(58 days)
Not Found
No
The description details standard signal processing and analysis of pulse waveform data to determine blood pressure and pulse rate, which is typical for non-AI/ML blood pressure monitors. There is no mention of AI, ML, or related concepts in the summary.
No.
The device is described as a "digital monitor intended for use in measuring blood pressure and pulse rate," and it "detects the appearance of irregular heartbeats," which are diagnostic or monitoring functions, not therapeutic. It does not treat or cure any condition.
Yes
The device detects irregular heartbeats and gives a warning signal, which is a form of diagnosis, even though its primary function is measurement.
No
The device description explicitly mentions hardware components such as a battery, AC adaptor, pump, electronically controllable valve, and cuffs, indicating it is a physical device with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population." It works by applying pressure to the arm and analyzing the pulse waveform. This is a non-invasive measurement taken directly from the body, not from a specimen.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens.
Therefore, based on the provided information, this device falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN
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 specified Omron cuffs in three sizes to encompass arms ranging from 9 to 17 inches in circumference.
The device also detects the appearance of irregular heartbeats during measurement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arms (for cuff placement)
Indicated Patient Age Range
Adult
Intended User / Care Setting
Intended User: Over the counter
Care Setting: Home
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)
Performance Testing:
- Verification Testing
- Testing for compliance to IEC 60601-1
- Testing for compliance to IEC 60601-1-2
- Testing for compliance to AAMI SP10
- Comparative Testing to the Predicate
- Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2. This testing was performed on 85 adults with results showing compliance to the standard.
Key results: The HEM-7200-Z (BP742) met all requirements specifications and standards requirements and were found to be equivalent in comparison to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of pressure indicator: +/- 3 mmHg or 2% of reading
Accuracy Pulse Rate: +/-5%
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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
0
Premarket Notification 510(k) Section 5 - 510(k) Summary
| 510(k) Summary |
|---|
| Page 1 of 5 |
| 6/27/2012 |
AUG 2 9 2012 Omron Healthcare, Inc. 1925 West Field Court Tel - 847-247-5626 Lake Forest, IL 60045 USA Fax - 847-247-5626 Official Contact: Mirna DiPano- Director, Quality & Regulatory Proprietary or Trade Name: Model HEM-7200-Z (BP742) Common/Usual Name: Noninvasive blood pressure measurement system. Classification Name/Code: DXN - Noninvasive blood pressure measurement system. 21CFR 870.1130 Class II Device: Model HEM-7200-Z (BP742) Predicate Device: Omron - HEM-741CRELN - K052153
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 specified Omron cuffs in three sizes to encompass arms ranging from 9 to 17 inches in circumference.
The device also detects the appearance of irregular heartbeats during measurement.
Intended User Over the counter
Patient Population
This device is intended for use on adults
1
510(k) Summary Page 2 of 5 . 6/27/2012
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.
Summary of substantial equivalence
The HEM-7200-Z (BP742) was compared to the predicate HEM-741CRELN (K052153 ) as in the device comparison table below.
The software algorithm used for determining blood pressure and pulse rate in the HEM-7200-Z (BP742) is identical to that used in the predicate Omron HEM-741CRELN 510(k) K052153.
2
Premarket Notification 510(k)
Section 5—510(k) Summary
Omron HEM-7200-Z (BP742
510(k) Summary
Device Compariso
| Omron Hem-7200-Z (BP742) 510(k) not known | Omron HEM-741CRELN 510(k) K052153 | Comment | |
|---|---|---|---|
| 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. | 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. | Identical | ||
| Patient Population | Adult | Adult | Identical |
| Environment of Use | Home | Home | Identical |
| Prescriptive | OTC | OTC | Identical |
| Patient Connection | Yes via cuff | Yes via cuff | Identical |
| Technology | Oscillometric | Oscillometric | Identical |
| Measurement range | Pressure: 0-299mmHg | ||
| Pulse rate: 40 to 180 bpm | Pressure: 0-299 mmHg | ||
| Pulse rate: 40 to 180 bpm | Identical | ||
| Accuracy or pressure indicator | +/- 3 mmHg or 2% of reading | +/-3 mmHg or 2% of reading | identical |
| Accuracy Pulse Rate | +/-5% | +/-5% | Identical |
| Inflation Method | DC rolling pump | DC rolling pump | Identical |
| Deflation Method | Dynamic linear deflation | Dynamic linear deflation | Identical |
| Display Type | LCD | LCD | Identical |
| Irregular pulse detection | Yes | Yes | Identical |
| Auscultatory | No | No | Identical |
| Power Source | AA battery or AC adapter | AA battery or AC adapter | Identical |
| Operating Conditions | Temperature: 10° to 40° C | ||
| Humidity: 15 to 90% RH | Temperature: 10° to 40° C | ||
| Humidity: 30 to 85% RH | Similar | ||
| Storage Conditions | Temperature: -20° to 60° C | ||
| Humidity: 10 to 95% RH | Temperature: -20° to 60° C | ||
| Humidity: 10 to 95% RH | Identical | ||
| Dimensions | 141 mm (L) x 123 mm (W) × 85 mm (H) | 141 mm (L) x 121 mm (W) × 86 mm (H) | Similar |
| Weight | 12 oz | 12 3/4 oz | Similar |
PDF Page 17 of 526
3
510(k) Summary Page 4 of 5 6/27/2012
Differences Between Other Legally Marketed Predicate Devices
The OmronHEM-7200-Z (BP742) is viewed as substantially equivalent to the predicate device because: The HEM-7200-Z (BP742) uses the exact same technology and has substantially equivalent indications for use. The differences that exist between the devices are insignificant in the terms of safety or effectiveness.
Indications -
The indications for use are identical
Prescriptive - The HEM-7200-Z (BP742) and H HEM-741CRELN are both OTC.
Design and Technology - The HEM-7200-Z (BP742) has equivalent design and features as the predicate and has the identical technology to the predicate.
Performance and Specifications - The HEM-7200-Z (BP742) has equivalent specifications of performance as the predicate.
Compliance with standards - The HEM-7200-Z (BP742) and predicate device declare compliance with IEC 60601-1 and IEC 60601-1-2.
Materials -
The patient contact materials of the device (the cuffs) have been cleared in other 510(k) submissions as described in Section 15 - Biocompatibility. Materials are detailed in Section 15 as well.
Environment of Use -
The HEM-7200-Z (BP742) and predicate are both intended for home use
Patient Population -
The HEM-7200-Z (BP742) and predicate are both for adult populations
4
510(k) Summary Page 5 of 5 6/27/2012
Performance Testing:
We have performed bench tests and found that the HEM-7200-Z (BP742) met all requirements specifications and standards requirements and were found to be equivalent in comparison to the predicate. Testing includes the following:
- . Verification Testing
- . Testing for compliance to IEC 60601-1
- . Testing for compliance to IEC 60601-1-2
- . Testing for compliance to AAMI SP10
- Comparative Testing to the Predicate .
Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2. This testing was performed on 85 adults with results showing compliance to the standard.
Conclusion
Omron maintains that the HEM-7200-Z (BP742) is substantially equivalent to the predicate HEM-741CRELN (K052153 ) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 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 enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding the top half of the circle. The text is written in a sans-serif font and is arranged to follow the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 29 2012
Omron Healthcare, Inc. c/o Paul Dryden ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134
Re: K121932
Trade/Device Name: HEM-7200-Z (BP742) Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: II (two) Product Code: DXN Dated: June 27, 2012 Received: July 2, 2012
Dear Mr. 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.
6
Page 2 - Mr. Paul Dryden
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K121932
Indications for Use Statement
Page 1 of 1
510(k) Number: (To be assigned)
Device Name: HEM-7200-Z (BP742)
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.
Prescription Use
(Part 21 CFR 801 Subpart D)
or
Over-the-counter use XX (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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number
Page 4.2 PDF Page 14 of 520