(82 days)
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No
The description focuses on the mechanical components and intended use as an accessory, with no mention of AI/ML terms or functionalities.
No
The device is described as an accessory used with blood pressure measurement systems, indicating it aids in diagnosis/measurement rather than providing therapy.
No
Explanation: The Unimed Blood Pressure Cuff is described as an accessory used in conjunction with non-invasive blood pressure measurement systems. Its function is to inflate and wrap around a limb to facilitate blood pressure measurement, but it does not independently perform diagnosis or interpret the measurement data. It is a component for a system that measures a physiological parameter, which may then be used for diagnostic purposes, but the cuff itself is not the diagnostic device.
No
The device description clearly outlines physical components like tubing, an inelastic sleeve, an inflatable bladder, and hook and loop closure, indicating it is a hardware device.
Based on the provided information, the Unimed Blood Pressure Cuff is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an accessory used in conjunction with non-invasive blood pressure measurement systems. This is a physiological measurement taken directly from the patient's body.
- Device Description: The description details a physical device that is wrapped around a limb to facilitate a physical measurement.
- Lack of IVD Characteristics: There is no mention of analyzing samples taken from the body (like blood, urine, tissue, etc.) or performing tests in vitro (outside of the living body). IVDs are designed to examine these types of samples to provide information about a person's health.
- Performance Standards: The listed performance standards (ANSI/AAMI SP10, ISO 10993) are related to the performance and biological safety of medical devices that interact with the body, not specifically IVD testing.
Therefore, the Unimed Blood Pressure Cuff is a medical device used for a physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Unimed Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
Product codes (comma separated list FDA assigned to the subject device)
DXO
Device Description
The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to a non-invasive blood pressure measurement system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's limb
Indicated Patient Age Range
pediatric and adult
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Unimed Blood Pressure Cuff has been tested according to the following standards:
- ANSI/AAMI SP10, Manual, electronic or automated sphygmomanometers, 2002+A1:2003+A2:2006+(R)2008
- ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing, 2003
- ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, 2009
- ISO 10993-10, Biological evaluation of medical devices -- Part 10: Tests for irritation and delayed-type hypersensitivity, 2002+A1:2006
Key results: The few differences do not affect the safety and effectiveness of the subject devices. Thus, the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0