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K Number
K132293
Device Name
SYVEK RADIAL BAND
Manufacturer
MARINE POLYMER TECHNOLOGIES
Date Cleared
2014-07-31

(373 days)

Product Code
DXC,SYV
Regulation Number
870.4450
Type
Traditional
Panel
CV
Reference & Predicate Devices
K122405
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Syvek Radial™ Band is a compression device to assist hemostasis of the radial artery after a transradial procedure.

Device Description

Syvek Radial™ Band is a sterile, single use, disposable device. The Syvek Radial™ Band is a radial artery compression device consisting of a clear medical grade polyurethane compression bladder, which is connected to both the pump and the release valves.

AI/ML Overview

The provided text focuses on the 510(k) summary for the Syvek Radial Band, a vascular clamp. The information is limited to establishing substantial equivalence to a predicate device and does not contain details about a detailed study with acceptance criteria for device performance as typically expected for diagnostic AI/ML devices.

However, based on the provided text, I can infer and structure the information as best as possible within the constraints of the request.

Here's a breakdown of the available information and how it relates to your request:

Acceptance Criteria and Device Performance

The provided 510(k) summary is for a physical medical device (a vascular compression band), not an AI/ML diagnostic device, and therefore the "acceptance criteria" and "device performance" are framed around demonstrating substantial equivalence to a predicate device rather than precise diagnostic metrics like sensitivity or specificity.

Acceptance Criteria (Inferred from Substantial Equivalence Claim):
The primary acceptance criterion is substantial equivalence to the predicate device, the Datascope Corp.; Air-Band Radial Compression Device (K122405), in terms of safety and effectiveness. This is demonstrated by:

  1. Equivalent Intended Use and Configuration: The device must have the same intended use and similar physical configuration as the predicate.
  2. Equivalent Materials: The materials used must be equivalent.
  3. Similar Product Design: The overall design should be similar.
  4. Similar Operation: Manual operation (inflated/deflated) similar to the predicate.
  5. Biocompatibility: Meet ISO 10993 standards for cytotoxicity, sensitization, and irritation/intracutaneous reactivity.
  6. Pressure Equivalence: Demonstrate similar pressure performance (peak and hold pressure for extended periods) to the predicate device.

Reported Device Performance (from "Performance Data" and "Summary" sections):

Acceptance Criterion (Inferred)Reported Device Performance
Intended Use & Configuration Equivalence"The Syvek Radial™ Band has the same intended use and configuration (wristband) as the predicate device, AIR - BAND (K122405)."
Materials Equivalence"The materials used are equivalent..."
Product Design Similarity"...and the product design is similar to that of the predicate device."
Operational Similarity"Syvek Radial™ Band is manually operated (inflated/deflated) like the predicate device."
Biocompatibility (per ISO 10993)"Biocompatibility Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity testing... indicated the test articles met all test requirements."
Pressure Equivalence to Predicate (AIR-BAND)"Pressure equivalency testing included both peak and hold pressure for extended periods of time. The Syvek Radial™ Band and the predicate device demonstrated similar performance in this testing."
Overall Safety and Effectiveness (Conclusion based on above)"The conclusions drawn from nonclinical testing demonstrate that the Syvek Radial™ Band is as safe, effective and performs as well as the legally marketed predicate device, AIR-BAND."

Study Details (as inferable from the provided text):

Since this is a submission for a physical device, not an AI/ML algorithm, many of the requested points are not applicable or the information is not provided.

  1. Sample Size Used for the Test Set and Data Provenance:

    • Sample Size: Not explicitly stated for any of the performance tests (biocompatibility or pressure equivalence). It only mentions "test articles" for biocompatibility and generic "testing" for pressure equivalence.
    • Data Provenance: The studies were benchtop testing and biocompatibility testing, likely conducted by the manufacturer or contracted labs. Country of origin not specified (Marine Polymer Technologies is based in the US). These tests are inherently "prospective" in the sense that they are conducted specifically for this submission, but not on human patients in a clinical trial.

  2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

    • Not Applicable. For benchtop and biocompatibility testing of a physical device, "ground truth" is established by adherence to engineering specifications, recognized standards (like ISO 10993), and direct measurement against a predicate device. This doesn't involve expert human interpretation in the same way as, for example, reading medical images.

  3. Adjudication Method for the Test Set:

    • Not Applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies where human interpretation of medical data determines ground truth, often with disagreement between reviewers. For mechanical and biocompatibility testing, outcomes are typically definitive measurements or pass/fail criteria.

  4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

    • No. This type of study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance, which is not applicable to a physical compression band like the Syvek Radial Band. Therefore, there's no effect size reported.

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

    • Not Applicable. The Syvek Radial Band is a physical device, not an algorithm.

  6. The Type of Ground Truth Used:

    • Engineering/Performance Standards & Predicate Device Comparison:
      • For biocompatibility: ISO 10993 standards and their defined pass/fail criteria.
      • For pressure equivalence: Direct comparative measurements against the predicate device's measured pressure performance.

  7. The Sample Size for the Training Set:

    • Not Applicable. As a physical device, there is no "training set" in the context of machine learning.

  8. How the Ground Truth for the Training Set was Established:

    • Not Applicable. No training set exists for this device.

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).