(102 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 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 contains Cuff with bladder and Air Hose. Air hose has single tube and double tube. Wrapped the cuff 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. The device 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 22 models with different size for different population with different arm size, and the 11 models of 22 are use single tube of air hose and other 11 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
The provided document is a 510(k) summary for the "Disposable Blood Pressure Cuff" by Wenzhou Xikang Medical Instruments Co., Ltd. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed acceptance criteria and study results for performance efficacy in the way a clinical trial or algorithm validation study would.
Instead, the "acceptance criteria" for this device are regulatory and technical standards, and the "study" demonstrating it meets these criteria are non-clinical tests to verify design specifications and compliance with recognized standards.
Here's an breakdown based on the information provided, recognizing that it's a regulatory submission rather than a performance study report:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The "Disposable Blood Pressure Cuff" is seeking 510(k) clearance, which is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" are compliance with relevant regulatory standards and the predicate device's characteristics, and the "study" involves non-clinical testing to verify this compliance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard/Predicate Feature) | Reported Device Performance (Summary from Submission) |
|---|---|---|
| Regulatory Classification | Product Code: DXQ | DXQ (Same as predicate) |
| Regulation No.: 21 CFR 870.1120 | 21 CFR 870.1120 (Same as predicate) | |
| Class: II | Class II (Same as predicate) | |
| Intended Use/Indications | Same as predicate device's disposable cuff. | 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 neonate, infant, child and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. (Same as predicate's disposable cuff indication). |
| Materials/Biocompatibility | Conform to ISO 10993 (part 5 & 10) | Conform with ISO10993-1 (ISO10993-5, ISO10993-10). Tests included: Cytotoxicity, Sensitization, Irritation. (Predicate also compliant with biocompatibility standards). |
| Technical Specifications | ||
| - Material Composition | Similar to predicate (non-woven, PVC) | Cuff (Patient contacted): PVC film stick non-woven fabric; Bladder: PVC; Air Hose: PVC; Hook tape: Nylon; Loop: Nylon. (Same materials as predicate, with explicit detail). |
| - Patient Populations | Adults/Pediatrics | Adults/Pediatrics (Same as predicate). |
| - Tube Number | One or two | One or two (Same as predicate). |
| - Limb Circumference | Conform to AHA bladder sizes recommendations | Conform to AHA bladder sizes recommendations. Range for Neonatal 1-5, Infant, Child, Small Adult, Adult, Large Adult, Thigh. (Some specific ranges are "little different" from predicate, but deemed not to raise safety/effectiveness issues based on performance testing). |
| - Pressure Range | 0-300mmHg | 0-300mmHg (Same as predicate). |
| - Max. Pressure | 400mmHg | 400mmHg (Same as predicate). |
| - Sterility | Non-sterile | Non-sterile (Same as predicate). |
| Performance Safety | Compliance with ISO 81060-1 (Non-Automated Measurement) | Compliance with ISO 81060-1, First Edition 2007 (Non-Invasive Sphygmomanometers - Part 1: Requirements and Test Methods for Non-Automated Measurement Type). (Full results not detailed in summary, but stated to meet specifications). |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of patients or cuffs in a typical clinical study. The testing appears to consist of laboratory measurements and evaluations against standards. For biocompatibility, standard test methods typically involve specific numbers of samples for in vitro (cytotoxicity, irritation) and in vivo (sensitization) tests, but these numbers are not detailed in this summary.
- Data Provenance: The testing was "non-clinical tests... conducted to verify that the proposed device met all design specifications." This indicates testing was likely performed by the manufacturer or a contract lab. The country of origin of the data is implicitly China, as the manufacturer is Wenzhou Xikang Medical Instruments Co., Ltd. (Wenzhou, Zhejiang, China). The data is retrospective, generated to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as this is not a study involving expert-derived ground truth (e.g., medical image interpretation). The "ground truth" here is compliance with established engineering and biocompatibility standards (e.g., ISO 81060-1, ISO 10993).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable as there are no expert interpretations or subjective assessments requiring adjudication. The evaluations are based on objective measurements against defined standards.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a blood pressure cuff and does not involve AI or human interpretation in the way a diagnostic imaging device would.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done in the context of an algorithm. The device itself is a standalone physical accessory. Its performance is evaluated through compliance with physical and biological standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is defined by international and recognized consensus standards for medical device safety and performance, specifically:
- ISO 81060-1: For non-invasive sphygmomanometer performance.
- ISO 10993-1, -5, -10: For biocompatibility.
- The "ground truth" for showing equivalence also includes the technical specifications and materials of the legally marketed predicate device.
8. The sample size for the training set:
- This is not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This is not applicable. As there is no training set for an AI algorithm.
§ 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).