(158 days)
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on established measurement technology (Masimo Rainbow SET) and comparison to a predicate device.
No
Explanation: The device is indicated for "non-invasive spot-check monitoring" of various physiological parameters (e.g., oxygen saturation, pulse rate, hemoglobin concentration). Monitoring is a diagnostic or observational function, not a therapeutic one that directly treats a condition.
Yes
The device is a Masimo Rad-67™ Pulse CO-Oximeter, and its indications for use explicitly state that it is for "non-invasive spot-check monitoring" of various physiological parameters such as "functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR)" and "total hemoglobin concentration (SpHb®)". Monitoring these parameters is a form of diagnostic activity, as it provides information about a patient's health status.
No
The device description explicitly states it is a "handheld device" and includes a "reusable sensor," indicating it is a hardware device with associated software, not a software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves testing blood, urine, tissue, etc., outside of the body.
- Device Function: The Masimo Rad-67™ Pulse CO-Oximeter and its accessories are described as non-invasive devices that monitor physiological parameters directly from the patient's body (functional oxygen saturation, pulse rate, total hemoglobin concentration). They do not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "non-invasive spot-check monitoring" and "continuous monitoring" of these parameters. This aligns with in-vivo monitoring, not in-vitro testing.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens.
Therefore, the Masimo Rad-67™ Pulse CO-Oximeter and its accessories fall under the category of non-invasive physiological monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Masimo Rad-67™ Pulse CO-Oximeter
The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are intended for use in clinical settings.
The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.
The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.
rainbow DCI-mini sensor
The rainbow DCI-mini sensor is intended for use in clinical and non-clinical settings.
The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.
The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.
Product codes
DQA
Device Description
The Masimo Rad-67™ Pulse CO-Oximeter is a handheld device that includes the Masimo Rainbow SET measurements.
The Rad-67™ has the same measurement technology and intended use as the cleared predicate, Pronto (K091057). The Rad-67™ includes Masimo Rainbow SET measurement technology, which enables the Rad-67™ to provide noninvasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi) and total hemoglobin concentration (SpHb®). The Rad-67™ can communicate through a wired or wireless connection to transfer data to external applications and devices.
The rainbow DCI-mini sensor, compatible accessory to the Rad-67™, is a reusable sensor that is compatible with Masimo rainbow SET technology and is intended for spot-check monitoring of functional oxygen saturation (SpO2), pulse rate (PR) and total hemoglobin (SpHb®). The rainbow DCImini sensor is indicated for adult, pediatic and infant populationsgeq 3kg for SpO2 and PR. The rainbow DCI-mini sensor is indicated for adult populations for SpHb®. The rainbow DCI-mini sensor measurement technology is the same as the predicate (rainbow DCI sensor cleared under K080238), except that the rainbow DCI-mini sensor has been designed to be smaller to accommodate a smaller application sites such as the great toe or thumb (for the infant population) and the finger (for adults and pediatric).
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 for SpO2 and PR. Adult patients for SpHb. Infant populations >= 3kg for SpO2 and PR.
Intended User / Care Setting
Clinical settings, 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
Clinical Validation Study (SpHb): The clinical accuracy of the SpHb performance was validated to obtain a 95% Limits of Agreement (LOA) specification over the range of 8-17g/dL as compared to tHb values determined by a HiCN reference method. # Subjects: 317. 95% LOA Accuracy[g/dL]: -1.82 to 2.04.
Clinical Validation Study (SpO2) (No motion): The clinical accuracy of the SpO2 performance specification for no motion conditions was validated to meet the 2% Arms specification, the same as the predicate. SpO2 Arms for no motion (70-100%). Bias: 0.05, Prec: 1.63, RMS: 1.63.
Clinical Validation Study (SpO2) (Motion): The clinical accuracy of the SpO2 performance specification for motion conditions was validated to meet the 2% Arms specification, the same as the predicate. SpO2 Arms for motion. Bias: -0.49, Prec: 1.92, RMS: 1.98.
- 5.6.1 Masimo performed the SpHb clinical validation testing of the SpHb performance using 317 adult subjects in the range of 8-17 g/dL. The 95% LOA was calculated for SpHb to be -1.82 to 2.04 g/dL over a specification range of 8-17 g/dL.
- 5.6.2 Masimo performed the clinical validation testing of the SpO2 performance under no motion on healthy, adult volunteers in the range of 70% to 100%. The ARMs for SpO2 under no motion was found to be 1.6% over the range of 70-100%.
- 5.6.3 Masimo performed the clinical validation testing of the SpO2 performance under motion on healthy, adult volunteers in the range of 70% to 100%. The ARMs for SpO2 under motion was found to be 1.9% over the range of 70-100%.
Key Metrics
SpHb Limits of agreement (LOA) over a range of 8-17 g/dL: -1.82 to 2.04 g/dL.
SpO2, no motion (70-100%): 2% ARMs, adults/pediatrics/infants.
SpO2, motion (70-100%): 3% ARMs, adults/pediatrics/infants.
SpO2, low perfusion (70-100%): 2% ARMs, adults/pediatrics/infants.
Pulse rate, no motion (25-240 bpm): 3bpm, adults/pediatrics/infants.
Pulse rate, motion (25-240 bpm): 5bpm, adults/pediatrics/infants.
Pulse rate, low perfusion (25-240 bpm): 3 bpm, adults/pediatrics/infants.
Predicate Device(s)
K091057- Masimo Rainbow SET Pronto Pulse CO-Oximeter
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Masimo Corporation Sindura Penubarthi Regulatory Affairs Manager 52 Discovery Irvine, California 92618
Re: K182887
Trade/Device Name: Masimo Rad-67 Pulse CO-Oximeter and Accessories Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: February 19, 2019 Received: February 21, 2019
Dear Sindura Penubarthi:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Todd D. Courtney -5 for Tina Kiang, Ph.D.
Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182887
Device Name Masimo Rad-67™ Pulse CO-Oximeter
Indications for Use (Describe) Indications For Use:
Masimo Rad-67™ Pulse CO-Oximeter
The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are intended for use in clinical settings.
The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.
The Masimo Rad-67™ Pulse CO-Oximeter and Accessories are indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.
rainbow DCI-mini sensor
The rainbow DCI-mini sensor is intended for use in clinical and non-clinical settings.
The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring and continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatric patients who are well or poorly perfused during both motion and no motion conditions.
The rainbow DCI-mini sensor is indicated for non-invasive spot-check monitoring of total hemoglobin concentration (SpHb®) for adult patients.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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Image /page/4/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the name is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
Section 5. 510(k) Summary
ട. 510(k) Summary
| Submitter and Address of
Manufacturing Facility: | Masimo Corporation
52 Discovery
Irvine, CA 92618
Phone: (949) 297-7000
FAX: (949) 297-7592 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Submitter | Sindura Penubarthi |
| Date: | October 11th 2018 |
| Official Correspondent | Sindura Penubarthi
Regulatory Affairs Manager
Masimo Corporation
Phone: (949)297-7541
SPenubarthi@Masimo.com |
| Trade Name: | Masimo Rad-67TM Pulse CO- Oximeter and Accessories |
| Common Name: | Oximeter |
| Classification Regulation/
Product Code: | 21 CFR 870.2700, Class II/DQA |
| Establishment Registration
Number: | 2031172 |
| Reason for Premarket
Notification: | New Device - Masimo Rad-67TM Pulse CO-Oximeter and
Accessories |
| Predicate Device: | K091057- Masimo Rainbow SET Pronto Pulse CO-Oximeter |
| Performance Standards | No performance standards for the above device have been
promulgated pursuant to Section 514. |
5.1 Device Description
The Masimo Rad-67™ Pulse CO-Oximeter is a handheld device that includes the Masimo Rainbow SET measurements.
The Rad-67™ has the same measurement technology and intended use as the cleared predicate, Pronto (K091057). The Rad-67™ includes Masimo Rainbow SET measurement technology, which enables the Rad-67™ to provide noninvasive spot-check monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), Perfusion Index (Pi) and total hemoglobin concentration (SpHb®). The Rad-67™ can communicate through a wired or wireless connection to transfer data to external applications and devices.
The rainbow DCI-mini sensor, compatible accessory to the Rad-67™, is a reusable sensor that is compatible with Masimo rainbow SET technology and is intended for spot-check monitoring of
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Image /page/5/Picture/2 description: The image shows the logo for Masimo Corporation. The logo consists of the word "Masimo" in a bold, sans-serif font, with a red circle containing a white waveform to the left. To the right of the logo is the text "MASIMO CORPORATION" followed by the address "52 Discovery, Irvine, CA 92618".
Section 5. 510(k) Summary
functional oxygen saturation (SpO2), pulse rate (PR) and total hemoglobin (SpHb®). The rainbow DCImini sensor is indicated for adult, pediatic and infant populations≥ 3kg for SpO2 and PR. The rainbow DCI-mini sensor is indicated for adult populations for SpHb®. The rainbow DCI-mini sensor measurement technology is the same as the predicate (rainbow DCI sensor cleared under K080238), except that the rainbow DCI-mini sensor has been designed to be smaller to accommodate a smaller application sites such as the great toe or thumb (for the infant population) and the finger (for adults and pediatric).
5.2 Significant Physical and Performance Characteristics of the Device
The table below provides the specifications for the Rad-67TM.
| Table 5.2 Rad-67TM Pulse CO-Oximeter Specifications | |
|---|---|
| FEATURE | Specification |
| Display | |
| Display type | Touchscreen, Color LCD (Backlit Active Matrix TFT LCD) |
| Measurement range | Functional Oxygen Saturation (SpO2):0-100% |
| Pulse Rate (PR): 0-240 beats per minute (bpm) | |
| Perfusion Index (Pi): 0.00-20% | |
| Pleth Variability Index (PVi): 0 to 100% | |
| Total Hemoglobin (SpHb): 0 to 25g/dL; 0 to 250 g/L; 0 to 15.5mmol/L | |
| Display resolution | SpO2:1% |
| PR:1bpm | |
| SpHb: 0.1, 0.5, 1 g/dL; 1g/L; 0.1, 0.5, 1 mmol/L | |
| Accuracy (ARMS) | Masimo rainbow SET Parameters |
| SpO2, no motion (70-100%) | 2%, adults/pediatrics/infants |
| SpO2, motion (70-100%) | 3%, adults/pediatrics/infants |
| SpO2, low perfusion (70-100%) | 2%, adults/pediatrics/infants |
| Pulse rate, no motion (25-240 bpm) | 3bpm, adults/pediatrics/infants |
| Pulse rate, motion (25-240 bpm) | 5bpm, adults/pediatrics/infants |
| Pulse rate, low perfusion (25-240 bpm) | 3 bpm, adults/pediatrics/infants |
| SpHb Limits of agreement (LOA) over a range of 8-17 g/dL | -1.82 to 2.04 g/dL |
| Mechanical | |
| Dimensions | 19.43 cm x 8.2 cm x 2.36 cm (7.6" x 3.2" x 0.9") |
| Weight | 0.37 kg. (0.81lbs) |
| Environmental | |
| Operating Temperature | 0 to 35 °C (32 to 95 °F) |
| Storage/Transport Temperature | -20°C to 45°C (-4°F to 113°F) |
| Operating Humidity | 10% to 95%, non-condensing |
| Storage/Transport Humidity | 10% to 95%, non-condensing |
| Operating Atmospheric Pressure | 540 mbar to 1060 mbar (540 hPa to 1060hPa) |
| Electrical | |
| AC power (power supply) requirements | 100-240Vac, 50/60 Hz, 0.5A |
| Power consumption |