Search Results
Found 1 results
510(k) Data Aggregation
(268 days)
The Acme Monaco Slidewire™ (Trademark Pending) is intended for use in diagnostic or interventional procedures to assist in directing a catheter to the desired anatomical locations in the coronary or peripheral vasculature.
The Acme Monaco Hydrophilic Guidewire, hereafter referred to as Acme Monaco Slidewire®, is composed of a Nickel Titanium (aka NiTi or Nitinol) core wire, jacketed with a durable polymer that is receptive to a coating. The polymer resin is blended with Tungsten, a radiopaque metal and affixed to the core wire via adhesive. The jacketed core wire is then coated with a hydrophilic coating. The Acme Monaco Slidewire of can be constructed to various lengths, diameters and distal configurations, is a single-use device and provided sterile for commercial distribution.
The provided document, K113162, describes the Acme Monaco Slidewire®. This is a 510(k) summary, which means the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving its own clinical effectiveness through a standalone clinical study. The performance testing outlined in the document is primarily to demonstrate that the device performs equivalently to its predicate.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative or pass/fail manner for each test. Instead, it states that "The results of the following performance tests have demonstrated substantial equivalence to the predicate device." This implies that the 'acceptance criteria' for each test was to perform comparably to the predicate device.
| Test Type | Reported Device Performance and Equivalence Statement |
|---|---|
| Performance Testing | |
| Tensile Strength | "The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable tensile strength to the predicate) |
| Torque Strength | "The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable torque strength to the predicate) |
| Torqueability | "The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable torqueability to the predicate) |
| Tip Flexibility | "The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable tip flexibility to the predicate) |
| Coating Adherence/Integrity | "The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable coating adherence/integrity to the predicate) |
| Catheter Compatibility | "The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable catheter compatibility to the predicate) |
| Surface Lubricity | "The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable surface lubricity to the predicate. Also, statement: "Both the predicate device and the Acme Monaco device retain their lubricity over multiple uses during a single procedure.") |
| Dimensional Verification | "The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable dimensions to the predicate or adherence to specifications for equivalent performance) |
| Resistance to corrosion | "The results of the following performance tests have demonstrated substantial equivalence to the predicate device." (Implies comparable corrosion resistance to the predicate) |
| Biocompatibility Testing | |
| Cytotoxicity (ISO 10993-5) | "The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests as required by ISO 10993 for biocompatibility, supporting substantial equivalence.) |
| Kligman Maximization | "The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.) |
| Intracutaneous Injection | "The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.) |
| Acute Systematic Injection | "The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.) |
| Rabbit Pyrogen | "The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.) |
| Hemolysis Complete | "The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.) |
| In Vitro Hemocompatibility | "The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.) |
| Dog Thromboresistance | "The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.) |
| Lee & White Clotting Time | "The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.) |
| Complemenent Activation Assay (C3a) | "The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.) |
| Complement Activation Assay (SC5-b-9) | "The following biocompatibility testing, performed in accordance with ISO-10993, has been performed on the Acme Monaco Slidewire®." (Implies the device passed these tests, supporting substantial equivalence.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for individual performance or biocompatibility tests. For some biocompatibility tests, details like "2 extracts/35 animals/Concurrent (+) controls" (Kligman Maximization) and "2 extracts" (Intracutaneous Injection, Acute Systematic Injection) are mentioned. For "Dog Thromboresistance," "2 animals" are specified. These are specific to those particular tests and don't represent a general "test set" sample size for overall device evaluation.
- Data Provenance: Not explicitly stated. Given it's a 510(k) for a medical device manufactured by Acme Monaco Corporation (based in New Britain, CT, USA), the testing would likely have been conducted in the US or by labs adhering to international standards (ISO). The testing is laboratory (bench) and animal-based, not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this document. The "test set" here refers to the physical guidewire prototypes and materials undergoing engineering and biological testing, not a dataset requiring human expert interpretation or ground truth establishment in a clinical context. The "ground truth" for these tests would be the measurement results against established specifications or comparison to the predicate device's measured performance.
4. Adjudication Method for the Test Set
This is not applicable as there is no human interpretation of data points or images requiring adjudication. The tests involve direct measurement of physical and biological properties.
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
This is not applicable. This document describes a physical medical device (guidewire), not an AI algorithm or software. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This document describes a physical medical device (guidewire), not an AI algorithm or software. Therefore, no standalone algorithm performance was evaluated.
7. The Type of Ground Truth Used
For the performance tests (tensile strength, torque, lubricity, etc.), the "ground truth" is measured physical properties compared against:
- Engineering specifications (implied by standardized testing)
- Performance of the legally marketed predicate device (as stated for substantial equivalence)
For biocompatibility tests, the "ground truth" is the biological response observed in the in vitro and in vivo models according to ISO 10993 standards, demonstrating no unacceptable adverse biological reactions.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" as this is not an AI/machine learning device. The guidewire design is based on engineering principles and materials science.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI model.
Ask a specific question about this device
Page 1 of 1