SMARTDOP 45 VASCULAR DOPPLER

• K Number: K050601
• Device Name: SMARTDOP 45 VASCULAR DOPPLER
• Manufacturer: KOVEN TECHNOLOGY, INC.
• Date Cleared: 2005-04-15 ( 37 days)
• Product Code: DPW ITX IYN
• Regulation Number: 870.2100

Intended Use

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.

Device Description

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: 1. 2 MHz for fetal heart rate 2. 4 MHz detections of arterial and venous blood flow velocity 3. 5 MHz detections of arterial and venous blood flow velocity 4. 8 MHz detections of arterial and venous blood flow velocity 5. 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

Predicate Devices

K954397

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details standard Doppler technology and signal processing, with no mention of AI or ML algorithms for analysis or interpretation.

Therapeutic

No
The device is described as diagnostic, used for detecting and analyzing blood flow and fetal heart rate, not for treating or preventing a condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body" multiple times, and the device is described as detecting and displaying various physiological measurements relevant to diagnosis, such as arterial and venous blood flow and fetal heart rate.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as probes, a hand-held unit, a speaker, an LCD display, and a printer, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Smartdop 45 is not an In Vitro Diagnostic (IVD) device.

Here's why:

• IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Smartdop 45 Function: The Smartdop 45 uses ultrasound to directly detect and measure blood flow velocity and fetal heart rate within the human body. It does not analyze samples taken from the body.
• Intended Use: The intended uses clearly state "Diagnostic ultrasound imaging or fluid flow analysis of the human body," focusing on in-vivo measurements.
• Device Description: The description details the process of transmitting and receiving ultrasound waves from the patient, not the analysis of biological samples.

Therefore, the Smartdop 45 falls under the category of a diagnostic ultrasound device used for in-vivo measurements, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

DPW, IYN, ITX

Device Description

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 pass through phase-shifting circuits to remove unnecessary signals and to provide a bi-directional readout. This phase-shifting technique, known for several decades, is a standard method employed in direction seeking technique. 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 D/A for 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:

• 1. 2 MHz for fetal heart rate
• 2. 4 MHz detections of arterial and venous blood flow velocity
• 3. 5 MHz detections of arterial and venous blood flow velocity
• 4. 8 MHz detections of arterial and venous blood flow velocity
• 5. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Extremities, Fetal

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)

The Smartdop 45 device has been subjected to extensive safety, performance, and validations prior to release. Final testing for the system includes various performance and validations performed to ensure that the device meets all of its functional requirements and tests designed to ensure the performance of its operation and application of applicable industry and safety standards.

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.

K954397

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

Regulation Number and Section

§ 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).

Summary

0

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 220
St. Louis, MO 63131
Telephone:	1-314-542-2101
Fax:	1-314-542-6020
Contact:	Heather Flotron
President
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:

• 1. 2 MHz for fetal heart rate
• 2. 4 MHz detections of arterial and venous blood flow velocity
• 3. 5 MHz detections of arterial and venous blood flow velocity
• 4. 8 MHz detections of arterial and venous blood flow velocity
• 5. 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".

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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 [phone]. 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 [phone] or [phone] 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 [phone].

:

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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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 | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | 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-skeletal
Conventional | | | | | | | | | | |
| 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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	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-skeletal
Conventional
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