HEM-9210T

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 20, 2017 Omron Healthcare, Inc. % Paul Dryden, Consultant Promedic. LLC 24301 Woodsage Dr. Bonita Springs, Florida 34134 Re: K163235 Trade/Device Name: HEM-9210T Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: March 22, 2017 Received: March 23, 2017 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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. Mude Jellman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K163235 Device Name Omron Healthcare HEM-9210T 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. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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" FORM FDA 3881 (8/14 Page 1 of 1 SC Publishing Services (301) 443-6740 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. PDF PAGE 36 of 867 {3}------------------------------------------------ | 510(k) Summary | |----------------| | Page 1 of 8 | | 11/15/2016 | | Omron Healthcare, Inc. | | |----------------------------|---------------------------------------------------------------------------------------| | 1925 West Field Court | | | Lake Forest, IL 60045 USA | | | Official Contact: | Renee Thornborough – Executive Director QA/RA | | Proprietary or Trade Name: | Model HEM-9210T | | Common/Usual Name: | Noninvasive blood pressure measurement system. | | Classification Name/Code: | DXN – Noninvasive blood pressure measurement<br>system.<br>21CFR 870.1130<br>Class II | | Device: | Model HEM-9210T | | Predicate Device: | Omron HEM-7311 K133379 | ### 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 Omron specified cuffs as specified below - Small 17-22cm arm cuff - circumference (PN: HEM-CS24) - Medium 22-42cm arm cuff circumference (PN: HEM-RML31) ● - . Extra Large (XL) cuff arm circumference 42-50cm (PN: HEM-RXL31) The device also detects the appearance of irregular heartbeats during measurement. The device can also send measurement data to third party applications. Transmission is via an integral FCC compliant Bluetooth Low Energy (BLE) module. ## Intended User Home user {4}------------------------------------------------ #### 510(k) Summary Page 2 of 8 11/15/2016 ### 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-9210T was compared to the predicate HEM-7311- K133379 in the device comparison table below. {5}------------------------------------------------ K163235 Omron HEM-9210T #### 510(k) Summary Page 3 of 8 11/15/2016 #### Device Comparison | | Predicate Devices | New Device | Comparison | | |---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------| | Model Name: | HEM-7311 | HEM-9210T | - | | | 510(k) Number | K133379 | --- | - | | | Indications | The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.<br>The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. | The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population.<br>The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings. | Identical | | | | Environmental of Use | Home | Home | Identical | | | Patient Population | Adult | Adult | Identical | #### Specifications / Features | Specification | HEM-7311 | HEM-9210T | Comparison | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------| | Measurement method | Cuff oscillometric method | Cuff oscillometric method | Identical | | Measurement range | 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. | Identical | | Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | Identical | | 510(k) Summary<br>Page 4 of 8<br>11/15/2016 | | | | | Specification | HEM-7311 | HEM-9210T | Comparison | | Applicable cuff<br>(Arm Circumference) | 17-22cm (HEM-CS24)<br>22-32cm (HEM-CR24)<br>22-42cm (HEM-RML31) | 17-22cm (HEM-CS24)<br>Cleared under K133379<br>22-42cm (HEM-RML31)<br>Cleared under K133379 | Similar to predicate,<br>additional range clinically<br>validated. | | | | 42-50cm (HEM-RXL31)<br>(New) | | | Accuracy of pressure indicator | Within ±3 mmHg or 2 % of reading | Within ±3 mmHg or 2 % of reading | Identical | | Accuracy of pulse rate | Within ±5 % of reading | Within ±5 % of reading | Identical | | Inflation method | Automatic by electric pump | Automatic by electric pump | Identical | | Deflation method | Automatic pressure release valve | Automatic pressure release valve | Identical | | Display | LCD digital display | LCD digital display | Identical | | Power Source | 4"AA"batteries or AC adapter | 4"AA"batteries or AC adapter | Identical | | Operating conditions | 10 to 40 °C<br>15 to 90 %RH | 10 to 40 °C<br>15 to 90 %RH | Identical | | Storage conditions | -20 to 60 °C<br>10 to 95 %RH | -20 to 60 °C<br>10 to 95 %RH | Identical | | Dimensions (mm) | 183 (W) × 230 (D) × 99 (H) mm | 107 (W) × 141 (D) × 79 (H) mm | Similar in size. Size is not a<br>factor in function of the<br>device | | Weight | Approx. 640g ( 1 lbs6 5/8 oz)<br>(not including battery) | Approx. 290g (10oz)<br>(not including battery) | Similar weight. Weight is<br>not a factor in function of<br>the device | | Irregular Heart beat Feature | Yes | Yes | Identical | | Page 5 of 8<br>11/15/2016 | | | | | Specification | HEM-7311 | HEM-9210T | Comparison | | Body movement detection | Yes | Yes | Identical | | Hypertension indicator | Yes | No | This feature does not affect<br>fundamental BP<br>measurement function | | Average of latest three measurements | Yes | No | This feature does not affect<br>fundamental BP<br>measurement function | | Provides an average of 3<br>measurements | Yes | No | This feature does not affect<br>fundamental BP<br>measurement function | | Multiple Users | Yes (2) | No | This feature does not affect<br>fundamental BP<br>measurement function | | Bluetooth | No | Yes | This feature does not affect<br>fundamental BP<br>measurement function | | Power supply | Regulates power voltage regardless of<br>battery voltage. | Regulates power voltage regardless of<br>battery voltage. | Identical | | Microprocessor | determines blood pressure and<br>pulse rate<br>controls the pump, the valve, and<br>the display<br>detects switch operations<br>stores measurement results<br>manages date and time | determines blood pressure and pulse<br>rate<br>controls the pump, the valve, and<br>the display<br>detects switch operations<br>stores measurement results<br>manages date and time | Identical | | Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor | Identical | | Specification | HEM-7311 | HEM-9210T | Comparison | | Rapid exhaust valve / Deflation<br>Valve | Active electronic control valve that<br>performs cuff air bleeding and release | Active electronic control valve that<br>performs cuff air bleeding and release | Identical | | Inflation source | DC rolling diaphragm pump | DC rolling diaphragm pump | Identical | | Display | LCD (Liquid Crystal Display) displays;<br>current cuff pressure systolic blood pressure diastolic blood pressure pulse rate error messages measurement results in the<br>memory | LCD (Liquid Crystal Display) displays;<br>current cuff pressure systolic blood pressure diastolic blood pressure pulse rate error messages | Similar, no memory function | | Controls | START/STOP Button Date/Time setting Button Up/Down Button User ID Selections Button | START/STOP Button | Simplified | | Cuff (included with device) | Soft Cuff(HEM-RML31) 22-42cm | Soft Cuff(HEM-RML31) 22-42cm | Identical | | Biocompatibility of materials | Surface contact<br>Skin<br>Limited duration of use < 24 hours | Surface contact<br>Skin<br>Limited duration of use < 24 hours | Identical | {6}------------------------------------------------ K163235 Omron HEM-9210T {7}------------------------------------------------ {8}------------------------------------------------ K163235 Omron HEM-9210T #### 510(k) Summary Page 6 of 8 11/15/2016 {9}------------------------------------------------ ### 510(k) Summary Page 7 of 8 11/15/2016 ### Differences Between Other Legally Marketed Predicate Devices: The Omron HEM-9210T is viewed as substantially equivalent to the predicate device because: The HEM-9210T uses the exact same technology and has identical indications for use. The differences that exist between the devices do not raise new issues 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 HEM-7311 510(k) K133379 Prescriptive - The HEM-9210T and predicate are OTC. Design and Technology - The HEM-9210T has equivalent design and features when compared to the predicate and has the identical technology to the predicate. Performance and Specifications – The HEM-9210T has equivalent specifications of performance when compared to the predicate. ### Materials - The HEM-CS24 and HEM-RML31 cuffs are identical to the cuffs cleared in the predicate. The patient contacting materials of the cuffs inclusive of the HEM-RXL31 have been tested in accordance with ISO 10993-1 and FDA Guidance. The tests included Cytotoxicity, Sensitization, and Irritation ### Patient Population - The HEM-9210T and predicate are indicated for adults Environment of Use - Home, Identical to the predicate Compliance with standards The HEM-9210T and predicate comply with AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 80601-2-30, and ANSI/AAMI/ISO 81060-2. ### Differences - There are no differences between the proposed device and the predicate device that raise any new safety and efficacy concerns. {10}------------------------------------------------ #### 510(k) Summary Page 8 of 8 11/15/2016 ## Performance Testing ## Non-clinical Testing #### Bench We have performed bench tests and found that the HEM-9210T met all requirements specifications and standards requirements and was found to be equivalent in comparison to the predicate. Testing includes the following: - Verification Testing - Testing for compliance to AAMI ES 60601-1 - Testing for compliance to IEC 60601-1-2, ● - Testing for compliance to IEC 60601-1-11 - Testing for compliance to IEC 80601-2-30 ● - . Comparative Testing to the predicate The results demonstrate that the devices perform as intended are substantially equivalent to the performance of the predicate and in accordance with applicable standards. ## Biocompatibility of Materials - The patient contacting materials of the cuff have been tested in accordance with ISO 10993-1 for Cytotoxicity, Sensitization, and Irritation. ISO 10993-1 considered the patient contacting as Surface, Skin, Limited duration of use. ## Human Factors / Usability We performed usability with 18 lay users. There were no failures, user errors or near misses. ### Clinical Testing Summary: Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2. This testing was performed on 92 patients with results showing compliance to the standard. ## Substantial Equivalence Conclusion Omron maintains that the HEM-7311 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