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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Pressure Accuracy	+/- 3 mmHg
Pulse Rate Accuracy	+/- 5%
Patient Population	Adult and pediatric (> 3 years old) with arm circumference from 5 to 20 inches. Demonstrated safety and effectiveness for pediatric application.
Compliance with Standards	IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, AAMI SP10, ANSI/AAMI/ISO 81060-2. Materials tested in accordance with ISO 10993-1 and FDA Guidance.
Irregular Heartbeat Detection	Yes (device detects the appearance of irregular heartbeats during measurement)
Measurement Range (Pressure)	0-300 mmHg
Measurement Range (Pulse Rate)	30 to 200 bpm

Study Details

2. Sample Size and Data Provenance

Test Set Sample Size: 50 adults and 35 children.
Data Provenance: Not explicitly stated, but the study was conducted to demonstrate clinical accuracy against a recognized standard (ANSI/AAMI/ISO 81060-2), implying clinical data from patients. No information on country of origin or whether it was retrospective or prospective is provided.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. For blood pressure measurement, the ground truth is typically established by trained technicians using a reference method (e.g., auscultation with a sphygmomanometer) during the clinical study.

4. Adjudication Method

This information is not provided in the document. For blood pressure clinical trials, multiple trained observers often take measurements simultaneously with the automated device to establish a robust ground truth, and if there are discrepancies, an adjudication method might be used for the reference measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not mentioned. This type of study is more common for diagnostic imaging AI systems where human readers interpret images with and without AI assistance. This device is a non-invasive blood pressure monitor, not an imaging device.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was implicitly done. The "Performance Testing" section states: "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." This refers to the device's (algorithm's) ability to accurately measure blood pressure on its own.

7. Type of Ground Truth Used

Clinical Reference Standard: The ground truth for the accuracy testing was established in accordance with ANSI/AAMI/ISO 81060-2. This standard typically involves simultaneous measurements by trained observers using a reference method (often auscultation) as the ground truth against the device under test.

8. Sample Size for Training Set

This information is not provided in the document. The document describes pre-market testing for a physical device with embedded software, not necessarily a machine learning model that requires a distinct "training set" in the modern AI sense. If the device's algorithm was developed using data, that detail is not included.

9. How Ground Truth for Training Set Was Established

This information is not provided as a "training set" in the AI context isn't explicitly mentioned or applicable based on the provided text. The device uses an oscillometric technology, which is a well-established method for blood pressure measurement, rather than a novel AI algorithm requiring extensive training data documentation in this submission.

Summary

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KII3185 11/5

510(k) Summary Page 1 of 5 21-Dec-11

Omron Healthcare, Inc.1925 West Field CourtLake Forest, IL 60045 USA	Tel - 847-247-5626Fax - 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 measurementsystem21CFR 870.1130Class II
Device:	Model - HBP-1300
Predicate Device:	Omron -- HEM-907XL -- K032305

Device Description:

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.

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510(k) Summary Page 2 of 5 21-Dec-11

Indications for Use:

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.

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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 mmHgPulse rate: 30 to 200 bpm	Pressure: 0-299 mmHgPulse 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

K113185

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		21-Dec-11
Storage Conditions	Temperature: -20° to 60° CHumidity: 10 to 95% RH123(W) x 201(D) x 99(H) mm	Temperature: -25° to +70 °CHumidity: 10 to 90% RH139(W) x 1310(D) x 203(H) mm	Similar
			Slight smallerWeighs less
DimensionsWeight	1.3 lbs	1.98 lbs
Differences Between Other Legally Marketed Predicate DevicesThe Omron HBP-1300 is viewed as substantially equivalent to the predicate device because: The HBP-1300 uses the exact same technology andhas substantially equivalent indications for use. The differences that exist between the devices are insignificant in the terms of safety oreffectiveness.
Indications - The indications for use are substantially equivalent. The HBP-1300 is also indicated for use with pediatric (>3 year old) patients andhas 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

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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.

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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

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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

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K113185

Indications for Use Statement

Page 1 of 1

K113182 510(k) Number:

HBP-1300 Device Name:

Indications for Use:

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

Regulation Number and Section

§ 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).