(84 days)
Not Found
No
The device description focuses on standard pulse oximetry technology, data output, alarms, and power options. There is no mention of AI, ML, or advanced data processing beyond basic signal analysis for SpO2 and pulse rate. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
A pulse oximeter is a diagnostic device that monitors physiological parameters, not a therapeutic device that treats a condition.
Yes
The device is a pulse oximeter intended for monitoring functional oxygen saturation and pulse rate, which are used to assess a patient's physiological state and aid in diagnosis.
No
The device description explicitly details hardware components such as an internal power supply (AC and battery), a carrying handle, a serial port, and an interface for nurse call systems. It also mentions compatible oxygen transducers (sensors), which are hardware.
Based on the provided information, the NPB-295 Pulse Oximeter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body in order to provide information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- NPB-295 Function: The NPB-295 Pulse Oximeter is described as a device for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It uses sensors placed on the patient's body to measure these parameters directly.
- No Specimen Examination: The device does not examine specimens (like blood or tissue) in vitro (outside the body). It performs its measurements in vivo (within the living body).
Therefore, the NPB-295 Pulse Oximeter falls under the category of a non-invasive medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the NPB-295 Pulse Oximeter is for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO3) and pulse rate of adult, pediatric and neonate patients. The environments of use are hospital, hospitaltype facilities, intra-hospital transport and the home. The intended use, patient population and environment of use are the same or similar to the predicate device, the N-3000 Pulse Oximeter.
The intended use of the NPB-295 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with nconatal, pediatric and adult patients, in hospital-type, intra-hospital transport and home cnvironments. For prescription use only.
Product codes
74 DQA
Device Description
The NPB-295 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate by use of one of a range of compatible Nellcor Puritan Bennett oxygen transducers (sensors). The or a range of compansio from of SpO₂ and pulse rate, and pulse amplitude by means of a "blip bar" presentation. The NPB-295 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 by an integral sealed 6V rechargeable lead-acid battery. The NPB-295 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-295 also includes adjustable alarm silence duration and other provided. configurable power on settings. The NPB-295 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-295 Pulse Oximeter has visual indicators for pulse search, motion, 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 has been 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 and RS-422 interface) that provides ASCII output of real-time data every two seconds. This data can be printed on serial printers. TThere is also an interface for nurse call systems through the rear connector. The device is also Flash ROM upgradable.
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
adult, pediatric and neonatal patients
neonatal, pediatric and adult patients
Intended User / Care Setting
For prescription use only.
hospital, hospital-type, intra-hospital transport and home environments.
hospital, hospitaltype facilities, intra-hospital transport and the home.
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
In addition, in-vitro and non-invasive controlled hypoxia studies were conducted to establish the NPB-295's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-295.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In addition, in-vitro and non-invasive controlled hypoxia studies were conducted to establish the NPB-295's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-295.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
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.(b)
Classification. Class II (performance standards).
0
1
NOV I 4 1997
Section 16. 510(k) Summary
Section 16.a Date Summary Prepared
22 August 1997
Section 16.b Company Information
Establishment:
Official Correspondent:
Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588
Roger D. Brown Regulatory Affairs Specialist Nellcor Puritan Bennett Inc. 11150 Thompson Avenue Lenexa, KS 66219 (913) 495-7146 (direct phone) (913) 495-7285 (fax)
Section 16.c Name of Device
Proprietary:
Common/Usual:
Pulse Oximeter
NPB-295 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 a comparison of product features as described in the labeling and promotional literature for predicate devices and the NPB-295, as well as testing to accepted industry standards. In addition, in-vitro and non-invasive controlled hypoxia studies were conducted to establish the NPB-295's accuracy and to ensure that the sensors meet their currently published accuracy specifications with the NPB-295. The predicate devices are as follows:
1
Section 16.e Device Description
The NPB-295 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate by use of one of a range of compatible Nellcor Puritan Bennett oxygen transducers (sensors). The or a range of compansio from of SpO₂ and pulse rate, and pulse amplitude by means of a "blip bar" presentation. The NPB-295 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 by an integral sealed 6V rechargeable lead-acid battery. The NPB-295 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-295 also includes adjustable alarm silence duration and other provided. configurable power on settings. The NPB-295 provides an audible low battery warning to alert the user of impending loss of power and consequent loss of monitoring capability. The NPB-295 Pulse Oximeter has visual indicators for pulse search, motion, 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 has been 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 and RS-422 interface) that provides ASCII output of real-time data every two seconds. This data can be printed on serial printers. TThere is also an interface for 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-295 Pulse Oximeter is for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO3) and pulse rate of adult, pediatric and neonate patients. The environments of use are hospital, hospitaltype facilities, intra-hospital transport and the home. The intended use, patient population and environment of use are the same or similar to the predicate device, the N-3000 Pulse Oximeter.
Section 16.g Technological Characteristics
The NPB-295 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-295 receives this electrical information from the sensor and processes the information by use of an oximetry algorithm to provide a real time value of SpO3, Pulse Rate and Pulse Amplitude.
The oximetry algorithm is contained in the NPB-295 "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 NPB-295 uses the same SpO, and Pulse Rate software algorithm to process the information from the sensor as the predicate device, N-3000, cleared under K942347 and K952316.
Image /page/1/Picture/9 description: The image contains the number 821 on the left side. To the right of the number is a blacked out rectangle. The number is written in a serif font. The image is simple and contains only these two elements.
2
Section 16.h Certification Statement
In accordance with the requirements of 21 CFR 807.87(j), the following certification is provided:
Nellcor Puritan Bennett Inc. believes that all data and information submitted in this premarket notification are truthful and accurate and no material fact has been omitted.
Roger D. Bu
Roger D. Brown Regulatory Affairs Specialist for Nellcor Puritan Bennett Inc.
3
Image /page/3/Picture/10 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 symbol. The symbol consists of three abstract human profiles facing to the right, layered on top of each other. The profiles are depicted with simple, flowing lines, creating a sense of unity and connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV I 4 1997
Mr. Roger D. Brown Nellcor Puritan Bennett Inc. 11150 Thompson Avenue Lenexa, Kansas 66219-2301
Re: K973147 NPB-295 Pulse Oximeter Regulatory Class: II (two) Product Code: 74 DQA Dated: Auqust 19, 1997 Received: August 22, 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 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 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 GMP regulation may result in requlatory 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.
4
Page 2 - Mr. 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 (301) 594–4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
5
| 510(k) Number (if known): | K973147 |
|---|---|
| --------------------------- | --------- |
Device Name: NPB-295 Pulse Oximeter
Indications For Use:
The intended use of the NPB-295 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. For use with nconatal, pediatric and adult patients, in hospital-type, intra-hospital transport and home cnvironments. 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)
:
ﻧﻪ ﺩﺭ ﺍﺳ
OR
Over-The-Counter Use
(Optional Format 1-2-96)
th. A. Cill.
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K973147 510(k) Number _