(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of guide wires, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a guidewire used to facilitate the placement of other therapeutic devices (balloon catheters), but it does not directly provide therapy itself.
No
Explanation: The device, a guide wire, is intended to facilitate the placement of balloon dilatation catheters. Its function is to aid in a therapeutic procedure (placement of catheters for dilatation), not to diagnose a condition.
No
The device description clearly describes a physical guide wire made of materials like stainless steel and platinum/tungsten alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for facilitating the placement of catheters within the peripheral or coronary vasculature. This is an invasive procedure performed in vivo (within a living organism).
- Device Description: The description details a physical guide wire designed to be inserted into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
IVDs are used to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device is a tool used during a medical procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Floppy and Intermediate Extra Long Guide Wires 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
Not Found
Device Description
The Floppy (2) and Intermediate (2) Extra Long Guide Wires have a nominal outside diameter of 0.014 inch measured at the distal spring coil. The guide wires are 300 cm (nominal) in length and have a distally attached 30 cm composite spring coil. For the 30 cm radiopaque guide wires, the entire spring coil is made of platinum/tungsten alloy. The spring coil of the 4 cm radiopaque guide wires is proximally made of stainless steel wire (26 cm) and has a distal platinum/tungsten alloy spring coil for opacity. For all guide wires, the core wire and spring coils, up to and including the tip, are coated with phosphoryIcholine polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral or coronary vasculature, not intended for use in the cerebral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
In vitro performance testing of the predicate devices was conducted according to the guidelines presented in FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance. 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 PC polymercoated guide wires are non-toxic and biocompatible for short term use in the vascular system. Bench performance and biocompatibity testing was not performed on the subject quide wires; there is no reason to believe the subject quide wires would yield dissimilar results.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K9622dd6
SEP 10 1996
510(K) Summarv
| Submitter's Name: | Biocompatibles Cardiovascular, Inc.
1049 Kiel Court
Sunnyvale, CA 94089
Tel: (408) 747-0200
Fax: (408) 747-1171 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mr. James Wood
Chief Engineer |
| 510(k) Summary Date: | June 12, 1996 |
| Device Names: | 1. 0.014" Floppy Extra Long Guide Wire with Phosphorylcholine
(PC) Polymer Coating and 30 cm Radiopaque Tip
2. 0.014" Intermediate Extra Long Guide Wire with
Phosphorylcholine (PC) Polymer Coating and 30 cm
Radiopaque Tip
3. 0.014" Floppy Extra Long Guide Wire with Phosphorylcholine
(PC) Polymer Coating and 4 cm Radiopaque Tip
4. 0.014" Floppy Extra Long Guide Wire with Phosphorylcholine
Polymer Coating and 4 cm Radiopaque Tip |
| Common Name: | Guide Wire - |
| Classification Name: | Catheter Guide Wire (21 CFR 870.1330) |
| Predicate Devices: | Biocompatibles 0.014" Floppy and Intermediate Guide Wires
with Phosphorylcholine Polymer Coating (K955135 - SE
Determination on April 9, 1996) |
Device Description:
The Floppy (2) and Intermediate (2) Extra Long Guide Wires have a nominal outside diameter of 0.014 inch measured at the distal spring coil. The guide wires are 300 cm (nominal) in length and have a distally attached 30 cm composite spring coil. For the 30 cm radiopaque guide wires, the entire spring coil is made of platinum/tungsten alloy. The spring coil of the 4 cm radiopaque guide wires is proximally made of stainless steel wire (26 cm) and has a distal platinum/tungsten alloy spring coil for opacity. For all guide wires, the core wire and spring coils, up to and including the tip, are coated with phosphoryIcholine polymer.
1
Intended Use:
The Floppy and Intermediate Extra Long Guide Wires 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.
Comparison of Technological Characteristics:
The 0.014" Floppy and Intermediate Extra Long Guide Wires with PC polymer coating are similar to the predicate quide wires. The subject quide wires and predicate quide wires are manufactured by the same company. The 30 cm spring coils and coil assembly with the core wire are identical between the predicate devices and two subject quide wires. The only difference between these two groups of wires is the overall length (175 cm vs 300 cm).
The remaining two 0.014" Floppy and Intermediate Extra Long Guide Wires have a 4 cm radiopaque alloy distal spring coil brazed to a 26 cm proximal stainless steel spring coil. The 4 cm radiopaque quide wires have one more joint than the predicate guide wires. The 4 cm guide wire core wire specifications are identical to the predicate device, with the exception of the additional 125 cm of length.
The predicate and four extra long guide wires have a stainless steel core wire that is taper ground distally to improve flexibility. The guide wires each have a full length core wire extending to the tip." The distal tip section of each quide wire is flattened to increase tip section flexibility and facilitate shapeability. Differences in tip section flexibility are made possible by changing the amount of taper in the core wire, distally, and the length of the flattened section between the second to last joint and tip joint. The core wire and entire length of spring coil of the guide wires are coated with PC polymer.
Packaging and Sterilization
The predicate and subject quide wires are packaged in the same materials and ethylene oxide sterilized by the same contract sterilizer. The quide wires are individually packaged in a lacquered paper and polyester-polypropylene composite plastic heat sealable pouch. The shelf life of the guide wires is one year. The one year shelf life for the quide wires was established following real-time aging.
Safety and Effectiveness:
In vitro performance testing of the predicate devices was conducted according to the guidelines presented in FDA's January 1995 Coronary and Cerebrovascular
2
Guidewire Guidance. 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 PC polymercoated guide wires are non-toxic and biocompatible for short term use in the vascular system. Bench performance and biocompatibity testing was not performed on the subject quide wires; there is no reason to believe the subject quide wires would yield dissimilar results.