HEM-9000AI

K081654 · Omron Healthcare, Inc. · DXN · Oct 10, 2008 · Cardiovascular

Device Facts

• Record ID: K081654
• Device Name: HEM-9000AI
• Applicant: Omron Healthcare, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended 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. 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 Story

HEM-9000AI-X is a dual-modality non-invasive blood pressure and arterial stiffness monitor. Inputs: oscillometric signals from upper-arm cuff; pulse wave signals from radial artery via wrist-worn applanation tonometer. Operation: cuff measures systolic/diastolic BP and pulse rate; tonometer applies pressure to radial artery to detect pulse wave. Central processor separates waveform into ejected and reflected components to calculate Augmentation Index (AI) and central systolic blood pressure (cSBP). Used in clinical settings (hospitals, clinics, physician offices) by healthcare professionals. Output: digital display of BP, pulse, AI, and cSBP. Provides non-invasive alternative to invasive hemodynamic monitoring; aids clinical assessment of arterial stiffness and central hemodynamics.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and identical design/functionality to the predicate device, with the addition of a calculated parameter (cSBP) derived from established applanation tonometry methods.

Technological Characteristics

Oscillometric NIBP measurement via upper-arm cuff; applanation tonometry via wrist sensor. Electrostatic capacitive and semiconductor pressure sensors. AC power source. Liquid crystal digital display. Dimensions: main unit 240x235x260mm; AI sensor 140x60x55mm. Operating range: 10-40°C, 15-85% RH. Software-based calculation of AI and cSBP.

Indications for Use

Indicated for adult patients (arm circumference 17-50 cm) for non-invasive measurement of systolic/diastolic blood pressure, pulse rate, radial augmentation index (AI), and central (aortic) blood pressure. Contraindicated for patients with known arrhythmia, insufficient peripheral circulation, acute low blood pressure/temperature, pacemaker users, seizure history, artificial heart, or where artery cannot be palpated. AI function not evaluated for patients with intra-ventricular conduction delays (VCD).

Regulatory Classification

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.

Predicate Devices

• Omron HEM-9000AI (K050233)
• AtCor SphygmoCor Px (K012487)
• AtCor Medical SphygmoCor CvMS (K070795)

Submission Summary (Full Text)

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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.<br>1200 Lakeside Dr.<br>Bannockburn, IL 60015 | Tel - 847-247-5609<br>Fax - 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 – K050233<br>AtCor SphygmoCor Px - K012487<br>AtCor Medical - SphygmoCor CvMS- K070795 |

#### 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.

#### 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 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).

| Patient Population: | Adults |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use: | Physicians' offices, hospitals, clinics and other medical facilities |
| Contraindications: | Patients with: known arrhythmia; insufficient peripheral circulation,<br>acute cases of low blood pressure or low temperature; who use a<br>pacemaker; experiencing seizure; should not have blood pressure<br>measurements taken from their arm; with an artificial heart; and whose<br>artery 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 device<br>HEM-9000AI-X | Predicate - K050233<br>HEM-9000AI |
|-------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Specification | | |
| BP Measurement method | Cuff oscillometric method | Cuff oscillometric method |
| Augmentation Index (AI)<br>Calculated parameter | Applanation tonometry<br>cSBP | Applanation tonometry<br>Not available |
| Measurement range | Pressure: 0 to 299 mmHg<br>Pulse Rate: 30 to 199 beats/min. | Pressure: 0 to 294 mmHg<br>Pulse 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 for<br>wrapping cuff. | Semiconductor pressure sensor for<br>wrapping cuff. |
| Deflation | Automatic via electromagnetic valve | Automatic via electromagnetic valve |
| Exhaust | Automatic rapid exhaust via<br>electromagnetic valve | Automatic rapid exhaust via<br>electromagnetic 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 device<br>HEM-9000AI-X | Predicate - K050233<br>HEM-9000AI |
|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Specification | | |
| Display | Liquid crystal digital display | Liquid crystal digital display |
| Operating conditions | 10 to 40 °C (50 to 104 °F)<br>15 to 85%RH | 10 to 40 °C (50 to 104 °F)<br>15 to 85%RH |
| Storage conditions | -20 to 60 °C (-4 to 140 °F)<br>10 to 95 %RH | -20 to 60°C (-4 to 140 °F)<br>10 to 95 %RH |
| Dimensions (mm)<br>Main unit<br>AI Pulse Wave sensor unit<br>AI Pulse Wave measurement unit | 240 (W) × 235 (D) × 260 (H) mm<br>140 (W) × 60 (D) × 55 (H) mm<br>170 (W) × 315 (D) × 145 (H) mm | 240 (W) × 235 (D) × 260 (H) mm<br>140 (W) × 60 (D) × 55 (H) mm<br>170 (W) × 315 (D) × 145 (H) mm |
| Weight (not including batteries)<br>Main unit<br>AI Measurement unit | Approx. 5.3 kg<br>Approx. 1.3 kg | Approx. 5.3 kg<br>Approx. 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 device<br>HEM-9000AI-X | Predicate – K012487<br>SphygmoCor Px |
|----------------------------|----------------------------|--------------------------------------------------------------------------------|
| Specification | | |
| cSBP Measurement<br>method | Applanation tonometry | Applanation tonometry<br>Note that the predicate K070795 also<br>measures 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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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 [phone]. 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
[phone] [phone] 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 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).

or

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_