(131 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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
The subject device is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is available in neonatal, infant, child and adult sizes. The subject device includes reusable blood pressure cuff. All the reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube. The reusable blood pressure cuff is reusable device, Model CK-XT-78211-XXX series are made of PU synthetic leather (Cuff) and TPU (Air Hose), and the PU synthetic leather (Cuff) is the material used to contacting with the patient's intact skin. Model CK-XT-78243-XXX series are made of Nylon (Cuff) and silica gel (Air Hose), and the Nylon (Cuff) is the material used to contacting with the patient's intact skin.
The provided text describes a 510(k) submission for a Reusable NIBP Cuff, demonstrating its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.
The document focuses on non-clinical data and biocompatibility testing, primarily to show compliance with international standards and substantial equivalence, rather than a direct comparison against specific performance acceptance criteria for the blood pressure measurement accuracy itself (which is typically addressed by standards like ISO 81060-2).
Therefore, it is not possible to fully answer the request based on the provided text. I will extract the available information and explicitly state what is missing.
Missing Information from the Provided Document:
- A table of specific acceptance criteria for blood pressure measurement accuracy and corresponding device performance data against these criteria. The document mentions compliance with ISO 81060-1 but does not provide the specific performance results or acceptance limits for accuracy from this standard.
- The exact sample size used for any performance testing related to blood pressure measurement accuracy.
- Data provenance (country of origin, retrospective/prospective) for any detailed performance study.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Whether a standalone (algorithm only) performance study was done.
- The specific type of ground truth used for performance validation (e.g., direct arterial measurement, oscillometric reference).
- Sample size for the training set (no training set mentioned as this is a physical medical device, not an AI/software device).
- How ground truth for the training set was established (not applicable).
Based on the provided text, here is the information available:
1. A table of acceptance criteria and the reported device performance
The document states that non-clinical tests were conducted to verify that the subject device met all design specifications and complied with specific standards, implying these standards define the acceptance criteria. However, explicit numerical acceptance criteria and the device's reported performance against them are not provided in a detailed table as requested.
The relevant standards mentioned are:
- ISO 81060-1: Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type, First Edition 2007.
- ISO 10993-5: Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity.
- ISO 10993-10: Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
For biocompatibility testing, the acceptance criteria are generally "no sensitization observed" and "Negligible (no observed primary irritation)" and passing cytotoxicity tests, which the device reportedly met. These are general statements rather than specific numerical criteria.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any performance testing related to NIBP accuracy. For biocompatibility, "the battery of testing" was mentioned, but specific sample sizes of biological material or animals are not detailed.
- Data Provenance: Not specified. The submission sponsor and correspondent are based in China (Shenzhen, P.R. China).
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 as the device is a physical NIBP cuff, not an AI/software device usually requiring expert ground truth in this context. The performance verification likely involved physical laboratory testing and possibly clinical studies, not expert review of images or data.
4. Adjudication method for the test set
- Not applicable/Not provided. This usually pertains to studies involving expert review for AI/image analysis.
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/Not provided. This pertains to AI-assisted diagnostic devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This pertains to AI/software performance. The device is a physical medical accessory.
7. The type of ground truth used
- For NIBP cuff performance (ISO 81060-1): The standard typically describes methods for validating the accuracy of non-invasive blood pressure measurements, often against a reference method (e.g., intra-arterial pressure measurement) or a validated simulator. The exact ground truth method used in their specific tests is not detailed in this summary.
- For Biocompatibility (ISO 10993-5, -10): The ground truth is established through standardized laboratory assays for cytotoxicity, sensitization, and irritation using accepted biological models (e.g., cell cultures, animal models, or human patch tests).
8. The sample size for the training set
- Not applicable. This device is a physical NIBP cuff, not a software or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is relevant for this type of 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).