HEM-7320

{0}------------------------------------------------ 510(k) Summary Page 1 of 8 1/30/2014 # MAR 0 4 2014 | Omron Healthcare, Inc.<br>1925 West Field Court<br>Lake Forest, IL 60045 USA | Tel - 847-247-5626<br>Fax- 847-680-6269 | MAR 0 4 201 | |------------------------------------------------------------------------------|----------------------------------------------------------------------------------|-------------| | Official Contact: | Renee Thornborough – Director QA/RA | | | Proprietary or Trade Name: | Model HEM-7320 | | | Common/Usual Name: | Noninvasive blood pressure measurement system. | | | Classification Name/Code:<br>system. | DXN – Noninvasive blood pressure measurement<br>21CFR 870.1130<br>Class II | | | Device: | Model HEM-7320 | | | Predicate Devices: | Omron – HEM -780N3 (HEM-7080-Z)- K061822<br>Omron – BP742 (HEM-7200-Z) – K121932 | | ### Device Description: The device is an automatic non-invasive blood pressure system. The device is battery powered and can also be powered from an IEC 60601-1 compliant AC adaptor. The device inflates a cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During deflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure. The device is intended to be used with an Omron specified cuff to encompass arms ranging from 9 to 17 inches in circumference. The device also detects the appearance of irregular heartbeats during measurement. The device has provisions for selecting two users, measurements from these users are stored in memory. The memory stores up to 100 of the latest measurements. It can also display an average of the last three values. Note that a number of documents in this submission include reference to the Cuff Wrapping Guide (or Cuff Wrapping Check). This feature has been removed from the device and is not part of this submission. Intended User Home user {1}------------------------------------------------ #### 510(k) Summary Page 2 of 8 1/30/2014 #### Patient Population This device is intended for use on adults. ### Indications for Use: The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. Environment of Use: Home Contraindications: There are no known contraindications. #### Predicate Device Comparison: The HEM-7320was compared to the predicates HEM -780N3 (HEM-7080-Z) - K061822 and BP742 (HEM-7200-Z) - K121932 in the device comparison table below. {2}------------------------------------------------ evice Compariso. | Model Name:<br>510(k) Number | Predicate Device<br>HEM-780N3 (HEM-7080-Z)<br>K061822 | Predicate Device<br>BP742(HEM-7200-Z)<br>K121932 | New Device<br>HEM-7320<br>TBD | |------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications | The device is a digital monitor intended<br>for use in measuring blood pressure and<br>pulse rate in adult patient population with<br>arm circumference ranging from 9 inches<br>to 17 inches (22 cm - 42 cm).<br>The device detects the appearance of<br>irregular heartbeats during measurement<br>and gives a warning signal with readings.<br>This blood pressure monitor compares<br>average blood pressure results to pre-<br>established AHA (American Heart<br>Association) hypertension guideline of<br>135/85 mmHg. The Omron 780N3 model<br>is not intended to be a diagnostic device.<br>Contact your physician if hypertensive<br>values are indicated. | The device is a digital monitor intended<br>for use in measuring blood pressure and<br>pulse rate in adult patient population.<br>The device detects the appearance of<br>irregular heartbeats during measurement<br>and gives a warning signal with readings. | The device is a digital monitor intended<br>for use in measuring blood pressure and<br>pulse rate in adult patient population.<br>The device detects the appearance of<br>irregular heartbeats during measurement<br>and gives a warning signal with readings.<br>Identical to K121932 | | Environment of Use | Home | Home | Home Identical to both predicates | | Patient Population | Adult | Adult | Adult Identical to both predicates | | Specifications / Features | | | | | Measurement method /<br>Principal of operation | HEM-7080-Z(HEM 780N3)<br>Cuff oscillometric method | BP742(HEM-7200-Z)<br>Cuff oscillometric method | HEM-7320<br>Cuff oscillometric method. Identical to<br>both predicates | | Measurement range | Pressure: 0 to 294 mmHg<br>Pulse Rate: 40 to 180 beats/min. | Pressure: 0 to 299 mmHg<br>Pulse Rate: 40 to 180 beats/min. | Pressure: 0 to 299 mmHg<br>Pulse Rate: 40 to 180 beats/min.<br>Identical to K121932 | | Pressure sensor | Electrostatic capacitive sensor | Semiconductor pressure sensor | Semiconductor pressure sensor. Identical<br>to K121932 | PDF Page 21 of 158 Page 3 {3}------------------------------------------------ | , Summary 1/30/2014<br>ist d (1)0<br>l<br>5 | |---------------------------------------------| |---------------------------------------------| | | HEM-7080-Z(HEM 780N3) | BP742(HEM-7200-Z) | HEM-7320 | |----------------------------------------|----------------------------------------------------------|-----------------------------------------|-----------------------------------------------------------------------------------------------------------| | Applicable cuff<br>(Arm Circumference) | 22-42cm | 22-42cm | 22-42cm, identical to both predicates | | Accuracy of pressure indicator | Within $\pm$ 3 mmHg or 2 % of reading | Within $\pm$ 3 mmHg or 2 % of reading | Within $\pm$ 3 mmHg or 2 % of reading<br>Identical to both predicates | | Accuracy of pulse rate | Within $\pm$ 5% of reading | Within $\pm$ 5% of reading | Within $\pm$ 5% of reading<br>Identical to both predicates | | Inflation method | Automatic by electric pump | Automatic by electric pump | Automatic by electric pump.<br>Identical to both predicates | | Deflation method | Active electronic control valve | Automatic pressure release valve | Automatic pressure release valve Identical<br>to K121932 | | Display | LCD digital display | LCD digital display | LCD digital display<br>Identical to both predicates | | Power Source | 4"AA"batteries or AC adapter | 4"AA"batteries or AC adapter | 4"AA"batteries or AC adapter<br>Identical to both predicates | | Operating conditions | 10 to 40 °C (50 to 104 °F)<br>30 to 85 %RH | 10 to 40 °C<br>15 to 90 %RH | 10 to 40 °C<br>15 to 90 %RH<br>Identical to K121932 | | Storage conditions | -20 to 60 °C<br>10 to 95 %RH | -20 to 60 °C<br>10 to 95 %RH | -20 to 60 °C<br>10 to 95 %RH<br>Identical to K121932 | | Dimensions (mm) | 131 (W) x 155 (D) ×84 (H) mm<br>without cuff and battery | 124(W)×161(D)×90(H) mm | 124 (W) x 161 (D) × 90 (H) mm, size is<br>not a factor in function of the device | | Weight | Approx. 420g<br>(not including cuff and batteries) | Approx. 340g<br>(not including battery) | Approx. 380g (13 3/8 oz) (not including<br>battery), weight is not a factor in function<br>of the device. | | Irregular Heart beat Feature | Yes | Yes | Yes, identical to both predicates | | Body movement detection | Yes | Yes | Yes, identical to both predicates | | Hypertension indicator | No | No | Yes, identical to K121932 | | TruRead™ | Yes | Yes | Yes identical to K061822 | Page 4 PDF Page 22 of 158 {4}------------------------------------------------ Technology / Features Comparisons | Technology / Features Comparison | HEM-7080-Z(HEM 780N3) | BP742(HEM-7200-Z) | HEM-7320 | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Power supply | Regulates power voltage regardless of battery voltage. | Regulates power voltage regardless of battery voltage. | Regulates power voltage regardless of battery voltage. Identical to both predicates | | Microprocessor | determines blood pressure and pulse rate<br>controls the pump, the valve, and the display<br>detects switch operations<br>stores measurement results<br>manages date and time | determines blood pressure and pulse rate<br>controls the pump, the valve, and the display<br>detects switch operations<br>stores measurement results<br>manages date and time | determines blood pressure and pulse rate<br>controls the pump, the valve, and the display<br>detects switch operations<br>stores measurement results<br>manages date and time<br>Identical to both predicates | | Pressure sensor | Electrostatic capacitive sensor | Semiconductor pressure sensor | Semiconductor pressure sensor, identical to K121932 | | Rapid exhaust valve | Active electronic control valve that performs cuff air bleeding and release | Automatic rapid air release valve. | Active electronic control valve that performs cuff air bleeding and release, identical to K061822 | | Deflation Valve | | Automatic pressure release valve | | | Inflation source | DC rolling pump | DC rolling pump | DC rolling pump Identical to both predicates | | Display | LCD (Liquid Crystal Display) displays;<br>current cuff pressure<br>systolic blood pressure<br>diastolic blood pressure<br>pulse rate<br>error messages<br>measurement results in the memory | LCD (Liquid Crystal Display) displays;<br>current cuff pressure<br>systolic blood pressure<br>diastolic blood pressure<br>pulse rate<br>error messages<br>measurement results in the memory | LCD (Liquid Crystal Display) displays;<br>current cuff pressure<br>systolic blood pressure<br>diastolic blood pressure<br>pulse rate<br>error messages<br>measurement results in the memory<br>Identical to both predicates | | Controls | START/STOP Button<br>Setting Button<br>Memory button<br>User ID Selections Button<br>Morning/Evening Average Buttons | START/STOP Button<br>Date/Time setting Button<br>Up/Down Button<br>User ID Selections Button | START/STOP Button<br>Date/Time setting Button<br>Up/Down Button<br>User ID Selections Button<br>Identical to K121932 | | | | | And American Manager States of State Annual Property of Children | | | HEM-7080-Z(HEM 780N3 | BP742(HEM-7200-Z) | HEM-7320 | | Cuff | between 9-17 inches(22- 42 cm). The cuff has<br>The cuff is applied to the arm circumference<br>an elasticity board to hold the arm.<br>A PRODUCTION CONTROLLERS CONTRACT CONTROLLET<br>A A M A M A M A B A B A B A B A B A L A L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L L | Wide Range Cuff, Standard Adult Arm Cuff ComFit Cuff(HEM-FL31) 22-42cm, new cuff<br>Large Cuff | to reduce dependence on bladder placement<br>relative to the brachial artery | | Materials | Patient contact materials of the cuff have<br>been cleared in the referenced 510(k) | Patient contact materials of the cuff have been<br>cleared in the referenced 510(k) | been tested in accordance with ISO 10993 and<br>Patient contact matcrials of the cuff have<br>FDA guidance | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | # K133383 Page 5 of 8 PDF Page 23 of 158 Page 5 {5}------------------------------------------------ 510(k) Summary Page 6 {6}------------------------------------------------ #### 510(k) Summary Page 7 of 8 1/30/2014 # Differences Between Other Legally Marketed Predicate Devices: The Omron HEM-7320 is viewed as substantially equivalent to the predicate devices because: The HEM-7320 uses the exact same technology and has identical indications for use. The differences that exist between the devices are insignificant in the terms of safety or effectiveness. #### Indications - The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. Discussion - These indications are identical to the predicate Omron BP742 (K121932). Prescriptive - The HEM-7320 and predicates are all OTC. Design and Technology - The HEM-7320 has equivalent design and features when compared to the predicates and has the identical technology to the predicate. Performance and Specifications - The HEM-7320 has equivalent specifications of performance when compared to the predicate. Compliance with standards - The predicate devices declare compliance with SP10, IEC 60601-1 and IEC 60601-1-2. The HEM-7320 complies with AAMI ANSI ES6060-1 (which replaced IEC 60601-1), IEC 60601-1-2 and ANSI/AAMI/ISO 81060-2 (which replaced SP10). The HEM-7320 also complies with IEC 80601-2-30 and IEC 60601-1-11 for home healthcare. #### Materials - The patient contacting materials of the cuffs has been tested in accordance with ISO 10993-1 and FDA Guidance. The tests included Cytotoxicity, Sensitization, and Intracutancous Reactivity. #### Patient Population - The HEM-7320 and predicates are indicated for adults Environment of Use - Home, Identical to the predicates #### Non-Clinical Testing Summary: We have performed bench tests and found that the HEM-7320 met all requirements specifications and standards requirements and were found to be equivalent in comparison to the predicate. Testing includes the following: - . Verification Testing to insure the device meets its specifications {7}------------------------------------------------ #### 510(k) Summary Page 8 of 8 1/30/2014 - Testing of hazard mitigations . - Testing for compliance to AAMI ANSI ES60601-1 . - . Testing for compliance to IEC 60601-1-2 - Testing for compliance to IEC 80601-2-30 . - Testing for compliance to IEC 60601-1-11 . - Comparative Testing to the predicates . #### Clinical Testing Summary: Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2 as documented in Section 20. Eighty five patients (40 males and 45 females) were recruited for the study. Standard auscultation method was used as the reference blood pressure (BP) measuring in the left upper arm. BP measurements were repeated alternatively with the device and auscultation in the same arm according to the sequence in AAMI. #### Substantial Equivalence Conclusion Omron maintains that the HEM-7320 is substantially equivalent to the predicate device in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards {8}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 4, 2014 Omron Healthcare, Inc. c/o Paul Dryden 24301 Woodsage Dr. Bonita Springs, FL 34134 US Re: K133383 > Trade/Device Name: HEM-7320 Regulation Number: 21 CFR 870.11307 Regulation Name: Noninvasive Blood Pressure Regulatory Class: Class II Product Code: DXN Dated: January 31, 2014 Received: November 6, 2013 #### Dear Paul Dryden: 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. {9}------------------------------------------------ Page 2 - Paul Dryden 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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 its Internet address 796-7100 or at 638 2041 or (301) (800) http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Image /page/9/Picture/7 description: The image shows the phrase "Sincerely yours,". Below the phrase is a signature that is illegible. The signature is written in black ink. The background is white. for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ #### 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) K133383 Device Name Omron HEM-7320 Indications for Use (Describe) The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population. The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. > K133383 Page 1 of 1 Type of Use (Select one or both, as applicable) ] Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. THE CONSULTION CONSULTION FOR FOR FOR FOR FOR CONLY CONLY - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2 - 1 - 3 - Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Image /page/10/Picture/14 description: The image shows a signature and a date stamp. The date on the stamp reads "2014.03.04" and the time is "14:53:17-05'00'". The text "for Bram Zuckerman" is printed below the date stamp.