(202 days)
Not Found
No
The description focuses on the unique probe design and signal processing techniques to achieve angle independence, not AI/ML. There are no mentions of AI, ML, or related concepts like training or test sets.
No.
The device measures blood flow velocities and is not described as treating or preventing any condition.
Yes
The device is an ultrasonic Doppler system that measures blood flow velocities, which is a diagnostic indicator used to evaluate circulatory health or issues.
No
The device description explicitly states it is a "computer-based ultrasonic Doppler blood velocity measuring system" and uses a "10 MHz CW probe," indicating the presence of hardware components (ultrasonic probe, computer system) beyond just software.
Based on the provided text, the EchoFlow BVM-1 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The EchoFlow BVM-1 is described as an ultrasonic Doppler system used to measure blood flow velocities in vessels beneath the skin or intraoperatively. This means it is used directly on or within the patient's body, not on a sample taken from the patient.
- The description focuses on in-vivo measurements. The entire description details how the device interacts with the body to measure blood flow in real-time, not how it analyzes a biological sample.
Therefore, the EchoFlow BVM-1 is an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EchoFlow BVM-1 is an ultrasonic Doppler system that can be used to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as ±15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.
Product codes (comma separated list FDA assigned to the subject device)
74CAS, 74JOP
Device Description
The EchoFlow velocity system is a computer-based ultrasonic Doppler blood velocity measuring system used to measure blood velocity in vessels beneath the skin. It can either be used for measurement on the surface of the skin, or for intraoperative measurements. A 10 MHz CW probe is used. When used intraoperatively, a sterile sheath covers the probe and 6 feet of cable coming from the probe. A unique feature of the system is that the angle between the probe and the axis of the blood vessel does not have to be known. An accuracy of 15% is maintained if this angle changes by as much as ±15°. This is done by using a unique probe that emits two beams at known angles with respect to each other, as explained in a later section. Thus, the system is well-adapted to measuring flow in blood vessels beneath the surface of the skin, where the exact angle of the axis of the blood vessel cannot be determined. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. It will not detect any signals at depths greater than 15.5 mm from the probe tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic Doppler
Anatomical Site
vessels beneath the skin
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests:
Electrical Safety
Doppler accuracy
Software validation
Depth penetration
Ultrasonic emissions tests
Clinical test:
Clinical validation of the operation of the system in animals and a human.
Conclusions:
The conclusions drawn from the non-clinical tests and clinical tests demonstrate that the device is as safe and effective, and performs as well or better than the legally marketed device identified in paragraph 3.
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.
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
§ 870.2880 Ultrasonic transducer.
(a)
Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.(b)
Classification. Class II (performance standards).
0
EchoCath Inc. 510(k) Submission EchoFlow Doppler Blood Velocity Meter 510(k) Summary
(1) Submitters name, address, telephone number, contact person, and date of preparation
Name: EchoCath Inc. Address: PO Box 7224 Princeton, NJ 08543 Telephone Number: 609-987-8400 Contact person:
Dr. George H. Myers Medsys Inc 377 Route 17 Hasbrouck Heights NJ 07604
201-727-1703 fax: 201-727-1708
Date of preparation: September 2, 1999
(2) Names
Trade name: EchoFlow Doppler Blood Velocity Meter BVM-1 Common Name: Doppler ultrasonic blood-flow measuring system Classification Name: Flowmeter, blood, ultrasonic, w/wo calibration, and Transducer, Ultrasonic
(3) Predicate devices:
(4) Description
The EchoFlow velocity system is a computer-based ultrasonic Doppler blood velocity measuring system used to measure blood velocity in vessels beneath the skin. It can either be used for measurement on the surface of the skin, or for intraoperative measurements. A 10 MHz CW probe is used. When used intraoperatively, a sterile sheath covers the probe and 6 feet of cable coming from the probe.
A unique feature of the system is that the angle between the probe and the axis of the blood vessel does not have to be known. An accuracy of 15% is maintained if this
1
angle changes by as much as ±15°. This is done by using a unique probe that emits two beams at known angles with respect to each other, as explained in a later section. Thus, the system is well-adapted to measuring flow in blood vessels beneath the surface of the skin, where the exact angle of the axis of the blood vessel cannot be determined. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. It will not detect any signals at depths greater than 15.5 mm from the probe tip.
(5) Intended Use
The EchoFlow BVM-1 is an ultrasonic Doppler system that can be used to measure blood flow velocities in blood vessels. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as ±15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.
(6) Comparison to Predicate Devices
(a) The EchoFlow system has the same intended use, method of application, and clinical utility as the predicate devices. It differs from them in that it has a special transducer (the "diffractive transducer") which makes it unnecessary to know the angle between the direction of blood flow and the plane of the transducer.
(b) Performance data
(1) Non-clinical tests:
Electrical Safety Doppler accuracy Software validation Depth penetration Ultrasonic emissions tests
(2) Clinical test
Clinical validation of the operation of the system in animals and a human.
(3) Conclusions
2
The conclusions drawn from the non-clinical tests and clinical tests demonstrate that the device is as safe and effective, and performs as well or better than the legally marketed device identified in paragraph 3.
3
EchoCath Inc. September 2, 1999
4
Diagnostic Ultrasound Indications for Use Form
Page 1 of 2
510(k) Number: K990642
Device Name: EchoFlow Doppler Blood Velocity Meter BVM-1
Indications For Use:
The EchoFlow BVM-1 is an ultrasonic Doppler system that can be used to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as ±15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
5
Diagnostic Ultrasound Indications for Use Form
Page 2 of 2
510(k) Number: K990642
Device Name: IOP10 Transducer for EchoFlow Doppler Blood Velocity Meter BVM-1
Indications For Use:
The IOP10 transducer for the EchoFlow BVM-1 is intended to be used with that unit to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as ±15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | N | |||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
(Please do not WRITE BELOW THIS LINE - Continue on another Page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 1999
David Vilkomerson, Ph.D. Executive Vice President EchoCath, Inc. P.O. Box 7224 08543-7224 Princeton, NJ
Re: K990642 EchoFlow™ Doppler Blood Velocity Meter Requlatory Class: II (two) Product Code: 74CAS and 74JOP February 23, 1999 Dated: Received: July 2, 1999
Dear Dr. Vilkomerson:
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 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). 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
7
Page 2 - David Vilkomerson, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahah, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
510(k) Number (if known): K990642
Diagnostic Ultrasound Indications for Use Form
Device Name: EchoFlow Doppler Blood Velocity Meter BVM-1
Indications for Use:
The EchoFlow BVM-1 is an ultrasonic Doppler system that can be used to measure blood flow velocities. It can be used either for measurement of vessels below the skin, or for intraoperative measurements. It is not intended for cardiac or fetal use. A 10 MHz probe is supplied. The unit maintains its specified accuracy even if the angle between the probe face and vessel axis is as much as ±15°, unlike conventional Doppler systems where the angle between the flow direction and the probe must be accurately known. The unit can detect large blood vessels at depths up to 12 mm and small blood vessels at depths up to 10 mm in normal tissue. The system will not detect any signals from vessels more than 15.5 mm from the probe.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bera K. Kemper a
Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number k 990642