ULTRA-CBX

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K' followed by the numbers '991486'. The numbers are written in a cursive style, and there is a line underneath the sequence. of Safety and Effect for the Endomyocardial Cardiac Biops NOV - 5 1999 Submitted by Medcanica, Inc. 8308 NW 74th Avenue Miami, FL 33166 Phone: (305) 863-1603 # Identification of a Legally Marketed Predicate Device The Medcanica, Inc. Endomyocardial Biopsy Forceps (EMB) is substantially equivalent to the BiPal Biopsy Forceps manufactured and marketed by the Cordis Corporation pursuant to 510(k) K914567. ### General Description The EMB is sterile, single use, radiopaque, disposable device that is delivered non-toxic and non-pyrogenic. The device is transvascularly deployed to the right ventricle of the heart for the acquisition of endomyocardial tissue samples Typically, the approach is made from the jugular vein or femoral arteries. The EMB consists of 4 major components: the moveable handle, end-effectors (jaws), core wire, and sheath. The core wire is attached to the handle. Moving the handle opens and closes the jaws. A typical EMB is shown in Figure 1, EMB (Jaws Open). Details of the jaws are shown separately in Figure 2, Jaw Assembly. Image /page/0/Figure/12 description: The image shows a medical instrument, possibly a biopsy tool or a similar surgical device. It features a long, slender shaft with a grasping or cutting mechanism at one end. The handle is complex, with multiple loops and levers, suggesting a design for precise control and manipulation during medical procedures. Figure 1, EMB (Jaws Open) {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows a technical drawing of a mechanical arm or gripper. The arm consists of a cylindrical body connected to a set of hinged jaws. The jaws are open, revealing their curved inner surfaces. The drawing is done in a simple line style, with no shading or color. Figure 2, Jaw Assembly #### Intended Use ﺮ The Endomyocardial Biopsy Forceps are designed for endomyocardial biopsies. ## Summary of Technological Characteristics The table below compares the technological characteristics of the EMB to the predicate device. | Feature | EMB | Predicate Device | |----------------------|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------| | 510(k) Number | To be determined | K914567 | | Manufacturer | Medcanica, Inc. | Cordis Corporation | | Sterile packaging | Mylar®/Tyvek® Pouch, Box | Mylar®/Tyvek® Pouch, Box | | Sterilization method | Ethylene Oxide | Ethylene Oxide | | Single Use | Yes | Yes | | Pyrogenicity | Non-pyrogenic | Non-pyrogenic | | Shelf life | 1 year initially, 3 years subsequent to<br>accelerated aging tests | 3 years | | Intended use | The Endomyocardial Biopsy For-<br>ceps are designed for endomyocar-<br>dial biopsies. | The Cordis biopsy forceps are de-<br>signed for endomyocardial biopsies. | | Formable tip | Yes | Yes | | Radiopaque | Yes | Yes | | Available Sizes | 5.4 and 7.0 French | 5.4 and 7.0 French | | Working lengths (cm) | 50 and 105 | 50 and 104 | | Jaw action | Double-action (both jaws move) | Double-action (both jaws move) | {2}------------------------------------------------ | Feature | EMB | Predicate Device | |-----------------------------------------------|------------------|--------------------| | Tip curve orientation marker | Handle Logo | Handle Logo | | Recirculating Blood Contact outer sheath | Teflon®, (FEP) | Teflon®, (PTFE) | | Recirculating Blood Contact Metallic Parts | Stainless Steel | Stainless Steel | | Color Coding | Yes | Yes | | Jaw Size Indication | Handle Logo | Strain Relief Logo | | Handle | 3-ring pull type | 3-ring pull type | | F5.4 minimum recommended sheath size (French) | 6 | 6 | | F7.0 recommended sheath size (French) | 7 | 7 | | Calculated (Labeled) Jaw Volume 5.4 F (mm³) | 2.20 | 1.84 | | Calculated (Labeled) Jaw Volume 7.0 F (mm³) | 5.20 | 5.03 | ## Summary of Performance Data The EMB meets the requirements of the following recognized consensus standards. - ASTM F899 95, Standard Specification for Stainless Steel Billet, Bar and Wire . for Surgical Instruments - Biological Evaluation of Medical Devices-Part 7: Ethylene oxide sterilization . residuals, American National Standard, ANSI/AAMI/ISO 10993-7:1995 - . Medical Devices-Validation and Routine Control of Ethylene Oxide Sterilization, ANSI/AAMI/ISO 11135-1994, Approved March 24, 1994 by the American National Standards Institute, Inc. Additionally, the EMB complies with the following standards: - Ethylene Oxide, Ethylene Chlorhydrin, and Ethylene Glycol, Proposed Maximum . Residue Limits and Maximum Levels of Exposure, 21 CFR, § 821.100, Proposed Rule, June 23, 1978. The EMB is substantially equivalent to the cardiac biopsy forceps manufactured and marketed by the Cordis Corporation pursuant to 510(k) K914567. Extensive bench testing of {3}------------------------------------------------ both devices has demonstrated this. Testing includes tensile, flexibility, dimensional, and performance tests. Furthermore, the device has similar technological characteristics to Cordis cardiac biopsy forceps. The recirculating blood contact materials of the device have been carefully selected for their long history of biocompatibility. Since the EMB meets the requirements of the stated standards and embodies technological characteristics essentially identical to those of the predicate device, we believe the device is safe and effective and that it performs as well as or better than the predicate device. The device has been designed and developed utilizing design control methods in compliance with the GMP. The EMB will be manufactured per specifications and good manufacturing practices that ensure the device is safe and effective for its intended use. {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three curved lines, possibly representing people or services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 5 1999 HOV Mr. Matthew A. Palmer President Medcanica, Inc. 19526 E. Lake Drive Miami, FL 33015 Re : K991486 ULTRA-CBX Requlatory Class: II (Two) Product Code: DWZ Dated: August 6, 1999 Received: Auqust 9, 1999 Dear Mr. Palmer: 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 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). 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 reqistration, 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 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 Requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations. {5}------------------------------------------------ Page 2 - Mr. Matthew A. Palmer 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21CFR 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.qov/cdrh/dsma/dsmamain.html". Sincerely yours, Nancy C. Bogdon for Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ # Indications for Use Page 1 of 1 510(k) Number (if known): K991486 Device Name Endomyocardial Biopsy Forceps Indications for Use: — The Endomyocardial Biopsy Forceps are designed for endomyocardial biopsies. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Kare R. Lamperle (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K991486 510(k) Number _ Prescription Use X (Per 21 CFR 801.109) OR Over-The-Counter Use No (Optional Format 1-2-96) Page 4 of 3