(114 days)
Not Found
No
The device description focuses on the hardware components (LEDs, photodiode, cable, connector) and the function of transmitting and receiving electrical signals for analysis by the oximeter. There is no mention of AI or ML in the device description, intended use, or performance studies summary. The analysis and display of patient information are attributed to the oximeter, not the sensor itself.
No
The device is described as an accessory for monitoring arterial oxygen saturation and pulse rate, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device monitors arterial oxygen saturation and pulse rate, which are physiological parameters used to assess a patient's condition for diagnostic purposes.
No
The device description explicitly states it is an "accessory device to an oximeter monitoring system" and describes physical components like LEDs, a photodiode, a laminated envelope with adhesive, a cable, and a multi-pin connector. This indicates a hardware component is central to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The description clearly states that this device is an "accessory device to an oximeter monitoring system." It functions as a transducer that attaches to the patient's body (finger or foot) to transmit and receive light signals for the oximeter to analyze and display patient information (oxygen saturation and pulse rate).
- No Specimen Examination: The device does not examine any specimens derived from the human body (like blood or tissue). It interacts directly with the patient's body to measure physiological parameters.
Therefore, the ReNu Medical Reprocessed Nellcor™ D-25 and N-25 Oximetry Sensors are not IVDs. They are external physiological monitoring sensors.
N/A
Intended Use / Indications for Use
Both the ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor are intended as single patient use O2 transducer/accessory sensors for use in conjunction with the Nellcor™ Oximeter system. The Model D-25 is used for patients >30 kg. The Model N-25 is used for neonates 40 kg. Both sensors are used for noninvasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate.
D-25 continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg.
N-25: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if 40 kg.
Product codes
NLF
Device Description
The ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.
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
The Model D-25 is used for patients >30 kg. The Model N-25 is used for neonates 40 kg.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on an assessment consisting of bench testing, clinical performance data, and non-clinical performance data the ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor function in a manner that is Substantially Equivalent to that of the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Nellcor™ D-25 Oximetry sensor, Nellcor™ N-25 Oximetry sensor
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
Section 13 Premarket Notification
510 (k) Summary
Submitters Name and Address: ReNu Medical, Inc. 9800 Evergreen Way Everett, WA 98024 Phone: 425-353-1110 Fax: 425-353-9116
FDA Registration Number: 3034520
Contact Person: L. Bruce Pierson Chief Operating Officer
NOV 2 9 2007
Date Summary Prepared: August 4, 2007
Trade or Proprietary Name(s): ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor, ReNu Medical Reprocessed Nellcor™ N-25 Oximetry Sensor
Common Name: Oximetry Sensor
Classification: Oximeter (21 CFR 870.2700) / NLF
Equivalent Device(s)
The ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Nellcor™ N-25 Oximetry Sensor are substantially equivalent to the Nellcor™ D-25 Oximetry sensor and Nellcor™ N-25 Oximetry sensor (respectively),
Device Description:
The ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor are accessory devices to an oximeter monitoring system. The oxisensor is designed as a transducer for the transmission of electrical signals from the oximeter to the patient and the return of patient modified signals back to the oximeter for analysis and display of patient information. The sensor contains three optical components; two light emitting diodes (LEDs) serve as light sources and one photodiode acting as a light detector LED and sensor are contained in a laminated envelope provided with an adhesive bandage for attachment a patient. A sensor package is attached to a cable terminated in a multi-pin connector that plugs into the oximeter.
1
Intended Use
Both the ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor are intended as single patient use O2 transducer/accessory sensors for use in conjunction with the Nellcor™ Oximeter system. The Model D-25 is used for patients >30 kg. The Model N-25 is used for neonates 40 kg. Both sensors are used for noninvasive monitoring of pulse oxygen hemoglobin saturation (SpO2) and pulse rate.
Technological Characteristics of the ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor Compared with the Nellcor™ D-25 Oximetry Sensor and Nellcor™ N-25 Oximetry Sensor
The predicate devices and the ReNu Medical Reprocessed devices contain identical components (LED, photodiode, laminated envelope, cable, and connector.) The means of patient attachment (adhesive bandage) is identical.
Summary of Comparison Tests
Based on an assessment consisting of bench testing, clinical performance data, and non-clinical performance data the ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor function in a manner that is Substantially Equivalent to that of the predicate devices.
Safety and Standards
The ReNu Medical Reprocessed Nellcor™ D-25 Oximetry Sensor and Reprocessed Nellcor™ N-25 Oximetry Sensor are designed to meet the following safety standards:
- EN 60601-1 t
- . EN60601-1-2
- Biocompatibility ISO10993-10 1995 EN 30993-1 .
Confidential
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed within a circle, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" surrounding it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2007
Mr. Bruce Pierson Chief Operating Officer ReNu Medical, Incorporated 9800 Evergreen Way Everett, Washington 98204
Re: K072194
Trade/Device Name: ReNu Reprocessed Nellcor Oximeter Sensor Model D-25, N-25 Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: October 26, 2007 Received: October 30, 2007
Dear Mr. Pierson:
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 - Mr. Pierson
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.
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): K072194
Device Name: ReNu Reprocessed Nellcor Oximeter Sensor Model D-25, N-25
Indications For Use:
D-25 continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg.
N-25: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if 40 kg.
XX Prescription Use (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)
unh Yohn
. 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . tion of Anesthesiology, General Hospital. Control, Control, Dental Devices
ber: K07 2194
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