(86 days)
The BMC Coaxial Injectable Catheter is intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
BMC Coaxial Injectable Catheter
I am sorry, but the provided text is a scanned FDA 510(k) clearance letter for a medical device and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth, or expert qualifications for AI/ML-based device evaluation.
The letter only states that the "BMC Coaxial Injectable Catheter" has been found substantially equivalent to a legally marketed predicate device for its stated indications for use. It outlines regulatory information regarding marketing, classification, and general controls.
Therefore, I cannot fulfill your request based on the provided input.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2002 MAR
Mr. Kris Shah VP, Product Development Baylis Mediccal Company, Inc. 33-5160 Explorer Drive Mississauga, Ontario L4W 4T7
Re: K014075
BMC Coaxial Injectable Catheter Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire. Regulatory Class: Class II Product Code: DQX Dated: November 28, 2001 Received: December 11, 2001
Dear Mr. Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality
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systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Dala Telle
Bram Zuckerman, M.D. Acting 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):_KOIYO75
Device Name: BMC Coaxial Injectable Catheter
Indications For Use:
The BMC Coaxial Injectable Catheter is intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K014075
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)
§ 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.