(81 days)
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The technology described is based on 12-wavelength technology for measurement.
No
The device is indicated for non-invasive spot checking of physiological parameters (SpO2, pulse rate, SpHb), which are diagnostic measurements rather than therapeutic interventions.
Yes
The device is indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb), which are measurements used to assess a patient's physiological state and potential medical conditions. This falls under the definition of a diagnostic device as it provides information used to aid in diagnosis or monitoring.
No
The device description explicitly states it is a "Pulse CO-Oximeter and Accessories" and mentions "12-wavelength technology for the measurement of total hemoglobin," which are hardware components. It also refers to the predicate device as a "Pulse CO-Oximeter," further indicating a hardware-based device.
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. They are performed outside of the body.
- Device Function: The Masimo Rainbow SET RadCheck Pulse CO-Oximeter is described as a noninvasive device that measures parameters like SpO2, pulse rate, and total hemoglobin directly from the patient's body (likely through a sensor placed on the finger or other extremity).
- Lack of Sample Analysis: There is no mention of collecting samples from the patient or performing any analysis on those samples in vitro.
The device is a noninvasive medical device used for monitoring physiological parameters directly on the patient.
N/A
Intended Use / Indications for Use
The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatic patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings.
Product codes (comma separated list FDA assigned to the subject device)
74DQA, 74DSA
Device Description
The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories (RadCheck) have modified intended use/indications for use in comparison to the Rad 57t Pulse CO-Oximeters and Accessories (Rad 57t) in the K080238 filing. The main difference is that the RadCheck in this filing is for spot checking, whereas the Rad 57t in K0808238 is for continuous monitoring. The keypad membrane and the software of the RadCheck also differ from the Rad 57t.
The RadCheck in this filing is similar in construction to the Rad 57t in the K0808238 filing, including the 12-wavelength technology for the measurement of total hemoglobin. The performance of the Radcheck is similar to the Rad 57t. Similar to the Rad 57t, the RadCheck provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, and total hemoglobin concentration (g/d) SpHb). Other information displayed by the RadCheck include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Total Arterial Oxygen Content (SpOC), battery life, and sensor status.
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
Adults, Pediatrics
Intended User / Care Setting
Trained personnel, with adult and pediatic patients...in clinical and non-clinical settings.
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 RadCheck complies with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the RadCheck:
- Risk Analysis
- Design Reviews
- Biocompatibility Testing
- Performance Testing
- Safety Testing
- Environmental Testing
- Clinical Testing
SpO2 accuracy was determined by testing on healthy adult volunteers in the range of 60-100% SpO2 against a laboratory CO-Oximeter.
The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population weight.
The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-oximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
The Masimo sensors have been validated for pulse rate accuracy for the range of 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: SpO2
During No Motion Conditions
Adults, Pediatrics: 60% - 80% ± 3%
Adults, Pediatrics: 70% - 100% ±2%
Adults, Pediatrics: 0% - 69% unspecified
Accuracy – SpO2
During Motion Conditions
Adults, Pediatrics: 70% - 100% ± 3%
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
During Motion Conditions
Adults, Pediatrics: 25 - 240 ± 5 bpm
Accuracy – Pulse Rate
Low Perfusion
Adults, Pediatrics: 25 - 240 ± 3 bpm
Accuracy: SpHb
Accuracy - SpHb
During No Motion Conditions
Adults, Pediatrics: 8 - 17 g/dl +1 g/dl
SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation in the range of 8 - 17 g/dl SpHb against a laboratory CO-oximeter. This variation equals plus or minus one standard deviation which encompasses 68% of the population. The SpHb accuracy has not been validated with motion or low perfusion.
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
K08.2052
| 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 16, 2008 |
| Trade Name | Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories |
| Common Name | Oximeter Sensor |
| Classification Name and Product Code: | Oximeter (74DQA) (870.2700) Cable, Transducer and Electrode (74DSA) (870.2900) |
| Substantially Equivalent Devices: | Masimo Rainbow SET Rad 57t Pulse CO-Oximeters and Accessories, 510(k) Number K080238 |
Device Description
The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories (RadCheck) have modified intended use/indications for use in comparison to the Rad 57t Pulse CO-Oximeters and Accessories (Rad 57t) in the K080238 filing. The main difference is that the RadCheck in this filing is for spot checking, whereas the Rad 57t in K0808238 is for continuous monitoring. The keypad membrane and the software of the RadCheck also differ from the Rad 57t.
The RadCheck in this filing is similar in construction to the Rad 57t in the K0808238 filing, including the 12-wavelength technology for the measurement of total hemoglobin. The performance of the Radcheck is similar to the Rad 57t. Similar to the Rad 57t, the RadCheck provides noninvasive monitoring of arterial oxygen saturation (%SpO2), pulse rate, and total hemoglobin concentration (g/d) SpHb). Other information displayed by the RadCheck include: Low Signal IQ (Low SIQ), Perfusion Index (PI), Total Arterial Oxygen Content (SpOC), battery life, and sensor status.
1
Predicate Device
The predicate device used in this filing is the Masimo Rainbow SET® Rad 57t Pulse CO-Oximeter (Rad 57t) and Accessories, 510(k) Number K080238.
Intended Use
The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatic patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings.
Technology Comparison
The Masimo Rainbow SET® RadCheck Pulse CO-Oximeter (Rad 57 Spotcheck) is substantially equivalent in design, principles of operation, materials, and performance to predicate device (the Rad 57t).
Similar to the Rad 57t, the RadCheck is designed, and manufactured for full compatibility with Masimo Rainbow pulse CO-Oximeter sensors with SpHb capabilities (K080238).
The RadCheck performance is equivalent to those of the Rad 57t, as following:
| FEATURES | SPECIFICATIONS |
|---|---|
| Display Ranges | Saturation (SpO2): 0% - 100% |
| Pulse Rate (bpm): 25 - 240 bpm | |
| Total Hemoglobin (SpHb): 0-25 g/dl | |
| Total Oxygen Concentration (SpOC): 0-35 ml/dl | |
| Perfusion Index: 0.02% - 20% | |
| Accuracy: SpO2 and Pulse Rate | See Footnotes 1, 2, 3, 4, and 5 |
| Accuracy – SpO2 | |
| During No Motion Conditions | Adults, Pediatrics: 60% - 80% ± 3% |
| Adults, Pediatrics: 70% - 100% ±2% | |
| Adults, Pediatrics: 0% - 69% unspecified | |
| Accuracy – SpO2 | |
| During Motion Conditions | Adults, Pediatrics: 70% - 100% ± 3% |
| 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 | |
| During Motion Conditions | Adults, Pediatrics: 25 - 240 ± 5 bpm |
| Accuracy – Pulse Rate | |
| Low Perfusion | Adults, Pediatrics: 25 - 240 ± 3 bpm |
| FEATURES | SPECIFICATIONS |
| Accuracy: SpHb | |
| Accuracy - SpHb | |
| During No Motion Conditions | Adults, Pediatrics: 8 - 17 g/dl +1 g/dl |
| SpHb accuracy has been validated on healthy adult male and | |
| female volunteers and on surgical patients with light to dark skin | |
| pigmentation in the range of 8 - 17 g/dl SpHb against a | |
| laboratory CO-oximeter. This variation equals plus or minus | |
| one standard deviation which encompasses 68% of the | |
| population. The SpHb accuracy has not been validated with | |
| motion or low perfusion. | |
| General | |
| Resolution | SpO2: 1% |
| Pulse Rate: 1 bpm | |
| SpHb: 0.1 g/dl | |
| Measurements | Low Signal IQ |
| Perfusion Index (PI) | |
| Total Oxygen Concentration (SpOC) | |
| Interfering Substances | Elevated levels of Methemoglobin (MetHb) may lead to |
| inaccurate SpO2 measurements Elevated levels of Carboxyhemoglobin (COHb) may lead to | |
| inaccurate SpO2 measurements. Severe anemia may cause erroneous SpO2 readings. Dyes, or any substance containing dyes, that change usual | |
| blood pigmentation may cause erroneous readings. Elevated levels of total bilirubin may lead to inaccurate SpO2, | |
| and SpHb readings | |
| Electrical | See Footnote 6 |
| Batteries | Non-Rechargeable |
| Circuitry | Microprocessor controlled |
| Firmware | Rainbow SET technology, MX-1 Board/Circuitry |
| Mechanical | |
| Material | Polycarbonate/ABS Blend |
| Environmental | |
| Operating Temperature | 41°F to + 104°F (5°C to +40°C) |
| Storage Temperature | -40°F to + 158°F (-40°C to +70°C) |
| Relative Humidity | 5% to 95% noncondensing |
| Operating Altitude | Operating Altitude: 500 mbar to 1,060 mbar pressure; -1,000 ft to |
| 18,000 ft (-304 m to 5,486m) | |
| Mode & Sensitivity | |
| Averaging Mode - SpO2 | Maximum sensitivity mode fixes perfusion limit to 0.02% |
| Alarms | |
| System | System failure |
| Battery Alarm | Low battery |
| FEATURES | SPECIFICATIONS |
| Display and Indicators | |
| Data Display | SpO2 (%) |
| Pulse rate (bpm) | |
| SpHb (g/dl) | |
| Perfusion index (%) | |
| SpOC (ml/dl) | |
| Signal IQ | |
| Pulse indicator | |
| Sensor life indicator | |
| Sensor status | |
| Status messages | |
| Battery status | |
| Compliance | |
| EMC Compliance | EN 60601-1-2, Class B |
| Electrical Safety | IEC 60601-1, |
| UL 60601-1 | |
| Type of Protection (battery power) | Internally Powered |
| Degree of Protection-Patient Cable | Type BF-Applied Part |
| Enclosed Degree of Ingress | IPX1 |
| Protection from Solids/ Liquids | |
| Mode of Operation | Spot check |
2
3
Footnotes
- SpO2 accuracy was determined by testing on healthy adult volunteers in the range of 1 60-100% SpO2 against a laboratory CO-Oximeter.
- 2 The Masimo sensors have been validated for no motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-Oximeter and ECG monitor. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population weight.
- ന The Masimo sensors have been validated for motion accuracy in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation in induced hypoxia studies while performing rubbing and tapping motions, at 2 to 4 Hz at an amplitude of 1 to 2 cm and a non-repetitive motion between 1 to 5 Hz at an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70-100% SpO2 against a laboratory CO-oximeter and ECG monitor. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- 4 The Masimo SET Technology has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo's simulator with signal strengths of greater than 0.02% and transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
4
- The Masimo sensors have been validated for pulse rate accuracy for the range of 5 25-240 bpm in bench top testing against a Biotek Index 2 simulator. This variation equals plus or minus one standard deviation which encompasses 68% of the population.
- 6 If the batteries are to be stored for extended periods of time, it is recommended that they be stored between -20 to +30°C, and at a relative humidity less than 85%. If stored for a prolonged period at environmental conditions beyond these limits, overall battery capacity may be diminished, and lifetime of the batteries may be shortened.
Test Summary
The RadCheck complies with the voluntary standards as detailed in this submission. The following quality assurance measures were applied to the development of the RadCheck:
- . 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 Rainbow SET® RadCheck Pulse CO-Oximeter and Accessories are substantially equivalent to the predicate device, with respect to safety, effectiveness, and performance.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 0 2008
Ms. Marguerite Thomlinson Manager of Regulatory Affairs Masimo Corporation 40 Parker Irvine, California 92618
Re: K082052
Trade/Device Name: Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 16, 2008 Received: July 21, 2008
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 such 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.
6
Page 2 - Ms. Thomlison
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Thlammels-Lund, mt for 11
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):
Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories Device Name:
Indications For Use:
The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial hemoglobin (SpO2), pulse rate, and total hemoglobin (SpHb). The Masimo Rainbow SET RadCheck Pulse CO-Oximeter and Accessories are indicated for use, by trained personnel, with adult and pediatric patients during both no motion and motion conditions, and for patients who are well or poorly perfused in clinical and non-clinical settings.
A.R. (MD)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
| Prescription Use
| X | AND/OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109 Subpart D) | (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)
Page 10 of 259 Masimo RadCheck 510(k)