The device is a sphygmomanometer intended to be used with a stethoscope or Doppler for indirect measurement of arterial blood pressure. This device includes an aneroid gauge. Koven Technology, Inc. intends to provide the device for use by healthcare providers. Our product is for both hospital and clinical use and are intended for pediatric through adults, excluding neonates.

Device Description

The FAST Sphyg by Koven is an aneroid sphygmomanometer that uses the auscultatory blood pressure technique in combination with a stethoscope or Doppler and occluding cuff to determine systolic and diastolic blood pressure measurement. The FAST Sphyg includes an aneroid qauge, as well as a battery powered air pump so the user can control the inflation. When the activation button is pushed on the device, the air pump inflates the cuff. When the activation button is released, inflation stops, but the system remains pressurized. The aneroid gauge on the device reflects this increase in pressure, which is displayed in mmHg. A release valve is activated through a trigger switch to manually deflate the cuff and notate the blood pressure measurement.

AI/ML Overview

The provided text describes the FAST Sphyg by Koven, an aneroid sphygmomanometer intended for indirect measurement of arterial blood pressure. The document focuses on establishing substantial equivalence to a predicate device and adherence to relevant performance standards.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance:

The document does not present a single, consolidated table explicitly labeled "acceptance criteria" and "reported device performance" in the context of clinical accuracy for blood pressure measurement. Instead, it refers to compliance with performance standards, primarily ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type.

However, the document lists other technical standards that the device meets, which can be considered acceptance criteria for electrical safety and electromagnetic compatibility:

Standard / Test	Acceptance Criteria / Test Level	Reported Device Performance / Compliance Level
ISO 81060-1:2007	Requirements and test methods for non-automated measurement type	Designed and tested to meet this standard. (Specific accuracy metrics not detailed in this excerpt)
IEC 60601-1 (2007) - Electrical Safety	Class II device (Protection class against electric shock)	Class II device, Internally powered equipment
	Type B applied part (Protection grade against electric shock)	Type B applied part
IEC 60601-1-2 (2007) - Electromagnetic Emissions
RF Emissions CISPR 11	Group 1	Group 1
RF Emissions CISPR 11	Class B	Class B
Harmonic Emissions IEC 61000-3-2	Class A	Class A
Flicker Emissions IEC 61000-3-3	Not Applicable	Not Applicable
IEC 60601-1-2 (2007) - Electromagnetic Immunity
Electrostatic Discharge (ESD) IEC 61000-4-2	±6kV Contact, ±8kV Air	±6kV Contact, ±8kV Air
Electrical Fast Transient/burst IEC 61000-4-4	±2kV for power supply lines, ±1kV for input/output lines	±2kV for power supply lines, ±1kV for input/output lines
Surge IEC 61000-4-5	±1kV differential mode, ±2kV common mode	±1kV differential mode, ±2kV common mode
Voltage dips, short interruptions, and variations	< 5% UT for 0.5 cycles, 40% UT for 5 cycles, 70% UT for 25 cycles, < 5% UT for 5 s	< 5% UT for 0.5 cycles, 40% UT for 5 cycles, 70% UT for 25 cycles, < 5% UT for 5 s
Power frequency (50/60 Hz) magnetic field	3 A/m	3 A/m
Conducted RF IEC 61000-4-6	3 Vrms (150 kHz to 80 MHz)	3 Vrms
Radiated RF IEC 61000-4-3	3 V/m (80 MHz to 2.5 GHz)	3 V/m

For the primary function of blood pressure measurement accuracy, the document states, "the FAST Sphyg has been designed and tested to meet the following standards: ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type." However, the specific accuracy acceptance criteria defined within ISO 81060-1 (e.g., mean difference and standard deviation between the device and reference method) and the actual reported performance data against these criteria are not detailed in this excerpt.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the excerpt. The document states that the device was "designed and tested to meet" ISO 81060-1:2007, but it does not describe the specific study, patient cohort, or sample size used for that testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the excerpt. For blood pressure measurement, the "ground truth" would typically come from a trained observer using a reference sphygmomanometer (e.g., mercurial sphygmomanometer or direct arterial measurement) following specific protocols, often involving multiple observers to mitigate bias (as per ISO standard requirements). However, no details on this are given.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the excerpt. Given that the device is a sphygmomanometer, adjudication would refer to how multiple measurements or observations by reference methods are reconciled, if applicable.
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:

This is not applicable to the FAST Sphyg by Koven. This device is a mechanical aneroid sphygmomanometer with a battery-powered pump, not an AI-assisted diagnostic tool for image analysis or interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable to the FAST Sphyg by Koven. It is a manually operated device where a healthcare provider uses a stethoscope or Doppler to interpret the Korotkoff sounds. There is no "algorithm" in the sense of an automated analytical process that provides a standalone reading without human involvement in the detection of sounds.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For blood pressure measurement devices, the ground truth is typically established by simultaneous measurements using a recognized reference method, such as a mercurial sphygmomanometer or direct invasive arterial pressure measurement, performed by trained observers. The document, however, does not explicitly state the specific "type of ground truth" used in its testing beyond mentioning compliance with ISO 81060-1:2007, which dictates such methods.
The sample size for the training set:

This information is not applicable/not provided. As an analog medical device (aneroid sphygmomanometer), the FAST Sphyg does not involve machine learning or AI models, and therefore does not have a "training set" in the computational sense.
How the ground truth for the training set was established:

This information is not applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

April 14, 2015

Koven Technology, Inc. Ms. Heather Bell, President 12125 Woodcrest Executive Dr., Ste. 320 St. Louis, MO 63141

Re: K143332

Trade/Device Name: FAST Sphyg by Koven Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II Product Code: DXO Dated: February 25, 2015 Received: March 3, 2015

Dear Ms. Bell:

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 (21 CFR

Public Health Service

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vour

Mude Jellm
for

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

Enclosure

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Indications for Use

510(k) Number: K143332

Device Name: FAST Sphyg by Koven

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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

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K143332

510(k) Summary, Section 5

Date of Preparation: October 27, 2014

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:	Heather Bell
Address:	12125 Woodcrest Executive Dr Ste 320
City, State and ZIP:	St Louis, MO 63141
Telephone:	314.542.2101
Fax:	314.542.6020
E-mail Address:	koven@koven.com

Device Name:

Trade/Proprietary Name:	FAST Sphyg by Koven
Common/Usual Name:	Blood Pressure Cuff
Regulation Number:	870.1120
Product Code:	DXQ

Substantial Equivalency:

The FAST Sphyg by Koven is substantially equivalent to other devices intended for use with a stethoscope or Doppler for indirect measurement of arterial blood pressure. The predicate device is the Aneroid and Mercurial Sphygmomanometer manufactured by American Diagnostic Corp., West Babylon, NY, with S.E number of K962655.

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Parameter	FAST Sphyg by Koven(This submission.)	Aneroid SphygmomanometersK962655
Indication forUse Statement	The device is asphygmomanometer intended tobe used with a stethoscope orDoppler for indirect measurementof arterial blood pressure. Thisdevice includes an aneroid gauge.Koven Technology, Inc. intends toprovide the device for use byhealthcare providers. Our productis for both hospital and clinical useand are intended for pediatricthrough adults.	The device is asphygmomanometer intended tobe used with a stethoscope forindirect measurement of arterialblood pressure. This device willinclude an aneroid gauge, as wellas, a mercurial manometer forsome models. AmericanDiagnostic intends to provide thedevice for use by healthcareproviders. Our products are forboth hospital and home use andare intended for newborns throughadults. Our device(sphygmomanometer) will be soldover the counter.
Regulation #	21 CFR § 870.1120	21 CFR § 870.1120
Product Codes	DXQ	DXQ
Target Patient	Humans	Humans
Gauge	Aneroid Gauge	Aneroid Gauge
Cuff inflation	User controlled inflation button	User controlled hand pumped
Cuff deflation	User controlled, trigger type	User controlled, trigger type

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General Overview:

The FAST Sphyg includes an aneroid qauge, as well as a battery powered air pump so the user can control the inflation. When the activation button is pushed on the device, the air pump inflates the cuff. When the activation button is released, inflation stops, but the system remains pressurized. The aneroid gauge on the device reflects this increase in pressure, which is displayed in mmHg. A release valve is activated through a trigger switch to manually deflate the cuff and notate the blood pressure measurement.

Clinical Applications:

Non-invasive arterial blood pressure measurement.

Principles:

Auscultatory blood pressure measurement:

As the heart beats, blood forced through the arteries cause a rise in pressure, called systolic pressure, followed by a decrease in pressure as the heart's ventricles prepare for another beat. This low pressure is called the diastolic pressure.

The sphygmomanometer inflates a cuff above expected systolic pressure using a pump. As the air release valve is opened, cuff pressure (slowly) decreases. When the cuff's pressure equals the arterial systolic pressure, blood begins to flow past the cuff, creating blood flow turbulence and audible sounds (called Korotkoff sounds). Using a stethoscope, these sounds are heard and the cuff's pressure is recorded. The blood flow sounds will continue until the cuff's pressure falls below the arterial diastolic pressure. The pressure when the blood flow sounds stop indicates the diastolic pressure.

Performance Standards:

No performance standards have been established for the FAST Sphyg under section 514 (864.5700) of the Federal Food and Drug Act. However, the FAST Sphyg has been designed and tested to meet the following standards:

. ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type

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IEC 60601-1 Medical electrical equipment 2007: ● Protection class against electric shock: Class II device Internally powered equipment Protection grade against electric shock: Type B applied part
IEC 60601-1-2 Medical electrical equipment Part 1-2: Collateral Standard . Electromagnetic compatibility (2007): Guidance and manufacturer's declaration - electromagnetic emissions and immunity

Emissions Test	Compliance	Electromagnetic Environment - Guidance
RF EmissionsCISPR 11	Group 1	The FAST Sphyg uses RF energy only for its internalfunction. Therefore, the RF emissions are very low andare not likely to cause any interference in nearbyelectronic equipment.
RF EmissionsCISPR 11	Class B	The FAST Sphyg is suitable for use in allestablishments, including domestic establishments andthose directly connected to the public low-voltagepower supply network that supplies buildings used fordomestic purposes.
HarmonicEmissionsIEC 61000-3-2	Class A
Flicker EmissionsIEC 61000-3-3	Not Applicable

ImmunityTest	IEC 60601Test Level	ComplianceLevel	Electromagnetic Environment -Guidance
ElectrostaticDischarge(ESD)IEC 61000-4-2	±6kV Contact±8kV Air	±6kV Contact±8kV Air	Floors should be wood, concrete orceramic tile. If floors are covered withsynthetic material, the relativehumidity should be at least 30%.
Electrical FastTransient/burst	±2kV for powersupply lines± 1kV for	±2kV for powersupply lines	Mains power should be that of atypical commercial or hospitalenvironment.

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IEC 61000-4-4	input/output lines	± 1kV forinput/output lines
SurgeIEC 61000-4-5	±1kV differentialmode± 2kV commonmode	±1kV differentialmode± 2kV commonmode	Mains power should be that of atypical commercial or hospitalenvironment.
Voltage dips,shortinterruptionsand voltagevariations onpower supplyinput linesIEC61000-4-11	< 5% UT(> 95% dip in UT)for 0.5 cycles40% UT(60% dip in UT)for 5 cycles70% UT(30% dip in UT)for 25 cycles< 5% UT(> 95% dip in UT)for 5 s	< 5% UT(> 95% dip in UT)for 0,5 cycles40% UT(60% dip in UT)for 5 cycles70% UT(30% dip in UT)for 25 cycles< 5% UT(> 95% dip in UT)for 5 s	Mains power should be that of atypical commercial or hospitalenvironment.
Powerfrequency(50/60 Hz)magnetic fieldIEC61000-4-8	3 A/m	3 A/mNOTE: UT is the a.c. mains voltage prior to application of the test level.	Power frequency magnetic fieldsshould be at levels characteristic of atypical location in a typicalcommercial or hospital environment

ImmunityTest	IEC 60601Test Level	ComplianceLevel	Electromagnetic Environment -Guidance
Conducted RFIEC 61000-4-6	3 Vrms150 kHz to 80MHz	3 Vrms	Portable and mobile RF communicationsequipment should be used no closer toany part of the FAST Sphyg, includingcables, than the recommendedseparation distance calculated from theequation applicable to the frequency ofthe transmitter.Recommended separation distance:d = $1.2\sqrt{P}$

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Radiated RFIEC 61000-4-3	3 V/m80 MHz to 2.5 GHz	3 V/m	$d = 1,2\sqrt{P}$ 80 to 800 MHz$d = 2,3\sqrt{P}$ 800MHz to 2,5 GHzwhere P is the maximum output powerrating of the transmitter in watts (W)according to the transmittermanufacturer and d is the recommendedseparation distance in meters (m).Field strength from fixed RF transmitters,as determined by an electromagneticsite survey, a should be less than thecompliance level in each frequencyrange. bInterference may occur in the vicinity ofequipment marked with the followingsymbol:Image: Interference Symbol
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption andreflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access theelectromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If themeasured field strength in the location in which the FAST Sphyg is used exceeds the applicable RF compliance level above

the FAST Sphyg should be observed to verify normal performance is observed, additional measures may be necessary, such as reorienting or relocating the FAST Sphyg.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Indication for Use Statement:

Contraindications:

Safety and effectiveness with neonate cuff sizes 1 through 5 is not established.

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Material that touches skin:

There are no materials on the FAST Sphyg that make contact with the patient skin. Cuffs sold separately.

Regulation Number and Section

§ 870.1120 Blood pressure cuff.

(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).