(46 days)
The disposable blood pressure cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. 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 includes disposable blood pressure cuff and reusable blood pressure, both disposable and reusable blood pressure cuff has same structure, which contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. The disposable blood pressure cuff is single use device, and which is made of non-woven fabrics & PVC (Cuff) and PVC (Air Hose), thereinto, the non-woven fabrics & PVC (Cuff) is the material used to contacting with the patient. The disposable blood pressure cuff has 18 models with different size for different population with different arm size, and the 9 models of 18 are use single tube of air hose and other 9 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. 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 10 models with different size for different population with different arm size, and the 5 models of 10 are use single tube of air hose and other 5 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system. Both disposable and reusable blood pressure cuff are provided as non-sterile.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the device (Disposable/Reusable Blood Pressure Cuff) as "substantially equivalent" to predicate devices, rather than presenting explicit acceptance criteria with numerical performance targets and reported device performance against those targets. The submission relies on demonstrating equivalence through adherence to recognized standards and comparison of features with predicate devices.
However, based on the non-clinical tests conducted, we can infer some "acceptance criteria" through compliance with the listed standards and the qualitative results:
| Criteria Category | Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | No cytotoxicity (ISO 10993-5) | "Under the conditions of the study, not cytotoxicity effect" |
| No irritation (ISO 10993-10) | "Under the conditions of the study, not an irritant" | |
| No sensitization (ISO 10993-10) | "Under conditions of the study, not a sensitizer." | |
| Functional/Performance | Compliance with ISO 81060-1:2012 (Non-Invasive Sphygmomanometers - Part 1: Requirements And Test Methods For Non-Automated Measurement Type) | "The test results demonstrated that the proposed device complies with the following standards" (including ISO 81060-1:2012) |
| Pressure Limits | 0-300 mmHg | 0-300 mmHg (matching predicate) |
| Cuff Sizes | Conform to AHA bladder sizes recommendations | Proposed device sizes are listed and compared to predicate sizes |
| Intended Use | Accessory for noninvasive blood pressure measurement systems | Matches predicate, "SE" (Substantially Equivalent) |
| Sterility | Non-sterile | Non-sterile (matching predicate) |
| Reuse | Disposable for single-patient use (Disposable cuff) | Matches predicate |
| Reusable (Reusable cuff) | Matches predicate |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a "test set" in the context of clinical data for performance evaluation. Instead, it refers to non-clinical tests conducted to verify design specifications and substantial equivalence.
- Sample Size for Non-Clinical Tests: Not explicitly stated (e.g., number of cuffs tested for biocompatibility or pressure limits). The document only mentions that "Non clinical tests were conducted."
- Data Provenance: The tests were conducted internally by the manufacturer (Xuzhou Maicuff Technology Co.,ltd.) or by a testing laboratory on their behalf, in the context of a 510(k) submission to the FDA. The country of origin for the manufacturing and testing would likely be China, where the company is based. The tests are prospective in the sense that they were conducted for this specific submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a blood pressure cuff and the testing described is non-clinical (biocompatibility, performance to standards), not a diagnostic or AI-driven device requiring expert adjudication of "ground truth" for patient cases.
4. Adjudication Method for the Test Set:
Not applicable, as there is no clinical test set requiring expert adjudication for ground truth. The evaluation is based on non-clinical testing against established standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." The device is a physical accessory (blood pressure cuff), not a diagnostic tool where reader performance would be a primary concern.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical accessory (a blood pressure cuff), not an algorithm or software. Therefore, an "algorithm only" performance study is irrelevant.
7. The Type of Ground Truth Used:
For the biocompatibility tests, the "ground truth" is established by the accepted scientific methodologies and criteria outlined in the ISO 10993 standards (e.g., cell viability for cytotoxicity, skin reaction assessment for irritation and sensitization).
For the functional/performance tests, the "ground truth" or reference values are derived from the requirements and test methods detailed in ISO 81060-1:2012 for non-invasive sphygmomanometers.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical medical accessory, not a machine learning model, so there is no concept of 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.
§ 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).