(225 days)
Med-link Reusable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and may be reused. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.
The proposed device, Med-link Reusable Blood Pressure Cuffs is rectangle soft inelastic sleeve with bladder, to which a single-tube or twin-tube is connected. It 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. It is available in various sizes for different limb range. It is provided non-sterile.
The Med-link Reusable Blood Pressure Cuff underwent non-clinical testing to assess its safety and essential performance. The acceptance criteria and reported device performance are based on compliance with specific ISO and IEC standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| Compliance with ISO 81060-1 (non-invasive sphygmomanometers) | Device tested and found to be in accordance with ISO 81060-1. |
| Compliance with IEC 80601-2-30 (automated non-invasive sphygmomanometers) | Device tested and found to be in accordance with IEC 80601-2-30. |
| Compliance with ISO 10993-5 (in vitro cytotoxicity) | Cytotoxicity Test conducted and passed. |
| Compliance with ISO 10993-10 (irritation and skin sensitization) | Skin Irritation Test and Skin Sensitization Test conducted and passed. |
| Pressure Limit | 0-300mmHg (matches predicate devices). |
| Sterility | Non-sterile (consistent with intended use and predicate devices). |
| Conformance to AHA bladder sizes recommendations | The device offers various sizes for neonatal, infant, pediatric, small adult, adult, large adult, and adult thigh, corresponding to recommended limb ranges. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific non-clinical test (ISO 81060-1, IEC 80601-2-30, biocompatibility tests). It indicates that "A series of safety, essential performance and biocompatibility tests were performed."
The provenance of the data is not specified in terms of country of origin or whether the tests were retrospective or prospective. It states the tests were "conducted in accordance with" the listed standards, implying a controlled testing environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The non-clinical testing primarily focuses on objective measurements against international standards rather than expert-derived ground truth as might be seen in diagnostic imaging studies.
4. Adjudication Method for the Test Set:
This information is not applicable and is not provided. The testing involves standardized laboratory and performance tests, not a judgmental adjudication process.
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:
This information is not applicable and is not provided. The device is a blood pressure cuff, not an AI-assisted diagnostic tool for which MRMC studies would typically be conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
This information is not applicable and is not provided. The device is not an algorithm, so standalone algorithm performance is not relevant. The performance of the cuff is evaluated as a physical accessory for blood pressure measurement systems.
7. The Type of Ground Truth Used:
The ground truth for the performance claims relies on:
- International Standards: Compliance with ISO 81060-1, IEC 80601-2-30, ISO 10993-5, and ISO 10993-10. These standards establish the acceptable technical performance and safety criteria for such devices.
- Biocompatibility Testing: Objective laboratory tests (cytotoxicity, skin irritation, skin sensitization) directly measure the device's interaction with biological systems against established thresholds.
- Predicate Device Comparison: The inherent assumption is that if the device performs equivalently to legally marketed predicate devices that have already met regulatory requirements, then it is safe and effective.
8. The Sample Size for the Training Set:
This information is not applicable to this type of medical device. Blood pressure cuffs are mechanical devices, and their performance is established through physical and biological testing, not machine learning models that require training sets.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the reasons stated in item 8.
§ 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).