(59 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 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 disposable 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 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 26 models with different size for different population with different arm size, and the 13 models of 26 are use single tube of air hose and other 13 models are use double tube of air hose, which is used for different noninvasive blood pressure measurement system.
The disposable blood pressure cuff is provided as non-sterile.
The provided document describes the 510(k) premarket notification for a Disposable Blood Pressure Cuff (K152465) by Shenzhen Vistar Medical Supplies Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K151290).
Here's an analysis of the acceptance criteria and the study that proves the device meets these criteria, based on the provided text:
Key Takeaways:
- This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness.
- The primary means of demonstrating compliance is through non-clinical testing against recognized industry standards and a comparison of specifications with the predicate device.
- No clinical study was included in this submission. Therefore, there is no information about human reader performance (MRMC studies) or standalone algorithm performance, as these are typically part of clinical trials for AI/software devices.
- The device is a physical medical device (blood pressure cuff), not a software or AI-driven diagnostic tool. Thus, concepts like "ground truth" in the AI sense, expert panels for ground truth establishment, or training sets are not directly applicable in the way they would be for an AI device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from recognized standards and comparison with the predicate device. The performance is reported as compliance with these standards or equivalence to the predicate.
| Acceptance Criteria / Specification | Reported Device Performance (Proposed Device) |
|---|---|
| Intended Use | "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." (Identical to Predicate) |
| Patient Populations | Adults/Pediatrics (Identical to Predicate) |
| Tube Configuration | One or two tube (Identical to Predicate) |
| Principles of Operation | "Bladder is wrapped around the patient's limb and secured by hook and loop closure Air hose is connected to the noninvasive blood pressure measurement systems" (Identical to Predicate) |
| Size | Conform to AHA bladder sizes recommendations. Has similar sizes and more size specifications than the predicate for different patient arm circumferences. |
| Neonatal 1 (3-6 cm) | |
| Neonatal 2 (4-8 cm) | |
| Neonatal 3 (6-11 cm) | |
| Neonatal 4 (7-13 cm) | |
| Neonatal 5 (8-15 cm) | |
| Infant (9-14.8 cm) | |
| Child (13.8-21.5 cm) | |
| Small Adult (20.5-28.5 cm) | |
| Adult (27.5-36.5 cm) | |
| Adult Long (27.5-36.5 cm) | |
| Large Adult (35.5-46 cm) | |
| Large Adult (35.5 - 46 cm) | |
| Thigh (45 - 56.5 cm) | |
| Single Use | Yes (Identical to Predicate) |
| Sterile | No (Identical to Predicate) |
| Pressure Range | 0-300 mmHg (Identical to Predicate) |
| Max. Pressure | 400 mmHg (Predicate: >350 mmHg) |
| Tubing Size (mm) | OD = 8.0; ID=4.0; L=200; (Identical to Predicate) |
| Max. Leakage |
§ 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).