(37 days)
The Smartdop 45 detects arterial and venous blood flow in extremities as well as fetal heart rate. The Smartdop 45 displays and prints bi-directional velocity waveform, numerical data and fetal heart rate with heart beat indicator. The Smartdop 45 probe selection is 2, 4, 5, 8 and 10 MHz.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Peripheral Vascular.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.
The Smartdop 45 is a hand held bi-directional Doppler is designed to obtain blood flow velocity. Ultrasound is transmitted from probe to patient and is reflected by the moving object (blood flow). The reflected ultrasound is received by the probe and is converted into electrical signals. The incoming Doppler Shifted signals are applied to the Velocity Circuity Circuits to remove unnecessary signals and to provide a bi-directional readout. This phase-shifting technique is a standard method employed in direction seeking Doppler, known for several decades. It continues in wide use.
The waveform data are applied to the CPU for all the digital processing on LCD Display. The waveform data are applied to the off for the routing to the routing to the speaker to operate the analogue signals before digital processing.
The LCD display can display combined bi-directionally separated waveforms. The printer can print out patient information and waveform.
Integrated speaker provide Doppler sounds. A headset can be used, when is used it will mute the speaker.
The following probes may be utilized with the Smartdop 45 Doppler:
- 2 MHz for fetal heart rate
- 4 MHz detections of arterial and venous blood flow velocity
- 5 MHz detections of arterial and venous blood flow velocity
- 8 MHz detections of arterial and venous blood flow velocity
- 10 MHz detections of arterial and venous blood flow velocity
The Smartdop 45 is intended for evaluation of the following:
- Fetal Heart rate
- ABI studies
- PEAK & MEAN blood velocity determinations
- Peripheral vascular procedures
- Blood pressure segmental studies
- Venous compressions
- Penile & digit systolic pressures
- Flow velocities in recovery room
The provided text is a 510(k) summary for the Koven Technology, Inc. Smartdop 45 Bi-Directional Doppler. It largely focuses on establishing substantial equivalence with a predicate device and safety information. There is no detailed study described that establishes explicit acceptance criteria with reported device performance in the way typically found in performance studies for AI/ML devices.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state quantitative acceptance criteria or detailed reported device performance in terms of metrics like sensitivity, specificity, accuracy, or similar performance measures for specific clinical tasks. Instead, it refers to "extensive safety, performance, and validation tests" and states the device "meets all of its functional requirements."
The closest the document comes to performance claims or criteria are the intended uses and the comparison to the predicate device. For example:
- "The Smartdop 45 detects arterial and venous blood flow in extremities as well as fetal heart rate."
- "The Smartdop 45 displays and prints bi-directional velocity waveform, numerical data and fetal heart rate with heart beat indicator."
- "The Smartdop 45 has the same device characteristics as the predicate device, except... a 2 MHz fetal heart rate 2 MHz probe capability."
- "The conclusion drawn from these tests is that the Smartdop 45 device is equivalent in safety and efficacy to its predicated device."
Since no specific performance metrics are given, a table of acceptance criteria and reported device performance cannot be created from the provided text.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set, nor does it provide information about data provenance. It mentions "extensive safety, performance, and validation tests" but offers no details on patients, samples, or data used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The document does not mention the use of experts to establish a ground truth for a test set. The testing appears to be functional and safety-focused, rather than a clinical performance study involving expert interpretation of results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Since no test set is described as being evaluated by experts, there is no mention of an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe an MRMC comparative effectiveness study. This device is a standalone diagnostic tool (Doppler), not an AI-assisted diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Test Data" section states that "The Smartdop 45 device has been subjected to extensive safety, performance, and validation tests prior to release... Final testing for the system includes various performance and validations prior to release. It includes tests designed to ensure that the device meets all of its functional requirements and operational performance capabilities."
This implies "standalone" testing was performed to verify the device's functional and operational performance, independent of human interpretation. However, the details of these tests are not provided. The device itself is intrinsically "standalone" in its function as a Doppler, providing data (waveforms, numerical data, heart rate) for a clinician to interpret.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify a type of ground truth. Given the nature of a Doppler device, ground truth for measuring blood flow or fetal heart rate would typically involve comparison to established medical standards or other validated measurement devices. However, this is not explicitly stated.
8. The sample size for the training set
The document does not mention a training set, as it is not describing an AI/ML device.
9. How the ground truth for the training set was established
Since no training set is mentioned, this information is not applicable and not provided.
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Summary
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92
Company making the submission: 1.
| Company making submission: | |
|---|---|
| Name: | Koven Technology, Inc. |
| Address: | 12125 Woodcrest Executive Dr.Suite 220St. Louis, MO 63131 |
| Telephone: | 1-314-542-2101 |
| Fax: | 1-314-542-6020 |
| Contact: | Heather FlotronPresident |
| Date: |
2. Device:
| Proprietary Name: | Smartdop 45 Bi-Directional Doppler |
|---|---|
| Common Name: | Bi-Directional Doppler Volume Flowmeter and |
| Classification Name: | Blood Flowmeter, Cardiovascular |
Predicate Device: 3.
Bidirectional Doppler W/Waveform Display, Smartdop 50 Koven Technology, Inc., K954397, 870-2100, DPW, Cardiovascular & Radiology
Classifications Names & Citations: 4.
21 CFR 870.2100 Cardiovascular Blood Flowmeter, Class II, DPW, Cardiovascular & Radiology
Description: 5.
The Smartdop 45 is a hand held bi-directional Doppler is designed to obtain blood flow velocity The Smartdop 40 is a hand notal breasound is transmitted from probe to patient wave and neart beats infough bitrasound: "The and is reflected by the moving object (blood bouy and moves straight through blophyed by the probe and is converted into electrical signals. how). The reliested unrasound is roosition in the Velocity Circuity Circuits to The incoming Doppic. Shifted organs and to provide a bi-directional readout. This phase-shifting remove unflecessary Sigrais and to provins is a standard method employed in direction seeking teonnique, know.for several decades. It continues in wide use.
{1}------------------------------------------------
The waveform data are applied to the CPU for all the digital processing on LCD Display, The waverom data are applied to the off for the routing to the routing to the speaker to oporate the analogue signals before digital processing.
The LCD display can display combined bi-directionally separated waveforms. The printer can print out patient information and waveform.
Integrated speaker provide Doppler sounds. A headset can be used, when is used it will mute the speaker.
The following probes may be utilized with the Smartdop 45 Doppler:
-
- 2 MHz for fetal heart rate
-
- 4 MHz detections of arterial and venous blood flow velocity
-
- 5 MHz detections of arterial and venous blood flow velocity
-
- 8 MHz detections of arterial and venous blood flow velocity
-
- 10 MHz detections of arterial and venous blood flow velocity
The Smartdop 45 is intended for evaluation of the following:
- Fetal Heart rate .
- ABI studies .
- PEAK & MEAN blood velocity determinations .
- Peripheral vascular procedures .
- Blood pressure segmental studies .
- Venous compressions .
- Penile & digit systolic pressures ●
- Flow velocities in recovery room .
Indications for use: 6.
The Smartdop 45 detects arterial and venous blood flow in extremities as well as fetal The Omartdop To decordop 45 displays and prints bi-directional velocity waveform, numerical data and fetal heart rate with heart beat indicator. The Smartdop 45 probe selection is 2, 4, 5, 8 and 10 MHz.
Contra-indications: 7.
None are known at this time.
Comparison: 8.
The Smartdop 45 has the same device characteristics as the predicate device, except The omartdop To have a 2 MHz fetal heart rate 2 MHz probe capability-The predicate device does not have computer interface capabilities.
{2}------------------------------------------------
Test Data: റ്റ്.
The Smartdop 45 device has been subjected to extensive safety, performance, and i he Smandop 43 device has been Subjoctou to oxien includes various performance
validations prior to release. Final testing for the system includes various and validations pror to release. I mailtooting for the meets all of its functional requirements and tests designed to ensure that the doviets have further been performed to ensure the performanoe opositivalpplicable industry and safety standards.
The Smartdop 45 device labeling includes instructions for safe and effective use. It includes Warning, Cautions, and guidance for use.
Literature Review: 10.
A review of literature pertaining to the safety of Doppler Blood Flowmeters has been a A review of illerature penaming to the been incorporated in the design of the Smartdop 45.
Conclusions: 11.
The conclusion drawn from these tests is that the Smartdop 45 device is equivalent in safety and efficacy to its predicated device.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is black against a white background. The words are arranged on a single line, with "Public Health" appearing before "Service".
Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
APR 1 5 2005
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Koven Technology, Inc. % Mr. J. Harvey Knauss Contract Consultant Delphi Consulting Group 11874 South Evelyn Circle HOUSTON TX 77071-3404
Re: K050601
Trade Name: Smartdop 45 Bi-Directional Blood Flow Meter with Waveform Display Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular blood flowmeter Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: DPW, IYN, and ITX Dated: March 7, 2005 Received: March 16, 2005
Dear Mr. Knauss:
We have reviewed your Section 510(k) premarket 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Smartdop 45 Bi-Directional Blood Flow Meter with Waveform Display, as described in your premarket notification:
Transducer Model Number
BT2M20S8C (2 MHz) BT4M05S8C (4 MHz) BT5M05S8C (5 MHz) BT8M05S8C (8 MHz) BT10M05S8C (10 MHz)
{4}------------------------------------------------
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.
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 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, (enclosed) 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.g., 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. It 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 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
{5}------------------------------------------------
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
:
Sincerely yours,
) fancy C brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{6}------------------------------------------------
Smartdop 45 Bi-Directional Blood Flow Meter Device
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Applications | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | N | |||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | N | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N- new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: _________________________________________________________________________________________________________________________________________________________
(Please DO NOT WRITE BELOW THIS LINE – Continue ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Flanci Brogden
(Division Sign-Of Division of Reproductiv and Radiological Device 510(k) Number
Prescription Use (Per 21 CFR 801.109)
17
{7}------------------------------------------------
Fetal Heart Rate Probe BT2M20S8C 2 MHz
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Applications | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | |||||||||||
| Fetal | P | ||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletalConventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) |
N- new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: __________________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
Nancy C. Brazier
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devic 510(k) Number
{8}------------------------------------------------
Arterial and Venous Blood Flow Velocity Probe BT4M05S8C 4 MHz
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Applications | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N- new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nanci Bourdon
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _
{9}------------------------------------------------
Arterial and Venous Blood Flow Velocity Probe BT5M05S8C 5 MHz
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Applications | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N- new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
(Please DO NOT WRITE BELOW THIS LINE – Continue on another Page IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Buxton
(Division Sign-Off) Abdominal, Division of Reproductive, and Radiological Devices 51()(k) Number _
{10}------------------------------------------------
Arterial and Venous Blood Flow Velocity Probe BT8M05S8C 8 MHz
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Applications | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N- new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Harry C. Brogdon
(Division Sign-Off) Division of Reproductive, and Radiological Devices 510|k) Number __
{11}------------------------------------------------
Arterial and Venous Blood Flow Velocity Probe BT10M05S8C 10 MHz
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Applications | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(Specify) | Other(Specify) | |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | P | |||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletalConventional | ||||||||||
| Musculo-skeletal Superficial | ||||||||||
| Other (specify) |
N- new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: _________________________________________________________________________________________________________________________________________________________
(Please DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
:
) Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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).