Fast Sphyg by Koven

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number: K143332 ## Device Name: FAST Sphyg by Koven Indications for Use: 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. 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. ₪ 11 17 11 17 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 1 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ 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. {4}------------------------------------------------ | Parameter | FAST Sphyg by Koven<br>(This submission.) | Aneroid Sphygmomanometers<br>K962655 | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for<br>Use Statement | The device is a<br>sphygmomanometer intended to<br>be used with a stethoscope or<br>Doppler for indirect measurement<br>of arterial blood pressure. This<br>device includes an aneroid gauge.<br>Koven Technology, Inc. intends to<br>provide the device for use by<br>healthcare providers. Our product<br>is for both hospital and clinical use<br>and are intended for pediatric<br>through adults. | The device is a<br>sphygmomanometer intended to<br>be used with a stethoscope for<br>indirect measurement of arterial<br>blood pressure. This device will<br>include an aneroid gauge, as well<br>as, a mercurial manometer for<br>some models. American<br>Diagnostic intends to provide the<br>device for use by healthcare<br>providers. Our products are for<br>both hospital and home use and<br>are intended for newborns through<br>adults. Our device<br>(sphygmomanometer) will be sold<br>over 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 | {5}------------------------------------------------ ## General Overview: 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. ## 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 {6}------------------------------------------------ - 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 Emissions<br>CISPR 11 | Group 1 | The FAST Sphyg uses RF energy only for its internal<br>function. Therefore, the RF emissions are very low and<br>are not likely to cause any interference in nearby<br>electronic equipment. | | RF Emissions<br>CISPR 11 | Class B | The FAST Sphyg is suitable for use in all<br>establishments, including domestic establishments and<br>those directly connected to the public low-voltage<br>power supply network that supplies buildings used for<br>domestic purposes. | | Harmonic<br>Emissions<br>IEC 61000-3-2 | Class A | | | Flicker Emissions<br>IEC 61000-3-3 | Not Applicable | | | Immunity<br>Test | IEC 60601<br>Test Level | Compliance<br>Level | Electromagnetic Environment -<br>Guidance | |------------------------------------------------------|---------------------------------------------|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Electrostatic<br>Discharge<br>(ESD)<br>IEC 61000-4-2 | ±6kV Contact<br>±8kV Air | ±6kV Contact<br>±8kV Air | Floors should be wood, concrete or<br>ceramic tile. If floors are covered with<br>synthetic material, the relative<br>humidity should be at least 30%. | | Electrical Fast<br>Transient/burst | ±2kV for power<br>supply lines<br>± 1kV for | ±2kV for power<br>supply lines | Mains power should be that of a<br>typical commercial or hospital<br>environment. | {7}------------------------------------------------ | IEC 61000-4-4 | input/output lines | ± 1kV for<br>input/output lines | | |-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Surge<br>IEC 61000-4-5 | ±1kV differential<br>mode<br>± 2kV common<br>mode | ±1kV differential<br>mode<br>± 2kV common<br>mode | Mains power should be that of a<br>typical commercial or hospital<br>environment. | | Voltage dips,<br>short<br>interruptions<br>and voltage<br>variations on<br>power supply<br>input lines<br>IEC61000-4-<br>11 | < 5% UT<br>(> 95% dip in UT)<br>for 0.5 cycles<br>40% UT<br>(60% dip in UT)<br>for 5 cycles<br>70% UT<br>(30% dip in UT)<br>for 25 cycles<br>< 5% UT<br>(> 95% dip in UT)<br>for 5 s | < 5% UT<br>(> 95% dip in UT)<br>for 0,5 cycles<br>40% UT<br>(60% dip in UT)<br>for 5 cycles<br>70% UT<br>(30% dip in UT)<br>for 25 cycles<br>< 5% UT<br>(> 95% dip in UT)<br>for 5 s | Mains power should be that of a<br>typical commercial or hospital<br>environment. | | Power<br>frequency<br>(50/60 Hz)<br>magnetic field<br>IEC61000-4-8 | 3 A/m | 3 A/m<br>NOTE: UT is the a.c. mains voltage prior to application of the test level. | Power frequency magnetic fields<br>should be at levels characteristic of a<br>typical location in a typical<br>commercial or hospital environment | | Immunity<br>Test | IEC 60601<br>Test Level | Compliance<br>Level | Electromagnetic Environment -<br>Guidance | |-------------------------------|--------------------------------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conducted RF<br>IEC 61000-4-6 | 3 Vrms<br>150 kHz to 80<br>MHz | 3 Vrms | Portable and mobile RF communications<br>equipment should be used no closer to<br>any part of the FAST Sphyg, including<br>cables, than the recommended<br>separation distance calculated from the<br>equation applicable to the frequency of<br>the transmitter.<br>Recommended separation distance:<br>d = $1.2\sqrt{P}$ | {8}------------------------------------------------ | Radiated RF<br>IEC 61000-4-3 | 3 V/m<br>80 MHz to 2.5 GHz | 3 V/m | $d = 1,2\sqrt{P}$ 80 to 800 MHz<br>$d = 2,3\sqrt{P}$ 800MHz to 2,5 GHz<br><br>where P is the maximum output power<br>rating of the transmitter in watts (W)<br>according to the transmitter<br>manufacturer and d is the recommended<br>separation distance in meters (m).<br><br>Field strength from fixed RF transmitters,<br>as determined by an electromagnetic<br>site survey, a should be less than the<br>compliance level in each frequency<br>range. b<br><br>Interference may occur in the vicinity of<br>equipment marked with the following<br>symbol:<br>Image: Interference Symbol | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.<br>NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and<br>reflection from structures, objects and people. | | | | | a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,<br>amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access the<br>electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the<br>measured 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: 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. ## Contraindications: Safety and effectiveness with neonate cuff sizes 1 through 5 is not established. {9}------------------------------------------------ # Material that touches skin: There are no materials on the FAST Sphyg that make contact with the patient skin. Cuffs sold separately.