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510(k) Data Aggregation
(59 days)
Disposable Blood Pressure Cuff Guard
This device has the potential to reduce or prevent patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It 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 of polyethylene coated on Tyvck. Blood pressure cuffs are used throughout the healthcare industry as a means of monitoring patient blood pressure. Because blood pressure cuffs are used on multiple patients there is a concern about cross contamination.
When the blood pressure cuffs become contaminated they should be cleaned. A blood pressure cuff Guard can reduce the need to clean blood pressure cuffs.
In order to address the cross contamination issue for blood pressure cuffs a blood pressure cuff Guard has been designed. The product is a non-sterile, clean, ready to use sleeve that is applied between the patient arm and the blood pressure cuff. The cuff Guard has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient.
The blood pressure cuff Guard is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff Guard becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff Guard.
The blood cuff Guard has a two layer structure. The inner layer is made of Tyvck. The outer layer is made of cast film of polyethylene.
The polyethylene is a fluid repellent, and is resistant to microbial penetration, thus provides a barrier between the pressure cuff and patient.
The whole guard is approximately 20 um thick and is available in various different length and width.
The guard is designed as pouchlike with one open, the blood pressure cuff can be packed into it and sealed with adhesive tape, and which can be secured around the patient arm by two velcro. The adhesive tapes are located at the edge of open and the Velcro located at the two ends of outer guard, both of them are not contact with the patient skin.
This document is a 510(k) summary for a Disposable Blood Pressure Cuff Guard (K150227). It describes the device's intention to reduce cross-contamination during blood pressure measurement and claims substantial equivalence to a predicate device.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative performance metric sense (e.g., a specific percentage reduction in microbial count). Instead, the acceptance criteria are implicitly linked to demonstrating substantial equivalence to a predicate device by showing that the proposed device meets design specifications and passes certain non-clinical tests.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | Proposed Device: "This device has the potential to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. It covers a blood pressure cuff to provide a barrier between patient and cuff." |
| Predicate Device: (Identical Indication) | |
| Biocompatibility (Cytotoxicity) | Proposed Device: "Under the conditions of the study, not cytotoxicity effect." |
| Predicate Device: "Comply with ISO 10993-5" | |
| Biocompatibility (Irritation) | Proposed Device: "Under the conditions of the study, not an irritant." |
| Predicate Device: "Comply with ISO 10993-10" | |
| Biocompatibility (Sensitization) | Proposed Device: "Under conditions of the study, not a sensitizer." |
| Predicate Device: "Comply with ISO 10993-10" | |
| Design Specifications (Dimensions, Adhesive Tape, Velcro) | Proposed Device: Bench testing for "performance of Dimensions, Adhesive Tape, Compatibility with BP Cuff and Velcro" was conducted. (Specific performance details are not provided, only that tests were done and "met all design specifications"). |
| Basic Design (Packaging the cuff vs. under the cuff) | Analysis 1 states: "The proposed device has different Design to the predicate device, the current design we used is pack the blood cuff, this way could fix the blood cuff around the arm more steadily during measurement process, so we consider this as the proposed device is SE with the predicate device." (This is an explanation for difference, not a performance metric per se). |
| Materials (Tyvek/Polyethylene vs. Polyethylene/Paper) | Analysis 2 states: "The proposed device has different materials to the predicate device, this different may causes potential biocompatibility risk, for this risk we conducted the biocompatibility test according to the ISO 10993-5 and ISO 10993-10, the test results showed that the proposed devices did not induce any risk relating to the cytotoxicity, irritation or sensitization." (This points to the biocompatibility results). |
| Closure Method (Velcro/Adhesive Tape vs. Adhesive Tape) | Analysis 3 states: "The proposed device has different closure method to the predicate device, but the Velcro has the effect to fix the guard and cuff, so we consider this as the proposed device is SE with the predicate device." (Similar to basic design, an explanation of difference leading to SE conclusion). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The non-clinical tests (biocompatibility, bench testing) would have involved a certain number of samples or specimens, but the exact count is not provided in this summary.
- Data Provenance: The tests were conducted by Pinghu Sama Medical Packing Co., Ltd. (China). The document does not specify if the data is retrospective or prospective, but as it's for a new device, it would implicitly be prospective testing of the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not stated. The ground truth for biocompatibility studies is typically established by laboratory testing against ISO standards and interpreted by qualified toxicologists or biologists, not through expert consensus in the way a medical image might be. For bench testing, the "ground truth" would be the design specifications and established engineering principles.
- Qualifications of Experts: Not applicable/not stated in this document.
4. Adjudication method for the test set:
Not applicable. This device's evaluation (biocompatibility and bench testing) does not involve a human reader or an adjudication process in the typical sense for diagnostic devices.
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 is a physical medical device (a cuff guard), not an AI-powered diagnostic tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Biocompatibility: The ground truth for biocompatibility was established by ISO standards (ISO 10993-5 for cytotoxicity and ISO 10993-10 for irritation and sensitization). The test results were compared against the requirements of these standards.
- Bench Testing: The ground truth for bench testing (Dimensions, Adhesive Tape, Compatibility with BP Cuff, Velcro) would be the device's own design specifications and functional requirements.
8. The sample size for the training set:
Not applicable. This device is not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an algorithm that requires a training set.
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