(29 days)
The ABP 92506 RMS is used to provide data to qualified medical personnel for the purpose of assessing the patient's cardiac health via blood pressure readings taken during daily activity for up to a 48-hour period.
The data is intended to provide preliminary blood pressure data from ambulatory patients for non-time critical applications only.
It is for use in hospitals, clinics or physicians offices by a qualified physician or trained staff member under the supervision of that physician.
Patient diagnosis is not to be performed solely based on the results of this device.
The Spacelabs Medical ABP 92506 Report Management System (RMS) is a PC-based software application that accepts data collected from one of Spacelabs Medical's ABP monitors through an electrically-isolated interface cable.
The ABP 92506 RMS has a graphical user interface (GUI) similar to most Microsoft applications such as Word, Excel, etc. that provides common windowing controls such as menus, icons, mouse support, wizards, etc. These controls allow the operator to communicate with the ABP monitor.
Additionally, the ABP 92506 RMS provides necessary initialization and configuration of operating parameters, as well as acquires the monitor's stored blood pressure reading data. These readings are combined with patient demographic entry data to create an ABP report that can be reviewed, edited, stored, confirmed and printed by a physician.
Furthermore, the ABP 92506 RMS application also performs simple summary trending calculations from the individual blood pressure readings to present global statistical results, such as mean and standard deviations for systolic, diastolic, MAP, heart rate and pulse pressure. These are calculated for intervals such as the entire recording period, day, night or period of time as defined by operator.
Finally, the ABP 92506 RMS application can import reports generated by the ABP 90121 RMS and ABP 90219 RMS, predecessors of the ABP 92506 RMS.
The provided document describes a 510(k) summary for the Spacelabs Medical ABP 92506 Report Management System (RMS). This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It's crucial to understand that a 510(k) submission primarily focuses on substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a rigorous clinical study in the way a Pre-Market Approval (PMA) application might. Therefore, the information you've requested regarding acceptance criteria, study details, and expert involvement is not explicitly present in this type of document because it's not typically required for a 510(k) for this kind of device.
This device is a software application that manages data from an Ambulatory Blood Pressure (ABP) monitor, not the monitor itself, and its primary function is data acquisition, presentation, and basic statistical calculations. The "validation" mentioned refers to software development and compliance with regulations like 21 CFR §11 (electronic records) and 45 CFR §164 (HIPAA administrative requirements), not clinical performance or diagnostic accuracy.
Here's a breakdown based on the document, highlighting what is and isn't available:
Acceptance Criteria and Device Performance
Since this is a 510(k) for a software management system, and not a diagnostic device with performance metrics like sensitivity/specificity, there are no specific numerical "acceptance criteria" for clinical performance reported in this summary. The "performance" demonstrated is its ability to comply with software regulations and to process and display data in a manner substantially equivalent to its predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | The ABP 92506 RMS is substantially equivalent to the Spacelabs Medical Ambulatory Blood Pressure Monitor (including 90219 RMS) (K855127) and the Spacelabs Medical Ambulatory Blood Pressure Monitor (including 90121 RMS) (K855127, Letter to File) in design concepts, technologies, materials, and intended uses. |
| Software Functionality: | Functions include: PC-based software application, graphical user interface (GUI) similar to Microsoft applications, initialization and configuration of operating parameters, acquisition of stored blood pressure data, creation/review/editing/storage/confirmation/printing of ABP reports, simple summary trending calculations (mean and standard deviations for systolic, diastolic, MAP, heart rate, pulse pressure for various intervals), and import of reports from predecessors. |
| Compliance with Federal Regulations: | The ABP 92506 RMS was developed following a robust software development process and was fully specified and validated through rigorous testing that supports compliance with 21 CFR §11 (Electronic records; electronic signatures) and 45 CFR §164 (Administrative requirements - likely HIPAA). |
| Safety and Effectiveness: | By demonstrating substantial equivalence to legally marketed predicate devices, the device is considered as safe and effective as those predicates for its stated intended use. |
Study Information (Based on the 510(k) Document)
-
Sample size used for the test set and the data provenance:
- The document does not mention a specific "test set" in terms of patient data or clinical images for performance evaluation. The "testing" referred to is against software specifications and regulatory compliance.
- No data provenance (e.g., country of origin, retrospective/prospective) is provided as there's no clinical data test set described for performance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. There is no described clinical "ground truth" establishment process by experts for performance evaluation as this is a data management system, not a diagnostic algorithm.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. There is no described test set requiring expert adjudication.
-
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 MRMC study was done or is mentioned. This device is a report management system and does not involve AI assistance for interpretation or improving human reader performance.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a software tool for managing data from an ABP monitor and is intended for use by qualified medical personnel. It doesn't perform diagnostic interpretations in a "standalone" fashion that would require such testing.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not mentioned. For a software management system, "ground truth" would relate to the accuracy of data import, calculations, and display, which are typically validated through software testing against known inputs and expected outputs, rather than clinical ground truth like pathology.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a "training set" for model development.
-
How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant for this type of software.
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JUN - 6 2003
K03/479 1 OF 2
510(k) Summary of Safety and Effectiveness Ambulatory Blood Pressure 92506 Report Management System
| Proprietary: | Ambulatory Blood Pressure (ABP) 92506 Report Management System (RMS) |
|---|---|
| Common: | Noninvasive blood pressure measurement system, accessory |
| Classification: | Class II – 21 CFR §870.1130 |
| Panel: | Cardiovascular |
| Contact Person: | Al Van Houdt, Director of Regulatory Affairs and Quality |
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992.
The Spacelabs Medical ABP 92506 Report Management System (RMS) is substantially equivalent to the following currently marketed device(s):
| Spacelabs Medical Ambulatory Blood Pressure Monitor(includes 90219 RMS) | K855127 |
|---|---|
| Spacelabs Medical Ambulatory Blood Pressure Monitor(includes 90121 RMS) | K855127 (Letter to File) |
The Spacelabs Medical ABP 92506 RMS is a PC-based software application that accepts data collected from one of Spacelabs Medical's ABP monitors through an electrically-isolated interface cable.
The ABP 92506 RMS has a graphical user interface (GUI) similar to most Microsoft applications such as Word, Excel, etc. that provides common windowing controls such as menus, icons, mouse support, wizards, etc. These controls allow the operator to communicate with the ABP monitor.
Additionally, the ABP 92506 RMS provides necessary initialization and configuration of operating parameters, as well as acquires the monitor's stored blood pressure reading data. These readings are combined with patient demographic entry data to create an ABP report that can be reviewed, edited, stored, confirmed and printed by a physician.
Furthermore, the ABP 92506 RMS application also performs simple summary trending calculations from the individual blood pressure readings to present global statistical results, such as mean and standard deviations for systolic, diastolic, MAP, heart rate and pulse pressure. These are calculated for intervals such as the entire recording period, day, night or period of time as defined by operator.
Finally, the ABP 92506 RMS application can import reports generated by the ABP 90121 RMS and ABP 90219 RMS, predecessors of the ABP 92506 RMS.
The Spacelabs Medical ABP 92506 RMS is designed to comply with the following and Federal Codes:
0000006
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| 21 CFR §11 | Applicable Sections of Department of Health and Human Services— Electronic records; electronic signatures |
|---|---|
| 45 CFR §164 | Applicable Sections of Department of Health and Human Services— Administrative requirements |
The ABP 90121 RMS and the ABP 92506 RMS are substantially equivalent in design concepts, technologies, materials and intended uses. The ABP 92506 RMS was developed following a robust software development process, and was fully specified and validated through rigorous testing that, in part, support the compliance of the ABP 92506 RMS to the above mentioned Federal Codes.
The ABP 92506 RMS is the next generation in the Spacelabs Medical ABP RMS family of products.
000007
KO 314 79
EOFE
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three overlapping profiles, creating a sense of depth and unity. The overall design is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 6 2003
Datex-Ohmeda, Inc. Spacelabs Medical c/o Mr. Al Van Houdt Director, Regulatory Affairs & Quality 5150 220th Ave SE Issaquah, WA 98029
Re: K031479
Trade Name: Ambulatory Blood Pressure (ABP) 92506 Report Management System (RMS) Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive blood pressure measurement system. Regulatory Class: Class II (two) Product Code: DXN Dated: May 8, 2003 Received: May 12, 2003
Dear Mr. Van Houdt:
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. Van Houdt
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 (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 may be obtained 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,
for
Br
Di
Mefacmeyn
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Office of Device Evaluation 5 Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K031479 |
|---|---|
| Device Name: | Ambulatory Blood Pressure (ABP) 92506 Report ManagementSystem (RMS) |
| Indications for Use: | The ABP 92506 RMS is used to provide data to qualifiedmedical personnel for the purpose of assessing the patient'scardiac health via blood pressure readings taken during dailyactivity for up to a 48-hour period.The data is intended to provide preliminary blood pressure datafrom ambulatory patients for non-time critical applications only.It is for use in hospitals, clinics or physicians offices by aqualified physician or trained staff member under the supervisionof that physician.Patient diagnosis is not to be performed solely based on theresults of this device. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Mekimyer for B. Zuckerman
(Medi-Cal Sign Off)
in Sign-()It) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number:
Prescription Use (Per 21CFR801.109)
OR Over-The-Counter Use
Image /page/4/Picture/8 description: The image shows a sequence of numbers. The numbers are all zeros, except for the last digit, which is an eight. The sequence of numbers is "000008".
§ 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).