The Bidop 7 is intended for the detection of arterial and venous blood flow in the extremities as well as fetal heart sounds. The Bidop 7 displays bi-directional velocity waverical data and fetal heart rate with heartbeat indicator. The Bidop 7 probe selection is 2, 5, 8, and 10 MHz.

Device Description

The Bidop 7 is designed to provide both qualitative and quantitative information. The qualitative information mainly includes color visual display of waveform's shapes, including qualitative analysis of Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms.

AI/ML Overview

Here's an analysis based on the provided document regarding the acceptance criteria and study for the Bidop 7:

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain detailed clinical study data for establishing sensitivity, specificity, or detailed performance metrics against a clinical ground truth for a novel AI/ML device. The "study" here refers to the testing performed to demonstrate compliance with standards and equivalence to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy derived from a clinical efficacy study. Instead, the "acceptance criteria" are implied by compliance with recognized standards and the demonstration of substantial equivalence to a predicate device (Smartdop 45, K050601).

Acceptance Criteria (Implied by Regulatory Compliance & Substantial Equivalence)	Reported Device Performance (Summary from Document)
Safety:	- Designed to meet IEC 60601-1 (Medical electrical equipment 2007)
Electrical Safety	- Designed to meet IEC 60601-1-2 (Electromagnetic compatibility 2007)
Electromagnetic Compatibility	- Designed to meet IEC 60601-2-37 (Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment 2007-08)
Ultrasonic Safety & Performance	- Designed to meet FDA Marketing Clearance of Diagnostic Ultrasound Systems and Transducers guidance.
Diagnostic Ultrasound Equivalence	- Designed to meet ISO 14971 (Application of risk management to medical devices 2007-10-01).
Risk Management	- Designed to meet FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices guidance.
Cybersecurity	- "The conclusion drawn from these tests is that the Bidop 7 non-invasive peripheral vascular diagnostic system is equivalent in safety and efficacy to the predicate device."
Efficacy/Performance:	- Qualitative information: Color visual display of waveform shapes (PPG, Doppler).
Qualitative Display	- Quantitative information: Aid in obtaining systolic segmental blood pressures (ABI, TBI), additional quantitative measurements for Doppler blood flow velocity waveforms.
Quantitative Measurement Accuracy	- Detection of arterial and venous blood flow in the extremities, and fetal heart sounds.
Intended Use Performance	- Displays bi-directional velocity waveforms, numerical data, and fetal heart rate with heartbeat indicator.
Display Features	- Operated with 2, 5, 8, and 10 MHz probes.
Probe Compatibility	- "The general method of device construction and technology are identical" to the predicate (Smartdop 45, K050601), with the only noted difference being the absence of an integrated printer in the Bidop 7.
Substantial Equivalence to Predicate	- "Bidop 7 non-invasive peripheral vascular diagnostic system is equivalent in safety and efficacy to the predicate device."
Software Life Cycle:	- Designed to meet IEC 62304 (Medical device software – Software life cycle processes 2006-05).
Software Development Compliance

2. Sample size used for the test set and the data provenance

The document does not describe a clinical "test set" in the context of an efficacy study with a specified sample size or data provenance (e.g., country of origin, retrospective/prospective). The testing described relates to engineering and regulatory compliance with standards, and comparison to the predicate device in terms of technology and indications for use. No patient data or clinical study data is detailed for an independent test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical test set for efficacy is described, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication method is described.

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

Not applicable. The Bidop 7 is a cardiovascular blood flowmeter, not an AI-assisted diagnostic imaging device for which MRMC studies comparing human readers with and without AI assistance would typically be conducted. The document does not mention any AI components or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The Bidop 7 is a medical device that produces diagnostic information (waveforms, numerical data, fetal heart rate) for interpretation by a human clinician. It is not an algorithm performing a standalone diagnostic task without human involvement. The document describes laboratory and engineering tests for compliance with standards and equivalence.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied in AI/ML performance evaluation (e.g., against pathology or clinical outcomes) is not discussed in this 510(k) summary. The comparison is primarily against specifications in standards and the performance characteristics of an existing predicate device. The underlying principle of operation (Doppler effect, photoplethysmography) itself is the "truth" that the device is designed to measure.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed with training data.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML product developed with training data.

Summary of the Study (as described in the document):

The "study" presented in this 510(k) summary primarily consists of engineering verification and validation testing to ensure the Bidop 7 complies with relevant medical device standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971) and FDA guidance for ultrasound systems and cybersecurity. The core of the submission demonstrates substantial equivalence to the predicate device, the Smartdop 45 (K050601), rather than a de novo clinical efficacy study. The document asserts that the general method of device construction and technology are identical, leading to the conclusion that the Bidop 7 is equivalent in safety and efficacy. No clinical trial data or performance metrics on a patient cohort are provided here; the focus is on technical compliance and equivalence.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 5, 2021

Koven Technology, Inc. % Harvey Knauss Consultant Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071

Re: K201114

Trade/Device Name: Bidop 7 Regulation Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: Class II Product Code: DPW Dated: April 21, 2020 Received: April 27, 2020

Dear Harvey Knauss:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K201114

Device Name

Bidop 7

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

V Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image is a logo for Koven Vascular Instruments. The logo features the word "KOVEN" in large, bold letters, with the "V" in blue. Below the word "KOVEN" is the text "TECHNOLOGY INCORPORATED". The tagline "Your Vascular Healthcare Partner" is at the bottom of the logo.

K201114 510(k) Summary

April 21, 2020

This Bidop 7 510(k) Summary of safety and effectiveness information is being submitted in accordance with 21 CFR Sec. 807.92. A 510(k) Statement is not provided.

Company making this submission:

Submitter / Owner
Company Name:	Koven Technology, Inc.
Address:	477 N. Lindbergh Blvd, Ste. 220
City, State and ZIP:	St. Louis, MO 63141
Telephone:	314-542-2101
Fax:	314-542-6020
Responsible Person:	Ms. Heather Bell, President
E-Mail Address:	koven@koven.com

Application Consultant
Name:	Mr. J. Harvey Knauss
Address:	11874 South Evelyn Circle
City, State and ZIP:	Houston, TX 77071
Telephone:	832-675-9281
Fax:	713-723-0786
E-mail Address:	harvey.knauss@gmail.com

Device:

Trade/Proprietary Name:	Bidop 7
Common/Usual Name:	Ultrasonic transducer
Classification Name:	Blood Flow meter,Cardiovascular
Regulation Number:	870.2100
Product Code:	DPW
Predicate Device Name	Smartdop 45
"K" Number	K050601

Substantial Equivalency:

The Bidop 7 is substantially equivalent to other devices intended for use in the non-invasive evaluation of peripheral vascular pathology now in market. The predicate device is the Smartdop 45 with 510(k) number of K050601.

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Image /page/4/Picture/0 description: The image is a logo for Koven Vascular Instruments. The logo features the company name in a stylized font, with the "V" in "Koven" in blue. Below the company name is the text "Technology Incorporated" and "Your Vascular Healthcare Partner".

Device description:

Clinical Applications:

The Bidop 7 clinical applications are:

ABI and TBI studies	Bi-directional Doppler extremity studies
Blood pressure segmental studies	PPG toe pressure & venous reflux studies

Principles:

Doppler blood velocity measurement and sounds for systolic pressures:

While obtaining Doppler arterial waveforms, blood flow velocity is detected through the ultrasound which is transmitted from probe to patient body and is reflected by the blood (hemolytic, etc.).

The unit amplifies the high frequency oscillation output and then supplies it to the transmitter transducer. It is converted to ultrasound by the transducer and the ultrasound is transmitted to external objects. The ultrasound moves straight through biophysical object and is reflected by the moving object (blood flow, fetal heartbeat etc.).

The reflected ultrasound is received by the receiving transducer and is converted into electric signals again.

The converted signals are amplified and then detected. After removing unnecessary noise from the signals and improving S/N ratio at the filter circuit, the Doppler shift signals are amplified and are converted to audible sounds through a speaker.

Simultaneously, the Doppler shift signals are applied to the CPU and converted to blood flow velocity waveform signals which can be displayed.

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Image /page/5/Picture/0 description: The image is a logo for Koven Vascular Instruments. The logo features the company name in a stylized font, with the "V" in "Koven" in blue. Below the company name is the text "Technology Incorporated" and "Your Vascular Healthcare Partner".

Photoplethysmography:

While taking toe pressures and/or waveforms with PPG probe as well as performing PPG venous reflex study, the unit senses the reflection of light from the hemoglobin of the red blood cells in surface vessels by utilizing infrared light with the probe.

Probes:

Model name		Freq.	Probe power (In situ)
Doppler probe:	ST8M05S8C	8MHz	720 mW/cm² or less
Doppler probe	ST5M05S8C	5MHz	720 mW/cm² or less
Doppler probe	ST10M5S8C	10MHz	720 mW/cm² or less
Doppler probe	ST2M05S8C	2MHz	94 mW/cm² or less
PPG probe:	PG-30

Indication for Use Statement:

The Bidop 7 is intended for the detection of arterial and venous blood flow in the extremities as well as fetal heart sounds. The Bidop 7 displays bi-directional velocity waveforms, numerical data and fetal heart rate with heartbeat indicator. The Bidop 7 probe selection is 2, 5, 8, and 10 MHz.

Testing:

The Bidop 7 was designed to meet the following Standards and Guidance:

IEC 60601-1 Medical electrical equipment 2007 ●
IEC 60601-1-2 Medical electrical equipment Part 1-2: Collateral Standard ● Electromagnetic compatibility (2007).
IEC 60601-2-37 Medical electronic equipment Part 2-37: Particular requirement . for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (2007-08).
IEC 62304 Medical device software – Software life cycle processes (2006-05).
ISO 14971, Medical devices Application of risk management to medical devices ● (2007-10-01).
FDA Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. ●
FDA Content of Premarket Submissions for Management of Cybersecurity in . Medical Devices.

Differences between Bidop 7 and Predicate:

The general method of device construction and technology are identical. The Smartdop 45 has an integrated printer, the Bidop 7 does not.

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Image /page/6/Picture/0 description: The image is a logo for Koven Vascular Instruments. The logo features the company name in a stylized font, with the "V" in "Koven" in blue. Below the company name is the tagline "Your Vascular Healthcare Partner."

Literature Review:

A review of the literature pertaining to the safety of the Bidop 7 range of non-invasive peripheral vascular diagnostic systems has been conducted and appropriate safeguards have been incorporated in the of the Bidop 7 of non invasive peripheral vascular diagnostic devices.

Conclusions:

The conclusion drawn from these tests is that the Bidop 7 non-invasive peripheral vascular diagnostic system is equivalent in safety and efficacy to the predicate device. Therefore, the Bidop 7 is substantially equivalent to the predicate.

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).