(22 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a slightly modified version of a predicate device with identical features, functions, and technologies except for the cuff design. There is no mention of any AI/ML capabilities in the intended use or device description.
No
The device is described as a monitor that measures blood pressure and pulse rate, and it explicitly states it is "not intended to be a diagnostic device." It is for "home use" and provides "warning signals" for irregular heartbeats and compares results to hypertension guidelines, but these are for informational purposes rather than direct treatment or diagnosis.
No
The "Intended Use / Indications for Use" section explicitly states, "The Omron 1500Pro model is not intended to be a diagnostic device."
No
The device description explicitly states it is a "blood pressure monitor" and mentions a "cuff design," indicating it includes hardware components for measuring blood pressure.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "measuring blood pressure and pulse rate" and is "not intended to be a diagnostic device."
- Device Description: The description focuses on monitoring blood pressure and pulse rate, which are physiological measurements, not in vitro tests.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (like blood, urine, etc.) or any in vitro testing procedures.
The device is a blood pressure monitor, which is a medical device used for physiological measurement, not an in vitro diagnostic device.
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 arm circumference ranging from 9 to 17 inches (22 - 42 cm) via an "arm in" cuff.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guidelines of 135/85 mm Hg.
The Omron 1500Pro model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. It is intended as an OTC device for home use.
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The Omron 1500Pro blood pressure monitor is a slightly modified version of the HEM-780N3 (K061822) blood pressure monitor.
The 1500Pro blood pressures monitor is intended to monitor:
- . Blood pressure
- . Pulse rate
The difference between the proposed 1500 Pro and the HEM-780N3 has to do with the cuff design. All other features, functions and technologies are identical to the predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arm
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home settings
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
Omron 1500 Pro
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 4 1-Feb-08
| Omron Healthcare, Inc. | |
|---|---|
| 1200 Lakeside Dr. | Tel - 847-247-5609 |
| Bannockburn, IL 60015 | Fax - 847-680-6269 |
| Official Contact: | Ranndy Kellogg - VP Marketing & Product Development |
| Proprietary or Trade Name: | 1500 Pro monitor |
| Common/Usual Name: | Monitor, Physiological, Patient (without arrhythmia detection or |
| alarms) | |
| Classification Name/Code: | DXN - System, Measurement, Blood-pressure, Non-invasive |
| Device: | Model - 1500 Pro |
| Predicate Devices: | Omron – HEM 780N3 – K061822 |
Device Description:
The Omron 1500Pro blood pressure monitor is a slightly modified version of the HEM-780N3 (K061822) blood pressure monitor.
The 1500Pro blood pressures monitor is intended to monitor:
- . Blood pressure
- . Pulse rate
The difference between the proposed 1500 Pro and the HEM-780N3 has to do with the cuff design. All other features, functions and technologies are identical to the predicate.
Indications for Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 to 17 inches (22 - 42 cm) via an "arm in" cuff.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guidelines of 135/85 mm Hg.
The Omron 1500Pro model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. It is intended as an OTC device for home use.
1
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 3 1-Feb-08
Adults Patient Population:
Environment of Use: Home settings
Contraindications: None
Summary of substantial equivalence
| Model Name:
Specification | New device
1500 PRO | Predicate - K061822
HEM-780N3 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Measurement method | Cuff oscillometric method | Cuff oscillometric method |
| Measurement range | Pressure: 0 to 294 mmHg
Pulse Rate: 40 to 180 beats/min. | Pressure: 0 to 299 mmHg
Pulse Rate: 40 to 180 beats/min. |
| Pressure sensor | Electrostatic capacitive sensor | Electrostatic capacitive sensor |
| Applicable cuff | Arm-in / Mounted cuff | Wrap around cuff |
| Accuracy of pressure indicator | Within ±3 mmHg or 2 % of reading | Within ±3 mmHg or 2 % of reading |
| Accuracy of pulse rate | Within ±5 % of reading | Within ±5 % of reading |
| Cuff inflation | Automatic inflation with air pump | Automatic inflation with air pump |
| Pressure sensor | Semiconductor pressure sensor for
wrapping cuff. | None |
| Slow cuff deflation (bleeding) | Deflation rate is controlled by an active
electronic control valve by 4 to 11
mmHg/s depending on pulse rate. | Deflation rate is controlled by an active
electronic control valve by 4 to 11
mmHg/s depending on pulse rate. |
| Rapid air release | By an active electronic control valve | By an active electronic control valve |
| Automatic shutting-down time | 5 minutes after a measurement
completion | 5 minutes after a measurement
completion |
| Irregular heart beat indication | displays an irregular heart beat symbol
when 2 irregular heart beats were
detected during a measurement. | displays an irregular heart beat symbol
when 2 irregular heart beats were
detected during a measurement. |
| Power source | AC adapter only | Battery (type "AA" × 4) or AC adapter |
| Display | Liquid crystal digital display | Liquid crystal digital display |
| Operating conditions | 10 to 40 °C (50 to 104 °F)
15 to 90 %RH | 10 to 40 °C (50 to 104 °F)
15 to 90 %RH |
| Storage conditions | -20 to 60 °C (-4 to 140 °F)
10 to 95 %RH | -20 to 60 °C (-4 to 140 °F)
10 to 95 %RH |
| Dimensions (mm) | 294 (W) × 286 (D) × 271 (H) mm | 131 (W) × 155 (D) × 85 (H) mm |
| Weight (not including batteries) | Approx. 2600g | Approx. 350g |
2
Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 1-Feb-08
Differences Between Other Legally Marketed Predicate Devices
The Model 1500 Pro is viewed as substantially equivalent to the following predicate device - Omron HEM 780N3 - K061822.
The difference between the two devices is the style of cuff. 1500 pro has an "arm-in" style and the predicate a wrap around style cuff. All other features, specifications, etc. are otherwise identical.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
3
Image /page/3/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
FEB 2 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Omron Healthcare, Inc. c/o Mr. Paul Dryden President ProMedic, Inc. 3460 Pointe Creek Court # 102 Bonita Springs, FL 34134
Re: K080289
1 500 Pro Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system Regulatory Class: Class II (two) Product Code: DXN Dated: February 01, 2008 Received: February 06, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2 - Mr. 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bfhimmerforfr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KO80289
Indications for Use Statement
Page 1 of 1
510(k) Number: (To be assigned)
Device Name: 1500 Pro
Indications for Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with arm circumference ranging from 9 to 17 inches (22 -42 cm) via an "arm in" cuff.
The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.
This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guidelines of 135/85 mm Hg.
The Omron 1500Pro model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.
It is intended as an OTC device for home use.
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)
Blummen
Division of Cardiovascular Devices
510(k) Number K080289