(202 days)
No
The summary describes a device for monitoring blood flow using ultrasonic technology and makes no mention of AI or ML. The focus is on equivalence to predicate devices and basic performance testing.
No
The device is intended for "monitoring the flow of blood within the vasculature," which is a diagnostic function, not a therapeutic one.
No
The device is described as monitoring the "flow of blood within the vasculature," which is a monitoring function, not a diagnostic one that identifies an illness or condition.
No
The device description explicitly states it is used "in conjunction with the SmanNeedle® Monitor" and mentions "Product specifications, components and materials". The performance studies also include "dimensional, strength, ultrasonic performance and biocompatibility testing," which are indicative of hardware components.
Based on the provided information, the P.D. Access™ / SmartNeedle® Device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "general vascular use for monitoring the flow of blood within the vasculature." This involves direct interaction with the patient's circulatory system to monitor a physiological process (blood flow).
- Device Description: The device is used in conjunction with a monitor and is described as a "Device" and "Needle," suggesting it's a physical instrument used for accessing the vasculature.
- Input Imaging Modality: The mention of "Ultrasonic" suggests the device likely uses ultrasound technology to monitor blood flow in vivo (within the living body).
- Anatomical Site: The anatomical site is the "vasculature," which is part of the living body.
In Vitro Diagnostic (IVD) devices, by definition, are used to examine specimens derived from the human body (such as blood, urine, tissue) outside of the body to provide information for diagnostic purposes. The P.D. Access™ / SmartNeedle® Device operates within the body to monitor a physiological function.
N/A
Intended Use / Indications for Use
The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmanNeedle® 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. 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 codes
Not Found
Device Description
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. Product specifications, components and materials of the P.D. Access™ / SmartNeedle® Device are similar to those of predicate devices. Construction is Needle/Probe or Introducer/Needle/Probe. The device operates at 14.3 MHz with Continuous mode. Output/Display is Audible.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Within the vasculature.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
CVD 18 gauge SmanNeedle® K903625, CVD 18 gauge SmanNeedle® K913746/A, CVD 20 gauge SmanNeedle® K913941/A, CVD 20 gauge SmanNeedle® K940804, TFX Medical Over the Needle Splittable Catheter K920208, TFX Medical Introducer Catheter K851141
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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
1
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.
2
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).
3
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.