(249 days)
The Hunter™ Super Soft and Soft guide wires with phosphorylcholine (PC) coating are intended to facilitate the placement of PTA and/or PTCA balloon catheters within the peripheral and coronary vasculature. This guide wire is 0.014-inch size and designed for safe use within appropriately sized balloon catheters. This device is not for use in the cerebral vasculature.
The Hunter guide wires are coated with a high molecular weight phosphorvicholine ("PC") polymer. The core wire and spring coils are coated with phosphorylcholine (PC). The PC coating aids in the prevention of thrombus formation on the guide wire tip during short-term clinical use. While the PC coating has been shown to resist thrombus accumulation during PTCA procedures, a clinical significance of this reduction has not been demonstrated. The guide wires are full-length core wire design having a distal 30cm long spring coil. PC-coated guide wires are available in 175cm and 300cm lengths with distal radiopaque platinum/fungsten spring coil lengths of 4cm and 30cm.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Soft Guide Wires with PC Coating:
Acceptance Criteria and Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria for the device. Instead, it describes the effectiveness of the PC coating in terms of its ability to reduce protein adsorption and thrombus formation, comparing it to a predicate device.
However, based on the "Safety and Effectiveness" section, we can infer the performance metrics reported:
| Acceptance Criterion (Inferred) | Reported Device Performance (PC-Coated Guide Wires) |
|---|---|
| Reduction in Fibrinogen Binding | Less than that to other common guide wire coating materials (demonstrated in vitro). |
| Resistance to Thrombus Formation | Effectively resisted thrombus deposition under variable conditions of clinical PTCA (demonstrated in a clinical study examining 50 PTCA procedures using Scanning Electron Microscopy). The text notes that "a clinical significance of this reduction has not been demonstrated" for the prevention of thrombus formation specifically, implying that the study demonstrated reduction in accumulation rather than prevention of a clinically relevant event. It also states the PC coating "aids in the prevention of thrombus formation...during short-term clinical use." |
| Reduction in Protein Adsorption | A fundamental characteristic, described as "reduction of protein adsorption (e.g. fibrinogen)." |
| Decrease in Platelet Adhesion | A fundamental characteristic, described as "decrease in platelet adhesion (and therefore activation and aggregation)." |
| Durability / Adherence | A "stable and durable polymer coating adheres to the otherwise hydrophobic substrate." |
| Sterilization Compatibility | Sterilizable by gamma radiation. |
| Biocompatibility | Implied by the lack of adverse findings and the nature of the K970938 approval for marketing. (No specific study details on biocompatibility are provided beyond the general safety and effectiveness statement). |
Study Information
Due to the nature of a 510(k) summary, specific, detailed study protocols are not included. However, we can extract the following:
1. Sample sizes used for the test set and the data provenance:
- Clinical Study:
- Sample Size: 50 clinical PTCA procedures.
- Data Provenance: The text refers to "clinical PTCA procedures," implying prospective human use data. The country of origin is not specified, but the submission is to the US FDA, so studies conducted in the US are highly probable, or at least accepted by the FDA.
- In Vitro Study:
- Sample Size: Not specified.
- Data Provenance: In vitro, laboratory setting.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the clinical study using Scanning Electron Microscopy (SEM): The text does not specify the number of experts or their qualifications who interpreted the SEM images or assessed thrombus deposition. It simply states the results "demonstrated the effectiveness."
- For the in vitro study on fibrinogen binding: No information on "experts" or "ground truth establishment" is applicable in the human expert sense, as this would be a laboratory measurement.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not mention any adjudication method for either the clinical or in vitro studies.
4. 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 device (guide wire with coating), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance for human readers was not performed.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a physical medical device. It does not involve a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical study: The ground truth for "resistance to thrombus deposition" was established through Scanning Electron Microscopy (SEM) examination of guide wires after use in 50 clinical PTCA procedures. This can be considered a direct observational "ground truth" of material performance in vivo.
- For the in vitro study: The ground truth for "fibrinogen binding" was established through laboratory measurements using an unspecified assay.
7. The sample size for the training set:
- Not Applicable. This is a physical device, not a machine learning model. There is no concept of a "training set" in the context of device approval of this nature.
8. How the ground truth for the training set was established:
- Not Applicable. As above, there is no training set for this type of device.
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510(k) Summary
Soft Guide Wires with PC Coating
Biocompatibles Cardiovascular Inc. 680 West Maude Avenue, Suite 2 Sunnyvale, CA 94086 USA
Contact Person:
Submitter's Name:
John P. Yianni, Ph.D. Technical Director
NOV 17 1997
October 20, 1997
Children Children Children Children Children Children Children Children Children
Device Names:
510(k) Summary Date:
Common Name:
Classification:
Predicate Device:
Medrad Inc. (K802473)
- Benzalkonium-Heparin Coated Guidewires .
Coronary and Peripheral Vascular Guide Wire
Class II - Catheter Guide Wire (21 CFR 870.1330)
Hunter 0.014 inch Super Soft and Hunter 0.014 inch
- Amplatz Heparin-Coated Wire Guide
- Thrombo-Resistant Coated Spring Guide
Device Description:
The Hunter guide wires are coated with a high molecular weight phosphorvicholine ("PC") polymer. The core wire and spring coils are coated with phosphorylcholine (PC). The PC coating aids in the prevention of thrombus formation on the guide wire tip during short-term clinical use. While the PC coating has been shown to resist thrombus accumulation during PTCA procedures, a clinical significance of this reduction has not been demonstrated. The guide wires are full-length core wire design having a distal 30cm long spring coil. PC-coated guide wires are available in 175cm and 300cm lengths with distal radiopaque platinum/fungsten spring coil lengths of 4cm and 30cm.
Intended Use:
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 0.014 inch size and designed for safe use within appropriately sized balloon catheters. The guide wires are not for use in the cerebral vasculature.
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Comparison of Technological Characteristics:
10-12-12
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The PC-solution is applied as a thin film, by dip coating, to the guide wire spring coil and core wire surfaces. A stable and durable polymer coating adheres to the otherwise hydrophobic substrate | PhosphoryIcholine polar head groups on the surface are hydrophilic. IUpon exposure to water or blood, PC molecules rapidly absorb water. The surface becomes lubricious and resistant to protein adsorption and cellular adhesion. The reduction of protein adsorption (e.g. fibrinogen) and decrease in platelet adhesion are fundamental characteristic of the PC coating. PC-coated surfaces are sterilizable by gamma radiation.
The benzalkonium-heparin (BH) coating solution is prepared from a precipitated heparin-quaternary ammonium complex (salt). The BH complex is applied to the guide wire by dip coating. The BH surface is hydrophobic rather than hydrophilic. The BH coating is soluble in water and, therefore, is easily leached from the surface over time. The recognized temporary protection against thrombus formation on BH-coated surfaces was considered adequate for most catheterization procedures.
Expression of the hydrophilic and blood compatible characteristics of PCcoated surfaces is dependent on the presence of water for hydration; no circulating protein cofactor is required. The predicate BH coating is sionificantly different from the PC-coating in that the heparin molecule is an indirect thrombin inhibitor and requires the presence of antithrombin III (ATIII) to complete the inhibition. The PC coating is inert to normal biochemical degradation processes. The fundamental differences between PC and BH coatings are the ability of the PC to reduce substrate clotting protein (fibrinogen) adsorption, resist platelet adhesion (and therefore activation and aggregation), and function independent of other cofactors (other than water).
Packaging and Sterilization
The PC-coated guide wires are packaged in Tyvek/Mylar heat sealed pouches and sterilized with gamma radiation, The package material of the BH-coated guide wires is also TyvekMylar and the method of sterilization is ethylene oxide gas.
Safety and Effectiveness:
The effectiveness of PC-coated guide wires at reducing protein adsorption and thrombus formation was confirmed by in vitro and clinical studies, respectively. Fibrinogen binding to PC-coated surfaces was less than that to other common guide wire coating materials. Five different groups of coated guide wires, including PC-coated guide wires, used to perform 50 clinical PTCA procedures were examined by scanning electron microscopy. The results of the clinical study demonstrated the effectiveness of the PC coating to resist thrombus deposition under the variable conditions of clinical PTCA,
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the circle is an abstract symbol that resembles an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 7 1997
Ms. Nancy F. Teague Consultant and Correspondent for Biocompatibles Cardiovascular, Inc. C.L. McIntosh Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
K970938 Re: Hunter™ 0.014 inch Soft and Super Soft Guide Wires with PC Coating Requlatory Class: II (two) Product Code: DQX Dated: September 17, 1997 Received: September 18, 1997
Dear Ms. Teague:
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 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 reqistration, 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 Register. Please note: this response to your premarket
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notification submission does not affect any 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) 594-4648. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510(k) Number (if known): K970938
Hunter™ 0.014 inch Super Soft Guide Wire with PC Coating Device Name: and Hunter™ 0.014 inch Soft Guide Wire with PC Coating
Indications for Use:
The Hunter™ Super Soft and Soft guide wires with phosphorylcholine (PC) coating are intended to facilitate the placement of PTA and/or PTCA balloon catheters within the peripheral and coronary vasculature. This guide wire is 0.014-inch size and designed for safe use within appropriately sized balloon catheters. This device is not for use in the cerebral vasculature.
Tien K
(Division Sig
Division of Cas and Neurological 510(k) Number
(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
(Optional Format 1-2-96)
§ 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.