(89 days)
ACS DOC™ Extension Wire
Not Found
No
The description focuses on mechanical properties and compatibility of a physical medical device (a guide wire extension). There is no mention of software, algorithms, or data processing that would suggest AI/ML.
No.
The device is described as an extension wire for existing guide wires used during angioplasty procedures, indicating it is an accessory to a medical procedure rather than directly providing therapy itself.
No
The device is an extension wire used during angioplasty procedures to extend the working length of a guide wire. Its function is interventional, not diagnostic, as it does not gather or interpret data to identify a medical condition.
No
The device description clearly describes a physical, stainless-steel wire with specific dimensions and mechanical properties, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during an angioplasty procedure to extend the working length of a guide wire. This is an interventional procedure performed in vivo (within the body).
- Device Description: The description details a physical device (a wire) used to connect to another physical device (a guide wire) for mechanical purposes (extending length, transmitting axial forces).
- 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.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body during a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
DQX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
ACS DOC™ Extension Wire
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
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) GmbH |
| Ackerstrasse 6 | |
| CH-8180 Bülach | |
| Switzerland | |
| 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.
1
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.
2
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)