(151 days)
Not Found
No
The summary describes a reusable pulse oximetry sensor and its compatibility with existing monitors. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
The device is indicated for continuous noninvasive monitoring and spotchecking of physiological parameters (SpO₂ and pulse rate), not for therapeutic intervention.
Yes
The device is indicated for "continuous noninvasive monitoring and spotchecking of functional oxygen saturation of arterial hemoglobin (SpO₂)" and "pulse rate". Monitoring physiological parameters like SpO2 and pulse rate is a diagnostic function, as it provides information about the patient's health status.
No
The device description explicitly states it is a "Reusable Soft Oximetry Sensors" and mentions "Biocompatibility Testing," "Performance Testing," and "Safety Testing," which are associated with physical hardware components, not software alone.
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 used for the "continuous noninvasive monitoring and spotchecking 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 in vitro (outside the body).
- Device Description: The description refers to the device as "Reusable Soft Oximetry Sensors" and mentions their compatibility with "pulse oximeter monitors". Pulse oximetry is a non-invasive method.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples in vitro.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a sensor that directly measures physiological parameters from the patient.
N/A
Intended Use / Indications for Use
The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spotchecking 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 hospital-type facilities, mobile, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
74DQA, 74DSA
Device Description
The Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) are fully compatible reusable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The DBI/P Sensors are also fully compatible for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-oximeter monitors. Additionally, the DBI Sensors are also compatible with Nellcor and Nellcor compatible pulse oximeter monitors.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The DBI/P Sensors comply with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the DBI/P Sensors:
- Risk Analysis
- Design Reviews
- Biocompatibility Testing
- Performance Testing
- Safety Testing
- Environmental Testing
- Clinical Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy – SpO2 During No Motion Conditions: Adults, Pediatrics: 70% - 100% ± 2%; Adults, Pediatrics: 0% - 69% unspecified
Accuracy – SpO2 Low Perfusion: Adults, Pediatrics: 70% - 100% ± 2%; Adults, Pediatrics: 0% - 69% unspecified
Accuracy – Pulse Rate During No Motion Conditions: Adults, Pediatrics: 25 - 240 ± 3 bpm
Accuracy – Pulse Rate Low Perfusion: Adults, Pediatrics: 25 - 240 ± 3 bpm
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
AUG 10 2009
510(k) SUMMARY
K09 0662
| Submitted by: | Masimo Corporation
40 Parker
Irvine, CA 92618
949-297-7000
FAX 949-297-7001 |
|---------------------------------------|-----------------------------------------------------------------------------------------|
| Company Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs |
| Date Summary Prepared: | March 9, 2009 |
| Trade Name | Masimo SET Reusable Soft Oximetry Sensors |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | Oximeter (74DQA) (870.2700)
Cable, Transducer and Electrode (74DSA) (870.2900) |
| Substantially Equivalent Devices: | Masimo LNCS Oximetry Sensors , 510(k) No. K051212 |
Device Description
The Masimo SET Reusable Soft Oximetry Sensors (DBI/P Sensors) are fully compatible reusable sensors for use with Masimo SET and Masimo SET compatible pulse oximeter monitors. The DBI/P Sensors are also fully compatible for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-oximeter monitors. Additionally, the DBI Sensors are also compatible with Nellcor and Nellcor compatible pulse oximeter monitors.
Predicate Device
The predicate devices used in this filing are the Masimo LNCS Oximetry Sensors (K051212).
Intended Use
The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spotchecking 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 hospital-type facilities, mobile, and home environments.
1
510(k) SUMMARY
Technology
:
and the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the s
The DBVP Sensors are substantially equivalent in design, principles of operation, materials, and performance to predicate device LNCS Oximetry Sensors. The DBI/P Sensor performance is equivalent to those of the LNCS Oximetry Sensor.
The specifications for the DBI/P Sensors for adults (> 30 kg) and pediatrics (10-50 kg) are the following:
| FEATURES | SENSOR SPECIFICATIONS:
with Masimo SET and Masimo
Rainbow SET Technology | SENSOR SPECIFICATIONS:
with Nellcor and Nellcor
Compatible Technology |
|---------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Accuracy – SpO2
During No Motion
Conditions | Adults, Pediatrics: 70% - 100% $\pm$ 2%
Adults, Pediatrics: 0% - 69%
unspecified | Adults, Pediatrics: 70% - 100% $\pm$ 2%
Adults, Pediatrics: 0% - 69%
unspecified |
| Accuracy – SpO2
Low Perfusion | Adults, Pediatrics: 70% - 100% $\pm$ 2%
Adults, Pediatrics: 0% - 69%
unspecified | N/A |
| Accuracy – Pulse Rate
During No Motion
Conditions | Adults, Pediatrics: 25 - 240 $\pm$ 3 bpm | Adults, Pediatrics: 25 - 240 $\pm$ 3 bpm |
| Accuracy – Pulse Rate
Low Perfusion | Adults, Pediatrics: 25 - 240 $\pm$ 3 bpm | N/A |
Test Summary
The DBI/P Sensors comply with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the DBI/P Sensors:
- Risk Analysis ●
- Design Reviews .
- Biocompatibility Testing .
- Performance Testing .
- Safety Testing .
- Environmental Testing
- Clinical Testing
Conclusions
The information in this 510(k) submission demonstrates that the Masimo SET® Reusable Soft Oximetry Sensors are substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is centered in the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
AUG 10 2009
Re: K090662
Trade/Device Name: Masimo SET Reusable Soft Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: July 29, 2009 Received: August 4, 2009
Dear Ms. Thomlinson:
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 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- Ms. Thomlinson
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 (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), 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
far
Susan Runner, D.D.S., M.A. Acting Division 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):
Masimo SET Reusable Soft Sensors Device Name:
Indications For Use:
The Masimo SET Reusable Soft Sensors are indicated for the continuous noninvasive monitoring and spotchecking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult and pediatic patients during no motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments.
L. Arletta
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
-10(k) Number. 4 090662
Prescription Use (Per 21 CFR 801.109 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801.109 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Masimo 510(k) Trad-3/9/09 DBI & DBIP Sensors Page 10 of 262