(86 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional signal processing and display technology.
No
The device is a diagnostic tool used for continuous, non-invasive monitoring of physiological parameters (oxygen saturation and pulse rate); it does not provide therapy or treatment.
Yes
The device continuously monitors arterial oxygen saturation (SpO2) and pulse rates, which are physiological parameters used for assessing patient conditions. This monitoring provides information crucial for diagnosis and patient management.
No
The device description explicitly states it consists of hardware components including a pulse oximeter, connecting cable, and oximetry sensors, in addition to the Masimo SET technology.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rates". This is a measurement taken directly from the patient's body, not from a sample of bodily fluid or tissue.
- Device Description: The description reinforces that it "noninvasively calculate the functional or fractional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate". This further confirms it's a non-invasive monitoring device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are key characteristics of IVD devices.
Therefore, the Masimo SET® MS-1 P Pulse Oximeter and accessories are a non-invasive patient monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the Masimo SET pulse oximeter is the continuous nonitoring of functional or fractional saturation of arterial hemoglobin (SpO-) and pulse rate (measured by a SpO2 sensor) for adult, pediatric, and neonatal patients in a hospital and mobile environment.
Masimo SET® MS-1 P Pulse Oximeter and the LNOP® Series of Series of Patient Cables are indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rates during both no motion motion conditions for adult, pediatric, and neonatal patients in a hospital and mobile environment.
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 greater than 2,000 gms
- A single use oximetry sensor intended for neonates less than 2,000 gms
- 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 SETT MS-1P Pulse Oximeter.
Product codes (comma separated list FDA assigned to the subject device)
74 DQA
Device Description
Ine Masimo SET® MS-1P pulse oximeter and accessories is a device consisting of the Masimo SET technology in an Ohmeda 400 monitor, connecting cable, and oximetry sensors to nonivasively calculate the functional or fractional oxygen saturation of ancrial hemoglobin (SpO.) and pulse rate. It features two easy-to-read displays that present patient data and status information: a numeric LED (light-emitting diode) display that shows the SpO2 and phethysmographic LCD (liquid r stal display) that shows the waveform, the current high and low SpO2, and pulse rate limit setting, and messages as appropriate.
Features
- Several types of Masimo LNOP® sensors for flexibility.
- An automatic self-test at start-up.
- Automatic tiered alarm messages.
- Backlit and adjustable viewing-angle 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; the automatic pitch modulation reflects changing SpO2 level.
- 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.
- Short, medium, or long SpO2 response averaging modes.
- Adult or neonatal patient modes for default pulse rate alarm settings.
- Fractional or functional SpO2 calibration modes.
- Automatic storage of up to 12 hours of SpO2, pulse rate, and alarm limit violations in trend memory, which can be output through the RS-232 serial connector.
- Automatic scale plethysmographic waveform to provide a relative indication of sensor site perfusion level.
- Larger SpO2 digital display for clear differentiation from the pulse rate value.
The PC series connecting cables connects the monitor to the oximetry sensors and transfers LED drive power and the calibration drive to the oximetry sensors from the monitor receives the detector signal 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 as compared to 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 principles of operation of the Masimo SET® MS-IP pulse oximeter is that oxyhemoglobin differ in their absorption of red and infrared light (spectrophotomerry), 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 infrared light absorbed by the blood is related to hemoglobin oxygen saturation. The Masimo SET® MS-1P pulse oximeter decomposes the red and infrared pulsatile absorbance signal into an arterial signal plus a noise component and calculates the ratio of the arerial signals without noise. The ratio of the two arterial pulse-added absorbance signals and its value is used to find the SpO2 saturation in a look-up table built into the Masimo SETT MS-IP'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.
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
hospital and mobile environment.
qualified personnel only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical study: Clinical studies were performed using SET MS-1 P 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 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 results: The results from the clinical studies show that the Masimo SET® MS-IP Pulse Oximeter saturation accuracy values within ± 2 digits during no motion conditions and ± 4 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.
Bench testing: The Masimo SET® MS-1P Pulse Oximeter and accessories was subjected to bench testing using a simulator that determined the nerformance accuracy of the instruments against the simulator under the range of saturation and pulse rates that both devices specify.
Key results: The results of the bench testing showed that both the Masimo SET® MS-1P Pulse Oximeter and accessories returned the same saturation accuracy values within ± 2 digits and pulse within ± 3 digits when compared to the simulators used.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy
Saturation (% SpO2) - During No Motion Conditions
Adults: 70% - 100% ± 2 digits
Neonates: 0% - 69% unspecified, 70% - 100% ± 2 digits
Saturation (% SpO2) - During Motion Conditions
Adults: 70% - 100% ± 3 digits
Neonates: 0% - 69% unspecified, 70%-100% ± 3 digits
Pulse (bpm) - During No Motion Conditions
25 to 240 ± 3 digits
Pulse (bpm) - During Motion Conditions
Adults: 25 to 240 ± 5 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
1473887
Image /page/0/Picture/2 description: The image shows a date written in black ink. The date is "JAN - 8 1998". The month is abbreviated to three letters, and the year is written in full.
Image /page/0/Picture/3 description: The image shows the logo for Masimo, a medical technology company. Below the logo is the address 2552 Kelvin Avenue, Irvine, CA 92614. The phone number is 714-250-9688 and the fax number is 714-250-9686.
| 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: | October 10, 1997 |
| Trade Name | Masimo SET® MS-1P 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 MS-1 Pulse Oximeter and accessories
510(k) Number - K962603 |
Description of Masimo SET® MS-1P Pulse Oximeter
Ine Masimo SET® MS-1P pulse oximeter and accessories is a device consisting of the Masimo SET technology in an Ohmeda 400 monitor, connecting cable, and oximetry sensors to nonivasively calculate the functional or fractional oxygen saturation of ancrial hemoglobin (SpO.) and pulse rate. It features two easy-to-read displays that present patient data and status information: a numeric LED (light-emitting diode) display that shows the SpO2 and phethysmographic LCD (liquid r stal display) that shows the waveform, the current high and low SpO2, and pulse rate limit setting, and messages as appropriate.
Features
- Several types of Masimo LNOP® sensors for flexibility.
- An automatic self-test at start-up.
- Automatic tiered alarm messages.
- Backlit and adjustable viewing-angle 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; the automatic pitch modulation reflects changing SpO2 level.
- 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.
- Short, medium, or long SpO2 response averaging modes.
- Adult or neonatal patient modes for default pulse rate alarm settings.
- Fractional or functional SpO2 calibration modes.
100:
1
- Automatic storage of up to 12 hours of SpO2, pulse rate, and alarm limit violations in trend memory, which can be output through the RS-232 serial connector.
- Automatic scale plethysmographic waveform to provide a relative indication of sensor site perfusion level.
- Larger SpO2 digital display for clear differentiation from the pulse rate value.
The PC series connecting cables connects the monitor to the oximetry sensors and transfers LED drive power and the calibration drive to the oximetry sensors from the monitor receives the detector signal 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 as compared to 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 intended use of the Masimo SET pulse oximeter is the continuous nonitoring of functional or fractional saturation of arterial hemoglobin (SpO-) and pulse rate (measured by a SpO2 sensor) for adult, pediatric, and neonatal patients in a hospital and mobile environment.
Indications For Use:
Masimo SET® MS-1 P Pulse Oximeter and the LNOP® Series of Series of Patient Cables are indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rates during both no motion motion conditions for adult, pediatric, and neonatal patients in a hospital and mobile environment.
Principles of Operation
The principles of operation of the Masimo SET® MS-IP pulse oximeter is that oxyhemoglobin differ in their absorption of red and infrared light (spectrophotomerry), 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 infrared light absorbed by the blood is related to hemoglobin oxygen saturation. The Masimo SET® MS-1P pulse oximeter decomposes the red and infrared pulsatile absorbance signal into an arterial signal plus a noise component and calculates the ratio of the arerial signals without noise. The ratio of the two arterial pulse-added absorbance signals and its value is used to find the SpO2 saturation in a look-up table built into the Masimo SETT MS-IP'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.
Method of Operation
The method of operation of the Masimo SET MS-1P pulse oximeter is to turn on the monitor. An oximetery sensor is attached to a patient's finger and one end of a patient cable is connected to the other end connected to the MS-1P pulse oximeter module.
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 value, if required. The practitioner can then use the information that is continuously displayed on the monitor, and heard 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 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. Specifications and Operating Ranges
2
| Range | |
|---|---|
| Saturation (% SpO2) | 1% - 100% |
| Pulse Rate (bpm) | 25 - 240 |
| Accuracy | |
| Saturation (% SpO2) - During No Motion Conditions* | |
| Adults | 70% - 100% ± 2 digits |
| Neonates | 0% - 69% unspecified |
| 70% - 100% ± 2 digits | |
| Saturation (% SpO2) - During Motion Conditions** | |
| Adults | 70% - 100% ± 3 digits |
| Neonates | 0% - 69% unspecified |
| 70%-100% ± 3 digits | |
| Pulse (bpm) - During No Motion Conditions* | |
| 25 to 240 ± 3 digits | |
| Pulse (bpm) - During Motion Conditions** | |
| Adults | 25 to 240 ± 5 digits |
| Resolution | |
| Saturation (% SpO2) | 1% |
| Pulse Rate (bpm) | 1 |
| 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. | |
| Power | |
| Consumption | 15 watts typical |
| Voltage Range | 120 VAC at 60 Hz |
| Current approximately: | 0.1 ampere at 120 V |
| Fuses | |
| T2.0A/250V, 5 mm (OD) x 20 mm(L) | |
| Isolation | |
| Chassis Leakage Current | Less than 100 μAmp |
| Ground resistance | Less than 0.2 Ω |
| Environmental | |
| Operating Temperature | -4°F to + 104°F (-20°C to +40°C) |
| Storage Temperature | -4°F to + 140°F (-20°C to +60°C) |
| Relative Humidity | 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, and alarm messages via RS-232 serial port - up to 12 hours of stored data | |
| Display |
ز ز
1 0 8 2
3
Graphic display (Liquid Crystal Display)
Plethysmographic waveform High and low SpO2 alarm limits setting High and low pulse rate alarm limits setting Sensor condition alarms System operational status messages Alarm messages Contrast adjustment for best viewing
Numeric display (light emitting diodes)
Arterial oxygen saturation (SpO2) reading Pulse rate reading
Audio indicators
Adjustable volume audible pulse: OFF and levels 1 through 5 Adjustable volume audible alarm tone: levels 1 through 5 Pitch modulation reflects changing SpO2 levels 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 recharge-battery alarms
Modes
| Averaging mode: | Long (16 secs); Medium (8 secs - default), Short (6 secs) |
|---|---|
| Patient mode: | Adult (default), Neonatal |
| SpO2 calibration mode: | Fractional (default), Functional |
| Language mode: | English (default), French, German, Italian, Japanese, Spanish |
| EMI line frequency: | 60 Hz (default), 50 Hz |
Audible alarms
| Alarm | 1 through 5 (default = 3) |
|---|---|
| Pulse Beep | OFF and 1 through 5 (default = 2) |
| Volume setting of 1 | 55 decibels (minimum) |
| Volume setting of 5 | 85 decibels (maximum) |
Serial output, RS-232
Data output every 2 seconds; SpO2, pulse rate, alarm limit violation messages and displayed alarm/error messages 9600 B
1085
| A000 Daud | ||
|---|---|---|
| Full duplex | |
|---|---|
| Number of bits per character: | 8 |
| Parity | None |
| Bits | 1 start, 1 stop |
| Handshaking | CTS/RTS |
| Connector type | 9-pin standard D, female |
| Connector pin functions: | |
| 1 | chassis ground |
| 2 | receive data by the oximeter |
| 3 | transmit data from the oximeter |
| 5 | signal ground |
| 7 | RTS |
| 8 | CTS |
| Dimensions | |
| Height | 3.7 in (9.4 cm) |
| Width | 9.53 in (24.4 cm) |
| Depth | 8.86 in (22.5 cm) |
| Weight | 4.92 lbs (2.23 kg) |
4
- The Masimo MS-1P pulse oximeter with LNOP Adt sensors has been validated for no motion accuracy in The Mastino Mo-11 passe onthologic with Driver 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 MS-1P 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% SpOz 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.
Technological characteristics of the Masimo SET® MS-1P Pulse Oximeter compared to the Masimo SET® MS-1 Pulse Oximeter.
The technological characteristics of the Masimo SET® MS-IP Pulse Oximeter and the Masimo SET® MS-IP Pulse Oximeter both have the same or similar technological characteristics in design, materials, and energy source.
The design of both devices is the same in that both devices that monitor the functional oxygen saturation of arterial hemoglobin (SpO3) and pulse rate (measured by a SpO2 sensor) for adult, pediatric, and neonatal patients. The principles 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.
Masimo SET® MS-1P Pulse Oximeter operates under 120 VAC 60Hz while the Masimo SET® MS-1P Pulse Oximeter operates under 85 - 265 VAC 47-63 Hz. The Masimo SET® MS-IP Pulse Oximeter can also operate under 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.
5
Biocompatibility Testing
All patient contact materials were tested as Surface Devices with skin contact duration (>24 hr to 30 days) All patient of haberals not not lesse as Bartaco of Medical Devices - Part 1: Guidance on Selection of Tests. All patient as contacting material passed.
Nonclinical tests performed that support a determination of substantial equivalence.
The Masimo SET® MS-1P Pulse Oximeter and accessories was subjected to bench testing using a simulator that determined the nerformance accuracy of the instruments against the simulator under the range of saturation and pulse rates that both devices specify.
The results of the bench testing showed that both the Masimo SET® MS-1P 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 MS-1 P 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 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® MS-IP Pulse Oximeter saturation accuracy values within ± 2 digits during no motion conditions and ± 4 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.
Conclusions
The results of the environmetal testing demonstrated that the Masimo SET® MS-1P 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-10993-I: 1992 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests for Surface with skin contact for prolonged contact duration (>24 hr to 30 days).
The results of the bench testing demonstrates that the Masimo SET MS-1P Pulse Oximeter meets its performance requirements.
The results of the clinical testing demonstrates that the Masimo SET® MS-1P Pulse Oximeter and accessories meet its performance requirements during no motion and motion conditions.
The non-clinical and clinical testing performed demonstrates that the Masimo SET MS-IP Pulse Oximeter and accessories is safe, effective, and performs as well as the predicate device, the Masimo SET MS-IP Pulse Oximeter, and therefore, it is substantially equivalent to the Masimo SET® MS-1P Pulse Oximeter.
- ISSIMO CORPORATION .
6
Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 8 1998
Mr. James J. Cronin Masimo Corporation 2852 Kelvin Avenue Irvine, CA 92614-5826
Re: K973887 Masimo SET® MS-1P Pulse Oximeter and the LNOP® series of Sensors and Cables Regulatory Class: II (two) Product Code: 74 DQA October 10, 1997 Dated: Received: October 14, 1997
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 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 requlation 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 tor devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
7
Page 2 - 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Section 3 -- Indications for Use
510(k) Number (if known):
Device Name:
Masimo SET® MS-1P Pulse Oximeter and the LNOP® Series of Sensors and Cables
Indications For Use:
Masimo SET MS-1P Pulse Oximeter and the LNOP® Series of Sensors and PC Series of Patient Cables are indicated for the continuous noninyasive monitoring of arterial oxygen saturation (SyO-) and pulse rates during both no motion and patient motion conditions for adult, pediatric, and neonatal patients in a hospital and mobile environment.
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 greater than 2,000 gms
- A single use oximetry sensor intended for neonates less than 2,000 gms
- 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 SETT MS-1P Pulse Oximeter.
Contraindications For Use:
The Masimo SET MS-1 Pulse Oximeter and the LNOP Series of Sensors and PC Series of Patient Cables are contraindicated for use as apnea monitors.
The Masimo LNOP" Series of Disposable Sensors are contraindicated for patients that exhibit allergic reactions to addesive tape. The sensors must be removed and repositioned every eight (8) hours and if indicated by circulatory condition or skin integrity reapplied to a different monitoring site.
The Masimo LNOP Reusable sensor is contraindicated for use for prolonged periods of use. It is not intended for long-term monitoring. It must be removed and repositioned every 4 hours and if indicated by circulatory condition or skin integrity reapplied to a different monitoring site.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Joy Sapusten (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices | |||
|---|---|---|---|
| 510(k) Number | K973087 | ||
| Prescription Use | |||
| (Per 21 CFR 801.109) | or | Over-The-Counter Use | 0019 |
| (Optional Format 1-2-96) |
Section 3 Page 1
9
Section 3 - Indications for Use
510(k) Number (if known):
73887
WARNINGS
Explosion hazard. Do not use the Masimo SET MS-1P Pulse Oximeter in the presence of flammable anesthetics.
A pulse oximeter should NOT be used as an apnea monitor.
A pulse oximeter should be considered an early warning device. As a trend towards patient deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter to completely understand the patient's condition.
If an alarm condition occurs while the alarm silence period is set to off, only alarm indications will be visual displays and symbols related to the alarm condition.
The Masimo SET MS-1P Pulse Oximeter is to be operated by qualified personnel only.
Electric shock hazard. Covers to be removed only by technically qualified service personnel. There are no userserviceable parts.
To ensure patient electrical isolation, connect only to other equipment with electronically isolated circuits.
Do not connect to an electrical outlet controlled by a wall switch. Note:
As with all medical equipment, carefully route patient cabling to reduce the possibility of patient or strangulation.
Do not place the monitor or external power supply in any position that might cause it to fall on the patient. Do not lift the monitor by the power supply cord or patient cable, use only the handle on the monitor.
Do not use the Masimo SET MS-1P Pulse Oximeter or Masimo LNOP series of sensors during magnetic resonance imaging (MR) scanning. Induced current could potentially cause burns. The Masimo SET® MS-1 P Pulse Oxineter may affect the MRI image, and the MRI unit may affect the accuracy of the oximetry measurements.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
or
Over-The-Counter Use
0020
(Optional Format 1-2-96)