The Smartdop XT is intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for ankle-brachial index (ABI), toe- brachial index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs and/or Doppler probe. The optional foot temperature provides skin temperature readings on the foot. Collected data is captured and stored with Smart-XT-Link software that includes capabilities to print waveforms and export to into the facility's electronic health records.

It is not intended to be used in fetal applications or used inside the sterile field.

Device Description

The Smartdop XT with Smart-XT-Link is designed to provide both qualitative and quantitative information. The qualitative information mainly includes visual display of waveform's shapes. including qualitative analysis of Pulse Volume Recordings (PVR), 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. Foot skin temperature readings are done with optional temperature probe and can be displayed in either Fahrenheit or Celsius. All tests controlled and stored by computer with Smart-XT-Link software for Windows OS with capabilities to print waveform data and export to electronic health record management systems.

AI/ML Overview

Here's an analysis of the provided text regarding the Smartdop XT device, focusing on its acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K131623) is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance metrics against specific acceptance criteria for a novel device. The document mostly outlines a series of standards and guidance the device was designed to meet and states that testing was completed with acceptance to these standards. It doesn't explicitly list quantitative acceptance criteria with corresponding performance results in a table format.

However, based on the document's content, we can infer some implied acceptance criteria and the general statement of compliance:

Acceptance Criteria (Implied from Standards & Testing)	Reported Device Performance
Electrical Safety (IEC 60601-1)	"The Smartdop XT system have been subjected to... Electrical Safety... testing by certified laboratories." (Implied: Device met the safety requirements.)
Mechanical Safety (IEC 60601-1, etc.)	"The Smartdop XT system have been subjected to... Mechanical Safety... testing by certified laboratories." (Implied: Device met the safety requirements.)
Electromagnetic Compatibility (EMC) (IEC 60601-1-2)	"The Smartdop XT system have been subjected to... EMC emissions and immunity... testing by certified laboratories." (Implied: Device met the EMC requirements.)
Acoustic Output (IEC 60601-2-37)	"The Smartdop XT system have been subjected to... Acoustic Output... testing by certified laboratories." (Implied: Device met the acoustic output requirements for ultrasonic medical diagnostic equipment.)
Software Life Cycle Processes (IEC 62304)	"The Smartdop XT was designed to meet... IEC 62304 Medical device software Software life cycle processes (2006-05)." (Implied: Software development followed the standard processes, indicating reliability and safety.)
Risk Management (ISO 14971)	"The Smartdop XT was designed to meet... ISO 14971, Medical devices - Application of risk management to medical devices (2007-10-01)." (Implied: Risks were identified, evaluated, and controlled according to the standard.)
Non-invasive Sphygmomanometers (Automated) (ANSI/AAMI/IEC 80601-2-30)	"The Smartdop XT was designed to meet... ANSI/AAMI/IEC 80601-2-30:2009... Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers." (Implied: Device performance for automated blood pressure measurement complied with the standard.) The document doesn't provide specific numerical accuracy results for blood pressure measurements but implies compliance through adherence to this standard.
Non-invasive Sphygmomanometers (Non-automated) (ANSI/AAMI/ISO 81060-1)	"The Smartdop XT was designed to meet... ANSI/AAMI/ISO 81060-1:2007... Requirements and test methods for non-automated measurement type." (Implied: Device performance for non-automated blood pressure measurement complied with the standard.) Similar to the above, no specific numerical results are provided.
Functional Specifications (Device Master Record)	"Internally the Smartdop XT is subjected to unit testing, verification, performance testing, and validation to ensure that the device(s) meet all of their functional specifications listed in the Device Master Record." (Implied: All intended functions operate as designed.)
Equivalence to Predicate Device (Safety & Efficacy)	"The conclusion drawn from these tests is that the Smartdop XT non-invasive peripheral vascular diagnostic system is equivalent in safety and efficacy to the predicate device [Falcon/Pro, K111416]." (This is the overarching conclusion of the 510(k), implying performance is comparable to an already approved device.)

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for any clinical test set. The testing described is primarily focused on compliance with engineering and safety standards rather than clinical validation with a patient cohort. The document mentions "performance testing by certified laboratories" and "unit testing, verification, performance testing, and validation" internally, but these refer to bench testing and engineering verification, not clinical studies on patient data.

Therefore, information on data provenance (country of origin, retrospective/prospective) is also not available.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. Since the testing described is not a clinical study involving diagnosis or interpretation of medical images/data by experts, the concept of "ground truth" as established by medical experts for a test set doesn't apply in the context presented.

4. Adjudication Method for the Test Set

This information is not provided. As there's no mention of a clinical test set requiring expert interpretation or diagnosis, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to standards, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Given the nature of the device (an ultrasonic transducer for non-invasive peripheral vascular evaluation providing qualitative and quantitative information for examiner aid), it is likely designed for human-in-the-loop operation. The document describes it as aiding "the examiners in obtaining systolic segmental blood pressures."

No specific standalone algorithm performance study is described. The device is a diagnostic tool that provides data and waveforms, not an automated diagnostic algorithm meant to operate independently.

7. The Type of Ground Truth Used

Based on the described testing, the "ground truth" would be related to:

Engineering and Safety Standards: Compliance with the numerous IEC, ISO, and ANSI/AAMI standards listed (e.g., electrical safety, acoustic output limits, EMI/EMC limits).
Functional Specifications: The device's internal "functional specifications listed in the Device Master Record." This implies that the 'ground truth' for verification is defined by the manufacturer's own design requirements and expected performance parameters during bench testing.

There is no mention of ground truth established by expert consensus, pathology, or outcomes data in a clinical context within this document.

8. The Sample Size for the Training Set

The document does not mention or describe any training set for an algorithm. The Smartdop XT is an ultrasonic transducer and software system for data acquisition and display, not an AI/ML-based diagnostic algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, this information is not applicable/not provided.

Summary

{0}------------------------------------------------

K131623 page 1 of 5

Image /page/0/Picture/1 description: The image shows the logo for Koven Technology Incorporated. The logo is black and white and features the word "KOVEN" in large, bold letters. Below the word "KOVEN" is the phrase "TECHNOLOGY INCORPORATED" in smaller letters. The tagline "Your Vascular Healthcare Partner" is located below the company name.

JAN 17 2014

510(k) Summary, Section 5

Date of Preparation: April 26, 2013

This 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:	12125 Woodcrest Executive Drive, Ste. 320
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 Name:

Trade/Proprietary Name:	Smartdop XT with Smart-XT-Link
Common/Usual Name:	Ultrasonic transducer
Regulation Number:	870.2880
Product Code:	JOP

Substantial Equivalency:

The Smartdop XT is substantially equivalent to other devices intended for use in the noninvasive evaluation of peripheral vascular pathology now in market. The predicate device is the Falcon/Pro manufactured by Viasonix Ltd., Rammana, Israel, with S.E number of K111416.

Device description:

12125 Woodcrest Executive Drive, Ste. 320, St. Louis, MO 63141 314.542.2101 • 800.521.8342 • Fax: 314.542.6020 www.koven.com

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for Koven Technology Incorporated. The logo is in black and white and features the company name in large, bold letters. Above the company name is the text "Vascular Instruments". The logo is simple and professional, and it conveys a sense of quality and reliability.

Your Vascular Healthcare Partner

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. Foot skin temperature readings are done with optional temperature probe and can be displayed in either Fahrenheit or Celsius. All tests controlled and stored by computer with Smart-XT-Link software for Windows OS with capabilities to print waveform data and export to electronic health record management systems.

Clinical Applications:

The Smartdop XT with Smart-XT-Link clinical applications is:

ABI and TBI studies	Bi-directional Doppler lower extremitystudies
Blood pressure segmental studies	PPG toe pressure & venous reflux /studies
PVR arterial studies	Foot temperature readings

Principles:

Doppler blood velocity measurement:

While performing Doppler waveform test on Doppler Arterial Testing, 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 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.

Doppler blood pressure measurement:

The cuff pressure at the first signal is the systolic pressure. After confirming a return of the rhythmical blood flow signals, the CPU opens the air valve to dump the cuff pressure and converted to systolic pressure waveform signals which can be displayed.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Koven Technology Incorporated. The logo is in black and white and features the company name in a stylized font. Below the company name is the tagline "Your Vascular Healthcare Partner."

Oscillometry:

While taking blood pressure on Automatic Arterial Testing screen and deflating cuff for arm or leg after the inflation, the unit detects oscillations of the blood vessel synchronizing with each heart beat and determines the systolic pressure based on oscillometry algorithm.

Photoplethysmography:

While taking toe pressure with PPG probe as well as performing PPG venous reflux study, the unit senses the reflection of light from the hemoalobin of the red blood cells in surface vessels by utilizing infrared light with the probe.

Pneumoplethysmography (PVR):

While performing PVR waveform test for toes and legs on either Automatic or Doppler Arterial Testing, the unit assesses changes in blood volume in the tissues beneath an inflated cuff. Alterations in pressure are transmitted to a pressure transducer that records the volume changes through the cardiac cycle to produce a waveform.

Probes and Cuffs:

· Cuffs: Up to 14: Refer the following cuff size as example:

VC-10: 8 pcs.	For brachial, above knees, below
VC-12: 2 pcs.	knees ankles and high thighs
DVC-1.9: 2 pcs.	For great toes
VC-7.5: 2 pcs.	For transmetatarsal

• Probes:	Model name	Freq.	Probe power (In situ)
Doppler probe (8MHz):	BT8M05S8C (A)	8MHz	390 mW/cm² or less
Temperature probe:	TP-01

Indication for Use Statement:

The Smartdop XT is intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for ankle-brachial index (ABI), toe- brachial index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs and/or Doppler probe. The optional foot temperature probe provides skin temperature readings on the foot. Collected data is captured and stored with Smart-XT-Link software that includes capabilities to print waveforms and export to into the facility's electronic health records.

It is not intended to be used in fetal applications or used inside the sterile field.

12125 Woodcrest Executive Drive. Ste. 320. St. Louis, MO 63141 314.542.2101 · 800.521.8342 · Fax: 314.542.6020 www.koven.com

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Koven Vascular Instruments. The logo features the word "KOVEN" in large, bold letters, with the "V" extending down to form the first letter of the word "TECHNOLOGY" which is written in smaller letters below. The phrase "Your Vascular Healthcare Partner" is written in a smaller font below the logo.

Testing:

The Smartdop XT 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).
ANSI/AAMI/IEC 80601-2-30:2009 Medical electrical equipment Part 2-30: . Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers
ANSI/AAMI/ISO 81060-1:2007 Non-invasive sphygmomanometers Part 1: . Requirements and test methods for non-automated measurement type.

The Smartdop XT testing was completed with acceptance to the above Standards. The Smartdop XT device probes and cuff are previous FDA released devices, with complete and accepted testing and validation.

The Smartdop XT system have been subjected to Bio-Compatibility, Electrical Safety, Mechanical Safety. Acoustic Output. EMC emissions and immunity, and performance testing by certified laboratories. Internally the Smartdop XT is subjected to unit testing, verification, performance testing, and validation to ensure that the device(s) meet all of their functional specifications listed in the Device Master Record.

The Smartdop XT labeling includes instructions for safe and effective use, warning, cautions and guidance for use.

Literature Review:

A review of the literature pertaining to the safety of the Smartdop XT non-invasive peripheral vascular diagnostic systems has been conducted and appropriate safeguards have been incorporated in the design of the Smartdop XT non-invasive peripheral vascular diagnostic systems.

Differences between Smartdop XT and Predicate:

The general method of device construction and technology are the same. The Falcon/Pro computer screen has "touch screen" capabilities, the Smartdop XT does not. The Smartdop XT has four more pressure ports that the Falcon/Pro. The Smartdop XT does not have frequency analysis waveform display, only bidirectional Doppler display.

12125 Woodcrest Executive Drive, Ste. 320, St. Louis, MO 63141 314.542.2101 • 800.521.8342 • Fax: 314.542.6020 www.koven.com

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Koven Technology Incorporated. The logo includes the words "Vascular Instruments" at the top, followed by the word "Koven" in large letters. Below that, it says "Technology Incorporated" and "Your Vascular Healthcare Partner."

K131623 page 5 of 5

Conclusions:

The conclusion drawn from these tests is that the Smartdop XT non-invasive peripheral vascular diagnostic system is equivalent in safety and efficacy to the predicate device.

12125 Woodcrest Executive Drive, Ste. 320, St. Louis, MO 63141 314.542.2101 • 800.521.8342 • Fax: 314.542.6020 www.koven.com

{5}------------------------------------------------

Public Health Service

Image /page/5/Picture/13 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.

January 17, 2014

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Koven Technology, Inc. c/o Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071-3404 US

Re: K131623

Trade/Device Name: Smartdop xt Regulation Number: 21 CFR 870.2880 Regulation Name: Flow Meter, Blood, Cardiovascular Regulatory Class: Class II Product Code: JOP Dated: December 17, 2013 Received: December 19, 2013

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. 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 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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you Good Division of Small Manufacturers, International and Consumer Assistance at its toll-free

{6}------------------------------------------------

number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen-P.Faris -S

· for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use Statement

K131623 510(k) Number.

Device Name: Smartdop XT

It is not intended to be used in fetal applications or used inside the sterile field.

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Owen P.
Faris -S
Date: 2014.01.17 15:46:50
-05'00'

Section 4 510(k) Submission Page # 26

dcations for use Statement (2) do Houston, TX 77071

Regulation Number and Section

§ 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).