(116 days)
Not Found
No
The summary describes a Doppler-based device for detecting blood flow and does not mention any AI or ML components or capabilities.
No
The device is used to detect and audibly indicate blood flow for percutaneous vessel cannulation, which is a diagnostic or procedural aid, not a treatment.
Yes
Explanation: The P.D. Access Device and Monitor are used to detect and audibly indicate blood flow, which is a form of diagnosis to determine the presence and characteristics of blood flow for percutaneous vessel cannulation.
No
The device description explicitly mentions "components and materials" and describes testing that includes "dimensional, strength, ultrasonic performance and biocompatibility testing," which are characteristic of hardware devices, not software-only devices. The device is also intended for use in conjunction with a "Dual Frequency Monitor," further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The P.D. Access Device and Monitor are used in vivo (within the body) to detect blood flow during percutaneous vessel cannulation. They use Doppler ultrasound technology to audibly indicate blood flow within an artery or vein.
- Lack of Sample Analysis: The device does not analyze a sample taken from the body. It directly interacts with the blood flow within the vessel.
Therefore, the function and intended use of the P.D. Access device clearly fall outside the scope of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
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).
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.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.
Product codes (comma separated list FDA assigned to the subject device)
90 ITX
Device Description
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 P.D. Access device is a probe/needle construction with an ONC (Over-the-Needle Catheter) Introducer. The 24/26 Gauge P.D. Access device operates at 30 MHz. The P.D. Access Dual Frequency Monitor produces an audible output.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Doppler ultrasound (continuous wave)
Anatomical Site
Artery or vein (general vascular), Peripheral Vascular
Indicated Patient Age Range
all age aroups
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K963989, K913941, K940804, K903625, K913746, K851141
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
P.D. Access | 22 Gauge
P.D. Access
SmartNeedle | 20 Gauge
SmartNeedle | 18 Gauge
SmartNeedle |
|------------------------|------------------------------------------------|--------------------------------------------------------------|----------------------------------|----------------------------------|
| 510(k) # | Not Applicable | #K963989 | #K913941
#K940804 | #K903625
#K913746 |
| Trade
Name | P.D. Access
Device | P.D. Access
or
SmartNeedle® | SmartNeedle | SmartNeedle |
| Model # | 78110
78120 | 78050
78060
78070 | 77010 | 75010 |
| Frequency | 30 MHz | 14.3 MHz | 14.3 MHz | 14.3 MHz |
| Mode | Continuous | Continuous | Continuous | Continuous |
| Monitor | P.D. Access
Dual Frequency
14.3 / 30 MHz | P.D. Access
or
SmartNeedle | P.D. Access
or
SmartNeedle | P.D. Access
or
SmartNeedle |
| Indication | Blood Flow | Blood Flow | Blood Flow | Blood Flow |
| Construction | Probe
Needle
ONC Introducer | Probe
Needle
ONC Introducer
Peel Away
Introducer | Probe
Needle | Probe
Needle |
| Output/Display | Audible | Audible | Audible | Audible |
| Probe Diameter | .010 inches | .016 inches | .016 inches | .035 inches |
| Needle
Diameter | 24/26 Gauge | 22 Gauge | 20 Gauge | 18 Gauge |
| Introducer
Diameter | 22/24 Gauge | 22 Gauge | Not
Applicable | Not
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):
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_ ✓ | OR | Over-The-Counter Use_ |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | |
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, ENT, | ||
| 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
Application | A | B | M | PWD | CWD | Color
Doppler | Power
(Amplitude)
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
|----------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(Specify) | | | | | | | | | | |
| Intra-operative
Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-Rectal | | | | | | | | | | |
| Trans-Vaginal | | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | |
| Peripheral
Vascular | | | | | X | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal
Conventional | | | | | | | | | | |
| Musculo-Skeletal
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)