(59 days)
The reusable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in infant, pediatric and adult sizes.
The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, pediatric and adult sizes.
The proposed device is Reusable blood pressure cuff, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube.
During the operation process, the integrated inflatable bladder will wrapped around the patient's limb and secured by hook and loop closure, and the air hose will connected to the noninvasive blood pressure measurement systems.
The reusable blood pressure cuff is reusable device, and which is made of 210D Nylon TPU (Cuff) and PVC (Air Hose), thereinto, the 210D Nylon TPU (Cuff) is the material used to contacting with the patient.
The reusable blood pressure cuff has 16 models with different size for different population with different arm size, and the 8 models of 16 are use single tube of air hose and other 8 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
The Reusable blood pressure cuff is provided as non-sterile.
This document pertains to the 510(k) premarket notification for a Reusable Blood Pressure Cuff (K152468).
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present "acceptance criteria" as a separate, quantitative table for the device's main function (blood pressure measurement accuracy). Instead, it focuses on demonstrating substantial equivalence to a predicate device (K151290) through a comparison of various features and compliance with relevant standards for safety and performance.
The "Non-Clinical Test Conclusion" section indicates that the device met design specifications and was substantially equivalent, based on compliance with specific ISO standards.
| Acceptance Criteria (related to standards/tests) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility: | |
| ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity | "Under the conditions of the study, not cytotoxicity effect" |
| ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. | "Under the conditions of the study, not an irritant" |
| ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. | "Under conditions of the study, not a sensitizer." |
| Non-Invasive Sphygmomanometers Performance: | |
| ISO 81060-1:2012 Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type | Complies (implied by "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device") |
| Physical/Functional Characteristics (compared to predicate): | |
| Intended Use | SE (Substantially Equivalent) |
| Patient Populations | SE |
| Tube Configuration | SE |
| Principles of Operation | SE |
| Size (Cuff) | Differences noted, but deemed SE due to compliance with ISO 81060-1 and biocompatibility tests (Analysis 1) |
| Single Use | SE (However, the device name is "Reusable Blood Pressure Cuff", suggesting this might be a typo in the table if "Y" means "yes, single use". Given the device name and description, it's likely "N" for reusable, or the table refers to a single patient use during a visit, not a single lifetime use.) Correction: The "Single Use" row likely means "Single Patient Use", which is "Y", meaning it's used for one patient at a time, but it is reusable across different uses for that same patient. The overall context of "Reusable Blood Pressure Cuff" suggests it's not disposed of after a single measurement. |
| Sterile | SE ("No") |
| Pressure Range | SE (0-300 mmHg) |
| Max. Pressure | SE (400 mmHg vs >350 mmHg) |
| Tubing Size | SE (OD = 8.0; ID=4.0; L=200;) |
| Max. Leakage | SE ( |
§ 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).