(23 days)
The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. 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 subject device is categorized into two types of models according to its reusability.
This document describes the FDA's 510(k) clearance for a "Blood Pressure Cuff" by JKH USA, LLC. The key aspect of this clearance is the assertion that the subject device and the predicate devices are exactly the same. Therefore, the "study that proves the device meets the acceptance criteria" is primarily a claim of identity to previously cleared devices, rather than a new performance study.
Given this, I will tailor the response to reflect that the "study" is a comparison and assertion of sameness, rather than a novel clinical trial.
Here's the breakdown of the acceptance criteria and the "study" that supports it:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (as claimed by manufacturer) |
|---|---|
| Indications for Use Identical to Predicate | The Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure measurement systems. The cuff is non-sterile. It is available in neonatal, pediatric, and adult sizes. The cuff is not designed, sold, or intended for use except as indicated. (Identical to predicate) |
| Material Composition Identical to Predicate | Reusable Cuffs: PU Synthetic Leather, PVC composite nonwoven; Bladder: Transparent Polyurethane (TPU Film); Tubing: PVC; Hook: Molded Nylon; Loop: Nylon. (Identical to predicate) |
| Tube Configuration Identical to Predicate | One or two tube. (Identical to predicate) |
| Repeated Inflation Durability Identical to Predicate | For reusable cuffs: 10,000 inflations; 3,000 hook and loop closures. (Identical to predicate) |
| Pressure Limits Identical to Predicate | 0-300mmHg. (Identical to predicate) |
| Usage Type Identical to Predicate | Reusable and disposable. (Identical to predicate) |
| Sterility Status Identical to Predicate | Non-sterile. (Identical to predicate) |
| Compliance with Recognized Standards (Non-clinical) | The device meets: |
- ISO 81060-1 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
- ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
- ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity
- ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delayed-type hypersensitivity
(These standards were also presumably met by the predicate devices, and the claim of identicality implies continued adherence.) |
| Biocompatibility Established | Biocompatibility tests (cytotoxicity, sensitization, skin irritation) were conducted. Test results show no issue of cytotoxicity, sensitization, or skin irritation, given the skin contact duration of less than 30 days. |
| No Material or Design Modifications from Predicate | "The subject and predicate devices are exactly the same, and there is no any difference between them." "The blood pressure cuffs are identical to the cleared version and are not modified." |
| No Further Clinical Testing Necessary Due to Identity | "Since the blood pressure cuffs are identical, no further clinical testing is necessary." |
Details of the "Study" (Comparison and Assertion of Equivalence):
-
Sample sizes used for the test set and data provenance:
This 510(k) submission relies on a claim of identicality to previously cleared predicate devices (K112544 and K120364, both "Unimed Blood Pressure Cuff" from UNIMED MEDICAL SUPPLIES INC). Therefore, there is no new clinical test set or patient data presented for this specific submission for the purpose of demonstrating performance. The "sample" is effectively the previously validated predicate device itself. No country of origin for a new test set is provided, and the data provenance is historical, based on the previous clearance of the predicate. This is a retrospective comparison based on design specifications. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable (N/A) to this submission, as no new test set requiring expert ground truth establishment for a novel device performance study was conducted. The ground truth for the predicate devices would have been established at the time of their clearance through their respective validation studies. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A. No new test set requiring adjudication was performed. -
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:
N/A. This device is a passive blood pressure cuff, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or AI assistance is not relevant to its function. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. This device is a physical medical accessory, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests (biocompatibility and standard compliance), the ground truth is established by laboratory test results conforming to the specified ISO standards (e.g., in vitro cytotoxicity, irritation, sensitization tests). For the device's overall performance, the "ground truth" for this submission is the established performance and safety of the predicate devices, which presumably met their own ground truth requirements through standard validations (e.g., accuracy against a reference standard for a blood pressure monitoring system, which the cuff is an accessory to, although the cuff itself simply maintains pressure). -
The sample size for the training set:
N/A. This is a passive medical device, not a machine learning model. No training set for an algorithm was used. -
How the ground truth for the training set was established:
N/A. No training set for an algorithm was used.
§ 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).