Cuff Pilot™ and SureSeal™ with Cuff Pilot™.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical trial to prove efficacy against a specific set of acceptance criteria in the manner one might expect for a novel AI device. Therefore, some of the requested information, particularly regarding ground truth, expert adjudication, MRMC studies, and explicit acceptance numbers for performance metrics beyond general accuracy ranges, is not present because it's not typically part of a 510(k) for this type of device. The "acceptance criteria" here are largely implied by demonstrating equivalence to the predicate device's performance characteristics.
Cuff Pilot™
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Cuff Pilot™) |
|---|---|---|
| Pressure Range | 0 to 60 cm H₂O | 0 to 80 cm H₂O |
| Detection of "good range" | Color coded and a scale | Color coded zones |
| Accuracy | +/- 1 cmH₂O up to 30 cmH₂O; +/- 2 cmH₂O at 40 cmH₂O; +/- 5 cmH₂O at 60 cmH₂O | +/- 5 cmH₂O up to 80 cmH₂O |
| Repeatability | Tested for repeatability (predicate) | Tested for repeatability |
| Temperature Exposure Stability | Tested for accuracy after exposure to high and low temperatures (predicate) | Subjected samples to aging and exposure to cold and hot temperatures |
| Shelf-life | Not provided (predicate) | 3 years |
| Drop/Shipping Test | (Not explicitly mentioned for predicate) | Drop / Shipping test |
| Biocompatibility (Cytotoxicity) | Performed (predicate) | Non-reactive (ISO 10993-1 cytotoxicity testing performed) |
| MRI Use | Not labeled (predicate) | MR Safe based on lack of metal/magnetic materials per ASTM F2052-06 |
2. Sample size used for the test set and data provenance:
- Sample Size: Not explicitly stated. The studies are described as "bench testing" and "subjected samples," which implies a set of physical devices were tested, but the exact number isn't quantified in this summary.
- Data Provenance: The tests are non-clinical bench tests performed by the manufacturer (Teleflex Medical). There is no mention of country of origin for data as it's not human subject data. The studies are prospective in the sense that they were conducted for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable. This device is a mechanical pressure monitor, not an AI or diagnostic tool requiring expert interpretation for ground truth. The "ground truth" (actual pressure) would have been established using calibrated pressure measurement equipment during the bench testing.
4. Adjudication method for the test set:
- Not applicable for a mechanical device undergoing bench testing. The "adjudication" would be direct measurement against calibrated 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. This is a medical device, not an AI or diagnostic imaging system. No human reader studies (MRMC) were conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The Cuff Pilot™ is a standalone mechanical device. Its performance is evaluated intrinsically through the bench tests mentioned.
7. The type of ground truth used:
- Calibrated pressure measurements from laboratory equipment. The accuracy of the device's reading (color-coded zones) was compared against these known, precise pressure values.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set.
SureSeal™ with Cuff Pilot™
This device is the SureSeal™ supraglottic airway (which includes the Cuff Pilot™ attached). The information provided focuses on the SureSeal™ component's equivalence to a predicate (LMA Classic™) and the overall device's MR safety.
1. Table of Acceptance Criteria and Reported Device Performance:
| Attribute | Acceptance Criteria (Implied by Predicate - LMA Classic™) | Reported Device Performance (SureSeal™ with Cuff Pilot™) |
|---|---|---|
| Classification | Procode - CAE - airway, oropharyngeal; CFR – 868.5110; Class 1 - exempt | Procode - CAE – airway, oropharyngeal; CFR – 868.5110; Class 1 - exempt |
| Indications for Use | Achieving and maintaining control of airway during routine anesthetic procedures, emergency procedures; alternative to face mask, airway device in routine anesthesia, securing immediate airway in difficult situations, elective surgical procedures (no intubation), CPR. | Identical to predicate. |
| Patient Population | Patients who need an artificial airway | Identical to predicate. |
| Environments of Use | Hospitals, pre-hospital (EMS), extended care facilities, outpatient clinics, MRI suites (MR Conditional) | Hospitals, pre-hospital (EMS), extended care facilities, outpatient clinics, MRI suites (MR Safe when attached to airways that are MR Safe). |
| Technology | Inflatable cuff and tube that rest above the glottis opening | Identical to predicate. |
| Method of Inflating Cuff | Integrated pilot check valve with separate syringe. Manual | Used with Cuff Pilot™ and a separate syringe. Manual |
| Available Sizes | Sizes 1 to 6 | Sizes 1 to 6 |
| Single Patient, Disposable | Yes | Yes |
| MRI Use | MR Conditional | MR Safe based on lack of materials which contain metal or are magnetic per ASTM F2052-06. |
| Biocompatibility (Surface and External) | Surface and Externally communicating contact (indirect gas pathway); Tissue / Mucosa contact; Limited duration ( |
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).