(88 days)
The Unimed 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 cuff is not designed, sold, or intended for use except as indicated.
The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped 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 Unimed 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.
Here's the breakdown of the acceptance criteria and the study that demonstrates the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document indicates that the Unimed Disposable Blood Pressure Cuff was tested according to relevant standards to demonstrate its performance. The key acceptance criteria are derived from these standards and the comparison to the predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Intended Use | Indirect measurement of blood pressure; non-sterile and for single-patient use; available in neonatal, pediatric, and adult sizes. |
| Patient Populations Supported | Adults/Pediatrics |
| Tube Configuration | One or two tubes |
| Size (Range in cm) - Conformity to AHA Bladder Sizes | Neonate 1 (3-6), Neonate 2 (4-8), Neonate 3 (6-11), Neonate 4 (7-13), Neonate 5 (8-15), Infant (9-14.8), Child (13.8-21.5), Small Adult (20.5-28.5), Adult (27.5-36.5), Adult Long (27.5-36.5), Large Adult (35.5-46cm), Large Adult Long (35.5-46cm), Thigh (45-56cm). Note: States conformance to AHA recommendations. |
| Sterility | Not supplied sterile (Non-sterile). |
| Pressure Limits | 0-300mmHg |
| Biocompatibility | Complies with ISO 10993 biocompatibility evaluation (ISO 10993-1, ISO 10993-5, ISO 10993-10). |
| Basic Construction & Technology | Same as predicate device (inelastic sleeve with integrated inflatable bladder, hook and loop closure). |
| Safety and Effectiveness | No safety or effectiveness issues identified based on performance testing and comparison to predicate. |
2. Sample Sizes and Data Provenance:
The document does not explicitly state the sample sizes used for the performance testing or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "performance testing in this submission" but does not provide details on the number of subjects or the type of study conducted.
3. Number of Experts and Qualifications for Ground Truth:
This information is not provided in the document. The performance testing appears to be based on compliance with established medical device standards and comparison to a predicate device, rather than a study requiring expert-established ground truth in the context of diagnostic interpretation.
4. Adjudication Method:
Adjudication methods (e.g., 2+1, 3+1) are typically relevant for studies involving human interpretation of data where consensus is needed to establish ground truth. This type of method is not applicable to the performance testing described for the Unimed Disposable Blood Pressure Cuff, which focuses on physical and biological properties.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned. This device is a blood pressure cuff, an accessory for non-invasive blood pressure measurement, not an AI-powered diagnostic tool requiring human reader performance analysis. Therefore, the effect size of human readers improving with or without AI assistance is not relevant or reported.
6. Standalone Performance Study:
A standalone performance study focused on the device's technical specifications and compliance with standards was conducted. The document states: "The Unimed Blood Pressure Cuff has been tested according to the following standards:" and lists ANSI/AAMI SP10 and ISO 10993 series. These tests evaluate the device's inherent performance characteristics independently.
7. Type of Ground Truth Used:
The ground truth used for this device's evaluation is based on established medical device standards and regulatory requirements. Specifically:
- ANSI/AAMI SP10: This standard sets requirements for manual, electronic, and automated sphygmomanometers, which would include accuracy and performance criteria for the cuff component.
- ISO 10993 series: These standards establish the framework for biological evaluation of medical devices to ensure biocompatibility.
- Comparison to the predicate device (JOHNSON & JOHNSON MEDICAL, INC. Soft-Cuff K974080): The predicate device serves as a benchmark for demonstrating substantial equivalence in terms of intended use, basic construction, technology, and performance.
8. Sample Size for the Training Set:
This concept is not applicable here. The Unimed Disposable Blood Pressure Cuff is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
As there is no "training set" for this type of device, this question is not applicable. The device's performance is assessed against established engineering and biological safety standards.
§ 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).