(243 days)
Not Found
No
The document describes a software algorithm for optimizing performance in the presence of artifact, but it does not use terms like AI, ML, DNN, or describe training/test sets indicative of AI/ML development. The performance studies focus on standard accuracy metrics and artifact management based on "Quality Factor Groups," which doesn't necessarily imply AI/ML.
No
The device is described as obtaining blood pressure and pulse rate measurements, indicating it is a diagnostic or monitoring device, not one that treats or cures a condition.
Yes
The device obtains vital signs (systolic, diastolic, and mean arterial blood pressures and pulse rate), which are measurements used by healthcare professionals to diagnose and monitor patient conditions.
No
The device description and performance studies clearly indicate this is a hardware module ("Advanced NIBP Module") that is used with existing hardware monitors ("DINAMAP MPS Select Family of Monitors"). While it includes a "Software Algorithm," the device itself is a physical component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Advanced NIBP Module measures blood pressure and pulse rate using the oscillometric method. This is a non-invasive measurement taken directly from the patient's body (via a cuff), not from a sample taken from the body.
- Intended Use: The intended use clearly states it's for obtaining blood pressure and pulse rate in a clinical setting, not for analyzing biological samples.
Therefore, the device falls under the category of a physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Advanced NIBP Module is designed for use with the DINAMAP MPS TM Select TM 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DXN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
small adult, adult, large adult, thigh, neonatal
Intended User / Care Setting
qualified healthcare personnel trained in its use / hospital, outpatient surgery and healthcare practitioner facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical and bench studies were conducted to demonstrate performance (safety and effectiveness) of the Advanced NIBP Module Software Algorithm. The module from a hardware perspective, including environmental and EMC testing, was cleared for marketing with the previously mentioned, currently marketed DINAMAP MPS Select Portable and the DINAMAP MPS Select Multiparameter System.
Clinical studies consistent with the recommendations of ANSI/AAMI SP10 (10/92) American National Standard for Electronic or Automated Sphygmomanometers were conducted with Advanced NIBP Module Software. Results demonstrated the recommended accuracy (mean ± 5 mmHg, standard deviation ≤ 8 mmHg).
Bench testing demonstrated that:
- average measurement time is reduced in the Advanced NIBP module when compared to the standard NIBP module; and that
- displayed NIBP values are properly managed in the presence of artifact on the basis of Quality Factor Groups
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Attachment B
3/29/99
510(k) Summary
K 982641
| Date | March 11, 1999 |
|---|---|
| Contact | Darlene T. Korab, Manager |
| Regulatory Affairs | |
| Critikon, LLC | |
| 4110 George Road | |
| Tampa, FL 33634 | |
| Telephone: 813-887-2663: Telefax: 813-887-2263 | |
| E 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 blood | ||||
| pressure measurement | ||||
| system | 870.1130 | II | 2 |
Continued on next page
1
510(k) Summary, Continued
・・・・・・・
JO - OL-EUR 17 CISET INVIT ISSU 181 In I Imis
| Predicate
Devices | The Advanced NIBP Module is substantially equivalent to the currently
marketed DINAMAP MPS Select NIBP Module used with DINAMAP MPS
Select Monitors, including the DINAMAP MPS Select Portable Monitor and
the DINAMAP MPS Select Multiparameter System. The DINAMAP MPS
Select Portable Monitor received market clearance on September 19, 1997 via
Critikon, a Division of Johnson & Johnson Medical, Inc. 510(k) K971569.
The DINAMAP MPS Select Multiparameter System received market
clearance on August 15, 1996 via Johnson & Johnson Medical, Inc. 510(k)
K955113. | | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------|
| | Device | Manufacturer | 510(k) |
| | DINAMAP MPS Select
Multiparameter System | Johnson & Johnson Medical, Inc. | K955113 |
| | DINAMAP MPS Select
Portable Monitor | Johnson & Johnson Medical, Inc. | K971569 |
| Device
Description | 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. | | |
| Indications | 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 NIΒΡ
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, currently marketed NIBP for use with neonatal
cuffs. The device is intended for use by qualified healthcare personnel trained
in its use. | | |
| | Continued on next page | | |
.
r : J
2
510(k) Summary, Continued
| Technological
Characteristics | The Advanced NIBP Module has the same technological characteristics as the
predicate device, the DINAMAP MPS Select NIBP Module used in the
DINAMAP MPS Select Monitors - the DINAMAP MPS Select Portable and
the DINAMAP MPS Select Multiparameter System. Differences between the
modules are limited to the NIBP software algorithm for the population whose
cuff sizes include small adult, adult, large adult, and thigh. The neonatal
application of the Advanced NIBP Module remains the same as the
DINAMAP MPS Select NIBP Module.
There are no new technological characteristics. Both modular devices are
utilized in software-driven electronic systems. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Testing | Clinical and bench studies were conducted to demonstrate performance
(safety and effectiveness) of the Advanced NIBP Module Software
Algorithm. The module from a hardware perspective, including
environmental and EMC testing, was cleared for marketing with the
previously mentioned, currently marketed DINAMAP MPS Select Portable
and the DINAMAP MPS Select Multiparameter System.
Clinical studies consistent with the recommendations of ANSI/AAMI SP10
(10/92) American National Standard for Electronic or Automated
Sphygmomanometers were conducted with Advanced NIBP Module
Software. Results demonstrated the recommended accuracy (mean $\pm$ 5
mmHg, standard deviation $\leq$ 8 mmHg). |
| | Bench testing demonstrated that:
- average measurement time is reduced in the Advanced NIBP module
when compared to the standard NIBP module; and that - displayed NIBP values are properly managed in the presence of artifact on
the basis of Quality Factor Groups |
| Other
Information | Critikon, LLC will update and include in this summary any other information
deemed reasonably necessary by the FDA. |
3
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.
4
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
5
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