(79 days)
Not Found
No
The description focuses on standard pulse oximetry functions, user interface enhancements, and alarm features. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a pulse oximeter used for monitoring, not for treating any condition.
Yes
The device is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status and aid in diagnosis.
No
The device description explicitly states it is a "handheld, battery powered pulse oximeter" and mentions hardware components like a "user interface board," "keys," and a "display." This indicates it is a physical hardware device, not software only.
Based on the provided information, 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 OxiMax NPB-40 handheld pulse oximeter measures functional arterial oxygen saturation (SpO2) and pulse rate non-invasively by placing a sensor on the patient's body (typically a finger, toe, or earlobe). It does not analyze samples taken from the body.
- Intended Use: The intended use describes monitoring physiological parameters directly from the patient.
Therefore, the OxiMax NPB-40 is a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OxiMax™ NPB-40 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital type facilities, transport and mobile environments as well as in the home care environment.
Product codes
DQA
Device Description
The OxiMax NPB-40 is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and saturated oxygen in arterial blood. The OxiMax NPB 40 include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings and the OxiMax in-sensor data features. The OxiMax NPB-40 also has menu features to allow the user to set the time, date and measurement alarm limits
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arterial
Indicated Patient Age Range
adult, pediatric and neonatal
Intended User / Care Setting
hospital type facilities, transport and mobile environments as well as in the home care environment.
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
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Summary of Performance Studies
Performance data includes results from environmental testing, in-house clinical studies and laboratory testing. Environmental testing includes testing for electromagnetic compatibility, electrical safety and reliability.
Clinical and non-clinical laboratory testing was conducted to evaluate oxygen saturation and pulse rate accuracy of the OxiMax NPB-40 during non-motion and motion conditions as well as low perfusion levels.
The performance data demonstrates substantial equivalence between the OxiMax NPB-40 and the legally marketed predicates, the NPB-40 and the N-550 oximeters.
Key Metrics
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
Image /page/0/Picture/0 description: The image shows the logo for Tyco Healthcare. The word "Tyco" is in bold, black letters with a stylized design. Below the word "Tyco" is a horizontal line, and below the line is the word "Healthcare" in a smaller, italicized font.
:Ilcor r uritan Bennett AUG 1 1 2005
4280 Hacıenda Drive Pleasanton, CA 94588-2719
Tele: 925 463-4000 Fax: 925 463-4420
510(k) Summary
Submitted by:
Nellcor Puritan Bennett 4280 Hacienda Drive Pleasanton, CA 94588 FAX: (925) 463-4020
Company Contact:
Sarah Harrington, Regulatory Affairs Manager (925) 463-4151 sarah.harrington(a)tycohealthcare.com
Date Prepared:
OxiMax™ NPB-40 Pulse Oximeter Trade Name:
May 20, 2005
Oximeter (DQA)
21 CFR 870.2700
Pulse Oximeter Common/Usual Name:
Classification Name:
Substantially Equivalent Devices:
Nellcor Puritan Bennett NPB-40 Handheld Pulse Oximeter, K963707 Nellcor Puritan Bennett N-550 Pulse Oximeter, K021090
Device Description
The OxiMax NPB-40 is a handheld, battery powered pulse oximeter used for monitoring of pulse rate and saturated oxygen in arterial blood. The OxiMax NPB 40 include the addition of audible alarms, addition of keys and display icons in the user interface board to access the alarm settings and the OxiMax in-sensor data features. The OxiMax NPB-40 also has menu features to allow the user to set the time, date and measurement alarm limits
1
Intended Use
The OxiMax™ NPB-40 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital type facilities, transport and mobile environments as well as in the home care environment.
Technological Characteristics
The OxiMax NPB-40 shares the same intended use and indications for use as the predicate devices. The NPB-40 is indicated for spot check use, while the N-550 is intended for continuous use. The NPB-40 four button configuration panel has been redesigned and replaced with a new seven button panel to accommodate the additional OxiMax functionality. The N-550 also incorporates the OxiMax technology. Both the OxiMax NPB-40 and the N-550 have visual and audible alarms with adjustable limits.
Performance Data
Performance data includes results from environmental testing, in-house clinical studies and laboratory testing. Environmental testing includes testing for electromagnetic compatibility, electrical safety and reliability.
Clinical and non-clinical laboratory testing was conducted to evaluate oxygen saturation and pulse rate accuracy of the OxiMax NPB-40 during non-motion and motion conditions as well as low perfusion levels.
The performance data demonstrates substantial equivalence between the OxiMax NPB-40 and the legally marketed predicates, the NPB-40 and the N-550 oximeters.
Conclusion
The technological characteristics and the results of the performance data demonstrate that the OxiMax NPB-40 Handheld Pulse Oximeter is as safe and effective and performs as well or better than the legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, indicating an affiliation with a public health organization.
Image /page/2/Picture/2 description: The image shows the seal for the Department of Health and Human Services, USA. The seal is circular and contains the department's logo in the center. The logo is a stylized depiction of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the perimeter of the circle.
AUG 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sarah Harrington Regulatory Affairs Manager Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588-2719
Re: K051352
Trade/Device Name: OXIMAX NPB-40 Handheld Pulse Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: August 2, 2005 Received: August 3, 2005
Dear Ms. Harrington:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Harrington
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Nellcor Puritan Bennett
Statement of Indications for Use
K OS1362 510(k) Number (if known):
OxiMax™ NPB-40 Pulse Oximeter Device Name:
Indications For Use: -
The OxiMax™ NPB-40 handheld pulse oximeter is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric and neonatal patients in hospital type facilities, transport and mobile environments as well as in the home care environment.
Prescription Use _ X (Part 21 CRF 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Teresa Osborne
| (Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| K051352 |
510(K) NHOP BENDB 40 510(k) KOST 75 CONFIDENTIAL