(78 days)
The DeRoyal Sterile Neonatal Blood Pressure Cuff is indicated for use whenever non-invasive physiologic blood pressure need be obtained from the limbs (extremities) using the appropriate blood pressure monitor designed to operate together with the cuff.
The DeRoyal Sterile Neonatal Blood Pressure Cuff functions in the same manner as predicate devices in that it is intended to be used in conjunction with another device to determine a subject's blood pressure.
Device Design/ Materials Used/Physical Properties: The DeRoyal Sterile Neonatal Blood Pressure Cuff is made of materials commonly used for their purpose. The concept of use is that the device has an inflatable bladder in an elastic cuff (sleeve) with a mechanism for inflating and deflating the bladder. Both components, together, are used to determine a patient's blood pressure.
The provided K99 submission for the DeRoyal Sterile Neonatal Blood Pressure Cuff does not include acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against specific acceptance criteria.
The information provided outlines:
- Submitter Information: DeRoyal Industries, Inc.
- Device Names: DeRoyal Sterile Neonatal Blood Pressure Cuff
- Predicate Devices: Critikon, Ethox, and Lorin Medical blood pressure cuffs.
- Device Description: The cuff has an inflatable bladder in an elastic sleeve, mechanisms for inflation/deflation, and is made of commonly used materials (PVC film for the cuff, PVC for the bulb). It's available in neonatal sizes, is disposable, sterile, and has 1 or 2 tubings. It operates within a pressure range of 0-300 mmHg.
- Intended Use: To obtain non-invasive physiologic blood pressure from the limbs using an appropriate blood pressure monitor.
- Technological Comparison: A table comparing characteristics of the DeRoyal device with "Other Devices" (predicates), highlighting similarities in main cuff material, sizes, disposability, tubing options, and pressure range. It notes that predicate devices come in both sterile and non-sterile versions, while the DeRoyal device is sterile.
Therefore, it is not possible to complete the requested table and detailed study information based on the provided text.
The document's purpose is to satisfy the FDA's 510(k) requirements by demonstrating that the device is "substantially equivalent" to legally marketed predicate devices, implying that its safety and effectiveness are similar. This typically relies on a comparison of design, materials, intended use, and performance characteristics to existing devices, rather than a new clinical or extensive performance study with defined acceptance criteria for a novel 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).