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510(k) Data Aggregation
(147 days)
Flexicare Single Use Manometer is attached to the manometer port on Flexicare resuscitation bags to provide visual indication of the patient's airway pressure during ventilation. The device is intended to be used by trained personnel only within a hospital and/or pre-hospital environment.
Flexicare's Single Use Manometer is a single use device that can be attached to the manometer port on resuscitation bags to provide visual indication of the patient's airway pressure during manual ventilation. Flexicare's Single Use Manometer consists of end cap, clear housing with printed pressure scale, concertina seal, slider and stainless steel spring. When pressure rises, the spring is compressed raising the blue concertina seal and showing the pressure via markings on the manometer housing has calibrated marking at 20 cmH2O intervals between 0 through 60 cmH2O. The measured pressures are accurate to ± 1cmH2O. Flexicare's Single Use Manometer is supplied non-sterile and are for use by CPR-trained personnel only within a hospital and/or pre-hospital environments.
The document provided is a 510(k) Premarket Notification for the Flexicare Single Use Manometer. It describes the device, its intended use, and compares it to a legally marketed predicate device (Ambu Disposable Pressure Manometer, K040991) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Accuracy | ± 1 cm H₂O at 20, 40, 60 cm H₂O | Pass |
| Repeatability | Within accuracy tolerance (Graduation print and manometer slider overlap at each marked pressure graduation) | Pass |
| Leak Testing | No standard criteria available; Test for comparative use only (<1 ml/min stated in comparison table) | Comparable performance outcome between Flexicare's device and the predicate devices (Achieved <1 ml/min) |
| Drop Testing | ISO 10651-4: 2009 (within accuracy tolerance; mechanical integrity) | Pass |
| Visual Inspection | Samples free from any damage or defects (as per detailed methodology) | Pass |
| Cytotoxicity | ISO 10993-5:2009 | Pass |
| Irritation, Sensitization, Systemic toxicity, Extractables & Leachables | ISO 10993 compliant; ISO 10993-11:2009; ISO 10993-17:2009 | Pass |
| Particulate emissions (gas pathway) | EN ISO 18562-2:2017 | Pass |
| Accelerated Ageing | ASTM F1980 | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for each specific test in the test set. However, for "Visual Inspection," the methodology mentions "Inspect the packaging of each sample." For "Degree of Accuracy and Repeatability," it states, "Repeat step 1 - 7 a further 4 times at each pressure marking," implying multiple measurements on at least one device, or potentially multiple devices.
The data provenance is not specified in terms of country of origin, but the sponsor is Flexicare Medical Limited in the United Kingdom. The studies are retrospective as they are internal verification tests conducted by the manufacturer to demonstrate substantial equivalence to an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of device (a single-use manometer) does not typically involve expert review for establishing ground truth in performance testing. The "ground truth" for physical characteristics and performance (like accuracy, leak rate) is established through standardized physical measurements using calibrated equipment. Therefore, this information is not applicable to the context of this device and testing.
4. Adjudication method for the test set
Not applicable. As described above, the testing involves objective physical measurements against defined criteria and standards, not subjective assessments requiring adjudication.
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 mechanical medical device (manometer) for measuring airway pressure, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a purely mechanical device and does not involve any algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests for the manometer predominantly relied on reference measurements from calibrated equipment (e.g., digital pressure indicators, syringes for controlled pressure generation) and adherence to established national/international standards (e.g., ISO 10651-4, ISO 10993 series, EN ISO 18562-2, ASTM F1980). For tests without a specific standard (e.g., Leak Testing had no standard criteria available, used for comparative purposes), the ground truth for "pass" was determined by the manufacturer's pre-determined acceptance criteria and comparison to the predicate device's reported performance.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning or AI algorithm, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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