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510(k) Data Aggregation
(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 (< 4mm Hg/ min.) |
| Material | SE (210D Nylon TPU (Cuff) and PVC (Air Hose)) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set for the non-clinical tests (e.g., biocompatibility testing). It mentions compliance with ISO standards, which would imply specific sample size requirements within those standards.
- Data Provenance: Not explicitly stated regarding the origin of the test data (e.g., country of origin). The submission is from Shenzhen Vistar Medical Supplies Co., Ltd. in China, implying tests were likely conducted there or by affiliated labs. The studies were non-clinical, so the concept of retrospective or prospective data doesn't directly apply in the same way as clinical trials with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The non-clinical tests (biocompatibility, performance against ISO standards) typically rely on standardized laboratory procedures and equipment rather than expert human consensus for "ground truth." For example, cytotoxicity would be measured by laboratory assay, not expert opinion.
4. Adjudication Method for the Test Set
Not applicable in the context of these non-clinical tests. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, not for laboratory testing of device materials or physical performance.
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 device is a blood pressure cuff, a physical accessory for measurement. It does not involve AI, image interpretation, or human "readers" in the context of diagnostic decision-making. Therefore, an MRMC study is irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (blood pressure cuff), not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests was based on the requirements and methodologies specified in the relevant ISO standards:
- Biocompatibility: In vitro cytotoxicity results (ISO 10993-5) and in vivo irritation/sensitization results (ISO 10993-10) using standardized testing protocols.
- Performance (Blood Pressure Measurement): Requirements and test methods for non-automated measurement type as defined by ISO 81060-1. This standard would set specific limits for accuracy, leakage, etc., which serve as the "ground truth" for compliance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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