(98 days)
Not Found
No
The document does not mention AI, ML, or related terms like deep learning or neural networks. The technology described is Masimo SET, which is a signal processing technology for pulse oximetry, not explicitly AI/ML.
No
The device is described as a pulse oximeter intended for monitoring functional oxygen saturation and pulse rate. Its function is to measure and display physiological parameters, not to treat or therapeutically intervene in disease or injury.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is "intended for continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate," and monitoring is a diagnostic function.
No
The device description explicitly states it consists of hardware components including the pulse oximeter, connecting cable, and oximetry sensors, in addition to the Masimo SET technology (which likely includes software).
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 such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Masimo SET® Radical Pulse Oximeter is a non-invasive device that measures functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate directly from the patient's body using a sensor applied to the skin. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate... for adult, pediatric, and neonatal patients". This is a monitoring function performed directly on the patient.
- Device Description: The description reinforces that it "noninvasively calculate the function of arterial hemoglobin (SpO), and pulse rate".
Therefore, because the device operates by directly measuring physiological parameters from the patient's body without analyzing samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Masimo SET® Radical Pulse Oximeter and accessories is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and home environments.
The Masimo SET Radical Pulse Oximeter and accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter and accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, and home environments.
Product codes (comma separated list FDA assigned to the subject device)
74DQA
Device Description
The Masimo SET® Radical pulse oximeter and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the function of arterial hemoglobin (SpO), and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liquid crystal display) display that shows the SpO2, pulse rate values, and a plethysmographic waveform, the current high and low SpO2 and pulse rate limit setting, and messages as appropriate.
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, pediatric, and neonatal patients
Intended User / Care Setting
hospitals, hospital-type facilities, 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
The Masimo SET® Radical Pulse Oximeter and accessories was subjected to bench testing using a simulator the performance accuracy of the instruments against the range of saturation and pulse rates that both devices specify. The results of the bench testing showed that the Masimo SET® Radical Pulse Oximeter and accessories returned the same saturation accuracy values within ± 2 digits and pulse within ± 3 digits when compared to the simulators used.
Clinical Studies:
Human blood studies on healthy adult volunteers:
- During no motion and motion conditions, subjected to progressive induced hypoxia, and measuring arterial hemoglobin saturation value with the instruments against hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
- The results show saturation accuracy values for adults and pediatics within ± 2 digits during no motion conditions and ± 3 digits during motion when compared to the CO-Oximeter, and pulse rate accuracy values within ± 3 digits during no motion conditions and ± 5 digits during motion conditions when compared to the ECG.
Human blood studies on neonates:
- During no motion and motion conditions, measuring arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
- The results show saturation accuracy values for neonates to be within ± 3 digits during both motion conditions when compared to the CO-Oximeter, and pulse rate accuracy values to be within ± 3 digits during no motion conditions when compared to the ECG.
Human blood studies on subjects with low perfusion conditions:
- Subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
Clinical studies on neonates with low perfusions:
- Measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
The clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21CFR), Part 812 -Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
Saturation (% SpO2) - During No Motion Conditions:
- Adults, Pediatrics: 70% - 100% ± 2 digits
- Neonates: 70% - 100% ± 3 digits
Saturation (% SpO2) - During Motion Conditions:
- Adults, Pediatrics: 70% - 100% ± 3 digits
- Neonates: 70% - 100% ± 3 digits
Pulse Rate (bpm) - During No Motion Conditions:
- Adults, Pediatric, Neonates: 25 to 240 ± 3 digits
Pulse Rate (bpm) - During Motion Conditions:
- Adults, Pediatric, Neonates: 25 to 240 ± 5 digits
Resolution:
- Saturation (% SpO2): 1%
- Pulse Rate (bpm): 1
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
Image /page/0/Picture/3 description: The image shows the logo and contact information for Masimo. The logo is a stylized, bold typeface. Below the logo is the address: 2852 Kelvin Avenue, Irvine, CA 92614. The telephone and fax numbers are both listed as 949-250-9688.
| Submitted by: | Masimo Corporation
2852 Kelvin Ave
Irvine, CA 92614-5826
(714) 250-9688
FAX (714) 250-9686 |
|----------------------------------|--------------------------------------------------------------------------------------------------------|
| Company Contact: | James J. Cronin, Vice President, Regulatory Affairs/Quality Assurance |
| Date Summary Prepared: | September 27, 1999 |
| Trade Name | Masimo SET ® Radical Pulse Oximeter and accessories |
| Common Name | Pulse Oximeter and Sensor |
| Classification Name | Oximeter (74DQA) (870.2700)
Cable, Transducer and Electrode (74DSA) (870.2900) |
| Substantially Equivalent Devices | Masimo SET 2000 Pulse Oximeter and accessories
510(k) Number - K990966 |
Description of Masimo SET® Radical Pulse Oximeter
The Masimo SET® Radical pulse oximeter and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the function of arterial hemoglobin (SpO), and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liquid crystal display) display that shows the SpO2, pulse rate values, and a plethysmographic waveform, the current high and low SpO2 and pulse rate limit setting, and messages as appropriate.
Features
.
.
- Ability to perform as a stand alone monitor and a portable monitor
- Several types of Masimo LNOP® sensors for flexibility.
- . An automatic self-test at start-up.
- Backlit display for excellent visibility in subdued lighting conditions.
- . Direct access to user-selectable high and low alarm limits for SpO, and pulse rate.
- . An audible pulse indicator with an adjustable volume
- . Visual and audible (adjustable volume) alarms.
- An alarm-silence feature; silences audible alarms continuously until deactivated. .
- Status and alarm informational messages appear on the LCD.
- . 8, 12, or 16 second SpO2 response averaging modes.
- Trend data storage of up to 8 hr.
- Automatic scaled plethysmographic waveform
- Large SpO, digital display for clear differentiation from the pulse rate value.
1
The PC series of connecting cables connects the monitor to the oximetry sensors and transfers LED drive power to the oximetry sensors from the monitor and the monitor receives the detector signals from the oximetry sensor.
The LNOP® series of oximetry sensors measure the light absorption of blood from two light emitting diodes (LED's). Oxygen saturated blood absorbs light differently than unsaturated blood. The amount of light absorbed by the blood is used to calculate the ratio of oxygenated hemoglobin to total hemoglobin in arterial blood.
Intended use
The Masimo SET® Radical Pulse Oximeter and accessories is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, and home environments.
Indications For Use:
The Masimo SET Radical Pulse Oximeter and accessories are indicated for the continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter and accessories are indicated for use with adult, pediatic, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, and home environments.
Principles of Operation
The principles of operation of the Masimo SET Radical pulse oximeter are that oxyhemoglobin differ in their absorption of red and infrared light (spectrophotomery), the volume of arterial blood in tissue (and hence, light absorption by that blood) changes during the pulse (plethysmography), and that arterio-venous shunting is highly variable and that fluctuating absorbance by venous blood is a major component of noise during the pulse. Because oxyhemoglobin and deoxyhemoglobin differ in light absorption, the anount of red and infraced light absorbed by the blood is related to hemoglobin oxygen saturation. The Masimo SET® Radical pulse oximeter decomposes the red and infrared pulsatile absorbance signal into an arterial signal plus a noise component and calculates the ratio of the arterial signals without noise. The ratio of the two arterial pulse-added absorbance signals and its value is used to find the SpO2, saturation in an empirically derived equation in the Masino SET® Radical's software. The values in the look-up table are based upon human blood studies against a laboratory co-oximeter on healthy adult volunteers in induced hypoxia states during motion and non-motion conditions.
Method of Operation
The Masimo SET® Radical pulse oximeter is turned on. An oximetery sensor is attached to a patient's finger and of a patient cable is connected to the sensor and the other end connected to the Masimo SET® Radical pulse oximeter module.
The monitor will begin continuously displaying the patient's pulse pletors, pulse rate, and SoO, value. The practitioner can adjust the high and low alarm limits to their desired. The practitioner can then use the information that is continuously displayed on the monitor, and hear if an alam limit is reached, to help assess the condition of the patient and as an aide in determining if any intervention is required by the practitioner.
Once the practitioner determines the patient no longer requires monitoring, the cable is disconnected from the sensor, the oximetry sensor is removed (and disposed of if it is a single use device), and the power to the monitor is turned off.
Power Source
The Masimo SET Radical pulse oximeter is powered either with a voltage input of 100-230 Vac, 47 - 63 Hz. The detachable portable monitor operates on 4 AA batteries with and operating time of 2 hours.
2
Specifications and Operating Ranges
| Range | Saturation (% SpO2) | 1% - 100% |
|---|---|---|
| Pulse Rate (bpm) | 25 - 240 | |
| Perfusion | 0.02% - 20% | |
| Accuracy | Saturation (% SpO2) - During No Motion Conditions1 | |
| Adults, Pediatrics | 70% - 100% ± 2 digits | |
| 0% - 69% unspecified | ||
| Neonates | 70% - 100% ± 3 digits | |
| 0% - 69% unspecified | ||
| Saturation (% SpO2) - During Motion Conditions2,3 | ||
| Adults, Pediatrics2 | 70% - 100% ± 3 digits | |
| 0% - 69% unspecified | ||
| Neonates3 | 70% - 100% ± 3 digits | |
| 0% - 69% unspecified | ||
| Pulse Rate (bpm) - During No Motion Conditions1 | ||
| Adults, Pediatric, Neonates | 25 to 240 ± 3 digits | |
| Pulse Rate (bpm) - During Motion Conditions2,3 | ||
| Adults, Pediatric, Neonates | 25 to 240 ± 5 digits | |
| Resolution | Saturation (% SpO2) | 1% |
| Pulse Rate (bpm) | 1 | |
| Low Perfusion Performance4 | ||
| > 0.02% Pulse Amplitude | ||
| and % Transmission > 5% | Saturation (% SpO2) ± 2 | |
| Pulse Rate ± 3 digits | ||
| Interfering Substances |
Carboxyhemoglobin may erroneously increase readings. The level of increase is approximately equal to the amount of carboxyhemoglobin present. Dyes, or any substance containing dyes, that change usual arterial pigmentation may cause erroneous readings.
digits
Power
Voltage Input Range Maximum AC Power Consumption: 100-230 Vac, 47-63 Hz રડ VA
Fuses
1ASB, Metric, (5x20mm), 250V
3
Isolation
Chassis Leakage Current Ground resistance
Environmental
Operating Temperature Storage Temperature Relative Humidity
Less than 1.0 Ω
Less than 100 uAmp
41°F to + 104°F (5°C to +40°C) -40°F to + 158°F (-40°C to +70°C) 5% to 95% noncondensing
Circuitry
Microprocessor controlled Automatic self-test of oximeter when powered on Automatic setting of default parameters Automatic alarm messages Trend data output of SpO2, pulse rate - up to 8 hours of stored data
Display
Backlit LCD 480 x 160 dots 0.24 mm Pulse Rate, SpO2 %, Pleth wave, Alarms, Trends, Status messages
Audio indicators
Type
Pixels
Dot Pitch
Data Displayed
Adjustable volume audible pulse: OFF and 25% to 100% in 4 steps Adjustable volume audible alarm tone: levels and 25% to 100% in 4 steps Alarm silence (120 seconds); all mute (continuous silence) Pulse rate out-of-limits alarm SpO2 level out-of limits alarm Sensor condition alarms System failure and battery low alarms
Modes
Averaging mode: Sensitivity
Audible Volumes Alarm Pulse Beep 8, 12, and 16 seconds Normal and High
25% to 100% in 4 steps OFF and 25% to 100% in 4 steps
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| COM 1: A digital interface for network communication. | |
|---|---|
| Data output every second; SpO2, and pulse rate | |
| 9600 Baud bidirectional | |
| Number of bits per character: | 8 |
| Parity | None |
| Bits | 1 start, 1 stop |
| Handshaking | None |
| Connector type | 9-pin standard D, female |
| Connector pin functions: | |
| 1 | No Connection |
| 2 | Receive data - RS-232 ±9 V (±5 Vmin) |
| 3 | Transmit data - RS-232 ±9 V (±5 Vmin) |
| 4 | No Connection |
| 5 | Signal Ground Reference for COM 1 signals |
| 6 | No Connection |
| 7 | Request to send - Not used |
| 8 | Clear to send - Not used |
| 9 | No Connection |
PRINTER: A connection for optional printer.
| Connector pin functions: | |
|---|---|
| 1 | No Connection |
| 2 | Receive data -- Not used |
| 3 | Transmit data - RS-232 ±9 V (±5 Vmin) |
| 4 | No Connection |
| 5 | Signal Ground - Reference for Printer signals |
| 6 | No Connection |
| 7 | Request to send - Not used |
| 8 | Clear to send - RS-232 ±9 V (±5 Vmin) |
| 9 | No Connection |
| Dimensions | |
| Docking Station | |
| Height | 3.5 in (8.9 cm) |
| Width | 10.5 in (26.7 cm) |
| Depth | 7.7 in (19.6 cm) |
| Weight | 4.7 lbs (2.14 kg) |
| Portable | |
| Height | 8.9 in (22.6 cm) |
| Width | 3.3 in (8.4 cm) |
| Depth | 2.1 in (5.3 cm) |
| Weight | 1.3 lbs (0.59 kg) |
The Masimo SET® Radical pulse oximeter with LNOP+Adt sensors has been validated for no motion accuracy in human blood studies on healthy adult volunteers 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.
2 The Masimo SET® Radical pulse oximeter with LNOP-Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers 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. Plus or minus one standard deviation encompasses 68% of the population.
The Masimo SET® Radical pulse oximeter with LNOP-Neo and Neo Pt sensors has been validated for neonatal motion 3 accuracy in human blood studies on neonates while moving the neonate's foot at 2 to 4 Hz at an amplitude of 1 to 2 cm
5
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.
- The Masimo SET® Radical pulse oximeter 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 a % transmission of greater than 5% for saturations ranging from 70 to 100%. This variation equals plus or minus one standard deviation. Plus or minus one standard deviation encompasses 68% of the population.
Technological characteristics of the Masimo SET® Radical Pulse Oximeter compared to the Masimo SET® 2000 Pulse Oximeter.
The technological characteristics of the Masimo SET® Radical Pulse Oximeter and the Masimo SET® 2000 Pulse Oximeter both have the same or similar technological characteristics in design, materials, and energy source.
The design of both devices is the similar in that both devices that monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor) for adult, pediativ, and neonatal patients. The Masimo SET® Radical Pulse Oximeter also has fully functional detachable portable of operation and methods of operation for both devices is the same.
The materials used in both devices are similar. The instrument cases are formed of themoplastic materials. The electronics within the instruments are standard electronic parts (resistors, integrated circuits, wiring, connectors, etc.). The sensors and cables for both devices are formed of thermoplastic materials, adhesives, wires, electrical contacts, light emitting diodes, and photodetectors.
The Masimo SET® Radical Pulse Oximeter and the Masimo SET® 2000 Pulse Oximeter operate under 100 - 230 VAC 47-63 Hz and battery power.
Environmental Testing
Applicable environmetal testing per the Reviewers Guidance for Premarket Submissions - November 1993, i.e. electrical, mechanical and environmental were performed and all tests passed.
Biocompatibility Testing
All patient contact materials were tested as Surface with skin contact for prolonged contact duration (>24 hr to 30 days) as defined ISO-10993-1: 1992 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests. All patient contacting material passed.
Nonclinical tests performed that support a determination of substantial equivalence.
The Masimo SET® Radical Pulse Oximeter and accessories was subjected to bench testing using a simulator the performance accuracy of the instruments against the range of saturation and pulse rates that both devices specify.
The results of the bench testing showed that the Masimo SET® Radical Pulse Oximeter and accessories returned the same saturation accuracy values within ± 2 digits and pulse within ± 3 digits when compared to the simulators used.
Clinical tests performed that support a determination of substantial equivalence.
Clinical studies were performed using SET® Radical Pulse Oximeter on healthy adult volunteer subjects during no motion and motion conditions who were subjected to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against themoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
Clinical studies were performed using the Masimo SET® Radical Pulse Oximeter on neonates during no motion and motion conditions and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
6
Clinical studies were performed using the Masimo SET® Radical Pulse Oximeter subjects who were subjected to low perfusion conditions and to a progressive induced hypoxia and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
Clinical studies were performed using the Masimo SET® Radical Pulse Oximeter on neonates with low perfusions and measuring the arterial hemoglobin saturation value with the instruments against the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21CFR), Part 812 -Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.
The results from the clinical studies show that the Masimo SET Radical Pulse Oximeter saturation accuracy values for adults and pediatics within ± 2 digits during no motion conditions and ± 3 digits during motion when compared to the CO-Oximeter and the pulse rate accuracy values within ± 3 digits during no motion conditions and ± 5 digits during motion conditions when compared to the ECG.
The results from the clinical studies also show that the Masimo SET® Radical Pulse Oximeter saturation accuracy values for neonates to be within ± 3 digits during both motion conditions when compared to the CO-Oximeter and the pulse rate accuracy values to be within ± 3 digits during no motion conditions when conditions when compared to the ECG.
Conclusions
The results of the environmetal testing demonstrated that the Masimo SET® Radical Pulse Oximeter and accessories met the requirements of Reviewers Guidance for Premarket Submissions - November 1993.
The results of the biocompatibility testing demonstrates the all patient contacting material met the requirements of ISO-1093-1: 1992 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests for Surface Devices with skin contact for prolonged contact duration (>24 hr to 30 days).
The results of the bench testing demonstrates that the Masimo SET® Radical Pulse Oximeter meets its performance requirements.
The results of the clinical testing demonstrates that the Masimo SET® Radical Pulse Oximeter and accessories meet its performance requirements during no motion conditions and low perfusion conditions,
The non-clinical and clinical testing performed demonstrates that the Masimo SET Radical Pulse Oximeter and accessories is safe, effective, and performs as well as the predicate device, the Masimo SET® 2000 Pulse Oximeter, it is substantially equivalent to the Masimo SET® 2000 Pulse Oximeter.
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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 OCT
Mr. James J. Cronin Masimo Corporation 2852 Kelvin Avenue Irvine, CA 92614-5826
K992238 Re: ·Masimo SET® Radical Pulse Oximeter and the LNOP® Series of Sensors and Cables Regulatory Class: II (two) Product Code: 74 DQA September 28, 1999 Dated: September 29, 1999 Received:
Dear Mr. Cronin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
8
Page 2 - Mr. James J. Cronin
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Section 3 - Indications for Use
510(k) Number (if known): K992238
Device Name:
Masimo SET* Radical Pulse Oximeter and the LNOP® Series of Sensors and Cables
Indications For Use:
The Masimo SET® Radical Pulse Oximeter are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO) and pulse rate (measured by an SpO, sensor). The Masimo SET® Radical Pulse Oximeter and accessories are indicated for use with adult, pediatic, and neomatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospital-type facilities, and home environments.
The Masimo LNOP® Series of Sensors are indicated for the following:
- A single use oximenty sensor intended for adults and pediatrics greater than 30 kg
- A single use oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 kg
- A single use oximery sensor intended for neonates with good skin integrity less than 10 kg
- A single use oximetry sensor intended for neonates with poor skin integrity less than 1 kg
- A reusable oximetry sensor intended for adults and pediatrics greater than 30 kg
The Masimo PC Series of Patient Cables are indicated for use with the Masimo LNOP® Series of Sensors and the Masimo SET® Radical Pulse Oximeter.
(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 Cardiovascular, Respiratory, and Neurological Device
510(k) Number
| Prescription Use | × |
|---|---|
| (Per 21 CFR 801.109) |
or
Over-The-Counter Use
(Optional Format 1-2-96)