ADVANCED NIBP MODULE

K982641 · Johnson & Johnson Medical, Inc. · DXN · Mar 29, 1999 · Cardiovascular

Device Facts

• Record ID: K982641
• Device Name: ADVANCED NIBP MODULE
• Applicant: Johnson & Johnson Medical, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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.

Device Story

Advanced NIBP Module is a software modification for DINAMAP MPS Select monitors; utilizes oscillometric method to measure systolic, diastolic, mean arterial pressure, and pulse rate. Input: pressure signals from patient cuffs; output: blood pressure and pulse rate values displayed on monitor. Optimized for performance in presence of motion/vibration artifact; uses Quality Factor Groups to manage displayed values. Used in hospitals and outpatient facilities by trained healthcare personnel. Benefits include reduced measurement time and improved patient comfort. Healthcare providers use output for clinical monitoring and decision-making.

Clinical Evidence

Clinical studies conducted per ANSI/AAMI SP10 (10/92) standard for electronic sphygmomanometers. Results demonstrated accuracy with mean error ± 5 mmHg and standard deviation ≤ 8 mmHg. Bench testing confirmed reduced measurement time compared to standard module and effective management of artifact-affected values using Quality Factor Groups.

Technological Characteristics

Software-driven electronic system; oscillometric sensing principle. Hardware identical to predicate. Software algorithm modified for small adult, adult, large adult, and thigh cuff applications; neonatal application remains unchanged. Connectivity via integration with DINAMAP MPS Select monitor family.

Indications for Use

Indicated for use in hospital, outpatient surgery, and healthcare practitioner facilities to obtain systolic, diastolic, mean arterial blood pressure, and pulse rate. Compatible with small adult, adult, large adult, and thigh cuffs (Advanced NIBP) and neonatal cuffs (standard NIBP). Intended for use by trained healthcare personnel.

Regulatory Classification

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.

Predicate Devices

• DINAMAP MPS Select Multiparameter System (K955113)
• DINAMAP MPS Select Portable Monitor (K971569)

Submission Summary (Full Text)

{0}------------------------------------------------

Attachment B
3/29/99
510(k) Summary
K 982641

| Date | March 11, 1999 |
|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Darlene T. Korab, Manager<br>Regulatory Affairs<br>Critikon, LLC<br>4110 George Road<br>Tampa, FL 33634<br>Telephone: [phone]: Telefax: 813-887-2263<br>E Mail: [e-mail] |
| 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<br>pressure measurement<br>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<br>Devices | The Advanced NIBP Module is substantially equivalent to the currently<br>marketed DINAMAP MPS Select NIBP Module used with DINAMAP MPS<br>Select Monitors, including the DINAMAP MPS Select Portable Monitor and<br>the DINAMAP MPS Select Multiparameter System. The DINAMAP MPS<br>Select Portable Monitor received market clearance on September 19, 1997 via<br>Critikon, a Division of Johnson & Johnson Medical, Inc. 510(k) K971569.<br>The DINAMAP MPS Select Multiparameter System received market<br>clearance on August 15, 1996 via Johnson & Johnson Medical, Inc. 510(k)<br>K955113. | | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|---------|
| | Device | Manufacturer | 510(k) |
| | DINAMAP MPS Select<br>Multiparameter System | Johnson & Johnson Medical, Inc. | K955113 |
| | DINAMAP MPS Select<br>Portable Monitor | Johnson & Johnson Medical, Inc. | K971569 |
| Device<br>Description | Used with the DINAMAP MPS Select Family of Monitors, the Advanced<br>NIBP Module obtains systolic, diastolic and mean arterial pressures and pulse<br>rate via the oscillometric method. The Advanced NIBP Module optimizes<br>performance in the presence of artifact due to vibration and patient motion.<br>Reduced measurement time, a message for values that may be affected by<br>artifact and greater patient comfort differentiate Advanced NIBP Module<br>performance. | | |
| Indications | The Advanced NIBP Module is designed for use with the DINAMAP MPS<br>Select Family of Monitors, including the DINAMAP MPS Select Portable<br>Monitor and the DINAMAP MPS Select Multiparameter System. The<br>Advanced NIBP Module is intended to obtain a single patient's systolic,<br>diastolic and mean arterial blood pressures and pulse rate in the same intended<br>use environment as the DINAMAP MPS Select Family of Monitors: hospital,<br>outpatient surgery and healthcare practitioner facilities. The Advanced NIΒΡ<br>Module optimizes performance in the presence of artifact. The Module<br>combines Advanced NIBP for use with small adult, adult, large adult and<br>thigh cuffs with standard, currently marketed NIBP for use with neonatal<br>cuffs. The device is intended for use by qualified healthcare personnel trained<br>in its use. | | |
| | Continued on next page | | |

.

r : J

{2}------------------------------------------------

## 510(k) Summary, Continued

-

| Technological<br>Characteristics | The Advanced NIBP Module has the same technological characteristics as the<br>predicate device, the DINAMAP MPS Select NIBP Module used in the<br>DINAMAP MPS Select Monitors - the DINAMAP MPS Select Portable and<br>the DINAMAP MPS Select Multiparameter System. Differences between the<br>modules are limited to the NIBP software algorithm for the population whose<br>cuff sizes include small adult, adult, large adult, and thigh. The neonatal<br>application of the Advanced NIBP Module remains the same as the<br>DINAMAP MPS Select NIBP Module.<br>There are no new technological characteristics. Both modular devices are<br>utilized in software-driven electronic systems. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Testing | Clinical and bench studies were conducted to demonstrate performance<br>(safety and effectiveness) of the Advanced NIBP Module Software<br>Algorithm. The module from a hardware perspective, including<br>environmental and EMC testing, was cleared for marketing with the<br>previously mentioned, currently marketed DINAMAP MPS Select Portable<br>and the DINAMAP MPS Select Multiparameter System.<br>Clinical studies consistent with the recommendations of ANSI/AAMI SP10<br>(10/92) American National Standard for Electronic or Automated<br>Sphygmomanometers were conducted with Advanced NIBP Module<br>Software. Results demonstrated the recommended accuracy (mean $\pm$ 5<br>mmHg, standard deviation $\leq$ 8 mmHg). |
| | Bench testing demonstrated that:<br>1. average measurement time is reduced in the Advanced NIBP module<br>when compared to the standard NIBP module; and that<br>2. displayed NIBP values are properly managed in the presence of artifact on<br>the basis of Quality Factor Groups |
| Other<br>Information | Critikon, LLC will update and include in this summary any other information<br>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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Also, please note the regulation Compliance at [phone]. 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 [phone] or [phone] 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 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.

(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 <span style="text-decoration: overline;">✓</span><br>(per 21 CFR 801.109) | OR | Over-The Counter Use<br>(Optional Format 1-2-96) |
|--------------------------------------------------------------------------------------------|----|--------------------------------------------------|
|--------------------------------------------------------------------------------------------|----|--------------------------------------------------|

iv