(243 days)
The Advanced NIBP Module is designed for use with the DINAMAP MPS Select Family of Monitors, including the DINAMAP MPS Select Portable Monitor and the DINAMAP MPS Select Multiparameter System. The Advanced NIBP Module is intended to obtain a single patient's systolic, diastolic and mean arterial blood pressures and pulse rate in the same intended use environment as the DINAMAP MPS Select Family of Monitors: hospital, outpatient surgery and healthcare practitioner facilities. The Advanced NIBP Module optimizes performance in the presence of artifact. The Module combines Advanced NIBP for use with small adult, adult, large adult and thigh cuffs with standard NIBP for use with neonatal cuffs. The device is intended for use by qualified healthcare personnel trained in its use.
Used with the DINAMAP MPS Select Family of Monitors, the Advanced NIBP Module obtains systolic, diastolic and mean arterial pressures and pulse rate via the oscillometric method. The Advanced NIBP Module optimizes performance in the presence of artifact due to vibration and patient motion. Reduced measurement time, a message for values that may be affected by artifact and greater patient comfort differentiate Advanced NIBP Module performance.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Advanced NIBP Module:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI SP10) | Reported Device Performance (Advanced NIBP Module) |
|---|---|
| Mean difference (between device and reference) $\pm$ 5 mmHg | Mean $\pm$ 5 mmHg |
| Standard deviation (of differences) $\leq$ 8 mmHg | Standard deviation $\leq$ 8 mmHg |
| Reduced average measurement time compared to standard NIBP module | Average measurement time is reduced |
| Displayed NIBP values properly managed in the presence of artifact (based on Quality Factor Groups) | Displayed NIBP values are properly managed in the presence of artifact |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical test set. It mentions "Clinical studies...were conducted," but the number of patients or measurements is not provided. The data provenance is not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications used to establish ground truth for the clinical studies. Given the nature of blood pressure measurement, the "ground truth" would typically refer to a referent measurement method (like intra-arterial) rather than expert consensus on readings.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The device is a non-invasive blood pressure module, not an imaging or diagnostic device requiring human reader interpretation in the same way.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance assessment was done for the algorithm. The "Advanced NIBP Module Software Algorithm" was the subject of the clinical and bench studies. The clinical studies demonstrated its accuracy against the ANSI/AAMI SP10 standard, and bench testing focused on its performance in terms of measurement time and artifact management.
7. Type of Ground Truth Used
The ground truth used for the clinical accuracy study was presumably a reference blood pressure measurement method consistent with the ANSI/AAMI SP10 standard. This standard typically involves either direct intra-arterial blood pressure measurements or a simultaneous auscultatory method performed by trained observers using mercury sphygmomanometers, often with specific protocols for observer blinding and averaging to reduce bias.
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for a training set. This is a software modification of an existing device, and the focus of the submission is on testing the performance of the modified algorithm rather than describing its development.
9. How the Ground Truth for the Training Set was Established
The document does not provide information on how ground truth was established for any training set. As mentioned, the focus is on performance testing of a modified algorithm.
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Attachment B
3/29/99
510(k) Summary
K 982641
| Date | March 11, 1999 |
|---|---|
| Contact | Darlene T. Korab, ManagerRegulatory AffairsCritikon, LLC4110 George RoadTampa, FL 33634Telephone: 813-887-2663: Telefax: 813-887-2263E Mail: dkorab@crtus.jnj.com |
| Device Name | • Advanced NIBP Module |
The subject of this premarket notification is a software modification of the
currently marketed DINAMAP MPST™ Select™ NIBP Module used with the
DINAMAP MPS Select Family of Monitors, including the currently marketed
DINAMAP MPS Select Portable Monitor and the currently marketed
DINAMAP MPS Select Multiparameter System. In this premarket
notification, the terms new device, new module and new NIBP module are
used interchangeably with Advanced NIBP Module; and the terms predicate
device, standard module and standard NIBP module are used interchangeably
with DINAMAP MPS Select NIBP Module.
| Common Name | • Non-Invasive Blood Pressure Module |
|---|---|
| Classification | The classification name, 21 Code of Federal Regulations (CFR) Part and Paragraph number and classification of the Advanced NIBP Module follow. The tier categorization based on the list (January 27, 1994) distributed by the Office of Device Evaluation is also included. |
| Classification Name | 21 CFR Section | Class | Tier | |
|---|---|---|---|---|
| Noninvasive bloodpressure measurementsystem | 870.1130 | II | 2 |
Continued on next page
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510(k) Summary, Continued
・・・・・・・
JO - OL-EUR 17 CISET INVIT ISSU 181 In I Imis
| PredicateDevices | The Advanced NIBP Module is substantially equivalent to the currentlymarketed DINAMAP MPS Select NIBP Module used with DINAMAP MPSSelect Monitors, including the DINAMAP MPS Select Portable Monitor andthe DINAMAP MPS Select Multiparameter System. The DINAMAP MPSSelect Portable Monitor received market clearance on September 19, 1997 viaCritikon, a Division of Johnson & Johnson Medical, Inc. 510(k) K971569.The DINAMAP MPS Select Multiparameter System received marketclearance on August 15, 1996 via Johnson & Johnson Medical, Inc. 510(k)K955113. | ||
|---|---|---|---|
| Device | Manufacturer | 510(k) | |
| DINAMAP MPS SelectMultiparameter System | Johnson & Johnson Medical, Inc. | K955113 | |
| DINAMAP MPS SelectPortable Monitor | Johnson & Johnson Medical, Inc. | K971569 | |
| DeviceDescription | Used with the DINAMAP MPS Select Family of Monitors, the AdvancedNIBP Module obtains systolic, diastolic and mean arterial pressures and pulserate via the oscillometric method. The Advanced NIBP Module optimizesperformance in the presence of artifact due to vibration and patient motion.Reduced measurement time, a message for values that may be affected byartifact and greater patient comfort differentiate Advanced NIBP Moduleperformance. | ||
| Indications | The Advanced NIBP Module is designed for use with the DINAMAP MPSSelect Family of Monitors, including the DINAMAP MPS Select PortableMonitor and the DINAMAP MPS Select Multiparameter System. TheAdvanced NIBP Module is intended to obtain a single patient's systolic,diastolic and mean arterial blood pressures and pulse rate in the same intendeduse environment as the DINAMAP MPS Select Family of Monitors: hospital,outpatient surgery and healthcare practitioner facilities. The Advanced NIΒΡModule optimizes performance in the presence of artifact. The Modulecombines Advanced NIBP for use with small adult, adult, large adult andthigh cuffs with standard, currently marketed NIBP for use with neonatalcuffs. The device is intended for use by qualified healthcare personnel trainedin its use. | ||
| Continued on next page |
.
r : J
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510(k) Summary, Continued
| TechnologicalCharacteristics | The Advanced NIBP Module has the same technological characteristics as thepredicate device, the DINAMAP MPS Select NIBP Module used in theDINAMAP MPS Select Monitors - the DINAMAP MPS Select Portable andthe DINAMAP MPS Select Multiparameter System. Differences between themodules are limited to the NIBP software algorithm for the population whosecuff sizes include small adult, adult, large adult, and thigh. The neonatalapplication of the Advanced NIBP Module remains the same as theDINAMAP MPS Select NIBP Module.There are no new technological characteristics. Both modular devices areutilized in software-driven electronic systems. |
|---|---|
| Testing | Clinical and bench studies were conducted to demonstrate performance(safety and effectiveness) of the Advanced NIBP Module SoftwareAlgorithm. The module from a hardware perspective, includingenvironmental and EMC testing, was cleared for marketing with thepreviously mentioned, currently marketed DINAMAP MPS Select Portableand the DINAMAP MPS Select Multiparameter System.Clinical studies consistent with the recommendations of ANSI/AAMI SP10(10/92) American National Standard for Electronic or AutomatedSphygmomanometers were conducted with Advanced NIBP ModuleSoftware. Results demonstrated the recommended accuracy (mean $\pm$ 5mmHg, standard deviation $\leq$ 8 mmHg). |
| Bench testing demonstrated that:1. average measurement time is reduced in the Advanced NIBP modulewhen compared to the standard NIBP module; and that2. displayed NIBP values are properly managed in the presence of artifact onthe basis of Quality Factor Groups | |
| OtherInformation | Critikon, LLC will update and include in this summary any other informationdeemed reasonably necessary by the FDA. |
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 1999
Ms. Darlene T. Korab Manager, Regulatory Affairs Johnson & Johnson Medical, Inc. Critikon 4110 George Road Tampa, FL 33634
Re : K982641 Advanced NIBP Module Regulatory Class: II (Two) Product Code: 74 DXN Dated: February 26, 1999 Received: March 1, 1999
Dear Ms. Korab:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Darlene T. Korab
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Also, please note the regulation Compliance at (301) 594-4639. entitled, "Misbranding by reference to premarket notification" Other general information on your (21CFR 807.97). responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan, Ph.D.
Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment H
| INDICATIONS FOR USE | |
|---|---|
| Page 1 of 1 | |
| 510(k) Number (if known): | K982641 |
| Device Name: | Advanced NIBP Module |
| Indications for Use: |
The Advanced NIBP Module is designed for use with the DINAMAP MPS
TM SelectTM Family of Monitors, including the DINAMAP MPS Select Portable Monitor and the DINAMAP MPS Select Multiparameter System. The Advanced NIBP Module is intended to obtain a single patient's systolic, diastolic and mean arterial blood pressures and pulse rate in the same intended use environment as the DINAMAP MPS Select Family of Monitors: hospital, outpatient surgery and healthcare practitioner facilities. The Advanced NIBP Module optimizes performance in the presence of artifact. The Module combines Advanced NIBP for use with small adult, adult, large adult and thigh cuffs with standard NIBP for use with neonatal cuffs. The device is intended for use by qualified healthcare personnel trained in its use.
(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, Respiratory, and Neurological Devices
| 510(k) Number | K982641 |
|---|---|
| --------------- | --------- |
| Prescription Use ✓(per 21 CFR 801.109) | OR | Over-The Counter Use(Optional Format 1-2-96) |
|---|---|---|
| -------------------------------------------------------------------------------------------- | ---- | -------------------------------------------------- |
iv
§ 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).