(102 days)
None
No
The summary describes a standard pulse oximetry sensor with a memory chip for calibration and sensor information. There is no mention of AI, ML, or related concepts.
No.
The device is a sensor used for monitoring oxygen saturation and pulse rate, which is a diagnostic function, not a therapeutic one.
Yes
The device is a sensor used for continuous noninvasive monitoring of arterial oxygen saturation and pulse rate, which are diagnostic indicators of a patient's physiological state.
No
The device description explicitly states it is a "reusable sensor" consisting of an "internal frame containing the optical components and flexible circuit encapsulated in a synthetic, latex-free rubber overmold." This describes a physical hardware component, not a software-only device.
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 Nellcor DuraMax reusable oximetry sensor is a noninvasive device that measures arterial oxygen saturation and pulse rate by being placed on the patient's digit. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "continuous noninvasive arterial oxygen saturation and pulse rate monitoring," which is a physiological measurement, not an in vitro diagnostic test.
Therefore, the device falls under the category of a noninvasive physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The DuraMax® reusable digit sensor is intended for use with patients weighing 40 kg or more when noninvasive arterial oxygen saturation and pulse rate monitoring are required.
The Nellcor® DuraMax® reusable oximetry sensor is indicated when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing 40 kg or more.
Product codes
DQA
Device Description
The DuraMax is a reusable sensor, sized appropriately to fit the digit of a pediatric or adult patient weighing 40 kg or more.
The DuraMax sensor consists of an internal frame containing the optical components and flexible circuit encapsulated in a synthetic, latex-free rubber overmold.
The DuraMax sensor plug contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including Advanced Signal Evaluation, Intention and data set revision, and sensor model. The DuraMax sensor is compatible with Nellcor and other monitors incorporating either Nellcor R-Cal or OxiMAX (DigiCal) oximetry technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
digit
Indicated Patient Age Range
pediatric or adult patient
Intended User / Care Setting
Not Found
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
Human and bench tests were performed to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications.
The DuraMax sensor has been designed and tested for conformance with the applicable requirements of ISO 9919:2005, "Medical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use". When properly connected to an oximeter that is also compliant with this standard, the resulting system will comply with the standard.
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
Ko 70408
tyco
Healthcare
Nellcor Puritan Bennett MAY 25 2007
4280 Hacienda Drive Pleasanton, CA 94588-2719
Tele: 925 463-4300 Fax: 925 463-4020
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| Submitted by: | Nellcor Puritan Bennett, Inc. 4280 Hacienda Drive Pleasanton, CA 94588 |
|---|---|
| Company Contact: | James Bonds Senior Director Regulatory Affairs (925) 463-4371 Fax (925) 463-4020 |
| Date Summary Prepared: | February 9, 2007 |
| Trade Name: | DuraMax® Reusable Oximetry Sensor |
| Common/Usual Name: | Oxygen Sensor |
| Classification Name: | Oximeter (DQA) per 21 CFR §870.2700 |
| Substantially Equivalent Devices: | Nellcor Puritan Bennett, Inc., OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and OxiMax Sensors, K012891 |
510(k) Summary
DEVICE DESCRIPTION
The DuraMax is a reusable sensor, sized appropriately to fit the digit of a pediatric or adult patient weighing 40 kg or more.
The DuraMax sensor consists of an internal frame containing the optical components and flexible circuit encapsulated in a synthetic, latex-free rubber overmold.
The DuraMax sensor plug contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including Advanced Signal Evaluation, Intention and data set revision, and sensor model. The DuraMax sensor is compatible with Nellcor and other monitors incorporating either Nellcor R-Cal or OxiMAX (DigiCal) oximetry technology.
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INTENDED USE
The DuraMax® reusable digit sensor is intended for use with patients weighing 40 kg or more when noninvasive arterial oxygen saturation and pulse rate monitoring are required.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The Nellcor DuraMax sensor has the same technological characteristics as the Nellcor DS-100A reusable sensor. The sensor uses the same optical components as the DS-100A. The differences relate to dimensions, one-piece external design, materials of construction, and labeling.
DETERMINATION OF SUBSTANTIAL SUPPORT TESTS PERFORMED TO EQUIVALENCE
Human and bench tests were performed to support the determination of substantial equivalence. Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications.
The DuraMax sensor has been designed and tested for conformance with the applicable requirements of ISO 9919:2005, "Medical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use". When properly connected to an oximeter that is also compliant with this standard, the resulting system will comply with the standard.
CONCLUSIONS
The technological characteristics of the DuraMax sensor and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2007
Mr. James Bonds Senior Director Regulatory Affairs Nellcor Puritan Bennett, Incorporated 4280 Hacienda Drive Pleasanton, California 94588
Re: K070408
Trade/Device Name: Nellcor® DuraMax® Reusable Oximetry Sensor Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: April 30, 2007 Received: May 1, 2007
Dear Mr. Bonds
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 Eederal Register.
3
Page 2 - Mr. Bonds
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 and installents 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylvite Y. Michieu Ous.
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
Indications for Use
510(k) Number (if known): __
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Nellcor® DuraMax® reusable oximetry sensor is indicated when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing 40 kg or more.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Q.J. K070468
ാന of Anesthesiology, General Hospital, ്
ಿ(k) Number:_
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