(146 days)
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 < 3 kg, or finger if > 40 kg.
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.
The provided text describes a 510(k) summary for ReNu Medical's Reprocessed OxiMax Sensors, which are oximetry sensors. The submission focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness.
Here's an analysis of the provided text in relation to your questions, focusing on what is explicitly stated:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria with corresponding device performance metrics in numerical form. It broadly states that:
- "Reprocessed OxiMax Sensors were tested to demonstrate functional characteristics by bench testing and in vivo clinical studies."
- "Bench testing was performed to determine pulse rate accuracy using an OxiTest 7 simulator. Varying 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."
While it mentions "pulse rate accuracy" and "accuracy of SpO2," it does not specify what the acceptance thresholds for these accuracies were, nor does it provide the measured performance values for the reprocessed sensors.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: The document states "Clinical studies in vivo were performed on both Adult and Neonate subjects," but it does not provide specific sample sizes for these subject groups.
- Data provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given they are "in vivo clinical studies," they were likely prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The studies mentioned are clinical, implying direct measurement rather than expert interpretation of data. For oximetry sensors, "ground truth" for SpO2 accuracy would typically come from a co-oximetry blood gas analyzer, not expert consensus on images or other subjective data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to the type of device and study described. Oximetry sensor accuracy is typically determined by comparing the device's readings to a reference standard (e.g., co-oximetry), not through human adjudication of ambiguous cases.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic imaging devices where human interpretation is a key component. The ReNu Medical device is an oximetry sensor, a physiological measurement device, not an AI diagnostic tool that assists human readers.
- Effect size of human reader improvement: Therefore, this information is not applicable and not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Yes, the described "bench testing" and "in vivo clinical studies" focus on the performance of the reprocessed sensors themselves, indicating a standalone assessment of the device's accuracy. This is not an "algorithm only" performance as the device is hardware, but it evaluates the device's output independently.
- Without human-in-the-loop: The accuracy measurements (pulse rate and SpO2) are direct device outputs, not dependent on human interpretation in the sense of a human-in-the-loop system for AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the specific ground truth method, but for oximetry sensors, the established scientific method for "accuracy of SpO2" in clinical studies involves:
- Inducing a range of oxygen saturations in subjects.
- Simultaneously measuring arterial oxygen saturation using a co-oximeter (a laboratory device that directly measures different hemoglobin species from arterial blood samples).
- Comparing the sensor's readings to the co-oximeter's readings. This is the accepted "gold standard" for blood oxygen saturation measurement.
For "pulse rate accuracy," the ground truth would typically be derived from an ECG monitor.
8. The sample size for the training set
This information is not applicable as the device is a reprocessed medical sensor, not an AI/ML algorithm that requires a training set. The "reprocessing" involves cleaning, testing, and sometimes replacing components, but it does not involve machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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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.
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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 < 3 kg, or finger 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.
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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.
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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
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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 < 3 kg, or finger 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
§ 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).