(128 days)
Not Found
No
The description mentions a "minor modification of the predicate algorithm" for determining blood pressure and pulse rate, and the detection of irregular heartbeats. There is no mention of AI, ML, deep learning, or any related concepts. The performance studies focus on standard bench testing and clinical accuracy against a predicate device, not on training or validation of an AI/ML model.
No
The device is a digital monitor for measuring blood pressure and pulse rate, providing warnings for irregular heartbeats, but it does not treat or alleviate any condition.
Yes
The device measures physiological parameters (blood pressure and pulse rate) and detects irregular heartbeats, which are indicators providing information about a patient's health status. While it does not provide a definitive diagnosis, it offers data that can be used to monitor health and identify potential health issues, fitting the broad definition of a diagnostic device.
No
The device description explicitly states it is an "automatic non-invasive blood pressure system" that includes hardware components such as a wrist cuff, integral pump, electronically controllable valve, and is battery powered. While it uses software for analysis, it is not solely 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 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 non-invasive method (a cuff on the wrist). It does not analyze samples taken from the body.
Therefore, based on its intended use and how it functions, 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 with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).\nThe 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 by 2 "AAA" batteries, there is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During inflation 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 algorithm used to determine pulse rate, systolic and diastolic pressure is a minor modification of the predicate algorithm.
The device has a memory function that automatically stores up to 100 of the latest measurements. It can also display an average of the last three values
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
wrist
Indicated Patient Age Range
Adult
Intended User / Care Setting
Home user
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 BP652N 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy or 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
Omron BP652N (HEM-6300-Z)
| | 510(k) Summary
Page 1 of 5
11/12/2012 |
|--------------------------------------|------------------------------------------------|
| Omron Healthcare, Inc. | |
| 1925 West Field Court | Tel - 847-247-5626 |
| Lake Forest, IL 60045 USA | Fax- 847-680-5626 |
| Official Contact: | Renee Thornborough - Director QA/RA |
| Proprietary or Trade Name: | Model BP652N(HEM-6300-Z) |
| Common/Usual Name: | Noninvasive blood pressure measurement system. |
| Classification Name/Code:
system. | DXN - Noninvasive blood pressure measurement |
| | 21CFR 870.1130 |
| | Class II |
| Device: | Model BP652N(HEM-6300-Z) |
Predicate Device:
Omron – HEM-609N (HEM-6001-Z) - K042505
Device Description:
The device is an automatic non-invasive blood pressure system. The device is battery powered by 2 "AAA" batteries, there is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During inflation 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 algorithm used to determine pulse rate, systolic and diastolic pressure is a minor modification of the predicate algorithm.
The device has a memory function that automatically stores up to 100 of the latest measurements. It can also display an average of the last three values
The device also detects the appearance of irregular heartbeats during measurement.
PDF Page 15 of 810
Intended User Home user
Patient Population
This device is intended for use on adults.
MAR 2 1 2013
1
Premarket Notification 510(k) Section 5 - 510(k) Summary
Omron BP652N (HEM-6300-Z)
510(k) Summary Page 2 of 5 11/12/2012
Indications for Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).
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 BP652N(HEM-6300-Z) was compared to the predicate HEM-609N (K042505) as in the device comparison table below.
PDF Page 16 of 810
2
remarket Notification 510(
·
mron BP652N (HEM-6300-2
·
.
: :
| Device Comparison | Omron BP652N (HEM-6300-Z) | Omron HEM-609N 510(k) K042505 | Comment |
|---|---|---|---|
| Indications for Use | The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm). | ||
| 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 with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm). | ||
| 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 | No | Identical |
| Patient Connection | Yes via cuff | Yes via cuff | Identical |
| Technology | Oscillometric | Oscillometric | Identical |
| Measurement range | Pressure: 0-299 mmHg | ||
| Pulse rate: 40 to 180 bpm | Pressure: 0-299 mmHg | ||
| Pulse rate: 40 to 180 bpm | Identical | ||
| Pressure sensor | Piezo resistance sensor | Silicone capacitive sensor r | Similar |
| Accuracy or pressure indicator | $+/-3 mmHg$ or 2% of reading | $+/-3 mmHg$ | Similar |
| Accuracy Pulse Rate | $+/-5%$ | $+/-5%$ | Identical |
| Inflation Method | Piezo-electric pump | DC pump | Similar |
| Deflation Method | Internal valve | Internal valve | Identical |
| Display Type | LCD | LCD | Identical |
| Irregular pulse detection | Yes | Yes | Identical |
| Power Source | AAA batteries | AAA batteries | Identical |
| Operating Conditions | Temperature: 10° to 40° C | ||
| Humidity: 15 to 85% 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 | 89(W) x 61(D) x 13(H) mm | 70(W) x 54(D) x 37(H) mm | Similar |
| Weight | 80g | 110g | Similar |
:
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Page 5.3
PDF Page 17 of 81
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3
Omron BP652N (HEM-6300-Z)
510(k) Summary Page 4 of 5 11/12/2012
Differences Between Other Legally Marketed Predicate Devices
The Omron BP652N is viewed as substantially equivalent to the predicate device because: The BP652N 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 indications for use are identical.
Prescriptive - The BP652N and predicate are both OTC.
Design and Technology - The BP652N has equivalent design and features as the predicate and has the identical technology to the predicate.
Performance and Specifications - The BP652N has equivalent specifications of performance as the predicate.
Compliance with standards - The BP652N and predicate device declare compliance with SP10, IEC 60601-1 and IEC 60601-1-2. 100 - 100 -
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 BP652N and predicate are indicated for adults
Non-Clinical Testing Summary:
We have performed bench tests and found that the BP652N 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
PDF Page 18 of 810
4
Premarket Notification 510(k) Section 5 - 510(k) Summary
Omron BP652N (HEM-6300-Z)
510(k) Summary Page 5 of 5 11/12/2012
Testing to insure clinical accuracy of the device in accordance with ANSI/AAMI/ISO 81060-2.
Substantial Equivalence Conclusion
Omrop maintains that the RD652N is substantially equivalent to the predicate
Omron maintains that the BP652N is substantially equivalent to the predicate HEM-609N (K042505) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards
PDF Page 19 of 810
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5
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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 21, 2013
Omron Healthcare, Inc. c/o Mr. Paul Dryden, President ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134
Re: K123498
Trade/Device Names: BP652N (HEM-6300-Z) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: February 14, 2013 Received: February 15, 2013
Dear Mr. 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.
6
Page 2 - Mr. Paul Dryden, President
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 (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 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen Pyraris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K123498
Indications for Use Statement
Page 1 of 1
510(k) Number:
Device Name:
Omron BP652N (HEM-6300-Z)
(To be assigned)
Indications for Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm).
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)
Owen P. Faris -
2013.03.21
08:54:03 -04'00