(68 days)
Philips multi-patient and single-patient cuffs are intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the non-invasive measurement of infant, pediatric, and adult human blood pressure.
Philips air hoses are intended for use by, or under the supervision of, a licensed physician or other healthcare provider for the noninvasive measurement of neonatal, pediatric, and adult human blood pressure.
The Value Care Cuffs are a reusable single hose NBP cuff with a non-removable bladder. The Efficia Air hoses are standard tubing with compatible connector for the Value Care cuffs. The initial release encompasses six cuffs (Large Adult, Adult Long, Adult, Small Adult, Pediatric, Infant) and two air hoses (1.5 m and 3.0 m). They have color-coded tubings to differentiate them from other brands of cuffs and allow for quick cuff size identification. The patient contacting cuffs material is polyurethane coated polyester. The air hose tubing is made of PVC.
This document describes the Philips Value Care NBP Cuffs and Efficia Air Hoses. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the study proving direct adherence to those criteria for de novo approval.
However, based on the information provided, we can infer some details related to performance and testing:
Key Takeaways:
- Substantial Equivalence: The primary goal of this submission is to demonstrate that the Philips Value Care Cuffs and Efficia Air Hoses are substantially equivalent to the predicate device (Philips Easy Care family of cuffs cleared with K071885).
- Standards Compliance: The devices demonstrated compliance with the requirements of ANSI/AAMI/EC 80601-2-30 and ANSI/AAMI/EC 81060-1 as applicable to cuffs. These standards inherently contain acceptance criteria for non-invasive blood pressure cuffs.
- Performance Testing: The submission states that "performance testing completed demonstrates that the subject devices have level of safety and effectiveness as their predicate devices." This implies that the testing was designed to show comparable performance to the predicate and compliance with relevant standards.
Given the nature of a 510(k) submission, specific numerical acceptance criteria (e.g., mean difference and standard deviation of blood pressure measurements) for these cuffs would typically be found within the details of the referenced standards (ANSI/AAMI/EC 80601-2-30 and ANSI/AAMI/EC 81060-1). The document does not explicitly list these criteria in an accessible table format or provide detailed study results beyond the statement of compliance.
Therefore, the following answers are constructed based on the available information and reasonable inferences for a 510(k) submission concerning blood pressure cuffs. Many sections will note that specific details are "Not explicitly stated in the document" because the provided text is a summary focused on substantial equivalence rather than a full study report.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list a table of acceptance criteria and reported device performance directly. Instead, it states compliance with recognized standards.
Inferred/Expected Acceptance Criteria (based on ANSI/AAMI/EC 80601-2-30 and ANSI/AAMI/EC 81060-1 for NIBP cuffs, though not explicitly listed in the document):
| Performance Metric | Acceptance Criteria (Typical for NIBP cuffs) | Reported Device Performance (as per document) |
|---|---|---|
| Blood Pressure Accuracy | Mean difference (AI vs. Reference) ≤ 5 mmHg | "The subject cuffs with subject air hoses demonstrated compliance with the requirements of the standards ANS/AAM//EC 80601-2-30 and ANSI/AAMI/EC 81060-1 as applicable to cuffs." (Implies meeting the accuracy requirements within these standards.) |
| Standard Deviation (SD) | SD of differences (AI vs. Reference) ≤ 8 mmHg | Implied compliance with mentioned standards. |
| Pressure Loss/Leakage | Within specified limits (e.g., ≤ 10 mmHg/min) | Implied compliance with mentioned standards. |
| Cuff Durability/Fatigue | Withstand specified number of inflation/deflation cycles | "There are differences in material but testing of the subject devices demonstrates the same level of performance." (Implies comparable durability to predicate.) |
| Material Biocompatibility | Meet ISO 10993 requirements (or similar) | Not explicitly stated, but implied for device approval. |
| Alarm Functionality (if applicable) | Alarms activate correctly within specified thresholds | Not directly applicable for passive cuffs, but for connected NIBP monitors. |
| Physical Dimensions/Fit | Meet specified ranges for target patient populations | Variet of cuff sizes (Infant, Pediatric, Small Adult, Adult, Large Adult, Adult XL) indicates proper sizing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated in the document.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The testing "demonstrates compliance" and "same level of performance" but does not detail the study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts/Qualifications: Not applicable for blood pressure cuff accuracy testing. Ground truth for blood pressure is typically established using a reference measurement device (e.g., intra-arterial catheter or validated manometer) by trained technicians or clinicians. The document does not specify who conducted the measurements or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable or specified. Blood pressure measurement accuracy studies typically involve direct comparisons to reference instruments rather than expert adjudication of interpretations.
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
- MRMC Study: Not applicable. This device is a blood pressure cuff and air hose, which are hardware components, not an AI-powered diagnostic tool requiring reader performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a passive component for non-invasive blood pressure measurement. Its performance is evaluated in conjunction with an NIBP monitor, but it is not an algorithm. The "performance testing" would evaluate the cuff's physical and functional integrity in facilitating accurate measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth for blood pressure accuracy testing (implied by compliance with ANSI/AAMI standards) would typically be established by:
- Simultaneous, direct intra-arterial blood pressure measurements (considered the gold standard).
- Auscultatory measurements using a mercury manometer or another validated reference oscillometric device, performed by trained observers in a blinded fashion according to established protocols (e.g., AAMI/ISO 81060-2).
The document does not explicitly state the methodology for ground truth establishment, but it is implied by adherence to relevant standards.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is a hardware component and does not involve AI or machine learning models that require a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: 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).