(177 days)
This device is intended to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. Covers a blood pressure cuff to provide a barrier between patient and cuff.
This device is a cover for blood pressure cuffs. It is made non-woven polypropylene with a polyethylene coating. The product is a non-sterile, clean, ready to use sleeve that covers a blood pressure cuff. The cuff cover has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient. The blood pressure cuff cover is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff cover becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff cover.
The provided text describes a 510(k) premarket notification for the Ethox CUF-COVERTM, a blood pressure cuff cover. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the BOWEN MEDICAL SERVICES, INC. CUFF GUARD (K952825).
Based on the provided information, I can answer some of your questions, but many of the specific details you've asked for, particularly regarding new device acceptance criteria and study particulars for a modern AI/ML device, are not present in this document, as this is a traditional medical device submission from 2003.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is primarily done by showing similar intended use, technological characteristics, and safety and effectiveness.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (Ethox CUF-COVER™) |
|---|---|
| Intended Use: Reduce/prevent patient-to-patient cross-contamination during BP measurement, provide barrier between patient and cuff. | SAME as predicate, "except for single patient use only." (This is a slight difference but considered acceptable for equivalence, potentially improving safety). |
| Materials: Appropriate for the intended use and provide barrier function. | Thin non-woven polypropylene with a polyethylene coated inner layer. (Compared to "White spun plastic" of the predicate). Laboratory testing shows material is an effective microbial and air barrier. |
| Safety: Does not significantly affect diagnostic measurements (e.g., blood pressure). | Clinical testing shows the cover does not significantly affect blood pressure readings. |
| Effectiveness: Provides a barrier function against contamination. | Laboratory testing shows the material is an effective microbial and air barrier. Potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient. |
| Technological Characteristics: Similar design and function. | Made non-woven polypropylene with a polyethylene coating, single-patient use, clean, ready-to-use sleeve, Zip-Lock closure (vs. adhesive tape for predicate), translucent (vs. opaque for predicate). Sizes: Small, Medium, Large (vs. 6 sizes for predicate). Differences are judged not to raise new questions of safety or effectiveness. |
Study Information (Based on the provided text)
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Sample size used for the test set and the data provenance:
- Clinical Testing: The document mentions "Clinical testing shows the cover does not significantly affect blood pressure readings." However, the sample size and data provenance (e.g., country of origin, retrospective/prospective) for this clinical testing are NOT provided.
- Laboratory Testing: "Laboratory testing shows the material is an effective microbial and air barrier." Details on the sample size or methods for this lab testing are NOT provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) submission. This is a traditional device; the "ground truth" here is the physical performance and safety characteristics, not interpretations by experts of diagnostic images or data. The "ground truth" for the material barrier claims would be established by standard microbiological and material integrity tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to expert consensus in diagnostic studies (e.g., radiology). For this device, standard laboratory and clinical methods are used, not expert adjudication in that sense.
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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:
- No, an MRMC study was NOT done. This is a physical medical device (blood pressure cuff cover), not an AI/ML diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is irrelevant here.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone study was NOT done. Again, this is a physical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the barrier function: Laboratory test results demonstrating effectiveness as a microbial and air barrier would serve as the "ground truth."
- For the impact on blood pressure readings: Clinical measurements demonstrating that the cover does not significantly alter BP readings would be the "ground truth."
- For cross-contamination reduction: This is inferred from the barrier function and the single-patient use design, aligning with the intended use.
- Essentially, the ground truth is based on objective physical and physiological measurements from laboratory and clinical tests, not expert consensus on diagnostic interpretations.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML product, so there is no concept of a "training set" in the context of machine learning. The device design and materials are based on standard engineering and medical principles.
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How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.
§ 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).