(89 days)
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.
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.
Despite providing detailed information on the device description, intended use, and comparison with predicate devices, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner requested.
The document is a 510(k) summary for a medical device (guide wires), which is a premarket submission made to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. While it mentions safety and effectiveness based on bench and biocompatibility testing, it does not quantify specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot populate the table or answer the other questions as the necessary information (acceptance criteria, reported performance, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth details) is absent from the provided text.
The text does mention:
- Bench testing for tensile strength, torque strength, torqueability, and tip flexibility.
- Biocompatibility tests including Acute Systemic Toxicity, Skin Irritation, Skin Sensitization, Cytotoxicity, Hemolysis, and LAL Pyrogenicity.
- The conclusion that the devices are "safe and effective for their intended use" based on these tests.
However, it does not provide the specific acceptance values for these tests (e.g., "tensile strength must be > X N" and "device achieved Y N"), nor does it describe structured studies with defined test sets, training sets, or ground truth methodologies typically associated with assessing performance against explicit acceptance criteria.
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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:
ite : 12 :
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.
§ 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.