(103 days)
The Unimed disposable blood pressure cuff (Models U1682S-C51N to U1685S-C51N) is an accessory used in conjunction with noninvasive blood pressure measurement systems. It is non-sterile and for single-patient use. The cuff is available in neonatal sizes (4–15 cm limb circumference). The cuff is not designed, sold, or intended for use except as indicated.
The Unimed Disposable Neonatal NIBP Cuffs (Models U1682S-C51N, U1683S-C51N, U1684S-C51N, U1685S-C51N) are single-patient-use accessories for non-invasive blood pressure (NIBP) measurement. Each cuff is designed for neonatal limb circumferences ranging from 4 cm to 15 cm (Neonate 2 through Neonate 5) as follows.
- U1682S-C51N: 4 cm - 8 cm.
- U1683S-C51N: 6 cm - 11 cm.
- U1684S-C51N: 7 cm - 13 cm.
- U1685S-C51N: 8 cm - 15 cm.
The cuffs are intended to be used with compatible blood pressure monitors employing oscillometry. They are non-sterile, and are disposed of after single-patient use to reduce cross-contamination risks.
This 510(k) clearance letter is for a Disposable Neonatal NIBP Cuff. It does not describe an AI/ML powered medical device, nor does it detail a study involving AI/ML.
Therefore, many of the requested criteria related to AI/ML device validation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, etc.) are not applicable to this document.
The document primarily focuses on establishing substantial equivalence to a predicate device through non-clinical testing and material biocompatibility.
Here's the information that can be extracted from the provided text, primarily related to the non-clinical testing performed to meet acceptance criteria for a physical medical device:
Acceptance Criteria and Device Performance for Disposable Neonatal NIBP Cuff
The acceptance criteria for this device are primarily based on established international standards for non-invasive blood pressure cuffs and biocompatibility. The performance is demonstrated through non-clinical testing, confirming adherence to these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Compliance) | Reported Device Performance (Test Results) |
|---|---|
| ISO 81060-1:2007 (Non-invasive sphygmomanometers – Requirements and test methods for non-automated measurement type) | The device met all design specifications based on testing conducted in accordance with this standard. |
| ISO 80601-2-30:2018 (Medical electrical equipment — Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers) | The device met all design specifications based on testing conducted in accordance with this standard. |
| Biocompatibility - ISO 10993-5 (Tests for in vitro cytotoxicity) | The materials used in the proposed cuffs demonstrated biocompatibility, indicating suitability for intended use. |
| Biocompatibility - ISO 10993-10 (Tests for skin sensitization) | The materials used in the proposed cuffs demonstrated biocompatibility, indicating suitability for intended use. |
| Biocompatibility - ISO 10993-23 (Tests for irritation) | The materials used in the proposed cuffs demonstrated biocompatibility, indicating suitability for intended use. |
| Pressure Limits | The device operates within the accepted range of 0-300 mmHg, which is the same as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided document. The non-clinical testing likely involved a representative sample of each cuff model (U1682S-C51N, U1683S-C51N, U1684S-C51N, U1685S-C51N).
- Data Provenance: The document states "Non-clinical tests were conducted..." but does not specify the country of origin where the testing was performed. Given the manufacturer's location (Shenzhen, China), it's plausible the testing was conducted there or at a certified lab supporting the manufacturer. The testing is described as non-clinical, implying it was laboratory-based product verification and validation, not retrospective or prospective human clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable. This document describes the clearance of a physical medical device (NIBP cuff) via substantial equivalence, not an AI/ML algorithm. Therefore, there is no mention of "ground truth" derived from expert consensus on medical images or data. The "ground truth" for this device would be the defined specifications and performance requirements established by the relevant ISO standards.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trial settings, especially for AI/ML performance evaluation where multiple human readers might disagree on findings. For non-clinical device testing like this, adherence to predefined test protocols and specifications is the primary method of evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a non-AI medical device like a blood pressure cuff.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance evaluation of an algorithm was not done. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by compliance with recognized consensus standards (ISO 81060-1, ISO 80601-2-30, and ISO 10993 series for biocompatibility). The device's performance metrics are evaluated against the specific requirements and test methods outlined in these standards.
8. The Sample Size for the Training Set
This is not applicable. There is no training set mentioned as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. There is no training set mentioned as this is not an AI/ML 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).