(253 days)
The BP Cuff Barrier is a disposable non-sterile device with a medical purpose, worn by the patient as a barrier to prevent contamination between patient and blood pressure cuff.
Disposable BP Cuff Barrier 1081789, Disposable BP Cuff Barrier, Plastic Coated, 1030193
The provided text is a 510(k) premarket notification summary from the FDA for a "Disposable BP Cuff Barrier". This document is a regulatory approval, not a scientific study describing performance criteria and device efficacy. Therefore, I cannot extract the requested information about acceptance criteria, study details, or performance metrics from this text.
The document primarily focuses on:
- Device Description: Disposable BP Cuff Barrier, non-sterile.
- Intended Use: To prevent contamination between patient and blood pressure cuff.
- Regulatory Classification: Class II medical device, product code DXQ, regulated under 21 CFR 870.1120 (Blood Pressure Cuff).
- Substantial Equivalence: The FDA found the device substantially equivalent to legally marketed predicate devices.
The text does not contain information about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone performance studies.
- Type of ground truth used (pathology, expert consensus, outcomes data).
- Training set sample size.
- Ground truth establishment for the training set.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).