(225 days)
The Piolax Hydrophilic Guidewire is indicated for use for introduction and positioning of catheters within the peripheral vasculature in vascular diagnostic and therapeutic applications, particularly for arterial and venous applications in the cardiac, cerebral, and abdominal regions. The Guidewire is contraindicated for use in coronary vessels.
The Piolax Hydrophilic Guidewire is a tapered wire. composed of stainless steel or Ni-Ti alloy that is coated with a hydrophilic polymer. The hydrophilic polymer is composed of polyvinyl pyrrolidone and benzoyl peroxide. The Guidewire is provided with one of three differently shaped hydrophilic polymer-coated tips (i.e., straight, angled, J-shaped). The standard wire diameters are 0.58 mm, 0.72 mm, 0.79 mm, and 0.86 mm. The range for length of guidewires is 450 to 3,000 mm.
This document is a 510(k) summary for the Piolax Hydrophilic Guidewire. It describes the device, its intended use, and performance data used to establish substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request:
Analysis of the Piolax Hydrophilic Guidewire 510(k) Summary
This document describes a medical device called the "Piolax Hydrophilic Guidewire" and seeks to demonstrate its substantial equivalence to a predicate device, the "Terumo Radifocus® Guidewire M". Since this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are essentially demonstrating that the new device is as safe and effective as the predicate device. The "study that proves the device meets the acceptance criteria" refers to the testing performed to support this claim.
It's important to note that a 510(k) submission generally relies on bench testing and comparisons to a predicate device, rather than extensive clinical studies with human participants, especially for devices like guidewires. Therefore, many of your requested items about human study design, expert ground truth, and MRMC studies will not be applicable or explicitly stated in this type of document.
1. A table of acceptance criteria and the reported device performance
The document doesn't present a formal table of acceptance criteria with corresponding performance in a typical clinical study sense. Instead, the acceptance criterion for the 510(k) is "substantial equivalence" to the predicate device. The performance data presented are results from specific engineering and biocompatibility tests, with the conclusion that they demonstrate this equivalence.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Piolax Hydrophilic Guidewire) |
|---|---|
| Mechanical Performance: | |
| - Tensile Strength comparable to predicate | Consistent with FDA's Coronary and Cerebrovasculature Guidewire Guidance (Jan. 1995) |
| - Torque Strength comparable to predicate | Consistent with FDA's Coronary and Cerebrovasculature Guidewire Guidance (Jan. 1995) |
| - Torqueability comparable to predicate | Consistent with FDA's Coronary and Cerebrovasculature Guidewire Guidance (Jan. 1995) |
| - Tip Flexibility comparable to predicate | Consistent with FDA's Coronary and Cerebrovasculature Guidewire Guidance (Jan. 1995) |
| - Coating Adherence comparable to predicate | Consistent with FDA's Coronary and Cerebrovasculature Guidewire Guidance (Jan. 1995) |
| Biocompatibility: | |
| - Non-pyrogenic | Pyrogen rabbit extract test: Passed |
| - Non-hemolytic | Hemolytic extract test: Passed |
| - Non-cytotoxic | Cytotoxicity test: Passed |
| - Non-sensitizing | Sensitization test: Passed |
| - Non-irritating (intracutaneous) | Intracutaneous reaction test: Passed |
| - Low acute systemic toxicity | Acute systemic toxicity test: Passed |
| - Blood compatible | Blood compatibility test: Passed |
| - Meets USP pyrogen standards | USP rabbit pyrogen test: Passed |
| Shelf-life: | |
| - Stable for a reasonable duration | Shelf-life testing demonstrated a shelf-life expiration date of two years. |
Conclusion stated: "The test results demonstrate that the Piolax Hydrophilic Guidewire is substantially equivalent to the Terumo Radiofocus® Guidewire." And "All tests demonstrated that the Piolax Hydrophilic Guidewire is biocompatible." Further, "Based on results of the above testing, Piolax concludes that the Piolax Hydrophilic Guidewire is as safe and as effective as Terumo's Radifocus® Guidewire."
Regarding the device described and the nature of the submission (510(k) for a guidewire), many of the detailed requests for clinical study specifics will not be present. Here's why and what can be extracted:
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated for each test beyond "the Piolax Hydrophilic Guidewire" implying multiple units were tested. The mechanical and biocompatibility tests are typically performed on a statistically relevant number of samples, but the exact count isn't provided in this summary.
- Data provenance (e.g. country of origin of the data, retrospective or prospective): The tests were conducted by Piolax (Japan) to support the FDA submission. These are prospective bench/lab tests designed for regulatory approval, not retrospective or prospective clinical studies on human populations.
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 "ground truth" for mechanical and biocompatibility tests is based on established engineering standards and biological assay results, not expert interpretation of clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert reviews of clinical cases (e.g., imaging studies), not for bench testing of medical devices.
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 is not an AI-assisted diagnostic device. It is a physical guidewire used in interventional procedures. MRMC studies are typically for evaluating diagnostic imaging systems or AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable, as this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the mechanical performance tests (tensile strength, torque strength, torqueability, tip flexibility, coating adherence) would be quantitative measurements against predefined engineering specifications and/or direct comparison to the predicate device's performance data.
- The ground truth for biocompatibility tests (pyrogen, hemolytic, cytotoxicity, etc.) would be standardized laboratory assay results that determine if the leachates or materials cause adverse biological reactions, following established protocols (e.g., ISO 10993 series or specific USP standards).
- For shelf-life, the ground truth is stability testing data (e.g., accelerated or real-time aging studies) demonstrating that the device maintains its performance and safety characteristics over the claimed duration.
8. The sample size for the training set
- Not applicable. This is not a machine learning device. The "training set" concept is irrelevant here.
9. How the ground truth for the training set was established
- Not applicable.
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OCT 2 7 1998
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| II. | 510(k) SUMMARY | |
|---|---|---|
| ----- | ---------------- | -- |
| Date: | March 12, 1998 |
|---|---|
| Applicant's Address: | Piolax, Inc.51, Iwai-Cho, Hodogaya-KuYokohama 240-0023Japan |
| Manufacturing Facility Address: | 179, Kariba-Cho, Hodogaya-KuYokohama 240-0025Japan |
| Contact Person: | M. Elizabeth Bierman, Esq.Morgan, Lewis & Bockius LLP1800 M Street, N.W.Washington, D.C. 20036Tel: 202/467-7206Fax: 202/467-7176 |
| Trade Name: | Piolax Hydrophilic Guidewire |
| Classification Name: | Catheter Guidewire |
| Usual/Common Name: | Catheter Guidewire |
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Legally Marketed Terumo Radifocus® Guidewire M (K924202) Predicate Device:
Device Description: The Piolax Hydrophilic Guidewire is a tapered wire. composed of stainless steel or Ni-Ti alloy that is coated with a hydrophilic polymer. The hydrophilic polymer is composed of polyvinyl pyrrolidone and benzoyl peroxide. The Guidewire is provided with one of three differently shaped hydrophilic polymer-coated tips (i.e., straight, angled, J-shaped). The standard wire diameters are 0.58 mm, 0.72 mm, 0.79 mm, and 0.86 mm. The range for length of guidewires is 450 to 3,000 mm.
Intended Use: The Piolax Hydrophilic Guidewire is a catheter guidewire, coated with a hydrophilic polymer in order to reduce frictional resistance in two phases between the wire and the blood vessel and between the wire and the inner surface of the catheter, thereby allowing the Guidewire to more easily reach the intended area. The Piolax Hydrophilic Guidewire is intended for vascular therapeutic and diagnostic applications, particularly for arterial and venous applications in the cardiac, cerebral, and abdominal regions.
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The Piolax Hydrophilic Guidewire is contraindicated for use in coronary vessels.
Technological Characteristics:
The Piolax Hydrophilic Guidewire is composed of materials similar to that of the Terumo Radifocus® Guidewire. Both are composed of a stainless steel or similar alloy, with a urethane resin layer, and both have a hydrophilic polymer coating material. The Piolax Hydrophilic Guidewire differs in that its primary layer includes another resin (in addition to the urethane resin), that serves as a primer for the hydrophilic coating. Additionally, the composition of the hydrophilic coating differs. The diameters and lengths of the two wires are similar.
Performance Data: Piolax conducted tensile strength, torque strength, torqueability, tip flexibility, and coating adherence testing consistent with FDA's Coronary and Cerebrovasculature Guidewire Guidance (Jan. 1995). The test results demonstrate that the Piolax Hydrophilic Guidewire is substantially equivalent to the Terumo Radiofocus® Guidewire.
WADIA/131083.2
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In addition, Piolax conducted the following biocompatibility tests: pyrogen rabbit extract test; hemolytic extract test; cytotoxicity test; sensitization test; intracutaneous reaction test; acute systemic toxicity test; blood compatibility test; and USP rabbit pyrogen test. All tests demonstrated that the Piolax Hydrophilic Guidewire is biocompatible.
Shelf-life testing on the Piolax Hydrophilic Guidewire demonstrates that the device has a shelf-life expiration date of two years.
Based on results of the above testing, Piolax concludes that the Piolax Hydrophilic Guidewire is as safe and as effective as Terumo's Radifocus® Guidewire.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
OCT 2 7 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Piolax, Inc. c/o Ms. M. Elizabeth Bierman, Esq. Morgan, Lewis and Bockius LLP 1800 M Street, N.W. Washington, D.C. 20036
K980977 Re: Piolax Hydrophilic Guidewire Trade Name: Regulatory Class: II Product Code: DQX October 14, 1998 Dated: Received: October 14, 1998
Dear Ms Bierman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Elizabeth Bierman
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Piolax Hydrophilic Guidewire
Indications for Use:
The Piolax Hydrophilic Guidewire is indicated for use for introduction and positioning of catheters within the peripheral vasculature in vascular diagnostic and therapeutic applications, particularly for arterial and venous applications in the cardiac, cerebral, and abdominal regions. The Guidewire is contraindicated for use in coronary vessels.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR § 801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K980977
WA01A/190456.1
§ 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.