NPB-190 PULSE OXIMETER (NPB-190)

K971946 · Nellcor Puritan Bennett, Inc. · DQA · Aug 25, 1997 · Cardiovascular

Device Facts

• Record ID: K971946
• Device Name: NPB-190 PULSE OXIMETER (NPB-190)
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of the NPB-190 Pulse Oximeter is for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric and neonate patients. The environments of use are intra-hospital transport, the hospital, hospital-type facilities and the home. The intended use, patient, population and environment of use are the same or similar to the predicate devices, the NPB-40, N-200 and BCI 3304.

Device Story

NPB-190 Pulse Oximeter provides continuous, non-invasive monitoring of SpO2 and pulse rate. Device uses compatible Nellcor sensors containing red and infrared LEDs; photodiode detects light absorption through tissue. Internal engine processes analog signals via software algorithm to calculate SpO2, pulse rate, and pulse amplitude. Output displayed as digital values and "blip bar" on device screen. Features include audible/visual alarms for saturation, pulse rate, and pulse search; serial port (EIA-232) for real-time data output to printers or nurse call systems. Powered by AC or internal rechargeable lead-acid battery. Used by clinicians or patients in hospitals, transport, or home settings. Provides real-time physiological data to assist clinical decision-making and patient monitoring.

Clinical Evidence

Noninvasive controlled hypoxia studies were conducted to establish accuracy and ensure sensors meet published specifications. No other clinical data provided.

Technological Characteristics

Measures SpO2 via light absorption (red/infrared LEDs and photodiode). Powered by AC or 6V rechargeable lead-acid battery. Includes EIA-232 serial interface. Flash ROM upgradable. Software algorithm processes analog signals from sensors to calculate SpO2, pulse rate, and pulse amplitude. Same engine and algorithm as predicate NPB-40.

Indications for Use

Indicated for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in neonatal, pediatric, and adult patients. For prescription use only in hospital, intra-hospital transport, and home environments.

Regulatory Classification

Identification

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

Predicate Devices

• NPB-40 Handheld Pulse Oximeter (K963707)
• Nellcor N-200 Pulse Oximeter (K863784)
• BCI 3304 Oximeter (K962156)

Submission Summary (Full Text)

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K971946

## Section 16. 510(k) Summary

Section 16.a Date Summary Prepared

23 May 1997

AUG 25 1997

# Section 16.b Company Information

Establishment:

Official Correspondent:

Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588

Roger D. Brown Requlatory Affairs Specialist Nellcor Puritan Bennett Inc. 11150 Thompson Avenue Lenexa, KS 66219 [phone] (direct phone) [phone] (fax)

## Section 16.c Name of Device

| Proprietary: | NPB-190 Pulse Oximeter |
|-----------------|----------------------------|
| Common/Usual: | Pulse Oximeter |
| Classification: | Oximeter (§870.2700/74DQA) |

# Section 16.d Equivalent Devices

Substantial equivalence to the following legally marketed predicate devices with the same or similar indications for use has been demonstrated by comparison of product features as described in the labeling and promotional literature for predicate devices and the NPB-190, as well as testing to accepted industry standards. In addition, noninvasive controlled hypoxia studies were conducted to establish the NPB-190's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-190. The predicate devices are as follows:

- 1. NPB-40 Handheld Pulse Oximeter, Nellcor Puritan Bennett Inc., K963707
- 2. Nellcord N-200 Pulse Oximeter, Nellcor Puritan Bennett Inc., K863784
- 3. BCI 3304 Oximeter, BCI International Inc., K962156

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### Section 16.e Device Description

The NPB-190 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate by use of one of a range of compatible Nellcor Puritan Bennett oxygen transducers (sensors). The NPB-190 displays digital values of SpO- and pulse rate and pulse amplitude by means of a "blip bar" presentation. The NPB-190 can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable from 115V to 230V) or alternatively an integral sealed 6V rechargeable lead-acid battery. The NPB-190 is intended for prescription use with adult, pediatric and neonatal patients in hospital, hospital-type, intra-hospital transport and home environments.

Audible and visual alarms for high/low saturation, pulse rate and pulse search are The NPB-190 also includes adjustable alarm silence duration and other provided. configurable power on settings. The NPB-190 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-190 Pulse Oximeter has visual indicators for pulse search, power mode (i.e. battery or AC) and alarm silence in addition to alarm features.

In addition to the above mentioned device features, the instrument was designed to satisfy the needs of both the user and the patient. A convenient carrying handle is incorporated into the case. There is also a serial port (EIA-232 interface) that provides ASCII output of real-time data every two seconds. This data can be printed on serial printers and can interface with nurse call systems through the rear connector. The device is also Flash ROM upgradable.

### Section 16.f Intended Use

The intended use of the NPB-190 Pulse Oximeter is for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric and neonate patients. The environments of use are intra-hospital transport, the hospital, hospital-type facilities and the home. The intended use, patient, population and environment of use are the same or similar to the predicate devices, the NPB-40, N-200 and BCI 3304.

### Section 16.g Technological Characteristics

The NPB-190 Pulse Oximeter measures functional oxygen saturation by calculating the light absorption of tissue, bone, and blood in the sampling light beam path during the pulsatile cycle. Red and infrared LED's are utilized as light sources. A photodiode acting as a photodetector senses the signal strength of the two wavelengths of light, which vary inversely with the amount of light transmitted through the tissue. The NPB-190 receives this electrical information from the sensor and processes the information by use of an SpO2 software algorithm to provide a real time value of SpO2.

The software algorithm is contained in the NPB-190 "engine". The "engine" (part of the instrument that processes the analog signals from the sensors) consists of electrical circuitry and processors that calculate the SpO2, pulse rate, and pulse amplitude. The electrical circuitry of the NPB-190 engine is the engine used by the predicate device, NPB-40, cleared under K963707. The NPB-190 also uses the same SpO2 software algorithm to process the information from the sensor as the predicate device, NPB-40, cleared under K963707.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Roger D. Brown Regulatory Affairs Specialist Nellcor Puritan Bennett, Inc. 11150 Thompson Avenue Lenexa, Kansas 66219-2301 - --------------------------------------------------------------------------------------------------------------------------------------------------

AUG 25 1997

Re: K971946 NPB-190 Pulse Oximeter Regulatory Class: II (Two) Product Code: 74 DQA Dated: May 23, 1997 Received: May 27, 1997

Dear Mr. Brown:

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 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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 GMF regulation 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 regulations.

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Page 2 - Roger D. Brown

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 diagnostic 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 Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your 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/dsmamain.html."

Sincerely yours,

Thomas J. Callahan

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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K971946 510(k) Number (if known):

Device Name: NPB-190 Pulse Oximeter

Indications For Usc:

The intended use of the NPB-190 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulserate. For violiti neonatal, pediatric and adult patients, in hospital-type, intra-hospital transport and home environments. For prescription use only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number. K971946