(168 days)
K0801659
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or training/test sets for algorithms. The device description focuses on hardware design changes and performance specifications based on clinical studies.
No
The device is for monitoring purposes, providing continuous noninvasive measurements of various physiological parameters, but it does not treat or alleviate a medical condition.
Yes
The device continuously monitors physiological parameters like oxygen saturation, pulse rate, methemoglobin, and total hemoglobin, which are used to assess a patient's health status.
No
The device description explicitly details hardware components (emitter/detector/cable assembly, tape assembly) and their reusability, indicating it is not software-only.
Based on the provided information, the Rainbow Resposable Sensors are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- Device Function: The Rainbow Resposable Sensors are described as performing "continuous noninvasive monitoring" of various physiological parameters (SpO2, pulse rate, SpMet, SpHb). This monitoring is done on the patient's body using optical assessment, not on samples taken from the body.
- Method of Measurement: The device uses emitters and detectors to assess tissue oxygenation and other parameters directly on the patient. This is an in vivo measurement, not an in vitro test.
Therefore, the Rainbow Resposable Sensors fall under the category of non-invasive monitoring devices rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Rainbow Resposable Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Resposable Sensors are indicated 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, DSA, JKS
Device Description
The Rainbow Resposable Sensors are fully compatible sensors for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow Adhesive Sensors in the K0801659 filing.
The Rainbow Resposable Sensors have the similar intended use/indications for use and performance specifications as the Rainbow Adhesive Sensors in the K0801659 filing. The main difference is that the entire Rainbow Adhesive Sensor is single-patient use. However for the Rainbow Resposable Sensor, the tape assembly is single-patient use and the emitter/detector/cable assembly is detachable from the tape assembly. This emitter/detector/cable assembly is reusable. Also, the Rainbow Resposable Sensors are not indicated for the measurement of carboxyhemoglobin saturation and motion conditions.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility
Test results of all patient-contact materials used in the Rainbow Resposable Sensors demonstrated that the materials were non-toxic, non-irritating, and non-sensitizing.
Environmental
Applicable environmental testing per the Reviewers Guidance for Premarket Submissions -November 1993, i.e. electrical, mechanical and environmental were performed and all tests passed.
Clinical
Clinical studies for the Rainbow Resposable Sensors are similar to those of the Rainbow Adhesive Sensors, resulting in the following sensor specifications for adult and pediatric patients:
| Measurement | Accuracy Range | Accuracy |
|---|---|---|
| Arterial Oxygen Saturation (SpO2), No Motion | 60-80% | plus minus 3% |
| Arterial Oxygen Saturation (SpO2), No Motion | 70-100% | plus minus 2% |
| Arterial Oxygen Saturation (SpO2), Low Perfusion | 70-100% | plus minus 2% |
| Pulse Rate, No Motion | 25-240 bpm | plus minus 3 bpm |
| Pulse Rate, Low Perfusion | 25-240 bpm | plus minus 3 bpm |
| Methemoglobin (SpMet), No Motion | 1-15% | plus minus 1% |
| Total Hemoglobin Concentration (SpHb), No Motion | 8-17 g/dL | plus minus 1 g/dL |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See table under "Summary of Performance Studies" for Accuracy.
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.
K0801659
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
510(k) SUMMARY
| 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: | July 7, 2009 |
| Trade Name | Rainbow Resposable Pulse CO-Oximeter Sensors |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | Oximeter (74DQA) (870.2700)
Cable, Transducer and Electrode (74DSA) (870.2900) |
| Substantially Equivalent Devices: | Rainbow Adhesive CO-Oximetry Sensors, 510(k) Number K081655 |
Device Description
The Rainbow Resposable Sensors are fully compatible sensors for use with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeter monitors. They represent a design change to the Masimo Rainbow Adhesive Sensors in the K0801659 filing.
The Rainbow Resposable Sensors have the similar intended use/indications for use and performance specifications as the Rainbow Adhesive Sensors in the K0801659 filing. The main difference is that the entire Rainbow Adhesive Sensor is single-patient use. However for the Rainbow Resposable Sensor, the tape assembly is single-patient use and the emitter/detector/cable assembly is detachable from the tape assembly. This emitter/detector/cable assembly is reusable. Also, the Rainbow Resposable Sensors are not indicated for the measurement of carboxyhemoglobin saturation and motion conditions.
Predicate Devices
The predicate devices for this filing are the Rainbow Adhesive Pulse CO-Oximetry Sensors (K081659).
Intended Use/ Indications for Use
The Rainbow Resposable Sensors are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Resposable Sensors are indicated 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.
K090165-Resposable Sensors Masimo, 7/7/09 Page 2 of 3
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510(k) SUMMARY
Technology Comparison
The Rainbow Resposable Sensors are substantially equivalent in intended use, design, principles of operation, materials, and performance to predicate sensors and operate on identical principles of noninvasive optical assessment of tissue oxygenation using emitters and detectors.
They are designed, configured, and manufactured for full compatibility with Masimo Rainbow SET and Masimo Rainbow SET compatible pulse CO-Oximeters. The Rainbow Resposable Sensors are constructed of similar materials and components of equivalent specifications as used in the predicate devices, with accuracy that is also equivalent to those of the predicate devices.
Performance Testing
Biocompatibility
Test results of all patient-contact materials used in the Rainbow Resposable Sensors demonstrated that the materials were non-toxic, non-irritating, and non-sensitizing.
Environmental
Applicable environmental testing per the Reviewers Guidance for Premarket Submissions -November 1993, i.e. electrical, mechanical and environmental were performed and all tests passed.
Clinical
Clinical studies for the Rainbow Resposable Sensors are similar to those of the Rainbow Adhesive Sensors, resulting in the following sensor specifications for adult and pediatric patients:
| Measurement | Accuracy
Range | Accuracy |
|--------------------------------------------------|-------------------|--------------|
| Arterial Oxygen Saturation (SpO2), No Motion | 60-80% | $\pm$ 3% |
| Arterial Oxygen Saturation (SpO2), No Motion | 70-100% | $\pm$ 2% |
| Arterial Oxygen Saturation (SpO2), Low Perfusion | 70-100% | $\pm$ 2% |
| Pulse Rate, No Motion | 25-240 bpm | $\pm$ 3 bpm |
| Pulse Rate, Low Perfusion | 25-240 bpm | $\pm$ 3 bpm |
| Methemoglobin (SpMet), No Motion | 1-15% | $\pm$ 1% |
| Total Hemoglobin Concentration (SpHb), No Motion | 8-17 g/dL | $\pm$ 1 g/dL |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 9 2009
Ms. Marguerite Thomlinson Manager. Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
Re: K090165
Trade/Device Name: Rainbow Resposable Pulse CO-Oximeter Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA, DSA, JKS Dated: March 31, 2009 Received: April 6, 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,
Susan Runpe
Susan Runner, D.D.S., M.A. Acting 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):
Rainbow Resposable Pulse CO-Oximeter Sensors Device Name:
Indications For Use:
The Rainbow Resposable Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, methemoglobin saturation (SpMet), and/or total hemoglobin (SpHb). The Rainbow Resposable Sensors are indicated 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.
| 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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K090165-Resposable Sensors |
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