(277 days)
Med-link 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 proposed device, Med-link Disposable Blood Pressure Cuff is rectangle soft inelastic sleeve. There is a single-tube or twin-tube connected to a sealed gas chamber. It is wrapped around the patient's limb/thigh 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.
This document is a 510(k) premarket notification for the Med-link Disposable Blood Pressure Cuff. It aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on the FDA recognized consensus standard ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013 Non-Invasive Sphygmomanometers -Part 1: Requirements And Test Methods For Non-Automated Measurement Type, and ISO 10993 (Biological evaluation of medical devices) series for biocompatibility.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard Reference) | Reported Device Performance (Summary) |
|---|---|---|
| Performance | Compliance with ISO 81060-1:2007/ AAMI/ANSI/ISO81060-1:2007/(R)2013, Part 1: Requirements And Test Methods For Non-Automated Measurement Type | "Performance testing was performed on the subject device and results were compared with predicate device. Tests were conducted following applicable procedures outlined in the FDA recognized consensus standard of AAMI/ANSI/ISO81060-1:2007/(R)2013, and results met all relevant requirements in the test standard." |
| Biocompatibility | ISO 10993-1: Biological evaluation of medical devices-Part 1: Evaluation and testing | "A series of safety, essential performance and in vitro biocompatibility tests were performed... The tests listed below were conducted in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10." |
| ISO 10993-5: Test for in vitro cytotoxicity | "Cytotoxicity Test" performed. Data not explicitly detailed in summary but implied to meet criteria. | |
| ISO 10993-10: Tests for Irritation And Skin Sensitization | "Skin irritation Test" and "Skin Sensitization Test (the Guinea Pig maximization test)" performed. Data not explicitly detailed in summary but implied to meet criteria. | |
| Pressure Limit | 0-300mmHg matching predicate devices | Proposed device has a pressure limit of "0-300mmHg," which is identical to the primary and secondary predicate devices. |
| Sterility | Non-sterile matching predicate devices | Proposed device is "Non-sterile," which is identical to the primary and secondary predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing. It mentions "Performance testing was performed on the subject device," but does not specify the number of devices or measurements.
The data provenance is not specified regarding country of origin or specific study design (retrospective or prospective). The tests are described as "non-clinical testing," which suggests laboratory-based evaluations rather than human subject trials for the core performance and biocompatibility aspects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes the testing of a basic medical accessory (blood pressure cuff). The "ground truth" for its performance is established by objective measurements against a recognized standard (ISO 81060-1). There is no mention of experts establishing a "ground truth" in the way one might for diagnostic imaging or a subjective clinical assessment. The ground truth for biocompatibility is established through standardized laboratory tests.
4. Adjudication Method for the Test Set
Not applicable. The performance and biocompatibility tests are objective measurements against established standards, not subjective assessments requiring adjudication by multiple experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a 510(k) submission for a blood pressure cuff, which is a physical accessory, not an AI or imaging-based diagnostic device. Therefore, an MRMC comparative effectiveness study, which typically evaluates human readers' performance with and without AI assistance, is not relevant or applicable here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a passive accessory and does not involve an algorithm. Its function is to interface with a blood pressure measurement system.
7. Type of Ground Truth Used
The ground truth used for performance testing (accuracy and reliability of pressure transmission, cuff inflation/deflation, etc.) is the adherence to the ISO 81060-1 standard's objective requirements and test methods.
For biocompatibility testing, the ground truth is established by the results of standardized laboratory tests (Cytotoxicity, Skin Irritation, Skin Sensitization) as defined by the ISO 10993 series.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning algorithm and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
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).