(127 days)
No
The summary does not mention AI, ML, or related terms, and the device description focuses on established non-invasive measurement technology based on a predicate device.
No
The device is indicated for noninvasive spot checking and measurement of physiological parameters (SpO2, pulse rate, total hemoglobin). It is a diagnostic/monitoring device, not a therapeutic one as it does not treat or alleviate symptoms of a disease.
Yes
The device is indicated for "noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO₂), pulse rate, and total hemoglobin concentration (SpHb)," which are measurements used to inform a diagnosis.
No
The device description explicitly states it includes the "Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories," indicating a hardware component (the oximeter) is part of the device. The performance studies also describe measurements taken with the device, further suggesting a physical component.
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.
- Device description: The description clearly states that the Masimo Rainbow SET Pronto-7 is a noninvasive device. It measures parameters like SpO₂, pulse rate, and SpHb directly from the individual without requiring a sample to be taken from the body.
- Intended Use: The intended use describes "noninvasive spot checking" and use with "adult and pediatric individuals," not the analysis of biological samples.
Therefore, since the device operates noninvasively and does not analyze samples taken from the body, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO₂), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).
Product codes
DQA
Device Description
The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories (Pronto-7) include the noninvasive technology of measurement for functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate and total hemoglobin concentration (SpHb), which is based on the same technology of the predicate device, the Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories (Pronto), 510(k) no. K091057.
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 individuals
Intended User / Care Setting
trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).
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)
Clinical Studies: SpO2 accuracy has been validated in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation. Pronto-7 measurements on volunteers induced hypoxia in the range of 70-100% SpO2 are compared against a laboratory CO-oximeter and ECG monitor. SpHb accuracy has been validated with (arterial/ venous) blood from healthy adult male and female volunteers and on patients with light to dark skin pigmentation in the range of 6-18 g/dl SpHb, with Pronto-7 measurements compared against a laboratory CO-oximeter. Pulse rate accuracy has been validated on healthy adult male volunteers and on patients with light to dark skin pigmentation in the range of 40-110 bpm. The variation in these studies equals plus or minus one standard deviation encompasses 68% of the population.
Clinical Results: No device-related adverse events. The clinical studies were performed in accordance with ISO 9919:2005. The studies resulted in SpO3 accuracy (rms)
§ 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 a handwritten text that appears to be a combination of letters and numbers. The text reads 'Klo 403' in a bold, slightly irregular font. The characters are closely spaced, and the overall impression is that of a quick, informal note.
510(k) SUMMARY
| Submitted by: | Masimo Corporation
40 Parker
Irvine, CA 92618
949-297-7000
FAX 949-297-7592 |
|------------------------------------|------------------------------------------------------------------------------------------|
| Company Contact: | Marguerite Thomlinson, Manager of Regulatory Affairs |
| Date Summary Prepared: | April 23, 2010 |
| Trade Name | Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and
Accessories |
| Common Name | Oximeter |
| Classification Name/ Product Code: | Oximeter Section 870.2700/ Product Code DQA |
| Predicate Device: | Masimo Rainbow SET® Pronto Pulse CO-Oximeter and
Accessories, 510(k) Number - K091057 |
Device Description
The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories (Pronto-7) include the noninvasive technology of measurement for functional saturation of arterial oxygen hemoglobin (SpO2), pulse rate and total hemoglobin concentration (SpHb), which is based on the same technology of the predicate device, the Masimo Rainbow SET® Pronto Pulse CO-Oximeter and Accessories (Pronto), 510(k) no. K091057.
Intended Use/ Indications for Use
The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for noninvasive spot checking of functional saturation of arterial oxygen hemoglobin (SpO3), pulse rate, and total hemoglobin concentration (SpHb). The Masimo Rainbow SET Pronto-7 Pulse CO-Oximeter and Accessories are indicated for use by trained personnel, with adult and pediatric individuals, in clinical and non-clinical settings (e.g., hospital-type facilities, home, clinics, physician offices, blood donation facilities, and ambulatory surgery centers).
Technology Comparison
Features in the Pronto-7, which are not in the Pronto, include touch-screen user interface, pleth waveform display, rechargeable batteries or AC power, USB connection, flash memory, earphone jack, and wireless connection. The Pronto-7 has the following specifications:
| FEATURES | SPECIFICATIONS |
|---|---|
| Display Range | Saturation (SpO2): 0-100%; Pulse Rate (bpm): 30-250 bpm |
| (Total Hemoglobin (SpHb): 0-25 g/dl; Perfusion Index (PI): 0.02-20% | |
| Accuracy: | |
| Adults and Pediatrics > 30kg | SpO2: 70-100±2%; Pulse Rate: 30-250±3 bpm; SpHb: 6-18 g/dl ±1 g/dl |
| Resolution | SpO2: 1%; Pulse Rate: 1 bpm; SpHb: 0.1 g/dl |
| AC Power | Voltage Input: 100-240 VAC, 50-60 Hz; Max Power Consumption: 15 VA |
| Batteries | Rechargeable lithium polymer |
1
510(k) SUMMARY
| FEATURES | SPECIFICATIONS |
|---|---|
| Temperature | Operating/ Storage: 41 to 104°F (5 to 40°C)/ -40 to 158°F (-40 to 70°C) |
| Relative Humidity | 5 to 95% noncondensing |
| Operating Altitude | 500 to 1,060 mbar pressure; -1,000 to 18,000 ft (-304 to 5,486m) |
| Alarm | System Failure; Low Battery Alarm |
| Display and Indicators | SpO2 (%); Pulse Rate (bpm); SpHb (g/dl); Perfusion Index (%) |
| Display and Indicators | Pleth Waveform; Sensor Status; Status Messages; Battery Status |
| Connection/ Output | Wireless: Bluetooth 2.0; WiFi b/g; Flash Memory: Micro SD card slot |
| Earphone jack | Connection for standard 3.5 mm earphone jack |
| EMC/ Electrical Safety | |
| Compliance | EN 60601-1-2, Class B |
| EMC/ Electrical Safety | |
| Compliance | IEC 60601-1, UL 60601-1, Internally Powered, AC Power Class 2 |
| EMC/ Electrical Safety | |
| Compliance | Type BF-Applied Part, IPX1, Class 2 |
| Mode of Operation | Spot check |
Clinical Data Summary
Clinical Studies: SpO2 accuracy has been validated in human blood studies on healthy adult male and female volunteers with light to dark skin pigmentation. Pronto-7 measurements on volunteers induced hypoxia in the range of 70-100% SpO2 are compared against a laboratory CO-oximeter and ECG monitor. SpHb accuracy has been validated with (arterial/ venous) blood from healthy adult male and female volunteers and on patients with light to dark skin pigmentation in the range of 6-18 g/dl SpHb, with Pronto-7 measurements compared against a laboratory CO-oximeter. Pulse rate accuracy has been validated on healthy adult male volunteers and on patients with light to dark skin pigmentation in the range of 40-110 bpm. The variation in these studies equals plus or minus one standard deviation encompasses 68% of the population.
Clinical Results: No device-related adverse events.
The clinical studies were performed in accordance with ISO 9919:2005. The studies resulted in SpO3 accuracy (rms)