(116 days)
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 groups.
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.
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.
The CardioVascular Dynamics, Inc. P.D. Access™ Vascular Access Device and P.D. Access™ Dual Frequency Monitor received 510(k) clearance based on substantial equivalence to predicate devices, rather than a study demonstrating meeting specific acceptance criteria with performance metrics. The submission focuses on comparing the new device's characteristics to already legally marketed devices.
Here's an analysis based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
The provided documents do not define specific quantitative acceptance criteria or present performance metrics in a manner typical for a study proving device efficacy or accuracy like sensitivity, specificity, or AUC. Instead, the acceptance is based on demonstrating substantial equivalence in design, materials, indications, and overall safety and effectiveness compared to predicate devices.
The "reported device performance" is described qualitatively as:
| Acceptance Criteria Type (implied via substantial equivalence) | Reported Device Performance |
|---|---|
| Dimensional, Strength, Ultrasonic Performance | "These tests demonstrated that all of the items tested were within specification tolerances. There were no failures during these tests." |
| Biocompatibility | "These tests demonstrated that all of the items tested were within specification tolerances. There were no failures during these tests." |
| Overall Safety and Effectiveness | "Overall performance was safe and effective." (Based on similarity to predicate devices and aforementioned testing.) |
| Indications and Intended Use | "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)." "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)." |
| Product Technology, Performance Characteristics, Specs, Components, Materials | "Product technology, performance characteristics, specifications, components and materials of the P.D. Access device are similar to those of predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- The documents do not mention a specific "test set" in the context of an accuracy or performance study involving patient data or clinical outcomes.
- The testing described ("dimensional, strength, ultrasonic performance and biocompatibility testing") would have involved physical samples of the device components, not patient data.
- No information on provenance (country of origin, retrospective/prospective) of data is provided, as no clinical study data is presented for performance evaluation against ground truth.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No clinical test set requiring expert ground truth establishment is described. The evaluation was primarily based on engineering and biocompatibility testing against predefined specifications, and a comparison to predicate devices, not an expert-adjudicated test set for diagnostic accuracy.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The submission solely focuses on demonstrating substantial equivalence to predicate devices, not on comparing performance with and without AI assistance or evaluating human reader improvement. This device is a diagnostic tool (Doppler monitor and access device), not an AI-powered image analysis system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone performance study in the context of an algorithm or AI is not applicable. The P.D. Access device is a physical medical device (vascular access and Doppler monitor) that audibly indicates blood flow, designed for human clinical use, not a standalone algorithm. The "ultrasonic performance" testing would have verified its function, but this is distinct from AI algorithm performance.
7. Type of Ground Truth Used
- The "ground truth" for the engineering and biocompatibility tests would be the established device specifications and regulatory standards for material properties, dimensions, ultrasonic output, and biocompatibility.
- For the substantial equivalence claim, the "ground truth" is effectively the performance and safety profiles of the predicate devices, against which the new device was compared.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device does not involve AI/ML, there is no training set and therefore no ground truth establishment for one.
Summary based on the 510(k) submission:
The 510(k) cleared the P.D. Access™ Vascular Access Device and Dual Frequency Monitor based on its substantial equivalence to existing predicate devices. The evidence provided included:
- Engineering and material testing (dimensional, strength, ultrasonic performance, biocompatibility) demonstrating the device met its own specifications and performed without failures.
- A detailed comparison chart showing product technology, performance characteristics, specifications, components, and materials were "similar" to predicate devices.
- An assertion that its indications for use and intended use were "the same" as predicate devices.
The FDA decision letter confirms this, stating 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... or to devices that have been reclassified." There were no clinical studies or performance accuracy studies against a "ground truth" as would be seen for new diagnostic algorithms or complex AI devices.
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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.
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CardioVasculat Dynamics, Inc.
P.D. Accessfor Vascular At vesss Device
P.D. Access™ Dual Prequency Monitor
COMPARISON CHART
| 24/26 GaugeP.D. Access | 22 GaugeP.D. AccessSmartNeedle | 20 GaugeSmartNeedle | 18 GaugeSmartNeedle | |
|---|---|---|---|---|
| 510(k) # | Not Applicable | #K963989 | #K913941#K940804 | #K903625#K913746 |
| TradeName | P.D. AccessDevice | P.D. AccessorSmartNeedle® | SmartNeedle | SmartNeedle |
| Model # | 7811078120 | 780507806078070 | 77010 | 75010 |
| Frequency | 30 MHz | 14.3 MHz | 14.3 MHz | 14.3 MHz |
| Mode | Continuous | Continuous | Continuous | Continuous |
| Monitor | P.D. AccessDual Frequency14.3 / 30 MHz | P.D. AccessorSmartNeedle | P.D. AccessorSmartNeedle | P.D. AccessorSmartNeedle |
| Indication | Blood Flow | Blood Flow | Blood Flow | Blood Flow |
| Construction | ProbeNeedleONC Introducer | ProbeNeedleONC IntroducerPeel AwayIntroducer | ProbeNeedle | ProbeNeedle |
| Output/Display | Audible | Audible | Audible | Audible |
| Probe Diameter | .010 inches | .016 inches | .016 inches | .035 inches |
| NeedleDiameter | 24/26 Gauge | 22 Gauge | 20 Gauge | 18 Gauge |
| IntroducerDiameter | 22/24 Gauge | 22 Gauge | NotApplicable | NotApplicable |
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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.
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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
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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 |
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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 | |
|---|---|
| ------------------- | -- |
| ClinicalApplication | A | B | M | PWD | CWD | ColorDoppler | Power(Amplitude)Doppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative(Specify) | ||||||||||
| Intra-operativeNeurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ(Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-Rectal | ||||||||||
| Trans-Vaginal | ||||||||||
| Trans-Urethral | ||||||||||
| Intra-Luminal | ||||||||||
| PeripheralVascular | X | |||||||||
| Laparoscopic | ||||||||||
| Musculo-SkeletalConventional | ||||||||||
| Musculo-SkeletalSuperficial | ||||||||||
| 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)
§ 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.