22 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CATHETER/NEEDLE ASSEMBLY), 24 GAUGE P.D. ACCESS VASCULAR ACCESS DEVICE (CAR

{0}------------------------------------------------ CardioVascular Dynamics, Inc. P.D. Access™ Vascular Access Device P.D. Access™ Dual Frequency Monitor JAN 2 3 1998 510(k) Notification September 30, 1997 K9737/3 510(K) SUMMARY OF SAFETY & EFFECTIVENESS Submitted By: CardioVascular Dynamics, Inc. 13700 Alton Parkway Irvine, CA 92618 Contact Person: Pamela Misajon (714) 595-7333 P.D. Access™ Percutaneous Doppler P.D. Access Dual Frequency Monitor Diagnostic Ultrasound Transducer September 30, 1997 Vascular Access Device Summary Preparation: · Device: Classification Name: Predicate Devices: Introducer Catheter: Doppler Needle: CVD 18 gauge SmartNeedle® #K903625. SE Date: November 7, 1990 CVD 18 gauge SmartNeedle #K913746. SE Date: December 17, 1991 CVD 20 gauge SmartNeedle #K913941. SE Date: February 27, 1992 CVD 20 gauge SmartNeedle #K940804. SE Date: June 10, 1994 CVD 22 gauge P.D. Access/SmartNeedle #K963989. SE Date: April 24, 1997 CVD 22 gauge P.D. Access/SmartNeedle® #K963989. SE Date: April 24, 1997 TFX Medical Introducer Catheter #K851141 010 {1}------------------------------------------------ The P.D. Access™ device is intended to be used in conjunction with the P.D. Access Dual Frequency Monitor for general vascular use. The P.D. Access device is intended for general vascular use for audibly indicating the Doppler response to blood flow within an artery or vein. The indications and intended use for the P.D. Access device is the same as the predicate devices manufactured by CardioVascular Dynamics (i.e., P.D. Access/SmartNeedle). Product technology, performance characteristics, specifications, components and materials of the P.D. Access device are similar to those of predicate devices. Testing of the P.D. Access device included dimensional, strength, ultrasonic performance and biocompatibility testing. These tests demonstrated that all of the items tested were within specification tolerances. There were no failures during these tests. Overall performance was safe and effective. Comparisons were made based on the size, construction, materials and use. Refer to the comparison chart enclosed. There are many commercially available Doppler devices indicated for monitoring of blood flow within the general vasculature which were marketed prior to promulgation of the Medical Device Amendments (May 28, 1976) or have been found substantially equivalent to pre-enactment devices. The P.D. Access device is intended for use in the same manner. In particular, the P.D. Access device is equivalent in indications and intended use to devices manufactured by CardioVascular Dynamics, formerly manufactured by Advance Cardiovascular Systems (ACS). The P.D. Access Monitor was originally listed by Advanced Cardiovascular Systems (ACS) under the name SmartNeedle® Monitor on document number A877515. The P.D. Access device was originally listed by ACS under the name SmartNeedle on document number A877516. These devices were delisted by ACS, July 19, 1996. The P.D. Access Monitor is registered under the name SmartNeedle by CVD under document A899719 and the P.D. Access device under the name SmartNeedle document number A999797. {2}------------------------------------------------ CardioVasculat Dynamics, Inc. P.D. Accessfor Vascular At vesss Device P.D. Access™ Dual Prequency Monitor ## COMPARISON CHART | | 24/26 Gauge<br>P.D. Access | 22 Gauge<br>P.D. Access<br>SmartNeedle | 20 Gauge<br>SmartNeedle | 18 Gauge<br>SmartNeedle | |------------------------|------------------------------------------------|--------------------------------------------------------------|----------------------------------|----------------------------------| | 510(k) # | Not Applicable | #K963989 | #K913941<br>#K940804 | #K903625<br>#K913746 | | Trade<br>Name | P.D. Access<br>Device | P.D. Access<br>or<br>SmartNeedle® | SmartNeedle | SmartNeedle | | Model # | 78110<br>78120 | 78050<br>78060<br>78070 | 77010 | 75010 | | Frequency | 30 MHz | 14.3 MHz | 14.3 MHz | 14.3 MHz | | Mode | Continuous | Continuous | Continuous | Continuous | | Monitor | P.D. Access<br>Dual Frequency<br>14.3 / 30 MHz | P.D. Access<br>or<br>SmartNeedle | P.D. Access<br>or<br>SmartNeedle | P.D. Access<br>or<br>SmartNeedle | | Indication | Blood Flow | Blood Flow | Blood Flow | Blood Flow | | Construction | Probe<br>Needle<br>ONC Introducer | Probe<br>Needle<br>ONC Introducer<br>Peel Away<br>Introducer | Probe<br>Needle | Probe<br>Needle | | Output/Display | Audible | Audible | Audible | Audible | | Probe Diameter | .010 inches | .016 inches | .016 inches | .035 inches | | Needle<br>Diameter | 24/26 Gauge | 22 Gauge | 20 Gauge | 18 Gauge | | Introducer<br>Diameter | 22/24 Gauge | 22 Gauge | Not<br>Applicable | Not<br>Applicable | {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 3 1998 Pamela Misajon Manager, Regulatory Affairs and Quality Assurance Cardio Vascular Dynamics, Inc. 13700 Alton Parkway Irvine, California 92618 K973713 Re: P.D. Access™ Vascular Access Device 24/26 Gauge and P.D. Access™ Dual Frequency Monitor Dated: December 9, 1997 December 10, 1997 Received: Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX Dear Ms. Misajon: 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, Druq and Cosmetic Act. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration. This determination of substantial equivalence applies to the following transducers intended for use with the P.D. Vascular Access Device, as described in your premarket notification: ## Transducer Model Numbers 78120, 78110 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. র্বা substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action: In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {4}------------------------------------------------ Page 2 - Pamela Misajon This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.q., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded. The special report should reference the manufacturer's 510(k) number. T+ should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to: > Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 This letter will allow you to begin marketing your device as described in your 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 market. If you desire specific advice for your device on our labeling (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212. Sincerely yours, David G. Bryson illian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, .... ..... and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {5}------------------------------------------------ CardioVascular Dynamics, Inc. P.D. Access™ Vascular Access Device P.D. Access™ Dual Frequency Monitor 510(k) Notification September 30, 1997 Page of 1 510(k) Number (if known): K973713 Device Name: : P.D. Access Vascular Access Device P.D. Access Dual Frequency Monitor Indications For Use: P.D. Access Device: Is intended for use when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and introducer of this size or larger These additional probe/needle models are being incorporated to broaden the product line in order to accommodate both user preference and patient anatomies for all age aroups. P.D. Access Monitor: Is intended for use to audibly indicate the doppler response of blood flow within an artery or vein. It is intended for use only in conjunction with the P.D. Access Vascular Access Device. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |---------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------| | Prescription Use_ <span style="text-decoration: overline;">✓</span> | OR | Over-The-Counter Use_ | | (Per 21 CFR 801.109) | | (Optional Format 1-2-96) | | | (Division Sign-Off)<br>Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | | | 510(k) Number | K973713 | | {6}------------------------------------------------ ## Indications for Use Form Fill out one form for each ultrasound system and each transducer. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Mode of Operation | | |-------------------|--| |-------------------|--| | Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------| | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intra-operative<br>(Specify) | | | | | | | | | | | | Intra-operative<br>Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ<br>(Specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Trans-esophageal | | | | | | | | | | | | Trans-Rectal | | | | | | | | | | | | Trans-Vaginal | | | | | | | | | | | | Trans-Urethral | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | Peripheral<br>Vascular | | | | | X | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-Skeletal<br>Conventional | | | | | | | | | | | | Musculo-Skeletal<br>Superficial | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | Additional Comments:_ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CORCurrence of CDRH, Office of Device Evaluation (ODE) David A. Jeger (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K973713 Prescription Use (Per 21 CFR 801.109)