(112 days)
Indicated for use by health care professionals whenever there is a need for measuring the noninvasive blood pressure and pulse rate of patients. It is intended for use in patient monitors for measurement of blood pressure and for calculation of pulse rate of adults, pediatrics, and neonates in health care facilities.
The picoNIBP OEM module is a complete noninvasive arterial blood pressure measurement component intended for use in patient monitors. The picoNIBP OEM module incorporates all hardware control and signal processing and also the algorithms to derive systolic, diastolic, and mean blood pressure as well as the pulse rate. The derived data is provided to the patient monitor that incorporates the picoNIBP OEM module.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets them with quantitative results. It primarily focuses on regulatory information, specifically a 510(k) summary for the Philips picoNIBP OEM module.
However, based on the information provided, here's what can be inferred and what is explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Pass/Fail criteria were based on standards and on the specifications cleared for the predicate device. Test results demonstrated that the picoNIBP OEM module meets all reliability requirements and performance claims and showed substantial equivalence."
This indicates that specific performance metrics were tested against established standards and predicate device specifications. However, the actual numerical acceptance criteria and the reported device performance values are not present in the provided text.
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Verification and validation testing activities were conducted," but it does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide any information about experts used for establishing ground truth or their qualifications. Given that this device measures non-invasive blood pressure, the ground truth would likely be established through comparison with a reference method (e.g., invasive arterial blood pressure monitoring) rather than expert consensus on images or interpretations.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. This type of study is more relevant for diagnostic imaging interpretation, not typically for physiological measurement devices like a blood pressure module.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
The text states: "The picoNIBP OEM module incorporates all hardware control and signal processing and also the algorithms to derive systolic, diastolic, and mean blood pressure as well as the pulse rate." It also mentions "accuracy determination." This implies that the device (which includes its algorithms) was tested for its standalone performance. However, no specific study details or quantitative results are provided. The phrase "Pass/Fail criteria were based on standards and on the specifications cleared for the predicate device" strongly suggests a standalone performance evaluation against defined metrics.
7. Type of Ground Truth Used:
While not explicitly stated, for non-invasive blood pressure devices, the typical ground truth used in performance studies involves comparison to a "gold standard" reference method, such as invasive arterial blood pressure measurement. It is possible that the "standards" mentioned in the text refer to internationally recognized protocols for NIBP accuracy testing (e.g., ISO 81060-2). The document does not explicitly state the type of ground truth.
8. Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide any information about a training set or how its ground truth was established.
Summary of what is present and what is missing:
| Information Requested | Presence in Document |
|---|---|
| 1. Table of Acceptance Criteria & Reported Performance | Partially Present (conceptually): States "Pass/Fail criteria were based on standards and on the specifications cleared for the predicate device" and that "Test results demonstrated that the picoNIBP OEM module meets all reliability requirements and performance claims." However, the actual numerical acceptance criteria and reported performance values are NOT provided. |
| 2. Test Set Sample Size & Data Provenance | Absent: No mention of sample size or data provenance (e.g., retrospective/prospective, country of origin). |
| 3. Number & Qualifications of Ground Truth Experts | Absent: No mention of experts for ground truth establishment. For NIBP, ground truth is typically a reference measurement, not expert consensus. |
| 4. Adjudication Method | Absent. |
| 5. MRMC Comparative Effectiveness Study & Effect Size | Absent: Not applicable for this type of device (physiological measurement vs. diagnostic interpretation). |
| 6. Standalone Performance Study | Implied/Present: The document states the device has "algorithms to derive systolic, diastolic, and mean blood pressure as well as the pulse rate" and that "accuracy determination" was part of testing. It confirms that the device "meets all reliability requirements and performance claims," which suggests standalone performance was evaluated. However, specific study details or quantitative results of this standalone performance are NOT provided. |
| 7. Type of Ground Truth Used | Implied: Likely comparison to a "gold standard" reference method (e.g., invasive blood pressure) based on industry standards for NIBP accuracy, but not explicitly stated in the document. |
| 8. Training Set Sample Size | Absent: No mention of a training set. The device reuses an existing NIBP algorithm from a predicate device, suggesting the algorithm was already developed and validated within the predicate. |
| 9. How Training Set Ground Truth Was Established | Absent: No mention of a training set. The device reuses an existing NIBP algorithm from a predicate device, suggesting the algorithm was already developed and validated within the predicate. Therefore, this device's submission focuses on demonstrating substantial equivalence, not necessarily on a de novo algorithm development and training process within this specific 510(k). |
In essence, the provided 510(k) summary serves as a regulatory document affirming that the picoNIBP OEM module has undergone verification and validation testing to demonstrate substantial equivalence to predicate devices, and that it met internal and standard-based "Pass/Fail criteria." However, it lacks the detailed study methodology and quantitative performance data that would typically be found in a comprehensive clinical study report.
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SEP 1 4 2005
510 (k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.
- The submitter of this premarket notification is: Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str. 2 D-71034 Boeblingen, Germany Tel: ++49 7031 463-2840 Fax: ++49 7031 463-2442 Email: markus.stacha@philips.com
This summary was prepared on August 02, 2005.
- The name of the device is the picoNIBP OEM module. Classification name is as follows:
| Device Panel | Classification | ProCode | Description |
|---|---|---|---|
| CardiovascularDiagnosticDevices | §870.1130, II | DXN | Non-Invasive Blood-Pressure MeasurementSystem |
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The new device picoNIBP OEM module is in respect of non-invasive blood pressure (NIBP) substantially equivalent to previously cleared Philips Multi-Parameter Module M3001A marketed pursuant to K020531 (March 20, 2002) and Philips Measurement Server M3000A K001333 (May, 17, 2000). The new device is in respect of pulse rate substantially equivalent to the Philips Series 50XM (M1350B) Fetal/Maternal Monitor K954351 (March 08, 1996).
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The new device picoNIBP OEM module reuses the NIBP portion and the NIBP algorithm of the legally marketed Philips Multi-Parameter Module M3001A. The calculation of the pulse rate in the new device picoNIBP OEM module is carried out with exactly the same pulse rate alqorithm as in the predicate device Philips Series 50XM (M1350B) Fetal/Maternal Monitor. The picoNIBP OEM module is a complete noninvasive arterial blood pressure measurement component intended for use in patient monitors. The picoNIBP OEM module incorporates all hardware control and signal processing and also the algorithms to derive systolic, diastolic, and mean blood pressure as well as the pulse rate. The derived data is provided to the patient monitor that incorporates the picoNIBP OEM module.
-
The picoNIBP OEM module is intended for integration in patient monitors for measurement of blood pressure and for calculation of pulse rate of adults, pediatrics, and neonates in health care facilities.
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The new device picoNIBP OEM module has the same intended use and technological characteristics as the NIBP portion of the legally marketed predicate devices.
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Verification and validation testing activities were conducted to establish the performance, functionality, and reliability characteristics of the new device picoNIBP OEM module. Testing involved environmental, functional level tests, accuracy determination and safety and performance testing from the risk analysis. Pass/Fail criteria were based on standards and on the specifications cleared for the predicate device. Test results demonstrated that the picoNIBP OEM module meets all reliability requirements and performance claims and showed substantial equivalence.
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." written around the perimeter of the circle.
SEP I 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Philips Medizin Systeme Böblingen GmbH c/o Mr. Markus Stacha Senior Regulatory Affairs Engineer Cardiac and Monitoring Systems Hewlett-Packard Str. 2 D-71034 Böblingen Germany
Re: K051366
Trade Name: picoNIBP OEM Module Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: August 2, 2005 Received: August 5, 2005
Dear Mr. Stacha:
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. Markus Stacha
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) 276-0295.. 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,
Bhummon for
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): ____________________________________________________________________________________________________________________________________________________
Device Name: picoNIBP OEM module.
Indications for Use: Indicated for use by health care professionals whenever there is a need for measuring the noninvasive blood pressure and pulse rate of patients. It is intended for use in patient monitors for measurement of blood pressure and for calculation of pulse rate of adults, pediatrics, and neonates in health care facilities.
Over-The-Counter Use Prescription Use yes No AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blimmerman
§ 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).