(269 days)
The HEM-9000AI 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 measure/calculate radial augmentation index (AI). The HEM-9000AI is intended for use in physician's offices, hospitals, clinics and other medical facilities where non-invasive blood pressure and radial augmentation index measurements/calculations are performed on patients and invasive measurement is contraindicated.
The augmentation index (AI) function of the HEM-9000AI has not been evaluated on patients who have inter-ventricular conduction delays (IVCD).
The HEM-9000AI is an oscillometric NIBP measurement and applanation tonometry augmentation index (AI) measurement/calculation device. The HEM-9000AI utilizes both an oscillometric blood pressure detection technology via a cuff wrap at upper arm as well as a tonometry measurement at the radial artery at the HEM-9000AI measures the oscillometric signal for NIBP measurement and processes the data through its CPU and algorithm within the device. It provides measurements of systolic and diastolic blood pressures, as well as pulse rate for adult patients with 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 eiected wave and the reflected wave components. AI is derived from the pulse wave by calculating the amplitude-ratio of "reflected wave" to "ejected wave" at the radial artery. All information appears on the device display and can be printed. The device is self-contained, single unit with both oscillsometric and tonometry signal detection built in.
Here's a breakdown of the acceptance criteria and study information for the HEM-9000AI, based on the provided 510(k) summary:
Acceptance Criteria and Reported Device Performance
The provided document specifically mentions two key performance aspects: Non-Invasive Blood Pressure (NIBP) measurement and Augmentation Index (AI) measurement/calculation.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance | Comments |
|---|---|---|---|
| NIBP Measurement | ANSI/AAMI SP-10:2002 | Validated by adhering to the tests in ANSI/AAMI SP-10:2002. | The device's NIBP algorithm and hardware are stated to be the same as the predicate device HEM-907XL, which was likely also validated to this standard. |
| Augmentation Index (AI) | Conformance to "device specification for this aspect" and "accuracy." | Clinical studies demonstrated that the calculation of Augmentation Index is highly reproducible. A direct comparison with the predicate SphygmoCor Px on 162 patients showed similar results for displayed radial AI. | While "highly reproducible" and "similar results" are reported, specific quantitative metrics (e.g., mean difference, standard deviation of differences) are not detailed in this summary. |
Study Details
Here's a summary of the study details based on the provided text:
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Sample Size used for the test set and the data provenance:
- Augmentation Index (AI) Comparison: 162 patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "sequential order" measurements on patients, suggesting a prospective design for this particular comparison.
- NIBP Testing: The document mentions "Clinical testing for the NIBP aspect was performed in accordance with the specific requirements established within ANSI/AAMI SP-10:2002." ANSI/AAMI SP-10 typically requires a certain number of subjects (e.g., 85 adult subjects) for clinical validation, but the exact count isn't specified here for the HEM-9000AI's NIBP component.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified in the provided summary. For NIBP validation against AAMI SP-10, the "ground truth" would typically be invasive arterial pressure measurements, not expert consensus. For AI, the "ground truth" was essentially the measurement from the predicate device (SphygmoCor Px).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. The clinical testing described does not involve subjective interpretations requiring adjudication.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a measurement device, not an AI-assisted diagnostic imaging or interpretation system that would typically involve human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The performance evaluation for both NIBP and AI describes the device's measurements/calculations as standalone outputs, without human interpretation of the algorithm's direct output being part of the primary evaluation. The comparison to the predicate device is a standalone performance metric.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- NIBP: Conformance to ANSI/AAMI SP-10:2002 typically implies comparison against invasive arterial blood pressure measurements as the reference standard (ground truth). This is not explicitly stated but is the common practice for such standards.
- Augmentation Index (AI): The "ground truth" for the AI comparison was the measurement obtained from the predicate device, SphygmoCor Px, on the left radial artery. The study aimed to show "similar results" to this established device.
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The sample size for the training set:
- Not specified. The document primarily discusses performance testing (validation) rather than explicit details about the development or training of the AI algorithms. The NIBP algorithm is stated to be the "same" as the HEM-907XL, suggesting it was already established. The AI calculation is mentioned, but its development process or training data size is not detailed.
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How the ground truth for the training set was established:
- Not specified. As noted above, details about algorithm development or training ground truth are not provided in this summary.
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510K Summary for HEM-9000AI
A. Submitter
Omron Healthcare, Inc. 1200 Lakeside Drive Bannockburn, IL 60015-1243 Telephone: 847-247-5732 Contact person: Jim Li, Ph.D. Date prepared: August 31. 2005
B. Device
| Proprietary Name: | HEM-9000AI |
|---|---|
| Trade Name: | Non-invasive blood pressure monitor with augmentation index |
| Regulation Number: | 21CFR870.1130 |
| Regulation Name: | Non-invasive blood pressure monitor |
| Regulation Class: | II |
| Product Code: | DXN |
C. Modified Device
HEM-907XL cleared under K032305
D. Predicate Devices
VP-1000/2000 cleared under K013434 SphygmoCor Px cleared under K012487
E. Device Description
The HEM-9000AI is an oscillometric NIBP measurement and applanation tonometry augmentation index (AI) measurement/calculation device. The HEM-9000AI utilizes both an oscillometric blood pressure detection technology via a cuff wrap at upper arm as well as a tonometry measurement at the radial artery at the HEM-9000AI measures the oscillometric signal for NIBP measurement and processes the data through its CPU and algorithm within the device. It provides measurements of systolic and diastolic blood pressures, as well as pulse rate for adult patients with 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 eiected wave and the reflected wave components. AI is derived from the pulse wave by calculating the amplitude-ratio of "reflected wave" to "ejected wave" at the radial artery. All
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information appears on the device display and can be printed. The device is self-contained, single unit with both oscillsometric and tonometry signal detection built in.
F. Intended Use
The HEM-9000AI 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 measure/calculate radial augmentation index (AI). The HEM-9000AI is intended for use in physician's offices, hospitals, clinics and other medical facilities where non-invasive blood pressure and radial augmentation index measurements/calculations are performed on patients and invasive measurement is contraindicated.
The augmentation index (AI) function of the HEM-9000AI has not been evaluated on patients who have inter-ventricular conduction delays (IVCD).
G. Substantial Equivalence
The HEM-9000AI is intended to measure systolic blood pressure and pulse rate in adults with an arm circumference of 17-50 cm (7-20 inches). The HEM-9000AI has the added capability of measuring/calculating augmentation index (AI). The HEM-9000AI uses the same technology as the HEM-907XL in that both devices have the same "Non- Invasive Blood Pressure" (NIBP) algorithm and hardware, including sensors, PCB boards and external cuffs for the NIBP measurement and utilizes the same oscillometric measurement technology. Both devices require that the upper arm be wrapped with a cuff for NIBP measurement. The HEM-9000AI uses the same signal detection and processing system of the HEM907XL.
The HEM-9000AI was tested to AAMI SP-10 performance standards, along with additional AI function testing. The intended use of the HEM-9000AI has not changed in respect to the NIBP of the HEM-907XL.
The HEM-9000AI and the predicate devices VP-1000/2000 and Sphygmocor Px all have the augmentation index (AI) function. The HEM-9000AI uses the same applanation tonometry technology as the VP-1000/2000 and Sphygmocor Px in measuring the pulse wave that is used to calculate the augmentation index. For the augmentation index calculation the VP-1000/2000 uses the pulse wave at the carotid artery of the test subject while the HEM-9000AI and Sphygmocor Px measure the Pulse Wave at the patient's radial artery. Clinical studies of the HEM-9000AI have demonstrated that the calculation of Augmentation Index is highly reproducible. A direct comparison of the displayed radial AI by the HEM-9000AI and the predicate SphygmoCor Px measured on the left radial artery in sequential order on 162 patients demonstrated that on the average, the two devices provide similar results.
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Performance Testing H.
The HEM-9000AI was validated by adhering to the tests in the ANSI/AAMI SP10:2002 for NIBP and by additional testing to verify that the radial augmentation indices calculated conformed to the device specification for this aspect. Testing also included Electrical Safety, Environmental, Biocompatibility and EMC. Clinical testing for the NIBP aspect was performed in accordance with the specific requirements established within ANSI/AAMI SP-10:2002. Additional clinical testing was performed to verify the AI specification and accuracy.
l. Conclusions
Omron Healthcare, Inc. has demonstrated through its comparison of performance with the predicate devices that the HEM-9000AI is substantially equivalent to the predicate devices for both the NIBP function and the Augmentation Index function of the device.
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OCT 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Omron Healthcare, Inc c/o James Li, Ph.D. General Manager, Business Development 1200 Lakeside Drive Bannockburn, Illinois 60015-1243
Re: K050233
Device Name: Omron HEM-9000AI Non-Invasive Blood Pressure Monitor with Augmentation Index Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measuring System Regulatory Class: Class II (two) Product Code: DXN Dated: August 31, 2005 Received: September 1, 2005
Dear Dr. Li:
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 indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. 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 Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither 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.
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Page 2 - James Li, Ph.D.
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); 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 a legally 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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman
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
510(k) Number (if known): K050233
Device Name: HEM-9000A!
Indications For Use:
The HEM-9000AI 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 measure/calculate radial augmentation index (AI). The HEM-9000AI is intended for use in physician's offices, hospitals, clinics and other medical facilities where non-invasive blood pressure and radial augmentation index measurements/calculations are performed on patients and invasive measurement is contraindicated.
The augmentation index (Al) function of the HEM-9000AI has not been evaluated on patients who have inter-ventricular conduction delays (IVCD).
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number
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§ 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).