(201 days)
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 is a digital monitor intended for use in measuring blood pressure and pulse rate.
The provided text is a 510(k) premarket notification approval letter for the Omron Intellisense™ Digital Blood Pressure Monitor, Model HEM-907XL. It largely focuses on regulatory approval and does not contain detailed information about specific acceptance criteria or the study that proves the device meets them. Therefore, I cannot fully answer your request based solely on the provided input.
However, I can interpret what would typically be required for such a device and infer some information based on the device type and regulatory context. I will highlight what is directly available and what is inferred/typical.
Here's an attempt to answer your questions based on the provided text and general knowledge of medical device approvals for non-invasive blood pressure monitors:
1. Table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific acceptance criteria or report device performance in a table format. For a blood pressure monitor, typical acceptance criteria would be based on recognized standards (e.g., AAMI, ISO 81060-2). These standards usually quantify accuracy as the mean difference and standard deviation between the device's readings and a reference method (like a sphygmomanometer used by trained observers).
Inferred/Typical Acceptance Criteria (based on standards like AAMI/ISO 81060-2):
| Parameter | Acceptance Criteria (Inferred/Typical) | Reported Device Performance (Not in document) |
|---|---|---|
| Mean Absolute Difference (all) | ≤ 5 mmHg | Not reported |
| Mean Difference (systolic) | ≤ ± 5 mmHg | Not reported |
| Mean Difference (diastolic) | ≤ ± 5 mmHg | Not reported |
| Standard Deviation (systolic) | ≤ 8 mmHg | Not reported |
| Standard Deviation (diastolic) | ≤ 8 mmHg | Not reported |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. For blood pressure monitors, clinical validation studies typically involve a minimum of 85 subjects (per AAMI/ISO standards) to ensure sufficient data points across various blood pressure ranges.
- Data Provenance: Not specified in the provided text. Such studies are typically prospective clinical trials. The country of origin is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified in the provided text. For blood pressure monitor validation, ground truth is established by multiple trained observers (typically 2 or 3) using a reference sphygmomanometer, often auscultatory.
- Qualifications of Experts: Not specified. They would typically be trained medical professionals or technicians highly proficient in manual blood pressure measurement using auscultation, with their performance regularly checked for inter-observer variability.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified in the provided text. If multiple observers are used, a common method involves two independent observers taking readings, and if their readings differ by more than a pre-defined threshold (e.g., 4 mmHg), a third independent observer would take an additional reading, or the measurements would be discarded/repeated. This is often referred to as a "double-observer" or "co-observer" method.
5. 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
- MRMC Study: No, this device (a digital blood pressure monitor) is not an AI-assisted diagnostic tool that involves radiologists or "human readers" in the sense of image interpretation. Therefore, an MRMC comparative effectiveness study where human readers improve with or without AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Yes, the fundamental performance assessment of a digital blood pressure monitor is inherently a standalone performance evaluation. The device's algorithm measures blood pressure and pulse rate automatically and independently, without direct human influence on the measurement process itself, aside from proper cuff placement and activation. The accuracy is then compared against a human-obtained reference standard.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For a blood pressure monitor, the ground truth would be established through expert consensus (or comparison) against a reference standard method, typically auscultatory measurement by trained observers using a mercury or an adequately validated aneroid sphygmomanometer.
8. The sample size for the training set
- Training Set Sample Size: This information is not applicable in the traditional sense of machine learning model training sets, as the Omron Intellisense™ Digital Blood Pressure Monitor is a hardware device with an embedded algorithm, not a machine learning model that undergoes continuous training with new data. Its calibration and core algorithm were developed and validated in a more traditional engineering sense. The closest equivalents would be the data used during initial algorithm development and internal testing, which is separate from the clinical validation (test set). This information is not typically disclosed in an FDA approval letter.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Similar to point 8, this is not applicable as a "training set" in the modern AI/ML context. The ground truth for developing the device's algorithms and calibration would have been established through controlled experimental settings using reference blood pressure measurement techniques (e.g., invasive arterial lines for initial validation, or highly controlled auscultatory measurements) to optimize the device's measurement accuracy. This developmental information is proprietary and not part of the public 510(k) summary.
Summary of Limitations:
The provided FDA letter is a regulatory approval document and focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed technical and clinical study report information that would typically include the specific data requested in your prompt. This type of detailed data would be found in the device's 510(k) submission, specifically the clinical validation study report, which is usually not included in the public-facing approval letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2004
Omron Healthcare, Inc. c/o Mr. Iwao Kojima Director of Technology 300 Lakeview Parkway Vernon Hills, IL 60061
Re: K032305
Trade Name: Omron Intellisense™ Digital Blood Pressure Monitor, Model HEM-907XL Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 21, 2003 Received: November 21, 2003
Dear Mr. Kojima:
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 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.
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Page 2 – Mr. Iwao Kojima
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 (301) 594-4646. 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/dsma/dsmamain.html.
Sincerely yours,
Donna R. La Lune
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): K032305
Device Name: OMRON INTELLISENSE™ DIGITAL BLOOD PRESSURE MONITOR, Model HEM-907XL
Indications For Use:
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).
Prescription Use (Part 21 CFR 801 Subpart D) AND/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)
Duma R. La June
(Division Sign-Off) ്vision of Cardiovascular Devices
510(k) Number_K032 3 05
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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).