← Product Code [ITX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX) · K963989 # P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE (K963989) _Cardiovascular Dynamics, Inc. · ITX · Apr 24, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K963989 ## Device Facts - **Applicant:** Cardiovascular Dynamics, Inc. - **Product Code:** [ITX](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX.md) - **Decision Date:** Apr 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1570 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmartNeedle® Monitor for general vascular use. The P.D. Access™ / SmartNeedle® Device is indicated and intended for general vascular use for monitoring the flow of blood within the vasculature. ## Device Story Device consists of needle/probe assembly used with SmartNeedle® (or P.D. Access™) Monitor; functions as ultrasonic blood flow monitor. Operates in continuous mode at 14.3 MHz frequency. Provides audible output to clinician to indicate blood flow status. Used for general vascular access procedures. Clinician monitors audible signals to confirm vessel location or blood flow during needle placement. Benefits include real-time feedback on vascular access, aiding in accurate needle positioning. ## Clinical Evidence Bench testing only. Testing included dimensional, strength, ultrasonic performance, and biocompatibility assessments. All items met specification tolerances with no failures reported. ## Technological Characteristics Ultrasonic blood flow monitor; 14.3 MHz operating frequency; continuous wave mode. Construction includes needle/probe assembly, optionally with ONC or peel-away introducers. Audible output display. Materials and specifications are consistent with predicate CVD SmartNeedle® devices. ## Regulatory Identification A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container. ## Predicate Devices - 18 gauge SmartNeedle® ([K903625](/device/K903625.md)) - 18 gauge SmartNeedle® ([K913746](/device/K913746.md)/A) - 20 gauge SmartNeedle® ([K913941](/device/K913941.md)/A) - 20 gauge SmartNeedle® ([K940804](/device/K940804.md)) - TFX Medical Over the Needle Splittable Catheter ([K920208](/device/K920208.md)) - TFX Medical Introducer Catheter ([K851141](/device/K851141.md)) ## Reference Devices - SmartNeedle® Doppler Monitor (A877515) - SmartNeedle® Introducer Needle for Doppler Monitoring (A877516) - SmartNeedle® Doppler Monitor (A899719) - SmartNeedle® Introducer needle for Doppler monitoring (A999797) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} CardioVascular Dynamics, Inc. 510(k) Notification P.D. Access™ Vascular Access Device SmartNeedle® Vascular Access Device APR 24 1997 # SECTION 2 - 510(K) SUMMARY K963989 Submitted By: CardioVascular Dynamics Incorporated (CVD) 13900 Alton Parkway, Suite 122 Irvine, CA 92618 714-457-9546 Contact: Michael Crocker Summary Preparation: September 18, 1996 Device: P.D. Access™ Vascular Access Device SmartNeedle® Vascular Access Device Classification Name: Ultrasonic Blood Flow Monitor Predicate Devices: CVD 18 gauge SmartNeedle® K903625 SE Date: November 7, 1990 CVD 18 gauge SmartNeedle® K913746/A SE Date: December 17, 1991 CVD 20 gauge SmartNeedle® K913941/A SE Date: February 27, 1992 CVD 20 gauge SmartNeedle® K940804 SE Date: June 10, 1994 Introducers TFX Medical Over the Needle Splittable Catheter K920208 TFX Medical Introducer Catheter K851141 The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmartNeedle® Monitor for general vascular use. The SmartNeedle® Monitor will also be marketed as the P.D. Access™ Monitor; and the Monitor Page 3 {1} CardioVascular Dynamics, Inc. 510(k) Notification P.D. Access™ Vascular Access Device SmartNeedle® Vascular Access Device graphics and labeling will be changed to reflect the name. Other than the name, the Monitors will be equivalent. There will be no change in safety and efficacy. The P.D. Access™ / SmartNeedle® Device is indicated and intended for general vascular use for monitoring the flow of blood within the vasculature. The indications and intended use for of the P.D. Access™ / SmartNeedle® Device are the same as predicate devices manufactured by CardioVascular Dynamics (the SmartNeedle®). Product specifications, components and materials of the P.D. Access™ / SmartNeedle® Device are similar to those of predicate devices. Testing of the P.D. Access™ / SmartNeedle® Device included dimensional, strength, ultrasonic performance and biocompatibility testing. These tests demonstrated that the all items tested were within specification tolerances. There were no failures during these tests. Overall performance was safe and effective. Page 4 {2} CardioVascular Dynamics, Inc. 510(k) Notification P.D. Access™ Vascular Access Device SmartNeedle® Vascular Access Device Comparisons are made based on the size, construction, materials and use. See the following comparison table. ## COMPARISON TABLE: ULTRASOUND DEVICES | | 22 gauge P.D. Access™ SmartNeedle® | 22 gauge P.D. Access™ SmartNeedle® with ONC introducer | 22 gauge P.D. Access™ SmartNeedle® with Peel Away introducer | 20 gauge SmartNeedle® | 18 gauge SmartNeedle® | | --- | --- | --- | --- | --- | --- | | 510(k) # | | | | K913941/A K940804 | K903625 K913746/A | | Trade Name | P.D. Access™ or SmartNeedle® | P.D. Access™ or SmartNeedle® | P.D. Access™ or SmartNeedle® | SmartNeedle® | SmartNeedle® | | Model # | 78050 | 78060 | 78070 | 77010 | 75010 | | Frequency | 14.3 MHz | 14.3 MHz | 14.3 MHz | 14.3 MHz | 14.3 MHz | | Mode | Continuous | Continuous | Continuous | Continuous | Continuous | | Monitor | P.D. Access™ or SmartNeedle® Monitor | P.D. Access™ or SmartNeedle® Monitor | P.D. Access™ or SmartNeedle® Monitor | P.D. Access™ or SmartNeedle® Monitor | P.D. Access™ or SmartNeedle® Monitor | | Indication | Blood flow | Blood flow | Blood flow | Blood flow | Blood flow | | Construction | Needle/ Probe | Introducer/ Needle/ Probe | Introducer/ Needle/ Probe | Needle/ Probe | Needle/ Probe | | Output/ Display | Audible | Audible | Audible | Audible | Audible | 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™ / SmartNeedle® Device is intended for use in the same manner. In particular, the P.D. Access™ / SmartNeedle® Device is equivalent in indications and intended use to devices manufactured by CardioVascular Dynamics, formerly manufactured by Advance Cardiovascular Systems (ACS). Page 5 {3} CardioVascular Dynamics, Inc. 510(k) Notification P.D. Access™ Vascular Access Device SmartNeedle® Vascular Access Device The SmartNeedle® Doppler Monitor was originally listed by Advanced Cardiovascular Systems (ACS) under document number A877515. The SmartNeedle® Introducer Needle for Doppler Monitoring was originally listed by Advanced Cardiovascular System (ACS) under document number A877516. These devices were delisted by ACS, July 19, 1996. The SmartNeedle® Doppler Monitor is registered by CVD under document number A899719 and the SmartNeedle® Introducer needle for Doppler monitoring under document number A999797. This is substantiated in the Comparison Table. Product literature is included. Page 6 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K963989](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/ITX/K963989) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com