(347 days)
The FlexiPort™ Blood Pressure Cuff is used in conjunction with noninvasive blood pressure measurement systems. The cuff is nonsterile and is available in pediatric through adult sizes. The device is not intended for neonatal applications. The FlexiPort™ Blood Pressure Cuffs are not designed, sold, or intended for use, except as indicated.
FlexiPort™ Blood Pressure Cuffs are designed with the FlexiPort™, a standardized connector for quick exchange of tubing and fittings that interface with manual or electronic sphygmomanometers and inflation devices. This allows the interface tubing (either one- or two-tube) to remain with the blood pressure measurement device, while the cuff can be easily removed and moved from one location to another to be used universally within a facility on multiple devices. The port connector can also rotate 360 degrees to reduce tube kinking.
The Welch Allyn FlexiPort™ Blood Pressure Cuff is designed to measure blood pressure in conjunction with noninvasive blood pressure measurement systems. The device is intended for pediatric through adult sizes and is not for neonatal applications.
1. Table of Acceptance Criteria & Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Conforms to ISO 10993-1 |
| Compatibility with other devices | Tested and demonstrated compatible with other devices |
| Reprocessing | Tested and demonstrated effective reprocessing |
| Packaging | Tested and demonstrated effective packaging |
| Sterilizability | Capable of being sterilized using ETO |
| Environmental | Not explicitly detailed, but implied to meet standards through overall testing |
| Mechanical Strength | Not explicitly detailed, but implied to meet standards through overall testing |
| Durability | Tested for repeated inflations; implied to meet durability standards |
| Accuracy | Conforms to AAMI SP10, 2002 requirements for Non-Automated Sphyg. |
| AAMI/AHA bladder sizes | Conforms to AAMI/AHA bladder sizes |
2. Sample size used for the test set and the data provenance:
The provided summary does not explicitly state a specific sample size for the test sets.
The data provenance is not explicitly mentioned but would be considered retrospective as the testing was done to demonstrate conformance to existing standards and predicate device characteristics, not as an ongoing clinical trial. The testing was conducted by Welch Allyn, Inc. in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given document. The study relies on established industry standards (AAMI SP10, ISO 10993-1, AAMI/AHA bladder sizes) and bench/laboratory testing, rather than expert interpretation of results from a specific test set requiring ground truth establishment by human experts.
4. Adjudication method for the test set:
An adjudication method is not applicable as the evaluation relies on objective measurements against predetermined standards and predicate device comparisons, not subjective interpretations requiring expert consensus.
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:
This is not applicable. The device is a blood pressure cuff and does not involve AI or human "readers" in the context of image interpretation or diagnostic assistance. It is a physical medical device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical blood pressure cuff, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance is based on:
- Established industry standards: AAMI SP10, ISO 10993-1, and AAMI/AHA bladder sizes.
- Bench and laboratory testing: Physical measurements and evaluations to demonstrate conformance to these standards and equivalence to predicate devices.
8. The sample size for the training set:
This is not applicable as there is no mention of a "training set" in the context of this physical medical device.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this device.
§ 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).