(89 days)
The Docking-Extension Wire is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
The SCHNEIDER Docking-Extension Wire is used to elongate the working length of compatible SCHNEIDER extendable guide wires. The stainless-steel Docking-Extension Wire has an outer diameter of 0.014" (0.36 mm) and a length of 130 cm. Its distal end bears a preformed superelastic connecting hypotube. This superelastic property allows the proximal end of the quide wire to be fixed in the hypotube to such an extent. that axial forces can easily be transmitted. A docking aid enables easy introduction of the extendable end of the guide wire into the hypotube. The device is compatible with the SCHNEIDER extendable guide wires (C-Thru, Hannibal and Clyde). The currently marketed guide wires had been slightly modified at the proximal end to create a tapered end in order to be accommodated into the hypotube of the Docking-Extension Wire. This modification does not in any way affect the safety or performance of the guide wire.
This is a 510(k) premarket notification for a medical device (Docking-Extension Wire), not a study evaluating an AI device. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Instead, the document details the equivalence testing performed to demonstrate that the new device is substantially equivalent to a predicate device.
Here's an analysis based on the provided text, addressing the applicable categories:
1. A table of acceptance criteria and the reported device performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Docking Joint Tensile Strength | Equivalent to predicate device (ACS DOC™ Extension Wire) | Substantial equivalence demonstrated through comparative performance testing. |
| Docking Junction Fatigue | Equivalent to predicate device (ACS DOC™ Extension Wire) | Substantial equivalence demonstrated through comparative performance testing. |
| Glued Bond Break Load | Equivalent to predicate device (ACS DOC™ Extension Wire) | Substantial equivalence demonstrated through comparative performance testing. |
| Compatibility with Interventional Devices | Functionally compatible with interventional devices (as predicate) | Substantial equivalence demonstrated through comparative performance testing. |
| Biocompatibility: Cytotoxicity | Non-cytotoxic (as per established biocompatibility standards) | Passed biocompatibility testing. |
| Biocompatibility: Coagulation | Compatible with blood coagulation (as per established standards) | Passed biocompatibility testing. |
| Biocompatibility: Indirect Hemolysis | Non-hemolytic (as per established biocompatibility standards) | Passed biocompatibility testing. |
| Biocompatibility: Intracutaneous Reactivity | Non-reactive (as per established biocompatibility standards) | Passed biocompatibility testing. |
| Biocompatibility: Systemic Toxicity | Non-systemically toxic (as per established biocompatibility standards) | Passed biocompatibility testing. |
| Biocompatibility: Sensitization | Non-sensitizing (as per established biocompatibility standards) | Passed biocompatibility testing. |
2. Sample sizes used for the test set and the data provenance
- The document does not specify the sample sizes (number of devices tested) for the comparative performance testing or the biocompatibility testing.
- The data provenance is from testing conducted by SCHNEIDER (Europe) GmbH in Switzerland. This is prospective testing specifically for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device equivalence study, not an AI study relying on expert-established ground truth for medical image interpretation or diagnosis. The "ground truth" here is the performance of the predicate device and established biocompatibility standards.
4. Adjudication method for the test set
- Not Applicable. There was no human adjudication process involved in comparing the device's technical performance. The evaluation was based on objective physical and chemical tests against the predicate device and recognized standards.
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 device, and therefore no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
- The "ground truth" for the performance testing was the performance characteristics of the legally marketed predicate device (ACS DOC™ Extension Wire) and established international standards for biocompatibility testing. The goal was to prove "equivalence in technological characteristics."
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI model, this question is not relevant.
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OCT 21 1998
10 510(k) Summary for the SCHNEIDER Docking-Extension Wire
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92. The assigned 510(k) number is
| Date prepared: | July 21, 1998 |
|---|---|
| Sponsor: | SCHNEIDER (Europe) GmbHAckerstrasse 6CH-8180 BülachSwitzerland |
| Contact: | Thomas Thaler, Ph. D.Director, Clinical and Regulatory Affairs |
| Trade/Proprietary Name: | Docking-Extension Wire |
| Classification: | Class II |
| Predicate Device: | ACS DOC™ Extension Wire |
Device Description:
The SCHNEIDER Docking-Extension Wire is used to elongate the working length of compatible SCHNEIDER extendable guide wires. The stainless-steel Docking-Extension Wire has an outer diameter of 0.014" (0.36 mm) and a length of 130 cm. Its distal end bears a preformed superelastic connecting hypotube. This superelastic property allows the proximal end of the quide wire to be fixed in the hypotube to such an extent. that axial forces can easily be transmitted. A docking aid enables easy introduction of the extendable end of the guide wire into the hypotube. The device is compatible with the SCHNEIDER extendable guide wires (C-Thru, Hannibal and Clyde). The currently marketed guide wires had been slightly modified at the proximal end to create a tapered end in order to be accommodated into the hypotube of the Docking-Extension Wire. This modification does not in any way affect the safety or performance of the guide wire.
Technological Characteristics:
Equivalence in technological characteristics was substantiated by comparative performance testing including docking joint tensile strength, docking junction fatigue and glued bond break load, and compatibility with interventional devices. Biocompatibility testing of the Docking-Extension Wire was conducted with regard to cytotoxicity, coagulation, indirect hemolysis, intracutaneus reactivity, systemic toxicity and sensitization.
The results of all testing indicated that the SCHNEIDER Docking-Extension Wire is equivalent to the ACS DOC™ Extension Wire and is, therefore, safe for the intended use.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Thomas Thaler, Ph.D. SCHNEIDER (Europe) GmbH Ackerstrasse 6 CH-8160 Bülach Switzerland
Re: K982592 Docking-Extension Wire Requlatory Class: II (two) Product Code: DQX Dated: July 22, 1998 Received: July 24, 1998
Dear Dr. Thaler:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket 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 requlations.
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Page 2 - Thomas Thaler, Ph.D.
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 requlation (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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Collehan
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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510(k) Number (if known):
Device Name:
Indications for Use:
Docking-Extension Wire
The Docking-Extension Wire is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
A. Doyle Ratliff
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.