The HEM-9000AI-X is intended to measure systolic and diastolic blood pressure and pulse rate in adults with an arm circumference of 17 - 50 cm (7-20 inches), and to calculate a radial augmentation index (AI) and central (aortic) blood pressure which is used on adult patients only.

The HEM-9000AI-X is intended for use in physicians' offices, hospitals, clinics and other medical facilities where non-invasive blood pressure and radial AI measurements/calculations are performed on patients and invasive measurement is contraindicated.

The Augmentation Index (AI) function of the HEM-9000AI-X has not been evaluated on patients who have intra-ventricular conduction delays (VCD).

Device Description

The modified HEM-9000AI-X is an oscillometric NIBP mcasurcment device and tonometer Augmentation Index detection device. The HEM-9000AI utilizes both an oscillometric blood pressure detection technology via a cuff wrap at the upper arm as well as a tonomcter measurement technology using the radial artery at wrist. The HEM-9000AI-X detects Korotkov (K) sounds for NIBP mcasurement via oscillometric signal detection and processes the data through its CPU and algorithm within the device. It provides measurements of systolic, diastolic and pulse pressures, as well as pulse rate for adult patients with an upper arm circumference in the range of 7 - 20 inches (17 - 50 cm). AI information is collected via tonometry by the placement of a set of sensors over the radial artery at the wrist. The tonometer applies pressure and compresses the radial artery until sensors detect the pulse wave (PW). The signal is sent back to the central processor which separates the superimposed waveform into the ejected wave and the reflected wave components. The device is self-contained, single unit with both oscillometric and tonometer signal detection built in.

The modification is the addition of a new measured (calculated) parameter referred to as central svstolic blood pressure (cSBP) or central blood pressure (cSBP). This new reported measurement is calculated with the late systolic pressure of reflected waves recorded by the applanation tonometry applied to the radial artery.

AI/ML Overview

The provided text describes the device HEM-9000AI-X, its intended use, and its substantial equivalence to predicate devices, focusing on the addition of central systolic blood pressure (cSBP) measurement. However, it does not include any specific acceptance criteria for performance, nor does it detail any study designed to prove the device meets such criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or details about training sets, as this information is not present in the provided document.

The document is a "Non-Confidential Summary of Safety and Effectiveness" for a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on presenting detailed performance study results against specific acceptance criteria.

Summary

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OCT 1 0 2008

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 3 6-Oct-08

Omron Healthcare, Inc.1200 Lakeside Dr.Bannockburn, IL 60015	Tel - 847-247-5609Fax - 847-680-6269
Official Contact:	Ranndy Kellogg - VP Marketing & Product Development
Proprietary or Trade Name:	HEM-9000AI
Common/Usual Name:	System, Measurement, Blood-Pressure, Non-invasive
Classification Name/Code:	DXN - System, Measurement, Blood-pressure, Non-invasive
Device:	Model - HEM-9000AI-X
Predicate Devices:	Omron - HEM-9000AI – K050233AtCor SphygmoCor Px - K012487AtCor Medical - SphygmoCor CvMS- K070795

Device Description:

Indications for Use:

The HEM-9000AI-X is intended to measure systolic and diastolic blood pressure and pulse rate in adults with an arm circumference of 17 - 50 cm (7 - 20 inches), and to calculate a radial augmentation index (AI) and central (aortic) blood pressure which is used on adult patients only.

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Non-Confidential Summary of Safety and Effectiveness Page 2 of 3 6-Oct-08

The Augmentation Index (AI) function of the HEM-9000AI-X has not been evaluated on patients who have intra-ventricular conduction delays (VCD).

Patient Population:	Adults
Environment of Use:	Physicians' offices, hospitals, clinics and other medical facilities
Contraindications:	Patients with: known arrhythmia; insufficient peripheral circulation,acute cases of low blood pressure or low temperature; who use apacemaker; experiencing seizure; should not have blood pressuremeasurements taken from their arm; with an artificial heart; and whoseartery cannot be found by palpation.

Summary of substantial equivalence

Table 1 presents the similarities and differences of the proposed HEM-9000AI-X and the predicate HEM-9000AI, K050233.

Model Name:	New deviceHEM-9000AI-X	Predicate - K050233HEM-9000AI
Specification
BP Measurement method	Cuff oscillometric method	Cuff oscillometric method
Augmentation Index (AI)Calculated parameter	Applanation tonometrycSBP	Applanation tonometryNot available
Measurement range	Pressure: 0 to 299 mmHgPulse Rate: 30 to 199 beats/min.	Pressure: 0 to 294 mmHgPulse Rate: 30 to 199 beats/min.
Pressure sensor	Electrostatic capacitive sensor	Electrostatic capacitive sensor
Applicable cuff	Wrap around 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 forwrapping cuff.	Semiconductor pressure sensor forwrapping cuff.
Deflation	Automatic via electromagnetic valve	Automatic via electromagnetic valve
Exhaust	Automatic rapid exhaust viaelectromagnetic valve	Automatic rapid exhaust viaelectromagnetic valve
Power source	AC power only	AC power only

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Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 6-Oct-08

Model Name:	New deviceHEM-9000AI-X	Predicate - K050233HEM-9000AI
Specification
Display	Liquid crystal digital display	Liquid crystal digital display
Operating conditions	10 to 40 °C (50 to 104 °F)15 to 85%RH	10 to 40 °C (50 to 104 °F)15 to 85%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)Main unitAI Pulse Wave sensor unitAI Pulse Wave measurement unit	240 (W) × 235 (D) × 260 (H) mm140 (W) × 60 (D) × 55 (H) mm170 (W) × 315 (D) × 145 (H) mm	240 (W) × 235 (D) × 260 (H) mm140 (W) × 60 (D) × 55 (H) mm170 (W) × 315 (D) × 145 (H) mm
Weight (not including batteries)Main unitAI Measurement unit	Approx. 5.3 kgApprox. 1.3 kg	Approx. 5.3 kgApprox. 1.3 kg

The difference between the proposed HEM-9000AI-X and the HEM-9000AI is only the addition of the calculated parametor, cSBP. All other features, and technologies are identical to the predicate.

Table 2 presents the similarities and differenccs of the proposed HEM-9000AI-X and the predicate AtCor Medical SphygmoCor Px, K012487.

Table of Comparison of cSBP measurement a Predicate vs. Proposed Model Table 2 –

Model Name:	New deviceHEM-9000AI-X	Predicate – K012487SphygmoCor Px
Specification
cSBP Measurementmethod	Applanation tonometry	Applanation tonometryNote that the predicate K070795 alsomeasures cSBP

Differences Between Other Legally Marketed Predicate Devices

The HEM-9000AI-X is viewed as substantially equivalcnt to the following predicate devices – Omron HEM-9000AI – K050233 and AtCor Medical SphygmoCor Px – K012487 and SphygmoCor CvMs – K070795.

There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a human figure in the negative space between the legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2008

Omron Healthcare, Inc. c/o Promedic, Inc. Mr. Paul E. Dryden President, Regulatory Consultant for Omron Healthcare 24301 Woodsage Drive Bonita Springs, FL 34134-2958

Re: K081654

Trade/Device Name: HEM 9000AI-X Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: September 6, 2008 Received: September 9, 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 iddictions for use stated in the enclosure) to legally marketed predicate devices marked in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendonation or to devices that have been reclassified in accordance with the provisions of the Federal Foond, Or to 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 I ... The general controls provisions of the Act include requirements for annual registration, l'isting 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. Dur. F 21 t 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 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

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Page 2 – Mr. Paul E. Dryden

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 Inquili marketed predicate device results in a classification for your device and thus, permits your device to proceed 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 Hits of Sinall
(200) 276-2150 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html (

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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Indications for Use Statement

Page 1 of 1

510(k) Number:

K081654 (To be assigned)

HEM 9000AI-X Device Name:

Indications for Use:

The Augmentation Index (AI) function of the HEM-9000AI-X has not been evaluated on patients who have intra-ventricular conduction delays (VCD).

Prescription Use XX (Part 21 CFR 801 Subpart D) 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)

ision of Cardiovascular Devices

KOBIC 54 510(k) Number_

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).