MODIFICATION TO GELBFISH VASCULAR DILATORS

{0}------------------------------------------------ #### NOV 8 2002 #### Summary of 510(k) Submission Section 11 ## 11.1 Type of Submission Special 510(k) Date of Submission: October 15, 2002 ## 11.2 Manufacturer VascuMetrix, LLC 2824 N. Power Rd. Suite 113-278 Mesa, AZ 85215 (480) 807-6300 Fax: (480) 807-6307 # 11.3 Contact Person Nick Raible President ### 11.4 Device | 510(k) Number: | K023507 | |-------------------|-------------------------------------------------------------------------------------------------| | Proprietary Name: | VascuMetrix Dilators | | Generic Name: | Dilator, Vessel, For Percuteneous Catheterization | | Classification: | Class II | | Relevant Section: | 870.1310 | | Product Code: | DRE | | Intended Use: | These devices are intended to be used over a guidewire to<br>dilate or calibrate blood vessels. | {1}------------------------------------------------ 11/623507 #### 11.5 Predicate Device | 510(k) Number: | K0012256 | |-------------------|-------------------------------------------------------------------------------------------------| | Proprietary Name: | Gelbfish Vascular Dilators | | Generic Name: | Dilator, Vessel, For Percuteneous Catheterization | | Classification: | Class II | | Relevant Section: | 870.1310 | | Product Code: | DRE | | Intended Use: | These devices are intended to be used over a guidewire to<br>dilate or calibrate blood vessels. | ### 11.6 Comparison to Predicate Device - 1. The original 510(k) on these dilators limited the shaft size to a shaft with "a lumen large enough to slide over an 0.035" guidewire." The modified devices will have shatts with smaller lumens. The modified devices will accommodate 0.018" and/or 0.014" guidewires. - 2. The original 510(k) on these dilators limited the tip size to an outer diameter size range of 2.0 mm to 7.0 mm. The modified devices will have tip sizes that range from 1.0 mm to 10.0 mm. - 3. The current device does not have any markings or etchings. The modified device will have the device size laser etched on the tip. #### 11.7 Conclusion Comparison of the original device with the modified device for physical properties, performance characteristics and intended use, indicate that these devices are substantially equivalent and that there are no additional safety issues. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a human figure. The text is in all capital letters and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 8 2002 VascuMetrix, LCC Mr. Nick Raible President 2824 N. Power Rd., Suite 113-278 Mesa, AZ 85215 Re: K023507 > Trade/Device Name: VascuMetrix Gelbfish Vascular Dilators Regulation Number: 21 CFR 870.1310 Regulation Name: Dilator, Vessel, For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: October 15, 2002 Received: October 18, 2002 Dear Mr. Raible: 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 {3}------------------------------------------------ ### Page 2 - Mr. Nick Raible forth in the quality 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 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ K023507 #### Indications For Use Section 10 The VascuMetrix Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels. . Nick Raible Nick Raible Date: 11-6-02 **Prescription Use** (Per 21 CFR 801.109) ✓ Division of Cardiovascular & Respiratory Devices 510(k) Number _______________________________________________________________________________________________________________ Ashley Barrant for DCD