RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE

K971281 · Medcomp · DQX · Oct 9, 1997 · Cardiovascular

Device Facts

• Record ID: K971281
• Device Name: RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE
• Applicant: Medcomp
• Product Code: DQX · Cardiovascular
• Decision Date: Oct 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended 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.

Device Story

The Raulerson One-Step Guidewire Insertion Bulb Needle is a manual surgical instrument used to facilitate percutaneous guidewire insertion. It functions as a conduit for guidewire placement prior to catheterization. The device is operated by qualified physicians in clinical settings. It simplifies the insertion process by providing a bulb-integrated needle design, allowing for direct guidewire passage. This aids in efficient vascular access, reducing procedural steps and potential complications during catheter placement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical needle with integrated bulb for guidewire insertion. Percutaneous application. No electronic components, software, or energy sources.

Indications for Use

Indicated for percutaneous guidewire insertion to facilitate subsequent catheter placement. Intended for use by qualified, experienced physicians only.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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
Regulatory 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 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 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 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D.
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

510(k) Number K971281

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Prescription Use ☑ (Per 21 CFR 801.109)