(89 days)
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No
The summary describes a physical medical device (guide wires) and its mechanical and biocompatibility testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No
The device, a guide wire, is intended to facilitate the placement of balloon dilatation catheters, not directly treat a disease or condition itself.
No
The device is a guide wire used to facilitate the placement of balloon catheters for therapeutic procedures (PTA/PTCA), not to diagnose a condition.
No
The device description clearly describes a physical guide wire with specific dimensions, materials, and coatings, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the guide wires are used to "facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature." This describes a device used within the body for a medical procedure, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details the physical characteristics of a guide wire used in interventional procedures (diameter, length, spring coil, coating). This aligns with a medical device used for navigation within the vascular system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This guide wire does not fit that description.
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Intended Use / Indications for Use
The Floppy and Intermediate guide wires and predicate devices are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.
Product codes
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Device Description
The Floppy and Intermediate guide wires have a nominal outside diameter of 0.014 inch measured at the distal spring coil. The guide wires are 176 vm long (nominal) and have a distally attached 30 cm composite spring coil. The most distal 4 vm of the spring coil is radiopaque. The core wire and spring coils, up to and including the tip, are coated with PCP.
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
peripheral or coronary vasculature
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)
The performance of BCP Floppy and Intermediate guide wires and ACS guide wires was compared by bench testing. The BCP Floppy and Intermediate guide wires were found to have adequate tensile strength, torque strength, torqueability, and tip flexibility. The biocompatibility tests conducted included Acute Systemic Toxicity, Skin Irritation, Skin Sensitization, Cytotoxicity, Hemolysis, and LAL Pyrogenicity. The PCP-coated guide wires are non-toxic and biocompatible for short term use in the vascular system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cardiovascular Systems, Inc. 0.014" Hi-Torque Advanced Floppy II® Guide Wire and 0.014" Hi-Torque Intermediate® Guide Wire
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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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JUN 26 1996
510(K) Summary
- Biocompatibles Limited Submitter's Name: Brunel Science Park Kinaston Lane Uxbridge Middlesex UB8 3PQ England Tel. +44 1895 274481 Mr. Neil McLachlan Contact Person: Regulatory Affairs Manager 510(k) Summary Date: March 29, 1996 Device Names: 0.014" Floppy Guide Wire with Phosphorvicholine Polymer (PCP) Coating and 4 cm Radiopague Tip and 0.014" Intermediate Guide Wire with PhosphoryIcholine Polymer (PCP) Coating and 4 cm Radiopaque Tip Common Name: Guide Wire Classification Name: Catheter Guide Wire (21 CFR 870.1330) Cardiovascular Systems, Inc. 0.014" Hi-Torque Predicate Devices: Advanced Floppy II® Guide Wire and 0.014" Hi-Torque Intermediate® Guide Wire
Device Description:
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The Floppy and Intermediate guide wires have a nominal outside diameter of 0.014 inch measured at the distal spring coil. The guide wires are 176 cm long (nominal) and have a distally attached 30 cm composite spring coil. The most distal 4 cm of the spring coil is radiopaque. The core wire and spring coils, up to and including the tip, are coated with PCP.
Intended Use:
The Floppy and Intermediate guide wires and predicate devices are intended for use to facilitate the placement of PTA and/or PTCA balloon dilatation catheters within the peripheral or coronary vasculature. The guide wires are designed for safe use with appropriately sized balloon catheters. The guide wires are not intended for use in the cerebral vasculature.
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Comparison of Technological Characteristics:
The 0.014" Floppy and Intermediate Guide Wires with PCP Coating and 4 cm Radiopaque Tip have similar technological characteristics as the predicate devices. The BCP and ACS guide wires are similar in design, materials, intended use, and sterilization.
The BCP and ACS 0.014" guide wires have a stainless steel core wire that is taper ground distally to improve flexibility. The two BCP guide wires and the ACS Intermediate guide wire have a full length core wire. The distal tip section of each style BCP guide wire is flattened to increase tip section flexibility. The ACS Intermediate guide wire has a round core wire passing into the middle ioint and continuing on to the tip. The ACS Floppy guide wire core terminates just past the middle joint. A stainless steel flat ribbon connects the middle joint and stainless steel tip.
A 30 cm (nominal) composite spring coil is concentrically positioned over the distal core wire or shaping ribbon of each guide wire. The proximal 26 cm (nominal) of BCP and ACS spring coils are made of stainless steel spring wire. Each manufacture has made the distal 3 - 4 cm of spring coil radiopaque through the use of platinum/tungsten spring coils. The BCP spring coil is formed at a joint proximal to the traditional middle joint and the spring coils are not attached to the core wire at this point. For both BCP and ACS guide wires, the spring coils are brazed (BCP) or soldered (ACS) to the central core wire at a joint proximal to the tip. For all quide wires, the tip section is shapeable.
The core wire and entire length of spring coil of the BCP guide wires are coated with PCP. The ACS guide wires have a Teflon coated core wire. The ACS spring coil proximal to the middle joint is coated with a silicone-based material (Microglide) and the coil distal to the middle ioint is uncoated.
Packaging and Sterilization
The BCP guide wires are individually packaged in a lacquered paper and polyesterpolypropylene composite plastic heat sealable pouch. The ACS product is packaged in Tyvek/Mylar heat sealable pouch. Both guide wire providers sterilize the product with ethylene oxide gas. The shelf life of the BCP guide wires is one year. The one year shelf life for the BCP guide wires was established following realtime aging. The shelf life of the ACS products is two years.
Safety and Effectiveness:
In FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance. The performance of BCP Floppy and Intermediate guide wires and ACS guide wires was
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compared by bench testing. The BCP Floppy and Intermediate guide wires were found to have adequate tensile strength, torque strength, torqueability, and tip flexibility. The biocompatibility tests conducted included Acute Systemic Toxicity, Skin Irritation, Skin Sensitization, Cytotoxicity, Hemolysis, and LAL Pyrogenicity. The PCP-coated guide wires are non-toxic and biocompatible for short term use in the vascular system.
Based on the indications for use, design and construction, and results of the bench and biocompatibility testing, the Biocompatibles 0.014" Floppy and Intermediate Guide Wires with PCP Coating and 4 cm Radiopaque Tip are safe and effective for their intended use.