(144 days)
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No
The device description and performance studies focus on mechanical properties and function, with no mention of AI or ML.
No.
The device facilitates the exchange of other interventional devices and maintains guide wire position but does not directly treat a condition or disease.
No
The device is described as an "Exchange Device" used to facilitate the exchange of interventional devices while maintaining guidewire position. Its description and performance studies focus on mechanical properties and function (e.g., tensile tests, locking force, holding force) rather than detecting, diagnosing, or monitoring medical conditions.
No
The device description clearly outlines physical components including a proximal control handle, a superelastic core wire, and a hypotube, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used within a guiding catheter to facilitate the exchange of an interventional device while maintaining the position of a guide wire within the vasculature. This describes a procedure performed in vivo (within the living body).
- Device Description: The description details a physical device designed for mechanical manipulation within the vasculature.
- Performance Studies: The performance studies described are bench testing (tensile, torsional, locking force, fatigue) and in vivo testing. These are typical tests for devices used within the body, not for analyzing samples outside the body.
- Anatomical Site: The anatomical site is the "vasculature," which is part of the living body.
IVD devices are designed to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information about a patient's health. This device does not perform any such analysis.
N/A
Intended Use / Indications for Use
The ACS ANCHORTM Exchange Device is used within a guiding catheter to facilitate the exchange of an interventional device while maintaining the position of a guide wire within the vasculature.
Product codes
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Device Description
The ACS ANCHORTM Exchange Device consists of a proximal control handle and a superelastic core wire within a single lumen hypotube approximately 96 cm. long. The control handle provides the userinterface to control the movement of the hypotube and the core wire. During an exchange procedure, the distal end of the core wire is wrapped around the guide wire to lock its position in the vasculature. The ACS ANCHOR™ Exchange Device is compatible with 0.010" through 0.018" diameter non-hydrophilic-coated guide wires and associated interventional devices (except the ROTOBLATOR® Rotational Angioplasty System) when at least 0.015" free space is available within the guiding catheter.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and in yivo testing have been completed to evaluate the performance of the ACS ANCHOR™ Exchange Device in combination with various interventional devices (e.g., PTCA dilatation catheters, atherectomy catheters, stent delivery systems).
Bench testing of the ACS ANCHOR™ Exchange Device consisted of the following tests: tensile tests, torsional strength tests, locking force test, and fatigue (cycling) test. The results of the tests demonstrated that the ACS ANCHOR™ Exchange Device is acceptable for its intended use. Comparison of the holding force between the ACS ANCHOR™ Exchange Device and the predicate device, The Magnet Exchange Device showed that the ACS ANCHOR™ Exchange Device is substantially equivalent to this predicate device.
In vivo testing was conducted to substantiate the use of the ACS ANCHOR™ Exchange Device with different interventional devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
The Magnet Exchange Device by Scimed Life Systems, Inc.
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990.
| 1. | Trade Name: | ACS ANCHOR™ Exchange Device |
|---|---|---|
| Common Name: | Guide Wire Extension/Exchange Device | |
| 2. | Device Classification: | Class II |
3. Performance Standards:
Performance standards have not been established under Section 514 of the Federal Food, Drug, and Cosmetic Act for guide wire extension/exchange devices.
4. Device Description:
ACS ANCHOR™ Exchange Device
は
The ACS ANCHORTM Exchange Device is used within a guiding catheter to facilitate the exchange of an interventional device while maintaining the position of a guide wire within the vasculature. The ACS ANCHOR™ Exchange Device consists of a proximal control handle and a superelastic core wire within a single lumen hypotube approximately 96 cm. long. The control handle provides the userinterface to control the movement of the hypotube and the core wire. During an exchange procedure, the distal end of the core wire is wrapped around the guide wire to lock its position in the vasculature. The ACS ANCHOR™ Exchange Device is compatible with 0.010" through 0.018" diameter non-hydrophilic-coated guide wires and associated interventional devices (except the ROTOBLATOR® Rotational Angioplasty System) when at least 0.015" free space is available within the guiding catheter.
న్న Summary of Substantial Equivalence:
Comparison of the new ANCHOR™ Exchange Device to the predicate device, The Magnet Exchange Device by Scimed Life Systems, Inc. indicates that the ANCHORTM Exchange Device is substantially equivalent to the predicate exchange device. Like the Magnet Exchange Device, the ACS ANCHORTM Exchange Device is used to facilitate the exchange of an interventional device without the use of a guide wire extension or exchange length wire. Both the ACS ANCHOR™ Exchange Device and the Magnet Exchange Device are designed to apply a holding force or "lock" on the guide wire to allow withdrawal or advancement of an interventional device over the guide wire while maintaining the guide wire position in the vasculature.
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Bench and in yivo testing have been completed to evaluate the performance of the ACS ANCHOR™ Exchange Device in combination with various interventional devices (e.g., PTCA dilatation catheters, atherectomy catheters, stent delivery systems).
6. Testing Data:
Biocompatibility
Biocompatibility testing was performed on sterilized ACS ANCHOR™ Exchange Devices according to the International Standard - Biological Evaluation of Medical Devices (ISO 10993-1:1992(E)) and showed that the ACS ANCHOR™ Exchange Device is biocompatible and is acceptable for its intended application.
Bench and In Vivo Testing
Bench testing of the ACS ANCHOR™ Exchange Device consisted of the following tests: tensile tests, torsional strength tests, locking force test, and fatigue (cycling) test. The results of the tests demonstrated that the ACS ANCHOR™ Exchange Device is acceptable for its intended use. Comparison of the holding force between the ACS ANCHOR™ Exchange Device and the predicate device, The Magnet Exchange Device showed that the ACS ANCHOR™ Exchange Device is substantially equivalent to this predicate device.
In vivo testing was conducted to substantiate the use of the ACS ANCHOR™ Exchange Device with different interventional devices.
7. Sterilization:
The ACS ANCHOR™ Exchange Device is sterilized by the same methods and following the same parameters as those used for currently marketed ACS guide wires and accessories. Sterilization validation of the device was performed and showed that the sterility assurance level (10d) is achieved.
8. Conclusion:
Based on the intended use and results of the testing, the ACS ANCHOR™ Exchange Device is deemed substantially equivalent to the predicate device, The Magnet Exchange Device by Scimed Life Systems, Inc.
Signed:
Joy Tan
Joy Tan, Regulatory Affairs Coordinator