(357 days)
Not Found
No
The description focuses on standard pulse oximetry technology with optical components and a memory chip for sensor information. There is no mention of AI or ML algorithms for data processing or interpretation.
No.
This device is for continuous noninvasive monitoring of SpO2 and pulse rate, which is a diagnostic function, not a therapeutic one.
No.
The device is used for continuous noninvasive monitoring of physiological parameters (SpO2 and pulse rate), which are measurements rather than diagnostic determinations.
No
The device description explicitly details hardware components including LEDs, a photodiode, a laminated envelope with an adhesive bandage, a sensor cable, a connector element, and a memory chip.
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. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The description clearly states that this device is a pulse oximeter sensor. It is used for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. This is done by attaching the sensor to the patient's body (e.g., finger, earlobe) and using light to measure oxygen levels in the blood in vivo (within the living body).
- No Sample Analysis: The device does not involve taking a sample from the patient and analyzing it outside the body.
Therefore, since the device operates by directly monitoring physiological parameters on the patient's body rather than analyzing a sample taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Reprocessed Oxisensor II and OxiMax Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. They are intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
NLF
Device Description
The Reprocessed Nellcor Oxisensor and OxiMax Sensors are designed for use with Nellcor and Nellcor-licensed pulse oximetry monitors that provide continuous noninvasive measurement of pulse rate and arterial oxygen saturation. The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and the photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to a laminated envelope is a sensor cable which terminates in a connector element that connects to the oximeter.
The sole difference between the OxiMax sensors and the Oxisensor II sensors is the OxiMax sensors each contain a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in sensor data, Advanced Signal Evaluation, lot code and data set revision, and sensor model.
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
neonatal, pediatric, and adult
Intended User / Care Setting
hospitals, hospital-type facilities, intra-hospital transport, and home environments.
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)
bench tests and laboratory tests
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
§ 870.2700 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/1 description: The image shows the word "tyco" in a bold, italicized font. The letters are black against a white background. There is a horizontal line underneath the word.
Healthcare
DEC 1 3 2004
4280 Hacienda Drive Pleasanton, CA 94588
Tele: 925 463-4000 Fax: 925 463-4020
Nellcor
510(k) Summary
| Submitted by: | Nellcor Puritan Bennett, Inc.
4280 Hacienda Drive
Pleasanton, CA 94588 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Luanne Ng
Regulatory Affairs Manager
(925) 463-4372
(925) 463-4020 -- FAX |
| Date Summary Prepared: | December 18, 2003 |
| Trade Name: | 1. Reprocessed Oxisensor II Sensor
2. Reprocessed OxiMax Sensor |
| Common/Usual Name: | Oximetry Sensor |
| Classification Name: | Oximeter, NLF per 21 CFR §870.2700 |
| Substantially Equivalent
Devices: | Sensors cleared with:
Nellcor N-395 Pulse Oximeter, K993637 and
OxiMax Pulse Oximetry System with N-595 Pulse
Oximeter, K012891 |
DEVICE DESCRIPTION
The Reprocessed Nellcor Oxisensor and OxiMax Sensors are designed for use with Nellcor and Nellcor-licensed pulse oximetry monitors that provide continuous noninvasive measurement of pulse rate and arterial oxygen saturation. The sensor contains three optical components: two light emitting diodes (LEDs) that serve as light sources and one photodiode that acts as a light detector. Both the LEDs and the photodiode are contained within a laminated envelope with an adhesive bandage for attachment to a patient. Attached to a laminated envelope is a sensor cable which terminates in a connector element that connects to the oximeter.
The sole difference between the OxiMax sensors and the Oxisensor II sensors is the OxiMax sensors each contain a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in sensor data, Advanced Signal Evaluation, lot code and data set revision, and sensor model.
1
INDICATIONS FOR USE
The Reprocessed Oxisensor II and OxiMax Sensors are intended for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. They are intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES
The technological characteristics of the subject devices and the predicate devices are identical. The predicate devices and the Reprocessed Oxisensor II and the OxiMax Sensors contain a photodetector that senses the signal strength of two wavelengths of light, which vary with the amount of light transmitted through the tissue. The Reprocessed Oxisensor II and OxiMax Sensors meet the same performance requirements as the predicate devices.
CONCLUSIONS
The technological characteristics of the Reprocessed Oxisensor II and OxiMax Sensors and the results of bench tests and laboratory tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices. The technological characteristics of the Reprocessed Oxisensor IIs and the OxiMax Sensors are identical in all aspects to those of the predicate devices.
2
Image /page/2/Picture/2 description: The image is a logo for the Department of Health and Human Services (HHS) in the USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2006
Ms. Luanne Ng Regulatory Affairs Manager Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588-2719
Re: K033973
Trade/Device Name: Reprocessed Oxisensor II and OxiMax Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: October 8, 2004 Received: October 12, 2004
Dear Ms. Ng:
This letter corrects our substantially equivalent letter of December 13, 2004.
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 (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 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. Ng
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 continue 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chin-Lin, Ph.D.
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
4
| Nellcor Oxisensor II |
|---|
| D-20 |
| D-25L |
| D-25 |
| N-25 |
| I-20 |
| Nellcor OxiMax |
| MAX-A |
| MAX-AL |
| MAX-I |
| MAX-P |
| MAX-N |
List of Models: Nellcor Reprocessed Oxisensor II and OxiMax Sensors
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