(227 days)
Not Found
No
The summary describes standard signal processing and data management capabilities, with no mention of AI or ML algorithms for analysis, interpretation, or decision support.
No.
The device is used for non-invasive evaluation of peripheral vascular pathology and does not provide therapy or treatment.
Yes
The device is intended for "non-invasive evaluation of peripheral vascular pathology in patients" and "detects systolic pressures for ankle-brachial index (ABI), toe-brachial index (TBI), and arterial and venous blood flow," which are all diagnostic activities.
No
The device description explicitly mentions hardware components like "cuffs and/or Doppler probe" and an "optional temperature probe." It also describes testing related to "device probes and cuff" and "Electrical Safety, Mechanical Safety, Acoustic Output." While software is a key component ("Smart-XT-Link software"), the device is a system that includes hardware.
Based on the provided information, the Smartdop XT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
- Smartdop XT Function: The Smartdop XT is described as a device for the non-invasive evaluation of peripheral vascular pathology in patients. It uses methods like Doppler ultrasound and photoplethysmography (PPG) applied directly to the patient's body (extremities) to measure blood flow, pressures, and temperature.
- No Specimen Examination: The device does not examine specimens (blood, tissue, etc.) in vitro (outside the body). All measurements are taken in vivo (within the living body).
Therefore, the Smartdop XT falls under the category of a non-invasive diagnostic device used directly on the patient, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JOP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound (Doppler), Photoplethysmography (PPG)
Anatomical Site
Peripheral vascular system (extremities, ankle, toe, arm, leg)
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 XT testing was completed with acceptance to the following Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971, ANSI/AAMI/IEC 80601-2-30, ANSI/AAMI/ISO 81060-1.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2880 Ultrasonic transducer.
(a)
Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.(b)
Classification. Class II (performance standards).
0
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:
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
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 extremity
studies |
|----------------------------------|---------------------------------------------------|
| 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
l'
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
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.
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