(28 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The technology described is standard pulse oximetry.
No
The device is described as a monitoring device that measures and displays vital signs (oxygen saturation and pulse rate). It does not provide any treatment or therapy.
Yes
The device continuously monitors physiological parameters (functional oxygen saturation of arterial hemoglobin and pulse rate), providing data that aid in the assessment of a patient's health status, which is a form of diagnostic monitoring.
No
The device description explicitly states it consists of hardware components including the pulse oximeter instrument, sensors, and cables, in addition to software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are 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 SET® Radical Pulse Oximeter with SatShare™ is described as a device that "noninvasively calculate the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." This is done by placing a sensor on the patient's body (e.g., finger, earlobe) and measuring light absorption.
- No Specimen Examination: The device does not involve the collection or analysis of any biological specimens from the patient. It directly measures physiological parameters in vivo (within the living body).
Therefore, the Masimo SET® Radical Pulse Oximeter with SatShare™ falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic.
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 (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatic, 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 (SpO-) 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 oximery sensor intended for adults and pediatrics greater than 30 kg
A single use oximetry sensor intended for nediatics 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 pediatives 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 SETº Radical Pulse Oximeter with SatShare™
The following are additional SatShare cables indicated for connection to the following multi-parameter monitors:
Ohmeda - RGM Respiratory Monitor and
Datex-Ohmeda - M-EST and M-ESTP Modlucs
Draeger - Vitalert 1000, 3200, Evita 2 dura, Julian Anesthetic Workstation, and Narcomed 4 Monitors Airshields - Multiparameter Monitor with Ohmeda SpO2
Datascope - Passport Monitor with Datascope SpO2 and Accutor Monitors with Nellcor SpO2 and Datascope SpO2
GE/Marquette - Tram 100A and Tram 500A modules with Ohmeda SpO2
Product codes (comma separated list FDA assigned to the subject device)
74 DQA, 74DSA
Device Description
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories is a device consisting of the Masimo SET I ho reasme of 2 - 1 the really and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial tecmoglobin (SpO2) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liguid crystal display) display 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.
-
- 6, 8, 12, 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 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.
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.
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, pediatic, 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)
Bench Testing:
The Masimo SET® Radical Pulse Oximeter with SatShare™ and accessories was subjected to beach 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 rate values within ± 3 digits when compared to the simulators used.
Clinical Testing:
- 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 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 notion. and motion conditions and measuring the arterial hemoglobin saturation value with the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
- Clinical studies were performed usino 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 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 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 Federal Regulations (21CFR), Part 812 -Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards.
Key Results from Clinical Studies:
- 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 satured on 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:
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 Conditions' Adults, Pediatric, Neonates: 25 to 240 ± 3 digits
Pulse Rate (bpm) - During Motion Conditions233 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
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
061
510(k) SUMMARY
JUL 1 1 2001
Image /page/0/Picture/3 description: The image shows the logo and contact information for Masimo. The logo features the company name in a bold, sans-serif font with a small graphic above the 'i'. Below the logo is the address: 2852 Kelvin Avenue, Irvine, CA 92614, followed by the telephone number 949-250-9688 and fax number 949-250-9686.
| 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: | June 12, 2001 |
| 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 I ho reasme of 2 - 1 the really and oximetry sensors to noninvasively calculate the functional oxygen saturation of arterial tecmoglobin (SpO2) and pulse rate. It features an easy-to-read display that presents patient data and status information: a LCD (liguid crystal display) display 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
-
- 6, 8, 12, 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 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 (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatic, 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 (SpO-) 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 SpO2 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.
1062
2
The monitor will begin continuously displaying the patient's pulse plethysmographic waveform, pulse rate, and SpQ 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 discomected 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 Conditions' Adults, Pediatric, Neonates 25 to 240 ± 3 digits
Pulse Rate (bpm) - During Motion Conditions233 25 to 240 ± 5 digits Adults, Pediatric, Neonates
Resolution
Saturation (% SpO2) Pulse Rate (bpm)
and % Transmission > 5%
1% 1
Low Perfusion Performance4 > 0.02% Pulse Amplitude
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 beach 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 rate values 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 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 notion. and motion conditions and measuring the arterial hemoglobin saturation value with the arterial hemoglobin oxygen determined from arterial blood samples with a CO-Oximeter.
Clinical studies were performed usino 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 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 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 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 satured on 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 Masino SET® Radical Pulse Oximeter with SatShare™ 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 with SatShare™ and accessories is safe, effective.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.
JUL 1 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Mr. James J. Cronin Masimo Corporation 2852 Kelvin Avenue Irvine, CA 92614
Re: K011851
Masimo SET® Radical Pulse Oximeter with SatShare™ and LNOP® series of Sensors and Cables Regulation Number: 870.2700 Regulatory Class: II (two) Product Code: 74 DQA Dated: June 12, 2001 Received: June 13, 2001
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 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). 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 regulation (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
8
Page 2 - Mr. James J. Cronin
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.
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 nredicate 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,
to Allertshausen fa,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Indications for Use
510(k) Number (if known): K011851
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 nominvasive 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, pediatio, and nonatal patients during both no motion and motions, for patients who are well or poorly perfused in hospitals, hospitals, 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 oximery sensor intended for adults and pediatrics greater than 30 kg
A single use oximetry sensor intended for nediatics 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 pediatives 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 SETº Radical Pulse Oximeter with SatShare™
The following are additional SatShare cables indicated for connection to the following multi-parameter monitors:
Ohmeda - RGM Respiratory Monitor and
Datex-Ohmeda - M-EST and M-ESTP Modlucs
Draeger - Vitalert 1000, 3200, Evita 2 dura, Julian Anesthetic Workstation, and Narcomed 4 Monitors Airshields - Multiparameter Monitor with Ohmeda SpO2
Datascope - Passport Monitor with Datascope SpO2 and Accutor Monitors with Nellcor SpO2 and Datascope SpO2 GE/Marquette - Tram 100A and Tram 500A modules with Ohmeda SpO2
(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 Devices | |
| 510(k) Number |
| Prescription Use (Per 21 CFR 801.109) | X |
|---|---|
| --------------------------------------- | --- |
or
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
510(k) Masino SET® Radical Pulse Oximeter with SatShare™