(88 days)
The coaxial dilator is used for percutaneous introduction of 0.035 inch or 0.038 inch guide wires into the vascular system following a small 21 Ga. needle stick.
The coaxial dilator set consists of an inner, tapered dilator with a slightly shorter outer dilator.
This document is a 510(k) premarket notification for a Coaxial Dilator Set. It is not a study demonstrating the performance of an AI/ML device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or AI-specific metrics.
The document discusses substantial equivalence to predicate devices, packaging, sterilization, and general safety and effectiveness for a medical device that assists in introducing guidewires into the vascular system. It does not involve any AI/ML components or performance metrics that would require the establishment of ground truth by experts or comparative effectiveness studies.
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K9 74 642
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to $513(i)(3)(A) of the Food, Drug, and cosmetic Act, Boston Scientific Corporation submits this summary of safety and effectiveness.
A. GENERAL INFORMATION
| Owner Operator Submitting this Premarket Notification: | Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01757(508) 650.8174 | MAR 1 3 1998 |
|---|---|---|
| Contact Person: | Wanda M. CarpinellaRegulatory Affairs Department | |
| Device Generic Name: | Coaxial Dilator | |
| Device Classification: | 74 DRE, Dilator, Vessel for Percutaneous Catheterization |
B. INDICATIONS FOR USE
The coaxial dilator is used for percutaneous introduction of 0.035 inch or 0.038 inch guide wires into the vascular system following a small 21 Ga. needle stick.
C. DESCRIPTIVE CHARACTERISTICS
The coaxial dilator set consists of an inner, tapered dilator with a slightly shorter outer dilator.
D. SUBSTANTIAL EQUIVALENCE
The proposed coaxial dilator set has been shown to be substantially equivalent to the coaxial dilator provided in Cook's Micropuncture Introducer Set and to Boston Scientific's peelable sheath and dilator.
E. PACKAGING, STERILIZATION, AND PYROGENICITY
The coaxial dilator set is packaged in a heat-sealed Tyvek/mylar pouch. The product is sterilized using ethylene oxide gas. Bacterial endotoxin levels are monitored for sterility release purposes.
F. CONCLUSION
. .
Based on the information presented, Boston Scientific Corporation believes that the proposed coaxial dilator set meets the minimum requirements that are considered acceptable for its intended use and is substantially equivalent to other currently marketed coaxial dilators,
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR / 3 1998
Ms. Wanda M. Carpinella Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Re: K974640 Coaxial Dilator Set Requlatory Class: II (two) Product Code: 74 DRE Dated: December 11, 1997 December 15, 1997 Received:
Dear Ms. Carpinella:
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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Page 2 - Ms. Wanda M. Carpinella
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. Callahan
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):
New Application
Device Name:
Coaxial Dilator Set
The coaxial dilator set is used for percutaneous Indications for Use: introduction of 0.035 inch or 0.038 inch guide wires into the vascular system following a 21 Ga. needle stick.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.)
Concurrence of CDRH, Office of Device Evaluaiton (ODE)
Dan A. R.
(Division Sign-Om)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K974640
Prescription Use (Per 21 CRF 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).