(91 days)
Not Found
No
The description focuses on standard signal processing and analysis of pulse waveform data, with no mention of AI/ML terms or methodologies. The performance studies are based on traditional clinical accuracy testing and comparisons to a predicate device, not AI/ML model validation.
No.
The device is a digital monitor for measuring blood pressure and pulse rate, which are diagnostic functions, not therapeutic interventions.
Yes
The device measures blood pressure and pulse rate, and detects irregular heartbeats, which are forms of diagnostic information used in healthcare settings.
No
The device description explicitly mentions hardware components such as a battery, AC adaptor, integral pump, electronically controllable valve, and cuffs. The software analyzes data from these hardware components.
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 about a person's health. This testing is 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 cuff. This is a non-invasive measurement performed on the body.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics. It's a non-invasive physiological monitoring 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 and pediatric (> 3 year old) patient population with arm circumference ranging from 5 inches to 20 inches (from 12 cm to 50 cm)
The device also detects the appearance of irregular heartbeats during measurement.
Model – HBP-1300 for prescriptive use by qualified medical personnel in hospitals, acute care settings, outpatient surgery, healthcare practitioner facilities
Product codes
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 five sizes to encompass arms ranging from 5 to 20 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
Arm
Indicated Patient Age Range
adult and pediatric (> 3 year old)
Intended User / Care Setting
Model – HBP-1300 for prescriptive use by qualified medical personnel in hospitals, acute care settings, outpatient surgery, healthcare practitioner facilities
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
Bench tests were performed and found that the HBP-1300 met all requirements specifications and standards requirements and were found to be equivalent in comparison to the predicate. Testing included:
- Verification Testing
- Testing for compliance to IEC 60601-1
- Testing for compliance to IEC 60601-1-2
- Testing for compliance to IEC 80601-2-30
- Testing for compliance to AAMI SP10
- Comparative Testing to the Predicate
Clinical accuracy testing was performed in accordance with ANSI/AAMI/ISO 81060-2 on 50 adults and 35 children, with results showing compliance to the standard.
Key Metrics
Accuracy or pressure indicator: +/- 3 mmHg
Accuracy Pulse Rate: +/-5%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KII3185 11/5
510(k) Summary Page 1 of 5 21-Dec-11
| Omron Healthcare, Inc.
1925 West Field Court
Lake Forest, IL 60045 USA | Tel - 847-247-5626
Fax - 847-247-5626 |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Official Contact: | Mirna DiPano- Director, Quality & Regulatory |
| Proprietary or Trade Name: | Model - HBP-1300 |
| Common/Usual Name: | Noninvasive blood pressure measurement system. |
| Classification Name/Code: | DXN -- Noninvasive blood pressure measurement
system
21CFR 870.1130
Class II |
| Device: | Model - HBP-1300 |
| Predicate Device: | Omron -- HEM-907XL -- K032305 |
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 five sizes to encompass arms ranging from 5 to 20 inches in circumference.
The device also detects the appearance of irregular heartbeats during measurement.
Intended User
Model – HBP-1300 for prescriptive use by qualified medical personnel
Patient Population
This device is intended for use on adults and children of age 3-years and older.
1
510(k) Summary Page 2 of 5 21-Dec-11
Indications for Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult and pediatric (> 3 year old) patient population with arm circumference ranging from 5 inches to 20 inches (from 12 cm to 50 cm)
The device also detects the appearance of irregular heartbeats during measurement.
Environment of Use:
Model - HBP-1300 - Hospital, acute care settings, outpatient surgery, healthcare practitioner facilities
Contraindications
There are no known contraindications.
Summary of substantial equivalence
The HBP-1300 was compared to the predicate HEM-907XL (K032305) in the device comparison table below.
2
510(k) Summary
Device Comparis
| Device Comparison | |||
|---|---|---|---|
| Omron HBP-1300 | Omron HEM-907XL 510(k) K032305 | Comment | |
| Indications for Use | The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult and pediatric (> 3 year old) patient population with arm circumference ranging from 5 inches to 20 inches (from 12cm to 50 cm). | ||
| The device also detects the appearance of irregular heartbeats during measurement. | 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 7 inches to 20 inches (from 17 cm to 50 cm). | ||
| The device also detects the appearance of irregular heartbeats during measurement. | Addition of smaller cuff and pediatric category as appropriate for cuff sizes supported. | ||
| Patient Population | Adult and pediatric (> 3 years old) | Adult | As above |
| Environment of Use | Rx - Hospital, acute care settings, outpatient surgery, healthcare practitioner facilities | OTC | Rx |
| Patient Connection | Yes via cuff | Yes via cuff | identical |
| Technology | Oscillometric | Oscillometric | identical |
| Measurement range | Pressure: 0-300 mmHg | ||
| Pulse rate: 30 to 200 bpm | Pressure: 0-299 mmHg | ||
| Pulse rate: 30 to 199 bpm | Similar | ||
| Accuracy or pressure indicator | +/- 3 mmHg | The higher of +/-3 mmHg or 2% of reading | HBP-1300 more accurate |
| 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 | Yes | No – suggested to use stethoscope when irregular pulse is detected | Identical |
| Power Source | NiMH battery or AC adapter | NiMH battery or AC adapter | Identical |
| Operating Conditions | Temperature: 5° to 40° C | Temperature: 10° to 40° C | Similar |
3
| 21-Dec-11 | |||
|---|---|---|---|
| Storage Conditions | Temperature: -20° to 60° C | ||
| Humidity: 10 to 95% RH | |||
| 123(W) x 201(D) x 99(H) mm | Temperature: -25° to +70 °C | ||
| Humidity: 10 to 90% RH | |||
| 139(W) x 1310(D) x 203(H) mm | Similar | ||
| Slight smaller | |||
| Weighs less | |||
| Dimensions | |||
| Weight | 1.3 lbs | 1.98 lbs | |
| Differences Between Other Legally Marketed Predicate Devices | |||
| The Omron HBP-1300 is viewed as substantially equivalent to the predicate device because: The HBP-1300 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 substantially equivalent. The HBP-1300 is also indicated for use with pediatric (>3 year old) patients and | |||
| has been shown accurate clinically. | |||
| Prescriptive - The HBP-1300 is for prescriptive use. | |||
| Design and Technology - The HBP-1300 has equivalent design and features as the predicate and has the identical technology to the predicate. | |||
| Performance and Specifications - The HBP-1300 has equivalent specifications of performance as the predicate. | |||
| Compliance with standards - The HBP-1300 and predicate device declare compliance with IEC 60601-1 and IEC 60601-1-2. | |||
| Materials - The patient contacting materials of the cuffs has been tested in accordance with ISO 10993-1 and FDA Guidance. | |||
| Environment of Use - | |||
| Model - HBP-1300 - Hospital, acute care settings, outpatient surgery, healthcare practitioner facilities |
4
510(k) Summary Page 5 of 5 21-Dec-11
Patient Population - The HBP-1300 is indicated for adult and pediatric populations, safety and effectiveness for the pediatric application has been demonstrated clinically and in accordance with the applicable FDA recognized consensus standard.
Performance Testing:
We have performed bench tests and found that the HBP-1300 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 IEC 80601-2-30 .
- 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 50 adults and 35 children with results showing compliance to the standard.
Conclusion
Omron maintains that the HBP-1300 is substantially equivalent to the predicate HEM-907XL (K032305) 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 & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 2 7 2012
Omron Healthcare, Inc. c/o Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134
K113185 Re: Trade/Device Name: HBP-1300 Regulatory Number: 21 CFR 870.1130 Regulation Name: 21 OFF 8787115-0
Regulation Name: Non-invasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: 74 DXN Dated: December 21, 2011 Received: December 22, 2011
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premainted is substantially equivalent (for the indications
referenced above and have determined the device is substantials in interstate referenced above and have determined the arredicate devices marketed in interstate for use stated in the encrosure) to regally manced provice Amendments, or to commerce prof to May 20, 1970, the characters and othe provisions of the Federal Food. Drug, devices that have been reciassified in accordance in a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval archaratrals provisions of th and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act You may, therefore, market the uevice, subject to the gainst for amual registration, listing of
general controls provisions of the Act include requirements for annual misbran general controls provisions of the rice listed in and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note: CDRT docs not evaluate informations are truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
in he If your device is classified (See above) into enate elass = (- p.
may be subject to additional controls. Existing major regulations affecting your device can be
6
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 (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/CDRH/CDRHOffices/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,
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K113185
Indications for Use Statement
Page 1 of 1
K113182 510(k) Number:
HBP-1300 Device Name:
Indications for Use:
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult and pediatric (> 3 year old) patient population with arm circumference ranging from 5 inches to 20 inches (from 12 cm to 50 cm)
The device also detects the appearance of irregular heartbeats during measurement.
Model -- HBP-1300 for prescriptive use by qualified medical personnel in hospitals, acute care settings, outpatient surgery, healthcare practitioner facilities
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (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)
ﻟﻤﺴ
Olvision Sign-Off) Division of Cardiovascular Devices
510(k) Number K113185