(81 days)
Not Found
No
The document describes a reusable soft sensor for pulse oximetry and its compatibility with different monitoring technologies. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is indicated for monitoring and spot-checking, not for treatment or therapy.
No.
The device's stated intended use is for "continuous noninvasive monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," which are measurements, not diagnoses.
No
The device description explicitly states it is a "Reusable Soft Oximetry Sensors," which are hardware components. The submission is about demonstrating compatibility of these sensors with different pulse oximeter technologies.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being for the "continuous noninvasive monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate". This is a measurement taken directly from the patient's body (non-invasive), not from a sample of bodily fluid or tissue that is tested in vitro (in a lab setting).
- Device Description: The description focuses on the sensor's function in measuring physiological parameters from the patient.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are characteristic of IVD devices.
Therefore, the Masimo SET Reusable Soft Sensors are a non-invasive medical device used for physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
DQA
Device Description
The Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) have been cleared under K090662 for use with Masimo SET and Masimo SET -compatible pulse oximeter monitors as well as Nellcor and Nellcor compatible pulse oximeter monitors. This submission presents data demonstrating that the DBI/P Sensors also are compatible for use with pulse oximeter monitors incorporating Philips FAST SpO2 Technology. Two additional M-LNCS sensors with M-15 connectors are included in this notification.
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
adult and pediatric patients
Intended User / Care Setting
hospitals, hospital-type facilities, mobile, 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and clinical testing of the Masimo SET Reusable Soft Oximetry Sensors was performed using monitors incorporating Philips FAST SpO2 Technology and the results demonstrate that the SpO2 and pulse rate accuracy is equivalent to the performance data submitted for the previously cleared Masimo sensors.
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
1113596 510(k) Summary
| Submitter: | Masimo Corporation
40 Parker
Irvine, CA 92618
(949) 297-7000
Fax: (949) 297-7592 |
|--------------------|----------------------------------------------------------------------------------------------|
| Company Contact: | David Collette
Senior Manager, Regulatory Affairs |
| Date Prepared: | January 25, 2012 |
| Trade Name: | Masimo SET® Reusable Soft Oximetry Sensors |
| Regulation Number: | 21 CFR 870.2700 |
| Regulation Name: | Pulse Oximeter (Oximetry Sensors) |
| Regulatory Class: | Class II |
| Product Code | DQA |
| Cleared Device: | K090662 – Masimo SET Reusable Soft Oximetry Sensors |
Device Description
The Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) have been cleared under K090662 for use with Masimo SET and Masimo SET -compatible pulse oximeter monitors as well as Nellcor and Nellcor compatible pulse oximeter monitors. This submission presents data demonstrating that the DBI/P Sensors also are compatible for use with pulse oximeter monitors incorporating Philips FAST SpO2 Technology. Two additional M-LNCS sensors with M-15 connectors are included in this notification.
Indications for Use
The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatric patients during no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
1
Comparative Analysis
There are no changes to the design of the device cleared in K090662. Specifically, the principles of operation performance and materials of the device remain unchanged from the existing Masimo SET Reusable Soft Oximetry Sensors.
Validation Testing
Bench and clinical testing of the Masimo SET Reusable Soft Oximetry Sensors was performed using monitors incorporating Philips FAST SpO2 Technology and the results demonstrate that the SpO2 and pulse rate accuracy is equivalent to the performance data submitted for the previously cleared Masimo sensors.
Conclusion
Data presented in this submission demonstrate that, when used with pulse oximetry monitors incorporating the Philips FAST Technology, the Masimo SET Reusable Soft Oximetry Sensors are substantially equivalent to the cleared device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. David Collette Senior Manager, Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
FEB 2 4 2012
Re: K113596
Trade/Device Name: Masimo SET® Reusable Soft Oximetry Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: January 25, 2012 Received: January 26, 2012
Dear Mr. Collette:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaller by 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to de vices mat nat i SAct (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment . For (10) ............................................................................................................................... approval application (11th 1). . The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, requirents for unnual regionant 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 (1 Mrs), it may be sucject to adame Federal Regulations, Title 21, Parts 800 to 898. In device can be found in the Code of Feather regains concerning your device in the Federal Register.
3
Page 2 - Mr. Collette
Please be advised that FDA's issuance of a substantial equivalence determination does not r rease be actived that 12 a determination that your device complies with other requirements moun mat 1 Dr may Federal statutes and regulations administered by other Federal agencies. or the receively 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 (reporting of meated: as not total 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you acon o sportion w.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 15809.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 Compilation" (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/ReportaProblem/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 I ou nike 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,
Wh 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
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Indications for Use
510(k) Number: K.113596
Device Name: Masimo SET® Reusable Soft Oximetry Sensors
Indications for Use:
The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive The Mashino SET Kedsable Soft Sensons are installed of arterial hemoglobin (SpOz)
monitoring and spot-checking of functional oxygen saturation of artections during monioring and spor-checking of functional only goss with adult and pediatric patients during and pulse fale (fileasured by an SpO2 sensor) for ass or well or poorly perfused in hospitals, hospitaltype facilities, mobile, and home environments.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: | K113596 |
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