(185 days)
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No
The 510(k) summary describes a mechanical device (needle) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as a guidewire insertion bulb needle used in preparation for catheter placement, which is a procedural tool rather than a device intended to directly treat a disease or condition.
No
Explanation: The device is described as a guidewire insertion needle used for catheter placement, which is a procedural tool rather than a device intended to identify or monitor medical conditions.
No
The 510(k) summary describes a physical medical device (a guidewire insertion bulb needle) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "GUIDEWIRE INSERTION IN PREPARATION FOR CATHETER PLACEMENT" and is "INSERTED PERCUTANEOUSLY." This describes a surgical or interventional procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside of the body (in vitro).
The description of the MEDCOMP RAULERSON® ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE aligns with a medical device used for a procedure on a patient, not for testing samples in a lab.
N/A
Intended Use / Indications for Use
THE MEDCOMP RAULERSON® ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE IS DESIGNED FOR GUIDEWIRE INSERTION IN PREPARATION FOR CATHETER PLACEMENT. IT IS INSERTED PERCUTANEOUSLY. IT IS INTENDED TO BE INSERTED BY QUALIFIED, EXPERIENCED PHYSICIANS ONLY. THIS PRODUCT IS NOT MEANT TO BE USED FOR ANY PURPOSE OTHER THAN THAT WHICH IS INDICATED ABOVE.
Product codes
DQX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
qualified, experienced physicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be a stylized caduceus, a symbol often associated with medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Jeanne M. Cush Regulatory Affairs Coordinator Medcomp 1499 Delp Drive Harleysville, Pennsylvania 19438
OCT - 9 1997
Re : K971281 Raulerson® One-Step Guidewire Insertion Bulb Needle Requlatory Class: II (two) Product Code: DQX Dated: July 15, 1997 Received: July 21, 1997
Dear Ms. Cush:
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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Eederal 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 regulations.
1
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 Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K971281 |
|---|---|
| Device Name: |
Indications For Use:
THE MEDCOMP RAULERSON® ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE IS DESIGNED FOR GUIDEWIRE INSERTION IN PREPARATION FOR CATHETER PLACEMENT. IT IS INSERTED PERCUTANEOUSLY. IT IS INTENDED TO BE INSERTED BY QUALIFIED, EXPERIENCED PHYSICIANS ONLY. THIS PRODUCT IS NOT MEANT TO BE USED FOR ANY PURPOSE OTHER THAN THAT WHICH IS INDICATED ABOVE.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K97128 510(k) Number. Prescription Use Over-The-Counter Use OR (Per 21 CFR 801.109) (Optional Formal 1-2-96)