(73 days)
Not Found
No
The description details standard signal processing and analysis of pulse waveform data to determine blood pressure and pulse rate, without mentioning AI or ML techniques. The irregular heartbeat detection is also described as a standard feature, not explicitly linked to AI/ML.
No
The device is a digital monitor for measuring blood pressure and pulse rate, not for providing therapy.
No
The device is described as a "digital monitor intended for use in measuring blood pressure and pulse rate." While it detects irregular heartbeats and gives a warning signal with readings, this feature is for alerting the user to a potential issue rather than providing a diagnosis of a medical condition. A diagnostic device would typically offer information about the presence, nature, or extent of a disease.
No
The device description explicitly mentions hardware components such as a battery, AC adaptor, pump, electronically controllable valve, and a cuff. It is an automatic non-invasive blood pressure system, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device function: The described device is a blood pressure monitor. It measures physiological parameters (blood pressure and pulse rate) directly from the patient's body using a cuff and sensors. This is an in vivo measurement, not an in vitro test on a sample.
- Intended Use: The intended use clearly states it's for "measuring blood pressure and pulse rate in adult patient population." This is a direct physiological measurement.
Therefore, based on the provided information, the device is 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm
Indicated Patient Age Range
Adult
Intended User / Care Setting
Home user
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)
Non-Clinical Testing Summary:
We have performed bench tests and found that the HEM-7311 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 .
- Testing of hazard mitigations .
- Testing for compliance to AAMI ANSI ES 60601-1 .
- 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 predicate .
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 (39males and 46 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy of pressure indicator: Within +/- 3 mmHg or 2 % of reading
Accuracy of pulse rate: Within +/- 5% of reading
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 7 11/1/2013
JAN 16 2014
| Omron Healthcare, Inc.
1925 West Field Court
Lake Forest, IL 60045 USA | Tel - 847-247-5626
Fax- 847-680-6269 |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Official Contact: | Renee Thornborough – Director QA/RA |
| Proprietary or Trade Name: | Model HEM-7311 |
| 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-7311 |
| Predicate Devices: | 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.
Intended User
Home user
Patient Population
This device is intended for use on adults.
PDF PAGE 38 of 1228
1
510(k) Summary Page 2 of 7 11/1/2013
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-7311was compared to the predicate BP742 (HEM-7200-Z) -- K121932 in the device comparison table below.
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
2
Premarket Notification 510(
Omron HEM-731
510(k) Summary
evice Compariso
| Predicate Device | New Device | |
|---|---|---|
| Model Name: | BP742(HEM-7200-Z) | HEM-7311 |
| 510(k) Number | K121932 | TBD |
| 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. | 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 to predicate | ||
| Environment of Use | Home | Home Identical to predicate |
| Patient Population | Adult | Adult Identical to predicate |
| Specifications / Features | ||
| Measurement method / | ||
| Principal of operation | BP742(HEM-7200-Z) | |
| Cuff oscillometric method | HEM-7311 | |
| Cuff oscillometric method. Identical to predicate | ||
| Measurement range | Pressure: 0 to 299 mmHg | |
| Pulse Rate: 40 to 180 beats/min. | Pressure: 0 to 299 mmHg | |
| Pulse Rate: 40 to 180 beats/min. | ||
| Identical to predicate | ||
| Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor. Identical to predicate |
| Applicable cuff | ||
| (Arm Circumference) | 22-42cm | (small 17-22cm), standard (22-32cm) and (large 22-42cm), similar to predicate, additional range clinically validated |
| Accuracy of pressure indicator | Within $\pm$ 3 mmHg or 2 % of reading | Within $\pm$ 3 mmHg or 2 % of reading Identical to predicate |
| Accuracy of pulse rate | Within $\pm$ 5% of reading | Within $\pm$ 5% of reading |
| Identical to predicate |
3
Premarket Notification 510(k)
Section 5 – 510(k) Summary
Omron HEM-731
| 510(k) Summary | Page 4 of 7 | 11/1/2012 |
|---|---|---|
| ---------------- | ------------- | ----------- |
| Page 4 of 7
| 11/1/2013 | ||
|---|---|---|
| BP742(HEM-7200-Z) | HEM-7311 | |
| Inflation method | Automatic by electric pump | Automatic by electric pump. |
| Identical to predicate | ||
| Deflation method | Automatic pressure release valve | Automatic pressure release valve Identical to predicate |
| Display | LCD digital display | LCD digital display |
| Identical to predicate | ||
| Power Source | 4"AA"batteries or AC adapter | 4"AA" batteries or AC adapter |
| Identical to predicate | ||
| Operating conditions | 10 to 40 °C | |
| 15 to 90 %RH | 10 to 40 °C | |
| 15 to 90 %RH | ||
| Identical to predicate | ||
| Storage conditions | -25 to 60 °C | |
| 10 to 95 %RH | -20 to 60 °C | |
| 10 to 95 %RH | ||
| similar to predicate | ||
| Dimensions (mm) | 123(W) × 141(D) × 85 (H) mm | 183 (W) × 230 (D) × 99 (H) mm, size is not a factor in |
| function of the device | ||
| Weight | Approx. 340g | |
| (not including battery) | Approx. 640g (22 5/8 oz) (not including battery), weight is not a | |
| factor in function of the device. | ||
| Irregular Heart beat Feature | Yes | Yes, Identical to predicate |
| Body movement detection | Yes | Yes, Identical to predicate |
| Hypertension indicator | Yes | Yes, Identical to predicate |
| TruRead™ | No | Provides an average of 3 measurements |
| Technology / Features Comparison | ||
| Power supply | BP742(HEM-7200-Z) | |
| Regulates power voltage regardless of battery voltage. | HEM-7311 | |
| Regulates power voltage regardless of battery voltage. Identical | ||
| to predicate | ||
| Page 5 of 7 | ||
| 11/1/2013 | ||
| BP742(HEM-7200-Z) | HEM-7311 | |
| Microprocessor | determines blood pressure and pulse rate | |
| controls the pump, the valve, and the display | ||
| detects switch operations | ||
| stores measurement results | ||
| manages date and time | determines blood pressure and pulse rate | |
| controls the pump, the valve, and the display | ||
| detects switch operations | ||
| stores measurement results | ||
| manages date and time | ||
| Identical to predicate | ||
| Pressure sensor | Semiconductor pressure sensor | Semiconductor pressure sensor, Identical to predicate |
| Rapid exhaust Valve | Automatic rapid air release valve. | |
| Deflation Valve | Automatic pressure release valve | Active electronic control valve that performs cuff air bleeding and |
| release, identical in function to predicate | ||
| Inflation source | DC rolling pump | DC rolling pump Identical to predicate |
| Display | LCD (Liquid Crystal Display) displays; | LCD (Liquid Crystal Display) displays; |
| current cuff pressure | current cuff pressure | |
| systolic blood pressure | systolic blood pressure | |
| diastolic blood pressure | diastolic blood pressure | |
| pulse rate | pulse rate | |
| error messages | error messages | |
| measurement results in the memory | measurement results in the memory | |
| Identical to predicate | ||
| Controls | START/STOP Button | |
| Date/Time setting Button | ||
| Up/Down Button | ||
| User ID Selections Button | START/STOP Button | |
| Date/Time setting Button | ||
| Up/Down Button | ||
| User ID Selections Button | ||
| Identical to predicate | ||
| Cuff | Wide Range Cuff, Standard Adult Arm Cuff, Large Cuff HEM-CS24 (small 17-22cm), HEM-CR24 (standard 22-32cm) | |
| and Soft Cuff HEM-RML31 (large 22-42cm) | ||
| Materials | Patient contact materials of the cuff have been cleared | |
| in the referenced 510(k) | Patient contact materials of the cuff have been tested in | |
| accordance with ISO 10993 and FDA guidance |
4
Premarket Notification 510(k)
Section 5 – 510(k) Summary
Omron HEM-7311
.
510(k) Summary
:
5
510(k) Summary Page 6 of 7 11/1/2013
Differences Between Other Legally Marketed Predicate Devices:
The Omron HEM-7311 is viewed as substantially equivalent to the predicate device because: The HEM-7311 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-7311 and predicate are OTC.
Design and Technology - The HEM-7311 has equivalent design and features when compared to the predicate and has the identical technology to the predicate.
Performance and Specifications - The HEM-7311 has equivalent specifications of performance when compared to the predicate.
Compliance with standards - The predicate device complies with SP10, IEC 60601-1 and IEC 60601-1-2. The HEM-7311 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-7311 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 Intracutaneous Reactivity.
Patient Population -
The HEM-7311 and predicate are indicated for adults
Environment of Use - Home, Identical to the predicate
Non-Clinical Testing Summary: .
We have performed bench tests and found that the HEM-7311 met all requirements specifications and standards requirements and were found to be equivalent in comparison to the predicate. Testing includes the following:
6
510(k) Summary Page 7 of 7 11/1/2013
- Verification Testing to insure the device meets its specifications .
- Testing of hazard mitigations .
- Testing for compliance to AAMI ANSI ES 60601-1 .
- 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 predicate .
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 (39males and 46 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-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
7
Public Health Service
Image /page/7/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2014
Omron Healthcare, Inc. c/o Paul Dryden ProMedic. Inc 24301 Woodsage Dr. Bonita Springs, FL 34134 US
Re: K133379
.
Trade/Device Name: Hem-7311 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: November 19, 2013 Received: November 20, 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.
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.
8
Page 2 - Paul Dryden
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 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Owen P. Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use Statement
Page I of I
510(k) Number: (To be assigned)
Device Name:
Omron HEM-7311
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.
Environments of Use: Home Patient Population: Adult
| 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)
Digitally signed by
Owen P. Faris -S
Date: 2014.01.16
10:10:39-05'00'
Page 4.2