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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:

• 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:

2. 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.
3. 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.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. 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).
8. The sample size for the training set: Not applicable.
9. 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.

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This device is intended to reduce or prevent patient to patient cross contamination which can occur during blood pressure measurement procedures, for single patient use only. Covers a blood pressure cuff to provide a barrier between patient and cuff.

This device is a cover for blood pressure cuffs. It is made non-woven polypropylene with a polyethylene coating. The product is a non-sterile, clean, ready to use sleeve that covers a blood pressure cuff. The cuff cover has the potential to reduce transfer of patient contamination to the cuff and from the cuff to the patient. The blood pressure cuff cover is a single patient product designed to survive average use during an average hospital stay. If the blood pressure cuff cover becomes contaminated, soiled or torn during this time it would be replaced with a new blood pressure cuff cover.

The provided text describes a 510(k) premarket notification for the Ethox CUF-COVERTM, a blood pressure cuff cover. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the BOWEN MEDICAL SERVICES, INC. CUFF GUARD (K952825).

Based on the provided information, I can answer some of your questions, but many of the specific details you've asked for, particularly regarding new device acceptance criteria and study particulars for a modern AI/ML device, are not present in this document, as this is a traditional medical device submission from 2003.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This is primarily done by showing similar intended use, technological characteristics, and safety and effectiveness.

Study Information (Based on the provided text)

1. Sample size used for the test set and the data provenance:

   • Clinical Testing: The document mentions "Clinical testing shows the cover does not significantly affect blood pressure readings." However, the sample size and data provenance (e.g., country of origin, retrospective/prospective) for this clinical testing are NOT provided.
   • Laboratory Testing: "Laboratory testing shows the material is an effective microbial and air barrier." Details on the sample size or methods for this lab testing are NOT provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in the context of this 510(k) submission. This is a traditional device; the "ground truth" here is the physical performance and safety characteristics, not interpretations by experts of diagnostic images or data. The "ground truth" for the material barrier claims would be established by standard microbiological and material integrity tests.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This concept typically applies to expert consensus in diagnostic studies (e.g., radiology). For this device, standard laboratory and clinical methods are used, not expert adjudication in that sense.

4. 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:

   • No, an MRMC study was NOT done. This is a physical medical device (blood pressure cuff cover), not an AI/ML diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is irrelevant here.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No, a standalone study was NOT done. Again, this is a physical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the barrier function: Laboratory test results demonstrating effectiveness as a microbial and air barrier would serve as the "ground truth."
   • For the impact on blood pressure readings: Clinical measurements demonstrating that the cover does not significantly alter BP readings would be the "ground truth."
   • For cross-contamination reduction: This is inferred from the barrier function and the single-patient use design, aligning with the intended use.
   • Essentially, the ground truth is based on objective physical and physiological measurements from laboratory and clinical tests, not expert consensus on diagnostic interpretations.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML product, so there is no concept of a "training set" in the context of machine learning. The device design and materials are based on standard engineering and medical principles.

8. How the ground truth for the training set was established:

   • Not applicable for the same reason as point 7.

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Comparable to single tube Gastric lavage and stomach evacuator tubes.

Disposable, non-sterile tube for gastric lavage.

The lavage tube is used as a two way conduit from a lavage bag set to the stomach.

The tube is made of a flexible PVC that is easy to insert and comfortable for the patient. Water is released from a fluid source and flows into the stomach. The larger the tube, depending on patient age, the quicker the lavage can be completed. Once in the stomach, the water is drawn back up the tube and into a drainage bag. Pill fragments from the overdose are part of the discharged fluid. The extra port in the lavage tube simply allows better "back and forth" flow. This is done by allowing air to quickly replace the fluid drawn out during drainage.

The dual lumen lavage tube is an improvement to Ethox's current tubes to allow a quicker lavage. The extra lumen is a small diameter airway that acts as a vent allowing the lavage fluid in the main tube to pass in and out of the stomach without any "vapor lock" action.

This document is a 510(k) summary for a medical device called a "DUAL LUMEN GASTRIC LAVAGE TUBE". It is not a study demonstrating the performance of an AI/ML powered medical device against acceptance criteria.

Therefore, I cannot provide the requested information as it pertains to AI/ML device studies. The document describes a traditional medical device and its function, comparing it to existing similar devices. It does not involve algorithms, expert reviews, ground truth establishment, or any of the other criteria mentioned in your prompt that are specific to AI/ML powered devices.

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