(38 days)
A non-sterile disposable inflatable bladder and tube set for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure.
The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs consists of a cuff bladder manufactured from polyester reinforced vinyl. The cuff is closed with a hook and loop fastening system (Velcro Loop with vinyl backing and YKK PVC hook). The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs are disposable, non-sterile and latex free. Attached to the end of each PVC tube are a variety of connectors (PVC or Nylon) for use with most monitoring systems.
This document describes an FDA 510(k) premarket notification for a traditional medical device (blood pressure cuffs), not an Artificial Intelligence (AI)/Machine Learning (ML) device. As such, most of the requested information regarding AI/ML device studies (such as sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, and standalone performance) is not applicable.
However, I can provide information about the acceptance criteria and the methods used to demonstrate substantial equivalence for this device.
Acceptance Criteria and Device Performance
The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs are a conventional medical device. The acceptance criteria primarily revolve around demonstrating substantial equivalence to a predicate device (Ethox Corp. SURGI-2. CUF® Adult Blood Pressure Cuffs, K883977) in terms of intended use, safety, and effectiveness. Key performance criteria are related to biocompatibility and compliance with recognized standards.
Here's a table summarizing the acceptance criteria and reported device performance based on the provided document:
| Acceptance Criteria Category | Specific Criteria/Performance Goal | Reported Device Performance/Evidence |
|---|---|---|
| Intended Use | For monitoring blood pressure. | Met: "This device is intended for use in conjunction with a variety of blood pressure monitoring systems for determination of a persons blood pressure." (Same as predicate device). "Disposable. Non-sterile versions only." (Predicate was single patient use, sterile & non-sterile). |
| Biocompatibility | All patient contact components meet equivalent or more stringent biocompatibility standards than the predicate device. | Met: |
- Primary Cuff Material (Vinyl with polyester reinforcement): "printing currently being tested to FDA blue book memorandum #G95-1 requirements for prolonged skin contact. Product will only be released upon completion of this testing with acceptable results."
- Stub (PVC): "Performed MEM Elution Cytotoxicity testing found to be non-toxic. Performed Physico-Chemical Tests - C19 Found to meet USP Limits."
- Female Luer (Nylon): "USP Class II and Cytotoxicity MEM Elution."
- Quick Disconnect Connector (Nylon): "USP Class II and Cytotoxicity MEM Elution."
- Multi-purpose screw connector (PVC): "USP Class VI."
- Tube (Virgin PVC): "Constituent materials USP Class VI." |
| Performance Standards | Conforms to American Heart Association (AHA) recommendations. | Met: "Conforms to American Heart Association recommendations." |
| Additional Standards | (For 540X and 520X series) Conforms to EN1060-1,2, & 3. | Met: "The 540X and 520X series conform to EN1060-1,2, & 3." |
| Materials | Materials are suitable for the intended use and demonstrate equivalency/improvement over predicate. | Met: Detailed comparison of materials provided (e.g., cuff material changed from PVC to Vinyl with polyester reinforcement; connectors changed from Cycolac (ABS) to Nylon or PVC). All changes supported by biocompatibility testing. |
| General Design | Maintain core function while allowing for improvements in size range and connector options. | Met: "No changes to general cuff design aside from material changes referenced above." "changes in features/general design relate to size and adapter types which are improvements over the predicate device, allowing the product line to service a larger patient population and work with a wider range of ancillary monitoring equipment." |
| Sizes | Offer a range of sizes appropriate for the target population. | Met: Expanded size range from 15.0 cm to 50.0 cm (predicate was 17.0 cm to 50.0 cm), including a new 8P size. |
| Features | Compatible with most monitors. | Met: ("Compatible with most monitors. Latex Free."). The predicate device was also compatible with most monitors. |
| Labeling | Labeling clearly defines the device's characteristics and use. | Met: Current labeling provided in Attachment IV. |
Non-Applicable AI/ML Device Study Information:
Given that the device in question is a conventional disposable blood pressure cuff and not an AI/ML device, the following points are not applicable to the provided documentation:
- Sample size used for the test set and the data provenance: Not applicable for a non-AI/ML device. Testing focuses on material properties, biocompatibility, and compliance with performance standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for blood pressure cuffs refers to their physical properties and performance against established standards, not expert consensus on interpretations.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, "ground truth" would be objective measurements of material properties (e.g., tensile strength, cytotoxity assay results), compliance with dimensional specifications, and adherence to established performance standards (like AHA recommendations or EN1060).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Substantiation:
The Ethox SURGI-CUF® Adult Disposable Blood Pressure Cuffs demonstrate substantial equivalence through:
- Comparison to a Predicate Device: Detailed comparison table outlining similarities and differences in intended use, materials, design, sizes, and performance.
- Biocompatibility Testing: Extensive testing (e.g., USP Class III, USP Class II, USP Class VI, MEM Elution Cytotoxicity testing, Physico-Chemical Tests - C19, FDA blue book memorandum #G95-1 requirements) for all patient contact components to ensure safety and compliance.
- Compliance with Recognized Standards: Conformance to American Heart Association recommendations and EN1060-1,2, & 3 for specific series, indicating reliable performance.
- Design and Feature Improvements: Changes such as an expanded size range and diverse connector options are presented as improvements that broaden product utility while maintaining the core function.
The overall conclusion is that the device's intended use, product function, and design are substantially equivalent to the predicate device, and any material changes meet equivalent or more stringent biocompatibility standards.
§ 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).