P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE by CARDIOVASCULAR DYNAMICS, INC.

The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmanNeedle® Monitor for general vascular use. The SmanNeedle® Monitor will also be marketed as the P.D. Access™ Monitor; and the Monitor 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").

Device Description

AI/ML Overview

This 510(k) notification describes the P.D. Access™ / SmartNeedle® Device, a vascular access device intended for monitoring blood flow. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "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."

However, the specific quantitative "acceptance criteria" and "reported device performance" are not detailed in this summary. The summary only provides a qualitative statement of compliance. For example, it doesn't list a specific "strength tolerance" in Newtons and then a "reported strength" of X Newtons.

Acceptance Criteria (Implied)	Reported Device Performance
Within dimensional specifications	All items tested were within specification tolerances.
Within strength specifications	All items tested were within specification tolerances. There were no failures.
Acceptable ultrasonic performance	All items tested were within specification tolerances.
Acceptable biocompatibility	All items tested were within specification tolerances.
No failures during testing	There were no failures during these tests.
Overall safe and effective performance	Overall performance was safe and effective.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample sizes used for the dimensional, strength, ultrasonic performance, or biocompatibility tests. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable and not provided. The study described focuses on device performance against engineering specifications (dimensional, strength, ultrasonic, biocompatibility) rather than a diagnostic performance where expert ground truth would be required.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided, as the testing was against engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC comparative effectiveness study was not done. The device is a vascular access device with a monitoring function (audible blood flow). Its effectiveness is judged by meeting engineering specifications and being substantially equivalent to predicate devices, not by radiologists' diagnostic performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The concept of "standalone performance" as it applies to AI algorithms is not relevant here. This is a physical medical device. The "ultrasonic performance" testing would be considered the standalone performance of its monitoring capability. The document states this performance was within specification tolerances.

7. The Type of Ground Truth Used:

The "ground truth" for the tests described would be the pre-defined engineering specifications for dimensions, strength, ultrasonic output characteristics, and biocompatibility standards. These are objective measures rather than expert consensus, pathology, or outcomes data in the typical sense of diagnostic performance.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This device does not involve a "training set" in the context of machine learning or AI algorithms.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided, as there is no training set for this type of device.

Summary

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ardioVascular Dynamics, Inc. 510(k) Notification

D Arcass

APR 2 4 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:

Device:

Classification Name:

Predicate Devices:

P.D. Access™ Vascular Access Device

September 18, 1996

SmartNeedle® Vascular Access Device

Ultrasonic Blood Flow Monitor

CVD 18 gauge SmanNeedle® K903625 SE Date: November 7, 1990

CVD 18 gauge SmanNeedle® K913746/A SE Date: December 17, 1991

CVD 20 gauge SmanNeedle® K913941/A SE Date: February 27, 1992

CVD 20 gauge SmanNeedle® K940804 SE Date: June 10, 1994

Introducers

TFX Medical Over the Needle Splittable Catheter K920208

TFX Medical Introducer Catheter K851141

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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.

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.

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Comparisons are made based on the size, construction, materials and use. See the following comparison table.

COMPARISON TABLE: ULTRASOUND DEVICES

	22 gaugeP.D. Access™SmartNeedle®	22 gaugeP.D. Access™SmartNeedle®with ONCintroducer	22 gaugeP.D. Access™SmartNeedle®with Peel Awayintroducer	20 gaugeSmartNeedle®	18 gaugeSmartNeedle®
510(k) #				K913941/AK940804	K903625 K913746/A
TradeName	P.D. Access™orSmartNeedle®	P.D. Access™orSmartNeedle®	P.D. Access™orSmartNeedle®	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™orSmartNeedle®Monitor	P.D. Access™orSmartNeedle®Monitor	P.D. Access™orSmartNeedle®Monitor	P.D. Access™orSmartNeedle®Monitor	P.D. Access™orSmartNeedle®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).

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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 SmanNeedle® 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.

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
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.(b)
Classification. Class II.