(22 days)
Not Found
No
The device description details a traditional pulsed Doppler ultrasound system that produces an audible signal based on frequency shifts. There is no mention of any computational analysis, pattern recognition, or learning algorithms applied to the signal or data. The "distinctive tonal patterns" are described as being indicative of flow patterns, implying direct interpretation of the audible signal by the user, not automated analysis by the device itself.
No
The device is described as an evaluation tool for blood flow, providing an audible signal proportional to blood velocity. It does not mention any therapeutic action or treatment.
Yes
Explanation: The device is designed for the "evaluation of blood flow in uterine arteries" and produces a "varying audible signal" indicative of "flow pattern in terms of velocity vs. time." This functionality directly supports diagnosis by providing information about the physiological state of the uterine arteries.
No
The device description clearly outlines hardware components including a battery-powered transceiver unit, an 8 MHz Doppler device that plugs into the transceiver, ultrasonic transmitting and receiving sensors, and circuitry for amplification and signal processing. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
- Device Function: The VCS Doppler Transceiver is described as a pulsed Doppler ultrasound system that evaluates blood flow within the uterine arteries. This is an in vivo (within the living body) measurement.
- Method of Operation: The device uses ultrasound waves transmitted into the body and receives reflected signals to assess blood flow. This is a direct measurement within the patient, not an analysis of a specimen taken from the patient.
Therefore, the VCS Doppler Transceiver falls under the category of a medical device used for in vivo diagnostic imaging or measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VCS Doppler Transceiver is designed for the evaluation of blood flow in uterine arteries.
Product codes
DPW
Device Description
The VCS Doppler Transceiver is a battery powered pulsed Doppler ultrasound system designed for the evaluation of blood flow in vessels. An 8 MHz Doppler device, which plugs into the transceiver unit, emits a pulsed ultrasonic signal. A varying audible signal is produced when the device is placed upon a vessel within which there is flow. The frequency (i.e., pitch) of the signal is proportional to the blood velocity within the vessel. Distinctive tonal patterns are produced which are indicative of the flow pattern in terms of velocity vs. time. The volume of the tone may be adjusted by the means of a control on the transceiver. Rechargeable batteries power the transceiver. An 8 MHz transmitter in the transceiver periodically drives the ultrasonic transmitting sensor located at the tip of the device. The ultrasonic waves generated by the sensor travel through the tissue just under the device tip in a fairly narrow beam. The waves are then reflected back towards the device whenever they encounter a boundary between tissues of different densities. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the re-turning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterine arteries
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
Electrica Safety testing was conducted to IEC 60601-1 and UL 60601.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).
0
KOS2209
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA and 21 CFR 807.92.
- Submitter's name, address, telephone number, contact person, and date summary 1. prepared:
- Vascular Control Systems, Inc. Submitter: a. 32236-F Paseo Adelanto San Juan Capistrano, CA 92675 (949) 488-8700 Contact Person: Kathleen Roberts b. RA/QA Manager Telephone: (949) 488-8700 ext. 115 Fax: (949) 488-8708
- Date Summary Prepared: July 8, 2005 c.
Name of device, including trade name and classification name: 2.
- VCS Doppler Transceiver Trade/Proprietary Name: a.
- Flowmeter, Blood Classification name: b.
Identification of the predicate device or legally marketed devices to which 3. substantial equivalence is being claimed:
| a. | Company: | Koven and Associates |
|---|---|---|
| Device: | Mini Doppler II Ultrasound Flow Detector | |
| 510(k): | K915550 | |
| Date Cleared: | December 10, 1992 | |
| b. | Company: | Meadox Medicals, Inc. |
| Device: | MS Disposable Rigid Doppler Probe | |
| 510(k): | K930227 | |
| Date Cleared: | September 16, 1993 |
1
4. Description of the device:
The VCS Doppler Transceiver is a battery powered pulsed Doppler ultrasound system designed for the evaluation of blood flow in vessels. An 8 MHz Doppler device, which plugs into the transceiver unit, emits a pulsed ultrasonic signal. A varying audible signal is produced when the device is placed upon a vessel within which there is flow. The frequency (i.e., pitch) of the signal is proportional to the blood velocity within the vessel. Distinctive tonal patterns are produced which are indicative of the flow pattern in terms of velocity vs. time. The volume of the tone may be adjusted by the means of a control on the transceiver. Rechargeable batteries power the transceiver. An 8 MHz transmitter in the transceiver periodically drives the ultrasonic transmitting sensor located at the tip of the device. The ultrasonic waves generated by the sensor travel through the tissue just under the device tip in a fairly narrow beam. The waves are then reflected back towards the device whenever they encounter a boundary between tissues of different densities. During the intervals when the unit is not transmitting, the device passes any reflected signals that it receives to a receiving circuit. This circuit amplifies the re-turning echoes, compares their frequency to that of the transmitted signal and converts any frequency differences into an audible tone.
Intended use of the device: ર્ત
The VCS Doppler Transceiver is designed for the evaluation of blood flow in uterine arteries.
Statement of how the technological characteristics of the device compare to those of 6. the predicate or legally marketed device.
The VCS Doppler Transceiver has the same device characteristics of the predicate devices except the Meadox Medicals device is a 20MHz device.
7. Brief summary of nonclinical tests and results:
Electrical Safety testing was conducted to IEC 60601-1 and UL 60601.
8. Conclusion
The VCS Doppler Transceiver does not raise new issues of safety, effectiveness, or performance.
2
& HUMAN SEI
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2005
TUV Rheinland of North America, Inc. c/o Ms. Tamas Borsai 12 Commerce Road Newton, CT 06470
Re: K052209
VCS Doppler Transceiver, Model 09-0023-01 Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II (Two) Product Code: DPW Dated: August 12, 2005 Received: August 15, 2005
Dear Mr. Sall:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Tamas Borsai
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
R. Vocher
(Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Kos 2209
Device Name: VCS Doppler Transceiver
Indications for Use: The VCS Doppier Transceiver is designed for the evaluation of blood flow in uterine arteries.
Prescription Use _X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter-Use (21 CFR 801 Subpart C)
:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ______________________________________________________________________________________________________________________________________________________________________________
Concurrence of CDRH, Office of Device Evaluation (ODE)
sume P. So lumes
(Print or Type Name)
(Division Sign-Off) Division I Cardiovascular Devices
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510(x) Number K052209