(120 days)
Not Found
No
The description details standard signal processing and algorithmic calculations based on oscillometric and tonometry data, without mentioning AI or ML techniques.
No.
The device is intended for measuring and calculating blood pressure and pulse rate, and for detecting the augmentation index, which are diagnostic or monitoring functions, not therapeutic ones.
Yes
The device is intended to measure and calculate various physiological parameters (systolic and diastolic blood pressure, pulse rate, radial augmentation index, central blood pressure) to provide information about a patient's health status, which falls under the definition of a diagnostic device.
No
The device description explicitly states it is a "self-contained, single unit with both oscillometric and tonometer signal detection built in," indicating it is a hardware device with integrated software.
Based on the provided information, the HEM-9000AI-X is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of disease. This examination is performed outside of the living body.
- HEM-9000AI-X Function: The HEM-9000AI-X measures blood pressure and pulse rate directly from the patient's body using a cuff on the upper arm and a tonometer on the wrist. It also calculates a radial augmentation index and central blood pressure based on these in-vivo measurements.
- No Specimen Examination: The device does not analyze any biological specimens (like blood or urine) in a laboratory setting.
Therefore, the HEM-9000AI-X falls under the category of a non-invasive medical device used for physiological measurements directly on the patient.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
DXN
Device Description
The modified HEM-9000AI-X is an oscillometric NIBP measurement 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 tonometer measurement technology using the radial artery at wrist. The HEM-9000AI-X detects Korotkov (K) sounds for NIBP measurement 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 systolic 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm, radial artery at wrist
Indicated Patient Age Range
Adults
Intended User / Care Setting
Physicians' offices, hospitals, clinics and other medical 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 (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.
Omron - HEM-9000AI – K050233, AtCor SphygmoCor Px - K012487, AtCor Medical - SphygmoCor CvMS- K070795
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
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 - 847-247-5609
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
AtCor SphygmoCor Px - K012487
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.
1
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, |
| acute cases of low blood pressure or low temperature; who use a | |
| pacemaker; experiencing seizure; should not have blood pressure | |
| measurements taken from their arm; with an artificial heart; and whose | |
| 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
HEM-9000AI-X | Predicate - K050233
HEM-9000AI |
|-------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Specification | | |
| BP Measurement method | Cuff oscillometric method | Cuff oscillometric method |
| Augmentation Index (AI)
Calculated parameter | Applanation tonometry
cSBP | Applanation tonometry
Not available |
| Measurement range | Pressure: 0 to 299 mmHg
Pulse Rate: 30 to 199 beats/min. | Pressure: 0 to 294 mmHg
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
wrapping cuff. | Semiconductor pressure sensor for
wrapping cuff. |
| Deflation | Automatic via electromagnetic valve | Automatic via electromagnetic valve |
| Exhaust | Automatic rapid exhaust via
electromagnetic valve | Automatic rapid exhaust via
electromagnetic valve |
| Power source | AC power only | AC power only |
2
Non-Confidential Summary of Safety and Effectiveness Page 3 of 3 6-Oct-08
| Model Name: | New device
HEM-9000AI-X | Predicate - K050233
HEM-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 unit
AI Pulse Wave sensor unit
AI Pulse Wave measurement unit | 240 (W) × 235 (D) × 260 (H) mm
140 (W) × 60 (D) × 55 (H) mm
170 (W) × 315 (D) × 145 (H) mm | 240 (W) × 235 (D) × 260 (H) mm
140 (W) × 60 (D) × 55 (H) mm
170 (W) × 315 (D) × 145 (H) mm |
| Weight (not including batteries)
Main unit
AI Measurement unit | Approx. 5.3 kg
Approx. 1.3 kg | Approx. 5.3 kg
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
HEM-9000AI-X | Predicate – K012487
SphygmoCor Px |
|----------------------------|----------------------------|--------------------------------------------------------------------------------|
| Specification | | |
| cSBP Measurement
method | Applanation tonometry | Applanation tonometry
Note that the predicate K070795 also
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.
3
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
4
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
5
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_