(651 days)
Indications for use have not changed, and are equivalent to those of the predicate devices cited above.
Coating is a polymeric balloon mounted on a double lumen shaft, a design commonly referred to as a "Gruntzig style catheter". Proximally the product is fitted with a Y-connector system with two female luer fittings, one for passage of a guide wire, and the other for balloon inflation. The product is coated with Meadox's exclusive hydrophilic coating on the balloon, the tip and distal shaft.
This document describes a 510(k) premarket notification for a medical device, the MS CLASSIQUE™ Balloon Dilatation Catheter with HYDROPASS™ Hydrophilic Coating. It's an application for a modified device, not a study performing to derive acceptance criteria for a new device, consequently there is no information about acceptance criteria or specific study data of the type requested in your prompt.
Here's a breakdown of why the requested information cannot be provided from this document:
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A table of acceptance criteria and the reported device performance: Not available. This document is a summary of a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device. It states that the new device "meet currently established performance specifications for uncoated MS CLASSIQUE™ Balloon Dilatation Catheters" but does not detail what those specifications are or present specific performance data against them.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not available. No clinical test set or data provenance is mentioned. The submission relies on demonstrating equivalence through design, materials, and biocompatibility testing, not a de novo performance study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. There is no mention of a test set requiring expert ground truth establishment.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no test set requiring adjudication is described.
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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. This document is for a medical device (catheter), not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance, typically of imaging or AI systems.
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If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study requiring a ground truth is described. The "ground truth" for a device like this would be its physical properties and mechanical performance, which are stated to be equivalent to the predicate.
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The sample size for the training set: Not applicable. This document is not describing an AI/ML device that requires a "training set."
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How the ground truth for the training set was established: Not applicable for the same reason as above.
Summary from the provided text:
The document is a 510(k) summary for a modified balloon dilatation catheter. The modification is the addition of a HYDROPASS™ Hydrophilic Coating. The core argument for safety and effectiveness is substantial equivalence to existing predicate devices (K942293, K943298), which are also MS CLASSIQUE™ Balloon Dilatation Catheters but without the new coating.
The key points related to meeting criteria are:
- Biocompatibility Testing: Conducted in accordance with ISO-10993 standard, indicating safety for its labeled indications.
- Indications for Use: Unchanged and equivalent to predicate devices.
- Design Materials: Unchanged and equivalent to predicate devices.
- Performance Specifications: The product "meet currently established performance specifications for uncoated MS CLASSIQUE™ Balloon Dilatation Catheters," and package labeling will specify Mean or Average Burst Pressure.
In essence, the device is considered to meet acceptance criteria because its key characteristics (biocompatibility, indications, materials) are unchanged or proven safe, and its performance (e.g., burst pressure) is equivalent to the already approved predicate devices. There is no "study" in the sense of a clinical trial with a test set of patients/data described here; rather, the "proof" is based on engineering principles, materials science, and a comparison to legally marketed devices.
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MS CLASSIQUE™ Balloon Dilatation Catheter
HYDROPASS™ Hydrophilic Coating Catheter
HYDROPASS™ Hydrophilic Coating Cardiovascular 08/03/95
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MAY 1 6 1997
| 510(k) Summary of Safety & Effectiveness | |||
|---|---|---|---|
| GENERAL INFORMATION: | Sponsor: | Meadox Medicals, Inc.112 Bauer DriveOakland, NJ 07436 | |
| Contact Person: | Stephen B Anderson | ||
| Submission Date: | August 03. 1995 | ||
| DEVICE INFORMATION: | Generic Name: | Balloon Dilatation Catheter | |
| MS CLASSIQUE™ Balloon Dilatation CatheterTrade Name:w/HYDROPASS™ Hydrophilic Coating | |||
| Classification Name: | Cardiovascular - Percutaneous Catheter | ||
| PREDICATE DEVICE INFO: | The following devices, to which substantial equivalence is claimed, serve as predicatedevices for this premarket notification submission: | ||
| DEVICE DESCRIPTION: | Proprietary Name | ||
| K942293 | MS CLASSIQUE™ Balloon Dilatation Catheter | 10/18/94 | |
| K943298 | MS CLASSIOUE™ Balloon Dilatation Catheter | 09/08/94 | |
| Coating is a polymeric balloon mounted on a double lumen shaft, a design commonlyreferred to as a "Gruntzig style catheter". Proximally the product is fitted with a Y-connector system with two female luer fittings, one for passage of a guide wire, and theother for balloon inflation. The product is coated with Meadox's exclusive hydrophiliccoating on the balloon, the tip and distal shaft. | |||
| BIOCOMPATIBILITY: | Biocompatibility testing, conducted in accordance with the ISO-10993 standard, indicatesthat the MS CLASSIQUE™ Balloon Dilatation Catheter with HYDROPASSTMHydrophilic Coating is safe for it's labeled indications | ||
| INDICATIONS: | Indications for use have not changed, and are equivalent to those of the predicate devicescited above. | ||
| DESIGN MATERIALS: | Design materials have not changed, and are equivalent to those of the predicate devicescited above. | ||
| MANUFACTURING: | The manufacturing process now has an additional production step during whichHYDROPASS™ Hydrophilic Coating is applied to the catheter. | ||
| SPECIFICATIONS: | The package labeling of the MS CLASSIQUE™ Balloon Dilatation Catheter will nowspecify Mean or Average Burst Pressure. All MS CLASSIQUE™ Balloon DilatationCatheters with HYDROPASS™ Hydrophilic Coating meet currently establishedperformance specifications for uncoated MS CLASSIQUE™ Balloon Dilatation Catheters. | ||
| CONCLUSION: | The addition of HYDROPASS™ Hydrophilic Coating to MS CLASSIOUE™ BalloonDilatation Catheters does not alter the level of safety and effectiveness associated with thecurrently marketed products. |
MS CLASSIQUE™ is a trademark of Meadox Surgimed A/S.
HYDROPASS™ is a trademark of Meadox Medicals, Inc.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).