(90 days)
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.
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.
The provided 510(k) summary (K9622dd6) describes the device 0.014" Floppy Extra Long Guide Wire with Phosphorylcholine (PC) Polymer Coating and 30 cm Radiopaque Tip (and variants). However, it explicitly states that "Bench performance and biocompatibity testing was not performed on the subject quide wires". Instead, it refers to prior testing on predicate devices. Therefore, the requested information about the study proving the subject device meets acceptance criteria cannot be fully provided as no such study was conducted for this specific submission.
However, based on the information provided regarding the predicate device, here is a breakdown as requested:
1. Table of Acceptance Criteria and Reported Device Performance (for the Predicate Device):
| Acceptance Criteria (Inferred from Guidance and Testing) | Reported Device Performance (Predicate Device) |
|---|---|
| Adequate Tensile Strength | Met |
| Adequate Torque Strength | Met |
| Adequate Torqueability | Met |
| Adequate Tip Flexibility | Met |
| Acute Systemic Toxicity | Non-toxic |
| Skin Irritation | Met |
| Skin Sensitization | Met |
| Cytotoxicity | Met |
| Hemolysis | Met |
| LAL Pyrogenicity | Met |
| Biocompatible for short term use in the vascular system | Met |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but implied to be sufficient for a 510(k) submission based on FDA guidelines.
- Data Provenance: Not explicitly stated, but the tests were "conducted according to the guidelines presented in FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance." This suggests the tests were likely conducted by the manufacturer or a contract lab. The country of origin is not specified but given the FDA guidance, it's presumed to be relevant to US regulatory standards. The testing was retrospective relative to the current submission, as it was performed on "predicate devices."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the testing involves objective physical and biological properties of the device, not expert interpretation of outputs like in image analysis.
4. Adjudication method for the test set:
Not applicable for this type of objective performance and biocompatibility testing. The results are typically quantitative or qualitative (e.g., pass/fail relative to a defined standard).
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:
Not applicable. This device is a medical guide wire, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device.
7. The type of ground truth used:
The ground truth for the predicate device testing was based on:
- Established engineering specifications and test methods for physical properties (e.g., tensile strength, torque).
- Standardized biocompatibility tests with defined pass/fail criteria (e.g., ISO standards for cytotoxicity, pyrogenicity).
- Compliance with "FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance."
8. The sample size for the training set:
Not applicable. This section relates to the predicate device performance testing, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. This section relates to the predicate device performance testing, not a machine learning model.
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K9622dd6
SEP 10 1996
510(K) Summarv
| Submitter's Name: | Biocompatibles Cardiovascular, Inc.1049 Kiel CourtSunnyvale, CA 94089Tel: (408) 747-0200Fax: (408) 747-1171 |
|---|---|
| Contact Person: | Mr. James WoodChief 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 Tip2. 0.014" Intermediate Extra Long Guide Wire withPhosphorylcholine (PC) Polymer Coating and 30 cmRadiopaque Tip3. 0.014" Floppy Extra Long Guide Wire with Phosphorylcholine(PC) Polymer Coating and 4 cm Radiopaque Tip4. 0.014" Floppy Extra Long Guide Wire with PhosphorylcholinePolymer 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 Wireswith Phosphorylcholine Polymer Coating (K955135 - SEDetermination 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.
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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
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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.
§ 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.