(146 days)
Not Found
No
The description focuses on the hardware components (LEDs, photodiode, cable) and basic signal transmission for oxygen saturation and pulse rate monitoring. There is no mention of AI, ML, or complex data analysis beyond standard oximetry principles.
No
The device is a monitoring system that measures and displays patient information (oxygen saturation and pulse rate). It does not actively treat or restore health.
No
Explanation: The device is described as an accessory to an oximeter monitoring system used for continuous non-invasive monitoring of arterial oxygen saturation and pulse rate. Its function is to transmit electrical signals for analysis and display of patient information, which is a monitoring function, not a diagnostic one.
No
The device description explicitly details hardware components (LEDs, photodiode, laminated envelope, adhesive bandage, cable, connector) and their function in transmitting and receiving signals, indicating it is a physical sensor, 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 description clearly states that the OxiMax Sensors are used for continuous non-invasive arterial oxygen saturation and pulse rate monitoring. This involves placing the sensor on the patient's skin (foot or finger) to measure physiological parameters directly from the living body.
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples from the patient.
The device is a non-invasive physiological monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OxiMax Adult: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg.
OxiMax Pediatric: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients 10 - 50 kg.
OxiMax Infant: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients between 3 kg and 20 kg.
OxiMax Neonate: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if 40 kg.
Product codes (comma separated list FDA assigned to the subject device)
NLF
Device Description
The ReNy Medical Reprocessed OxiMax Sensors 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
OxiMax Adult: patients > 30 kg.
OxiMax Pediatric: patients 10 - 50 kg.
OxiMax Infant: patients between 3 kg and 20 kg.
OxiMax Neonate: patients foot if 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)
Reprocessed OxiMax Sensors were tested to demonstrate functional characteristics by bench testing and in vivo clinical studies. High level disinfection process validation testing was performed.
Bench testing was performed to determine pulse rate accuracy using an OxiTest 7 simulator. Varving environmental conditions and physical tests were performed for temperature and humidity.
Clinical studies in vivo were performed on both Adult and Neonate subjects to demonstrate accuracy of SpO2 in the reprocessed sensors.
Conclusion: Based on an assessment consisting of bench testing and clinical performance data the ReNu Medical Reprocessed Oximetry Sensors function in a manner that are Substantially Equivalent to that of the predicate devices.
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.
K033973 Nellcor Reprocessed Oxisensor II Sensor, Reprocessed OxiMax Sensor, K081927 ReNu Medical Reprocessed Masimo LNCS Adtx, LNCS Pdtx, LNCS Inf and LNCS Neo., K063661 ReNu Reprocessed Oxisensor D-20 and I-20, K072194 ReNu Reprocessed Oxisensor D-25 and N-25
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
Attachment 3 Section 11: 510k Summary
× 111773 510k 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
Date Summary Prepared: October 5, 2011
Trade or Proprietary Name(s): ReNu Medical Reprocessed OxiMax Sensors: Adult, Pediatric, Infant and Neonate
Common Name: Oximetry Sensors
Classification: Oximeter (21 CFR 870.2700) / NLF
Equivalent Device(s)
K033973 Nellcor Reprocessed Oxisensor II Sensor, Reprocessed OxiMax Sensor K081927 ReNu Medical Reprocessed Masimo LNCS Adtx, LNCS Pdtx, LNCS Inf and LNCS Neo. K063661 ReNu Reprocessed Oxisensor D-20 and I-20 K072194 ReNu Reprocessed Oxisensor D-25 and N-25
Device Description:
The ReNy Medical Reprocessed OxiMax Sensors 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
Comparison to Predicate
..
No significant changes or modifications that could significantly affect the models' safety or effectiveness are made to the Max Series models. In particular, no significant changes or modifications in design, material, chemical composition, energy source, or manufacturing process are made. And the intended use of the models - to monitor blood oxygen saturation and pulse rate in humans - remains the same. As such, the ReNu Medical reprocessed Max Series models are not changed or modified from the ReNu Medical reprocessed D-25, N-25, D-20 and I-20 models (which are lawfully marketed under 510(k)s), neither affect the safety or effectiveness of these devices, nor do they change or modify the device's intended use.
indications for Use
OxiMax Adult: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg.
OxiMax Pediatric: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients 10 - 50 kg.
OxiMax Infant: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients between 3 kg and 20 kg.
OxiMax Neonate: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients foot if 40 kg.
Functional and Safety Testing
Reprocessed OxiMax Sensors were tested to demonstrate functional characteristics by bench testing and in vivo clinical studies. High level disinfection process validation testing was performed.
Summary of Non-Clinical Tests
Bench testing was performed to determine pulse rate accuracy using an OxiTest 7 simulator. Varving environmental conditions and physical tests were performed for temperature and humidity.
Summary of Clinical Tests
Clinical studies in vivo were performed on both Adult and Neonate subjects to demonstrate accuracy of SpO2 in the reprocessed sensors.
Conclusion
Based on an assessment consisting of bench testing and clinical performance data the ReNu Medical Reprocessed Oximetry Sensors function in a manner that are Substantially Equivalent to that of the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three arms reaching upwards, symbolizing health, support, and well-being. The figure is positioned to the right of the department's name, which is arranged in a circular format around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. L. Bruce Pierson Chief Operating Officer ReNu Medical, Incorporated 9800 Evergreen Way Everett, Washington 98204
NOV 1 6 2011
Re: K111773
Trade/Device Name: ReNu Reprocessed Nellcor OxiMax Sensors, OxiMax Adult, OxiMax Pediatric, OxiMax Infant, OxiMax Neonate Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: NLF Dated: November 3, 2011 Received: November 14, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 - 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety /ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 4
Statement Indications for Use 1.
Indications for Use
Indications for Ose
510(k) Number (if known): _ KUL 123 Device Name: ReNu Reprocessed Nellcor OxiMax Sensors, OxiMax Adult, OxiMax Pediatric, OxiMax Infant, OxiMax Neonate Indications For Use:
OxiMax Adult: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients > 30 kg.
OxiMax Pediatric: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients 10 - 50 kg.
OxiMax Infant: continuous non-invasive arterial oxygen saturation and pulse rate monitoring of patients between 3 kg and 20 kg.
OxiMax Neonate: 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)
corrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Number: K111773