(14 days)
Not Found
No
The document describes a standard pulse oximeter using Masimo SET technology, which is a signal processing technology for motion artifact reduction, but it does not mention or imply the use of AI or ML.
No
Explanation: The device is intended for continuous monitoring of functional oxygen saturation and pulse rate, providing diagnostic information rather than directly treating or mitigating a disease or condition.
Yes
The device continuously monitors functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate, providing physiological data used by practitioners to assess a patient's condition.
No
The device description explicitly states it consists of hardware components including the Masimo SET technology, connecting cable, and oximetry sensors, in addition to the calculation software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that the Masimo SET® Radical Pulse Oximeter is a noninvasive monitoring device. It measures physiological parameters (SpO2 and pulse rate) directly from the patient's body using sensors attached externally (typically to a finger, toe, or earlobe). It does not involve the analysis of blood, urine, tissue, or other samples removed from the body.
- The device description focuses on external measurement. The description details the technology, cables, and sensors used to noninvasively calculate the parameters.
- The performance studies involve direct patient monitoring and bench testing with a simulator. They do not describe the analysis of biological samples.
Therefore, the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories falls under the category of a noninvasive medical device for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO- sensor) for adult, pediativ, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motions, for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multiparameter devices for display on those devices.
The Masimo LNOP® Series of Sensors are indicated for the following:
- A single use oximetry 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 oximetry 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
A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 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 with SatShare™.
Product codes (comma separated list FDA assigned to the subject device)
74DQA, 74DSA
Device Description
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation 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 detachable portable monitor
- Several types of Masimo LNOP® sensors for flexibility. .
- . An automatic self-test at start-up.
- . Ability to be connected to the sensor port of multi-parameter devices that allows the multi-parameter device to share the Masimo SET® Radical Pulse Oximetry measurements
- Ability to be connected to digital communication modules
- Backlit display for excellent visibility in subdued lighting conditions.
- Direct access to user-selectable high and low alarm limits for SpO2 and pulse rate.
- An audible pulse indicator with an adjustable volume
- Visual and audible (adjustable volume) alarms.
- An alarm-silence feature; silences audible alarms for 120 seconds or continuously until deactivated.
- Status and alarm informational messages appear on the LCD.
- 2, 4, 8, 10, 12, 14, or 16 second SpO2, response averaging modes.
- Trend data storage of up to 8 hours .
- Automatic scaled plethysmographic waveform
- Large SpO2 digital display for clear differentiation from the pulse rate value. .
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 receives the detector signals from the oximetry sensor.
This filing included additional SatShare cables that attach to the docking station and the oximeter sensor connector/port of additional validated multi-parameter device/modules enabling the SatShare™ feature of the Radical Pulse Oximeter with these multi-parameter devices.
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.
Principles of Operation
The principles of operation of the Masimo SET® Radical Pulse Oximeter with SatShare™ are that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry), 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 amount of red and infrared light absorbed by the blood is related to hemoglobin oxygen saturation. The Masimo SET® Radical Pulse Oximeter with SatShare™ 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 SpO3 saturation in an empirically derived equation in the Masimo SET® Radical II'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 nonmotion 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, pediativ, and neonatal 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)
Nonclinical tests:
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories was subjected to bench testing using a simulator that determined 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 with SatShare™ and accessories returned the same saturation accuracy values within ± 2 digits and pulse within ± 3 digits when compared to the simulators used.
Clinical tests:
Clinical studies were performed usino SET® Radical Pulse Oximeter with SatShare™ on healthy adult volunteer subjects during no motion and motions 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 with SatShare™ on neonates during no motion and motions 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 with SatShare™ on healthy adult volunteer 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 themoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
Clinical studies were performed using SET® Radical Pulse Oximeter with SatShare™ on neonates with low perfusion 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.
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 with Saturation accuracy values for adults and pediatrics within ± 2 digits during no motion conditions and ± 3 digits during motion conditions 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 specified saturation accuracy from 70% - 100% for neonates is based on the results from clinical studies with saturations down to 83% combined with clinical studies on adults to show that the Masimo SET® Radical Pulse Oximeter with SatShare™ to be within ± 3 digits during both motion conditions when compared to the CO-Oximeter, and the pulse rate accuracy values for neonates to be within ± 3 digits during no motion and ± 5 digits during motion conditions when compared to the ECG.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy (Adults, Pediatrics) - During No Motion Conditions: Saturation (% SpO2) 70% - 100% ± 2 digits; 0% - 69% unspecified. Pulse Rate (bpm) 25 to 240 ± 3 digits.
Accuracy (Neonates) - During No Motion Conditions: Saturation (% SpO2) 70% - 100% ± 3 digits; 0% - 69% unspecified. Pulse Rate (bpm) 25 to 240 ± 3 digits.
Accuracy (Adults, Pediatrics) - During Motion Conditions: Saturation (% SpO2) 70% - 100% ± 3 digits; 0% - 69% unspecified. Pulse Rate (bpm) 25 to 240 ± 5 digits.
Accuracy (Neonates) - During Motion Conditions: Saturation (% SpO2) 70% - 100% ± 3 digits; 0% - 69% unspecified. Pulse Rate (bpm) 25 to 240 ± 5 digits.
Low Perfusion Performance: Saturation (% SpO2) ± 2 digits; Pulse Rate ± 3 digits.
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
MAY 1 2 2003 510(k) SUMMARY
Image /page/0/Picture/2 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the address "2852 Kelvin Avenue, Irvine, CA 92614" and the phone number "Tel: 949-250-9688". The logo is a stylized version of the company name, with a curved line above the "i".
| 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: | April 24, 2003 |
| Trade Name | Masimo SET ® Radical Pulse Oximeter with SatShare ™ 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 Radical Pulse Oximeter with SatShare ™ and LNOP series of Sensors and
Cables
510(k) Number - K000126 |
Description of Masimo SET® Radical Pulse Oximeter with SatShare™
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET technology, connecting cable, and oximetry sensors to noninvasively calculate the functional oxygen saturation 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 detachable portable monitor
- Several types of Masimo LNOP® sensors for flexibility. .
- . An automatic self-test at start-up.
- . Ability to be connected to the sensor port of multi-parameter devices that allows the multi-parameter device to share the Masimo SET® Radical Pulse Oximetry measurements
- Ability to be connected to digital communication modules
- Backlit display for excellent visibility in subdued lighting conditions.
- Direct access to user-selectable high and low alarm limits for SpO2 and pulse rate.
- An audible pulse indicator with an adjustable volume
- Visual and audible (adjustable volume) alarms.
- An alarm-silence feature; silences audible alarms for 120 seconds or continuously until deactivated.
- Status and alarm informational messages appear on the LCD.
1
- 2, 4, 8, 10, 12, 14, or 16 second SpO2, response averaging modes.
- Trend data storage of up to 8 hours .
- Automatic scaled plethysmographic waveform
- Large SpO2 digital display for clear differentiation from the pulse rate value. .
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 receives the detector signals from the oximetry sensor.
This filing included additional SatShare cables that attach to the docking station and the oximeter sensor connector/port of additional validated multi-parameter device/modules enabling the SatShare™ feature of the Radical Pulse Oximeter with these multi-parameter devices.
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 with SatShare™ and accessories is intended for continuous nonitoring of functional oxygen saturation of arterial hemoglobin (SpO-) and pulse rate (measured by an SpO- sensor) for adult, pediativ, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.
Indications For Use:
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motions, for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) to multiparameter devices for display on those devices.
Principles of Operation
The principles of operation of the Masimo SET® Radical Pulse Oximeter with SatShare™ are that oxyhemoglobin and deoxyhemoglobin differ in their absorption of red and infrared light (spectrophotometry), 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 amount of red and infrared light absorbed by the blood is related to hemoglobin oxygen saturation. The Masimo SET® Radical Pulse Oximeter with SatShare™ 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 SpO3 saturation in an empirically derived equation in the Masimo SET® Radical II'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 nonmotion conditions.
Method of Operation
The Masimo SET® Radical Pulse Oximeter with SatShare™ is turned on. An oximetery sensor is attached to a patient's finger and one end of a patient cable is connected to the sensor and the other end connected to the Masimo SET® Radical Pulse Oximeter with SatShare™ module.
0046
2
The monitor will begin continuously displaying the patient's pulse plethysmographic waveform, pulse rate, and SpO2 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 alarm 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 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 with SatShare™ is powered either with a voltage input of 100-230 Vac, 47 – 63 Hz. The detachable portable monitor operates on 4 rechargeable Nickel Hydride batteries with and operating time of 2-4 hours.
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 digits | |
| 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.
3
Power
Voltage Input Range Maximum AC Power Consumption: 100-230 Vac, 47-63 Hz 55 VA
Battery
Type Operating Time Charge Time
4 Rechargeable Nickel Metal Hydride Batteries > 3 hours 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 with SatShare™ and accessories was subjected to bench testing using a simulator that determined 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 with SatShare™ 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 usino SET® Radical Pulse Oximeter with SatShare™ on healthy adult volunteer subjects during no motion and motions 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 with SatShare™ on neonates during no motion and motions 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 with SatShare™ on healthy adult volunteer 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 themoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
Clinical studies were performed using SET® Radical Pulse Oximeter with SatShare™ on neonates with low perfusion 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.
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 with Saturation accuracy values for adults and pediatrics within ± 2 digits during no motion conditions and ± 3 digits during motion conditions when
6
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 specified saturation accuracy from 70% - 100% for neonates is based on the results from clinical studies with saturations down to 83% combined with clinical studies on adults to show that the Masimo SET® Radical Pulse Oximeter with SatShare™ to be within ± 3 digits during both motion conditions when compared to the CO-Oximeter, and the pulse rate accuracy values for neonates to be within ± 3 digits during no motion and ± 5 digits during motion conditions when compared to the ECG.
Conclusions
The results of the environmetal testing demonstrated that the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories met the requirements of Reviewers Guidance for Premarket Submissions - November 1993.
The results of the biocompatibility testing demonstrates the all patient contactial met the requirements of ISO-10993-1. 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 with SatShare™ meets its performance requirements.
The results of the clinical testing demonstrates that the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories meet its performance requirements during no motion and motion conditions and low perfusion conditions.
The non-clinical and clinical testing performed demonstrates that the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is safe, effective.
051
7
Image /page/7/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 12 2003
Mr. James J. Cronin Vice President, Regulatory Affairs/Quality Assurance Masimo Corporation 2852 Kelvin Avenue Irvine, California 92614
Re: K031330
Trade/Device Name: Masimo SET Radical Pulse Oximeter with SatShare Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II (two) Product Code: 74 DQA Dated: April 24, 2003 Received: April 28, 2003
Dear Mr. Cronin:
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.
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);
8
Page 2 - Mr. James J. Cronin
labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
JoAnne Arbuckle
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K031330
Masimo SET® Radical Pulse Oximeter with SatShare™ and the LNOP® Series of Sensors and Cables Device Name:
Indications For Use:
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion conditions, for patients who are well or poorly perfused in hospital-type facilities, mobile, and home environments. In addition the Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is indicated to provide the continuous nonitoring data obtained from the Masimo SET® Radical Pulse Oximeter with SatShare™ of functional oxygen saturation of arterial hemoglobin (Sp(2) and pulse rate (measured by an Sp) sensor) to multiparameter devices for display on those devices.
The Masimo LNOP® Series of Sensors are indicated for the following:
- A single use oximetry 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 oximetry 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
A reusable oximetry sensor intended for pediatrics and small adults greater than 10 kg and less than 50 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 with SatShare™.
(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: K031330
Prescription Use
(Per 21 CFR 801.109)
or Over-The-Counter Use
(Optional Format 1-2-96)