Masimo O3 Regional Oximeter System

K162603 · Masimo Corporation · MUD · May 26, 2017 · Cardiovascular

Device Facts

• Record ID: K162603
• Device Name: Masimo O3 Regional Oximeter System
• Applicant: Masimo Corporation
• Product Code: MUD · Cardiovascular
• Decision Date: May 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics > 5 kg and < 40 kg in healthcare environments.

Device Story

Noninvasive regional oximetry system; measures cerebral tissue hemoglobin oxygen saturation (rSO2). Inputs: near-infrared light signals collected via adhesive sensors (emitter and two detectors) applied to forehead. Processing: O3 Module uses multi-distance diffuse reflectance spectroscopy to analyze light absorption in microvasculature (arterioles, capillaries, venules); calculates oxygenated/deoxygenated hemoglobin concentrations. Outputs: rSO2, Delta Baseline (Δbase), Area Under the Limit (AUL) index, and Delta SpO2 (ΔSpO2) displayed on host/backboard monitor (e.g., Masimo Root). Used in healthcare environments by clinicians. Provides continuous monitoring to detect regional oxygenation changes; aids clinical decision-making regarding tissue perfusion/ischemia. Benefits: noninvasive, real-time assessment of cerebral oxygenation.

Clinical Evidence

Clinical study on 33 pediatric patients (ages <1 to 12 years). Absolute ARMS calculated by comparing rSO2 measurements against arterial and jugular blood draws. Trending ARMS derived via comparative study using O3 Large Sensor as reference. Results: Absolute ARMS 5% (for SavO2 45%-85%) and Trending ARMS 3% (for SavO2 45%-85%).

Technological Characteristics

Multi-distance diffuse reflectance spectroscopy; near-infrared light source; two detectors. Adhesive, single-patient use sensors (non-sterile). Biocompatible (ISO-10993). Powered by host/backboard (Root). MOC-9 interface. Dimensions: 2.6x1.1x0.1 inch (pediatric). Operating temp: 5°C to 40°C. Connectivity: wired to O3 Module, then to host monitor.

Indications for Use

Indicated for adults ≥ 40 kg and pediatrics > 5 kg and < 40 kg in healthcare environments as an adjunct monitor for absolute and trended cerebral regional hemoglobin oxygen saturation (rSO2).

Regulatory Classification

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.

Predicate Devices

• Masimo O3 Regional Oximeter System (K160526)
• Invos 5100C with Pediatric SomaSensor (K082327)

Reference Devices

• Masimo Root Monitoring System (K140188)
• Masimo Root Monitoring System (K151644)
• Masimo Root Monitoring System (K153225)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 26, 2017

Masimo Corporation Marguerite Thomlinson Sr. Director, Regulatory Affairs 52 Discovery Irvine, California 92618

Re: K162603

Trade/Device Name: Masimo O3 Regional Oximeter System Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: April 25, 2017 Received: April 26, 2017

Dear Marguerite Thomlinson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

William J. Heetderks -S 2017.05.26 11:06:05 -04'00'

Carlos L. Peña, Ph.D., M.S. for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K162603

Device Name

Masimo O3 Regional Oximeter System

#### Indications for Use (Describe)

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics > 5 kg and < 40 kg in healthcare environments.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"></span> <span style="font-size: 10pt;"><b> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</b></span> |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"></span> <span style="font-size: 10pt;"><b> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</b></span> |

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Image /page/3/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white line running through it, followed by the word "Masimo" in black, bold letters. To the right of the word "Masimo" are the words "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

| Submitter and Address of<br>Manufacturing Facility: | Masimo Corporation<br>52 Discovery<br>Irvine, CA 92618<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Date: | May 10, 2017 |
| Contact: | Marguerite Thomlinson<br>Senior Director, Regulatory Affairs |
| Trade Name: | Masimo O3 Regional Oximeter System |
| Common Name: | Oximeter, Tissue Saturation |
| Classification Regulation/<br>Product Code: | 21 CFR 870.2700, Class II/MUD |
| Establishment Registration<br>Number: | 2031172 |
| Reason for Premarket<br>Notification: | New Device - Masimo O3 Pediatric Sensor |
| Predicate Device: | K160526 – Masimo O3 Regional Oximeter System<br>K082327- Invos 5100C with Pediatric SomaSensor |
| Performance Standards | No performance standards for the above device have been<br>promulgated pursuant to Section 514. |

## Device Description

The Masimo Regional Oximetry System (O3 System) includes the O3 Sensors and the O3 Module. The O3 System measures hemoglobin under the sensor, allowing clinicians to continuously and accurately determine the absolute and trend measurements of regional blood oxygenation saturation in the tissue (rSO2). The O3 Sensors includes optical components that collect physiological signals. The O3 Module includes Masimo technology for processing those signals which resulted in regional oximetry (rSO2) measurements. In turn, these measurements are displayed on the Host/Backboard device.

The O3 Sensor is a single-patient use adhesive sensor and is supplied non-sterile. The O3 Sensor, comprising of an emitter and two detectors, is applied to the patient's forehead at one end. The other end of the sensor is connected to a patient cable which in turn is connected to

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Image /page/4/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the company name is the text "Masimo Corporation" and the address "52 Discovery, Irvine, CA 92618" in a smaller, gray font.

the 03 Module. Up to two 03 Sensors can be connected to each 03 Module and both sensors can be connected to a patient.

The O3 Module includes Near InfraRed Spectroscopy (NIRS) technology. The O3 Sensor uses multiple wavelengths in the range of near infrared wavelengths to measure light absorption in the tissue. The O3 Sensors and O3 Module make up the O3 System for the monitoring of absolute regional hemoglobin oxygen saturation of blood (rSO2) under the sensors. The O3 System does not have its own power. The O3 Module is powered by connecting to a Host/Backboard Device such as the Root Monitoring System (Root in turn is powered by either AC power or internal rechargeable batteries.

The O3 System provides the following key measurements:

- Regional Oxygenation (rSO2): Regional tissue oxygenation level in the deep tissue ● local to the sensor site, including cerebral tissue
- Delta Baseline (Abase): Relative difference in rSO2 with respect to baseline rSO2 ●
- Area Under the Limit (AUL index): Index that quantifies the duration (amount of time the patient stays below rSO2 low alarm limit) and depth (refers to the gap between the patient's rSO2 level and the rSO2 low alarm limit) of patient's stay below the user-defined rSO2 low alarm limit (LAL)
- Delta SpO2 (ΔSpO2): The difference between SpO2 and rSO2. The source of SpO2 . is from peripheral SpO2 measurement (using pulse oximeter).

| O3 System Specifications | |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| FEATURE | SPECIFICATION |
| Display | |
| Display Range | Regional Oxygen Saturation (rSO2): 0-99%<br>Δbase: 0-99%<br>(Δbase is the difference between regional and baseline rSO2) |
| Display Resolution for Measurements | rSO2: 1%<br>Δbase: 1% |
| rSO2 Measurement Accuracy, Adults ≥ 40kg | Absolute ARMS, 4% for SavO2 of 45%-85%<br>Trending ARMS, 3% for SavO2 of 45%-85% |
| SO2 Measurement Accuracy,<br>Pediatrics ≥ 5 kg and < 40 kg | Absolute ARMS, 5% for SavO2 of 45%-85%<br>Trending ARMS, 3% for SavO2 of 45%-85% |
| General | |
| Visual/audible alarm | Host/backboard device (Root per K140188, K151644 and<br>K153225) is IEC60601-1-8 compliant |
| Storage/recording | Host/backboard device (Root per K140188, K151644 and<br>K153225) trend/data storage |

See the table below for the O3 System specifications.

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Image /page/5/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white line running through it, followed by the word "Masimo" in black, bold letters. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

| O3 System Specifications | |
|---------------------------------------------------|----------------------------------------------------------------------------------------------|
| FEATURE | SPECIFICATION |
| Electrical | |
| AC Power or<br>Battery, Rechargeable<br>Interface | Host/backboard device (Root per K140188, K151644 and<br>K153225) provides power to O3 System |
| O3 Module Connection | MOC-9 interface with host/backboard device (Root per<br>K140188, K151644 and K153225) |
| Mechanical | |
| O3 Module: Dimensions/Weight | 5x1.8x0.6 inch/ 7 oz |
| O3 Large Sensor: Dimensions/Weight | 2.9x1.5x0.1 inch/0.20 oz. |
| O3 Pediatric Sensor: Dimensions/Weight | 2.6x1.1x0.1 inch/0.18 oz. |
| Environmental | |
| O3 Module | |
| • Operating Temperature | 0°C to +40°C, ambient humidity |
| • Storage Temperature | -40°C to +70°C, ambient humidity |
| • Operating/ Storage Humidity | 10% to 95%, non-condensing |
| • Altitude | Up to 12,000 feet (3700 meters) |
| O3 Large Sensor and O3 Pediatric Sensor | |
| • Operating Temperature | +5°C to +40°C |
| • Storage Temperature | -40°C to +60°C |
| • Humidity | 15% to 90% relative humidity |

## Intended Use

The O3 System, consisting of the O3 Sensors and O3 Module, is intended for noninvasive monitoring of absolute regional oxygen saturation. The computed saturation values are displayed on a host/backboard monitor such as the Masimo Root System (K140188, K151644 and K153225). The O3 System is intended to be used in healthcare environments.

## Indications For Use

The noninvasive Masimo O3 Regional Oximeter System and accessories are intended for use as an adjunct monitor of absolute and trended regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors. The Masimo O3 Regional Oximeter System and accessories are indicated for use on adults ≥ 40 kg and on pediatrics > 5 kg and < 40 kg in healthcare environments.

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Image /page/6/Picture/0 description: The image shows the Masimo Corporation logo. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

## Technological Characteristics

### Principle of Operation

The O3 System's operating principle is based on multi-distance diffuse reflectance spectroscopy. The O3 System use light to examine a cross-section tissue microvasculature (a mixed bed of arterioles, capillaries and venules) and analyzes the light returned after having passed through the tissues. The spectroscopic analysis determines concentrations of hemoglobin in its oxygenated and deoxygenated states.

### Mechanism of Action for Achieving the Intended Effect

The O3 Sensor is noninvasively applied to the patient on one end. The other end of the O3 Sensor connects to the O3 Module. In turn, the O3 Module connects to a Host/Backboard device. The 03 Sensor collects patient physiological signals which are processed by the O3 Module. The processed signals which resulted in rSO2 measurements are displayed on the Host/Backboard device.

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Image /page/7/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the word "Masimo" is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

# Summary of Technological Characteristics of Subject Device Compared to Predicate Device

| | | Table 12.5 | |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE | Masimo O3 Regional Oximeter System<br>(with O3 Pediatric Sensor) | Masimo O3 Regional Oximeter System<br>(with O3 Large Sensor) | Somanetics Invos System<br>(with Pediatric SomaSensor) |
| 510(k) Number | Pending | Predicate: K160526 | Predicate: K082327 |
| General Information | | | |
| Indications for Use (IFU) | The noninvasive Masimo O3 Regional<br>Oximeter System and accessories are intended<br>for use as an adjunct monitor of absolute and<br>trended regional hemoglobin oxygen<br>saturation of blood (rSO2) in the cerebral<br>region under the sensors. The Masimo O3<br>Regional Oximeter System and accessories are<br>indicated for use on adults ≥ 40 kg and on<br>pediatrics ≥ 5 kg and < 40 kg in healthcare<br>environments. | The noninvasive Masimo O3 Regional<br>Oximeter System and accessories are intended<br>for use as an adjunct monitor of absolute and<br>trended regional hemoglobin oxygen<br>saturation of blood (rSO2) in the cerebral<br>region under the sensors. The Masimo O3<br>Regional Oximeter System and accessories are<br>indicated for use on adults ≥ 40 kg in<br>healthcare environments. | The noninvasive INVOS 5100C is intended for use<br>as an adjunct monitor of regional hemoglobin<br>oxygen saturation of blood in the brain or in other<br>tissue beneath the sensor. It is intended for use in<br>individuals greater than 2.5 kg risk for reduced-flow<br>or no-flow ischemic states.<br>It is also intended for use as an adjunct trend<br>monitor of regional hemoglobin oxygen saturation<br>of blood in the brain or in other tissue beneath the<br>sensor in any individual. The clinical value of trend<br>data has not been demonstrated in disease states.<br>The INVOS System should not be used as the sole<br>basis for diagnosis or therapy. |
| Classification Regulation/<br>Product Code | Same as K160526 and K082327 | 21 CFR 870.2700/ MUD | 21 CFR 870.2700/ MUD |
| Principle of Operation | Same as K160526 | The O3 System operating principle is based on<br>multi-distance diffuse reflectance<br>spectroscopy. The device uses light to<br>examine a cross-section tissue<br>microvasculature (a mixed bed of arterioles,<br>capillaries and venules) and analyzes the light<br>returned after having passed through the<br>tissue. The spectroscopic analysis determines<br>concentrations of hemoglobin in its<br>oxygenated and deoxygenated states. | The Invos 5100C is a 2 wavelength, diffuse<br>reflectance spectroscopy system employing near<br>infrared light to estimate the percentage of<br>hemoglobin saturated with oxygen in tissue<br>underneath the sensor. An adhesive sensor<br>containing a light source and 2 photodiodes is<br>applied to the skin over the tissue of interest and the<br>returning light is analyzed for oxyhemoglobin and<br>deoxyhemoglobin light absorption. Absorption<br>signals from the photodiode closer to the light |

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Image /page/8/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold font. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

| | | Table 12.5 | |
|-----------------------|---------------------------------------------------------------|---------------------------------------|-----------------------------------------------------------------|
| | Masimo O3 Regional Oximeter System | Masimo O3 Regional Oximeter System | Somanetics Invos System |
| FEATURE | (with O3 Pediatric Sensor) | (with O3 Large Sensor) | (with Pediatric SomaSensor) |
| 510(k) Number | Pending | Predicate: K160526 | Predicate: K082327 |
| | | | source are subtracted from those from the farther |
| | | | photodiode where the returning photons penetrate |
| | | | more deeply in the tissue. |
| Patient Population | Adults $\u2265$ 40 kg<br>Pediatrics $\u2265$ 5 kg and < 40 kg | Adults > 40 kg | Pediatrics < 40 kg |
| Measurement Site | Same as K160526 and K082327 | Cerebral region, forehead | Cerebral region, forehead |
| Type of Use | Same as K160526 and K082327 | Single patient use | Single patient use |
| Sterility | Same as K160526 and K082327 | Supplied non-sterile | Supplied non-sterile |
| Accuracy (ARMS) * | | | |
| Absolute Accuracy | 5% for SavO2 of 45%-85% | 4% for SavO2 of 45%-85% | N/A |
| Trending Accuracy | 3% for SavO2 of 45%-85% | 3% for SavO2 of 45%-85% | 1.6% SaO2 of 74%-100% (per K082327 SaO2 range<br>is for adults) |
| Dimensions | | | |
| System Compatibility | | | |
| Monitoring System | Same as K160526 | Root Monitoring System with O3 Module | Invos System |
| Biocompatibility | | | |
| Materials | Same as K160526 and K082327 | Biocompatible, ISO-10993 compliant | Biocompatible, ISO-10993 compliant |
| Mechanical | | | |
| Overall Dimension | 2.6x1.1x0.1 inch | 2.9x1.5x0.1 inch | 3.0x1.5x0.1 inch |
| Weight | 0.18 oz | 0.20 oz | 0.2 oz |
| Environmental | | | |
| Operating Temperature | Same as K160526 | 5°C to 40°C | 16°C to 32°C |
| Storage Temperature | Same as K160526 | -40°C to 60°C | -20°C to 45°C |
| Humidity | Same as K160526 | 15% to 90% non-condensing | 20% to 80%, non-condensing |

^* AMS accuracy is a statistical calculation of the difference between device measurements. Approximately wo-thirds of the device measurements fell within +/- ARMs of the reference measurements in a controlled study.

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Image /page/9/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in a bold, sans-serif font. To the right of the logo is the text "Masimo Corporation" in a smaller, lighter font, followed by the address "52 Discovery, Irvine, CA 92618".

## Non-clinical Testing

The following tests, as applicable, were performed for the qualification of the subject devices, O3 System, in accordance with the requirements of the design control regulations and established quality assurance processes to demonstrate substantial equivalence with the predicate device:

- Electrical safety testing per IEC-60601-1 ●
- EMC testing per IEC-60601-1-2 ●
- Alarm testing per IEC-60601-1-8
- Optical safety testing per IEC-62471 ●
- Biocompatibility testing per ISO-10993
- . Usability testing per FDA Human Factors and Usability Draft Guidance
- Software verification per FDA Software Guidance ●
- Mechanical and environmental testing ●

The results demonstrate that all requirements and performance specifications were satisfied, and that the subject device is substantially equivalent to the predicate device.

## Clinical Testing

In the study for Absolute ARMS, rSO2 measurements were collected using the O3 System, including the O3 Module (K160526) and O3 Pediatric Sensor, on 33 male and female pediatric patients with ages ranging from less than one year to 12 years. Blood draws (arterial and jugular blood) were taken for each subject before and after his/her medical procedure. The rSO2 measurements were analyzed against blood draw measurements and the Absolute ARMs were calculated in the same manner as in K160526.

As the O3 Large Sensor trending accuracy was established with blood reference via K160526, the O3 Large Sensor was used as a reference in the comparative trending study with the O3 Pediatric Sensor. The rSO2 data was collected for both O3 Large Sensor and O3 Pediatric Sensor. The relative rSO2 value between the O3 Large Sensor and O3 Pediatric Sensor was then calculated. The Trending ARMs for the O3 Pediatric Sensor was derived by taking the relative error between the O3 Large Sensor and O3 Pediatric Sensor into account.

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Image /page/10/Picture/0 description: The image shows the logo for Masimo Corporation. The logo consists of a red circle with a white checkmark inside, followed by the word "Masimo" in black, bold letters. To the right of the logo is the text "MASIMO CORPORATION" in gray, followed by the address "52 Discovery, Irvine, CA 92618" also in gray.

# Conclusion

The clinical evaluation, non-clinical testing including safety testing, as included in this 510(k) submission, demonstrate that the subject device, O3 Pediatric Sensor, is substantially equivalent to its predicate with respect to safety and effectiveness.