(194 days)
The Serenity RIP and Serenity Body Position Sensors are intended to measure and output respiratory effort signals and body position, respectively, from a patient for archival in a polysomnography study. The sensors are accessories to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders.
The Serenity RIP and Serenity Body Position Sensors are intended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional.
The Serenity RIP and Serenity Body Position Sensors are not intended for the life monitoring of high risk patients, do not include or trigger alarms, and are not intended to be used as a critical component of:
- an alarm or alarm system;
- · an apnea monitor or apnea monitoring system; or
- · life monitor or life monitoring system.
Serenity sleep sensors are intended to measure and output physiologic signals used for Polysomnography (PSG) or Sleep Studies. These devices are to be used as an accessory to compatible amplifiers.
Typical sleep studies use sensors and electrodes to collect, digitize, and send physiological signals to a host PC.
Serenity sleep sensors are worn by the patient and connected directly to compatible inputs of an amplifier. The amplifier and related software then processes the signal for review by qualified practitioners to score polysomnograms and diagnose Sleep Disorders
The Serenity Body Position uses a 3-axis accelerometer to track the patient's body orientation; outputting a voltage which corresponds to one of 5 positions (sitting/upright, supine, prone, left-side, and rightside).
The Serenity RIP Sensor uses respiratory inductance plethysmography to output a waveform which corresponds to patient's respiratory effort. The patient wears an adjustable elastic belt which connects to the RIP driver, the RIP driver then connects to the host device. The Serenity RIP sensor is available for both thorax and abdomen. Thorax and abdomen versions are identical, except that they operate at different frequencies to avoid interference.
The provided text, K173868, details the 510(k) premarket notification for the Serenity Body Position Sensor and Serenity RIP Sensors. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for an AI-powered device. Therefore, a comprehensive answer to your request, particularly regarding AI-specific criteria, human reader improvement with AI assistance, and detailed ground truth establishment, cannot be fully extracted from this document as the device in question is a sensor, not an AI algorithm.
However, based on the information provided for the sensors, here's a breakdown of what can be inferred:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide acceptance criteria and reported performance in terms of clinical accuracy or diagnostic capabilities for the sensors themselves in a traditional table format with quantitative metrics. Instead, it demonstrates compliance with safety and performance standards and comparative performance to predicate devices.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety and Essential Performance | Compliance with IEC 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance) concerning: - Humidity Preconditioning - Determination of Applied Part and Accessible Parts - Legibility of Marking - Durability of Marking - Patient Leakage Current - Dielectric Voltage Withstand - Resistance to Heat - Excessive Temperature - Ingress of Liquids (IEC 60529) - Cleaning, Disinfection and Sterilization of ME Equipment and ME Systems - Enclosure Mechanical Strength (Push, Impact, Drop Test Hand-Held ME Equipment) - Mold Stress Relief | "All samples passed the acceptance criteria." (for both Serenity Body Position Sensor and Serenity RIP Sensor). The document notes that predicate devices were not found to publish testing to a basic safety standard. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility) concerning: - Radiated Emissions (CISPR11 ed5.0) - Electro-Static Discharge Immunity Test (IEC 61000-4-2 ed2.0) - Conducted, Radio-Frequency, Electromagnetic Immunity Test (IEC 61000-4-6 ed2.0) - Power Frequency Magnetic Field Immunity Test (IEC 61000-4-8 ed2.0) | "All samples passed the acceptance criteria." (for both Serenity Body Position Sensor and Serenity RIP Sensor). The document notes that predicate devices were not found to publish testing for electromagnetic compatibility. |
| Body Position Sensor Specific | The Serenity Body Position sensor is expected to accurately detect and output signals corresponding to 5 positions: Right Side, Left Side, Supine, Prone, and Upright (Sitting). It should also meet specified performance for: - Position test - Dielectric strength - Transition and Hysteresis - Output Impedance - Operational Battery Life Calculation - Dimensional Analysis - Output Noise - Connector Tests - Strap Fasten/Unfasten Cycle - Wire Construction Test - Operational Battery Voltage Range Test | "All samples passed the acceptance criteria." The document notes that predicate devices were not found to publish testing details. Comparative testing showed "equivalent performance of the Serenity sensors and the reference devices, using the same host system configurations." |
| RIP Sensor Specific | The Serenity RIP sensor is expected to accurately detect and output a waveform corresponding to respiratory effort. It should demonstrate performance equivalent to the predicate device in detecting respiratory effort from chest or abdomen movement. | Comparative testing showed "equivalent performance of the Serenity sensors and the reference devices, using the same host system configurations." |
| Predicate Comparison | The Serenity Body Position Sensor and Serenity RIP Sensors should demonstrate substantial equivalence to identified predicate devices (Braebon Ultima Body Position Sensor and Ambu RIPmate for technical characteristics, and Neurotronics Polysmith Sleep System/Nomad Sleep System for overall intended use and integration as accessories). This implies similar physical, electrical, and environmental designs, and no new questions of safety or effectiveness. | The document concludes: "Based on the results of the Intended Use Comparison, the Technical Comparison, and Testing Data, it is believed that the Serenity Body Position Sensor and Serenity RIP Sensors present no new questions of safety and effectiveness and, are substantially equivalent to the identified predicate. Both sensors have similar physical, electrical, and environmental designs. Both share the same intended use." |
| Biocompatibility | No toxic or irritating effects from patient contact. | "Not Applicable" for the regulatory submission, implying the materials are standard and well-understood for patient contact, or fall under a category where specific biocompatibility testing for this 510(k) was not deemed necessary for substantial equivalence given the context of a sensor accessory. The document notes that predicate devices were not found to publish biocompatibility information. |
| Sterility | If applicable, the device should meet sterility requirements. | "Not applicable." The document notes that predicate devices were not found to publish sterility information. |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: The document mentions "All samples passed the acceptance criteria" for the safety, EMC, and specific sensor verification tests. However, it does not specify the exact number of samples (devices) used for these tests. It's common for these types of engineering verification tests to use a small, representative sample size (e.g., 3-10 units) rather than large clinical trial numbers.
- Data Provenance: The tests appear to be retrospective engineering verification and validation tests conducted by the manufacturer, Neurotronics, Inc. The document does not specify the country of origin for the data or testing other than being performed by the applicant (Neurotronics, Inc.) located in Gainesville, Florida, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable/provided in the context of this 510(k) submission. This submission is for physical sensors that measure physiological signals (body position and respiratory effort) for archival in a polysomnography study. It is not an AI algorithm that performs an "analysis" or "diagnosis" by itself requiring expert consensus on ground truth for an AI test set. The sensors output raw signals, which are then analyzed by a "qualified sleep clinician." The expertise required is in the manufacturing and testing of medical devices to relevant standards, and the comparison is largely on technical specifications and intended use.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable/provided. Adjudication methods are typically used in clinical studies where multiple human readers interpret medical images or data and their interpretations need to be reconciled to establish a ground truth or resolve discrepancies, particularly for AI algorithm validation. This document describes engineering and performance verification of physical sensors, not a clinical study involving human interpretation consensus.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs. without AI assistance:
This is not applicable/provided. The device is a sensor, not an AI algorithm. Therefore, an MRMC study assessing human reader improvement with AI assistance is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable/provided. The device is a sensor, not an algorithm, and its output is explicitly stated to be "for archival in a polysomnography study" and for analysis "by a qualified sleep clinician." It is not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the sensor performance tests, the "ground truth" is established by engineering measurements and compliance with specified physical and electrical parameters and industry standards. For comparative performance, the ground truth is simply the measured output of both the new device and the predicate device when subjected to the same inputs/conditions, demonstrating "equivalent performance." There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for the sensor's direct output. The interpretation of the sensor data by a sleep clinician in a PSG study implicitly relies on established clinical ground truth for sleep disorders, but this is downstream from the sensor itself.
8. The sample size for the training set:
This is not applicable/provided. This device is a physical sensor, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
This is not applicable/provided, as no training set for an AI algorithm is involved.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 2, 2018
Neurotronics, Inc. David Pezet Quality Manager 4500 NW 27th Ave, Suite C2 Gainesville, Florida 32606
Re: K173868
Trade/Device Name: Serenity Body Position Sensor and Serenity RIP Sensors Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLV Dated: June 5, 2018 Received: June 8, 2018
Dear David Pezet:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay R. Gupta -S
For Carlos L. Peña, PhD, MS 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) K173868
Device Name
Serenity Body Position Sensor and Serenity RIP Sensors
Indications for Use (Describe)
The Serenity RIP and Serenity Body Position Sensors are intended to measure and output respiratory effort signals and body position, respectively, from a patient for archival in a polysomnography study. The sensors are accessories to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders.
The Serenity RIP and Serenity Body Position Sensors are intended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional.
The Serenity RIP and Serenity Body Position Sensors are not intended for the life monitoring of high risk patients, do not include or trigger alarms, and are not intended to be used as a critical component of:
- an alarm or alarm system;
- · an apnea monitor or apnea monitoring system; or
- · life monitor or life monitoring system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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5 510(k) Summary
5.1 Summary Date:
June 5, 2018
5.2 510K SUBMITTER:
| Neurotronics, Inc. | Phone: | 352.372.9955 | |
|---|---|---|---|
| 4500 NW 27TH AVE STE C2Gainesville, FL 32606 | Fax: | 815.550.2871 | |
| Name:Email: | David Pezetquality@neurotronics.com | Title:Phone: | Quality Manage352.372.9955 |
5.2.2 Establishment Registration Number: 1063925
5.3 DEVICE TYPE (COMMON NAME):
Body Position Sensor Respiratory Inductance Plethysmography (RIP) Sensor
5.4 PROPRIETARY NAME OF THE DEVICE:
Serenity Body Position Sensor and Serenity RIP Sensors
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5.5 CLASSIFICATION:
5.5.1 Product Code
It is recommended the Serenity Body Position Sensor and Serenity RIP Sensor be classified as a Class II device by the Neurology Panel under 21 CFR Part 882.1400 "Neurological Diagnostic Devices", product code OLV "Standard Polysomnograph With Electroencephalograph".
Serenity Body Position Sensor
| Product Code | Device | Regulation Description | RegulationNumber |
|---|---|---|---|
| OLV | Standard PolysomnographWith Electroencephalograph | Electroencephalograph | 882.1400 |
Serenity RIP Sensor
| ProductCode | Device | Regulation Description | RegulationNumber |
|---|---|---|---|
| OLV | Standard PolysomnographWith Electroencephalograph | Electroencephalograph | 882.1400 |
5.5.2 Predicate Device
| Submitter/Holder | Device Name | Regulation | Classification(s) | 510(K) |
|---|---|---|---|---|
| Neurotronics, Inc. | Polysmith Sleep System | 882.1400 | OLV, OLZ, DQA | K142774 |
Reference Devices
| Submitter/Holder | Device Name | Regulation | ProductCodes | 510(K) |
|---|---|---|---|---|
| Neurotronics, Inc. | Nomad Sleep SystemRecorder, Model PMU800 | 882.1835 | GWL, DQA,MNR | K092699 |
| Braebon Medical Corp. | Ultima Body PositionSensor | 882.5050 | LEL | K981969 |
| Ambu A/S | RIPmate; SleepmateRespiratory Effort Sensor | 868.2375 | BZQ | K903300 |
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5.6 DESCRIPTION
Serenity sleep sensors are intended to measure and output physiologic signals used for Polysomnography (PSG) or Sleep Studies. These devices are to be used as an accessory to compatible amplifiers.
Typical sleep studies use sensors and electrodes to collect, digitize, and send physiological signals to a host PC.
Serenity sleep sensors are worn by the patient and connected directly to compatible inputs of an amplifier. The amplifier and related software then processes the signal for review by qualified practitioners to score polysomnograms and diagnose Sleep Disorders
Image /page/5/Figure/4 description: The image is a block diagram of a basic sleep study setup. It shows the patient area with a patient connected to patient sensors. The sensors are connected to an amplifier, which is also connected to external auxiliary devices and a PC. The PC is connected to audio/video equipment and a sleep clinician.
The Serenity Body Position uses a 3-axis accelerometer to track the patient's body orientation; outputting a voltage which corresponds to one of 5 positions (sitting/upright, supine, prone, left-side, and rightside).
Image /page/5/Picture/6 description: The image shows a wearable device, possibly a health tracker or sensor, attached to a black strap. The device has a white casing with a logo or design on top. The strap appears to be made of a soft, flexible material, suggesting it is designed for comfortable wear against the skin. The device is likely used for monitoring physiological data or activity levels.
The Serenity RIP Sensor uses respiratory inductance plethysmography to output a waveform which corresponds to patient's respiratory effort. The patient wears an adjustable elastic belt which connects to the RIP driver, the RIP driver then connects to the host device. The Serenity RIP sensor is available for both thorax and abdomen. Thorax and abdomen versions are identical, except that they operate at different frequencies to avoid interference.
Image /page/5/Picture/8 description: The image shows two different medical devices. The first device is a gray, rounded device with two wires coming out of it. The device has a screen that shows a person's abdomen with the letters "ABD" below it. The second device is a black belt with a buckle.
5.7 INTENDED USE
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The Serenity RIP and Body Position Sensors are intended to measure and output respiratory effort signals and body position, respectively, from a patient for archival in a polysomnography study. The sensors are accessories to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders.
The Serenity RIP and Body Position Sensors are intended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional.
The Serenity RIP and Body Position Sensors are not intended for the life monitoring of high risk patients, do not include or trigger alarms, and are not intended to be used as a critical component of,
- an alarm or alarm system:
- · an apnea monitor or apnea monitoring system; or
- · life monitor or life monitoring system.
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5.8 PREDICATE COMPARISON
5.8.1 Intended Use Comparison
K142774 Neurotronics, Inc. Polysmith Sleep System Intended Use (includes Sphinx PMU710)
"The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a sleep study. The physiological signals are recorded and conditioned for analysis and display. The data may be analyzed in real-time or offline on dedicated polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of sleep disorders.
The device is intended for use by healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under direct supervision of a medical professional.
The device is intended for use on both adults and children only under the direction of a physician or qualified sleep technician.
The device, or any accessory, does not include alarms, and is not intended to be used as a critical component of an alarm system.
The device, or any accessorv, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.
The device, or any accessory, is not to be used alone as a life support device or as a critical component of a life support system."
Neurotronics Serenity Body Position and RIP Sensor Intended Use Comparison Discussion
The intended use of the Serenity Body Position and Serenity RIP Sensors does not conflict with the intended use of the primary predicate, the device type which it is intended to be an accessory to. Both are intended to be used for archival of a sleep study. for use with adults and children, do not include alarms or are intended to be used as a critical component of an alarm system, not to be used as an apnea monitor or as a component in an apnea monitoring system, and not to be used as a life support device or a critical component of a life support system.
Although the Sphinx is intended to be used within a medical facility, or outside a medical facility under direct supervision of a medical professional, the Serenity sensors are intended to be used within or outside a medical facility at the direction of a medical professional. The limitation of direct supervision by the Polysmith Sleep System is due to the amplifier and not because of the sensors: the Nomad PMU800 is also included as a reference device.
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K092699 Neurotronics, Inc. Nomad Sleep System Recorder, Model PMU800 Intended Use Comparison
"The Nomad device is a digital amplifier capable of measuring bio-potential signals that may be incorporated into a Polysomnogram.
The device is intended to measure, amplify, and record physiological signals acquired from a patient for archival in a Sleep Study, such as Limb Movement. Respiration Effort, and SpO2.
The data may be analyzed on dedicated Polysomnography software running on a personal computer by a qualified sleep clinician to aid in the diagnosis of Sleep Disorders.
This device, or any associated accessories, is not to be used alone as an apnea monitor or as a component in an apnea monitoring system.
This device, or anv associated accessories, is not to be used as a life support device or as a critical component of a life support system.
The device is not sterile."
Neurotronics Serenity Body Position and RIP Sensor Intended Use Comparison Discussion
The intended use of the Serenity Body Position and Serenity RIP Sensors does not conflict with the intended use of the reference device Nomad PMU800, also a device type which it is intended to be an accessory to. Both are intended to be used for archival of a sleep study, not to be used as an apnea monitor or as a component in an apnea monitoring system, not to be used as a life support device or a critical component of a life support system, and is not sterile.
The Nomad PMU800 is also intended to be used in or outside a medical facility at the direction of a medical professional, this is consistent with the intended use of the Serenity Body Position Sensor and Serenity RIP Sensor. Although the Nomad Indications for Use statement does not include body position, or use for children or adults, these are described in the 510k summary for K092699.
K981969 Braebon Medical Corporation Ultima Body Position Sensor Intended Use
"The Braebon Medical Corporation Ultima Body Position Sensor is intended for use during sleep disorder studies as an indicator of body position. The sensor uses a threevolt lithium battery and plugs directly into either a DC amplifier or multiplexer.
The target population of the Ultima Body Position Sensor is all children and adult patients who are screened during sleep disorder studies. The majority of the screening occur at a sleep laboratory although the sensor can also be used in home studies.
The Ultima Body Position Sensor is intended for use only by or on the order of a physician. "
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Neurotronics Serenity Body Position Sensor Intended Use Comparison Discussion
The Serenity Body Position Sensor intended use is identical to the Ultima Body Position Sensor. It is also intended to be used to indicate body position during sleep disorder studies. The target population is also both children and adults. The study environment also includes both sleep laboratories and the home. Both the Ultima Body Position Sensor and the Serenity Body Position Sensor are intended for use only by or under the order of a physician.
K903300 Ambu RIPmate; Sleepmate Respiratory Effort Sensor Intended Use
"The Ambu Sleepmate respiratory effort sensor is intended to detect respiratory effort from chest or abdomen movement during sleep research and clinical studies of sleep. This Belt is intended for use in supervised medical settings."
Neurotronics Serenity RIP Sensor Intended Use Comparison Discussion
The Serenity RIP Sensor share the same intended use as the Ambu RIPmate. Both are intended to detect respiratory effort of the chest or abdomen during sleep in a supervised medical setting. The Serenity RIP Sensor additionally, is intended for use outside of a medical setting under the direction of a medical professional.
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5.8.2 Technical Comparison
The Neurotronics Serenity Body Position Sensor and Serenity RIP Sensor share similar design form and characteristics. Of the differences, none are considered to effect intended use or safety and effectiveness.
| Body Position Sensor Comparison | Braebon Ultima BodyPosition Sensor | Neurotronics SerenityBody Position Sensor | |
|---|---|---|---|
| Image: [body position sensor comparison] | Image: [Braebon Ultima Body Position Sensor] | Image: [Neurotronics Serenity Body Position Sensor] | |
| PhysicalProperties | Battery | 3V Lithium | 3V Lithium |
| Battery Life | ~2 years | > 2 years | |
| EnvironmentalSpecifications | OperatingTemperature | 41°F - 90°F(5°C-32°C) | 50°F - 104°F(10°C - 40°C) |
| OperatingRelativeHumidity | 10% to 95% RH non-condensing | 0 to 93% RH non-condensing | |
| StorageTemperature | 32°F to 140°F(0°C to 60°C) | -4°F to 140°F(-20°C to 60°C) | |
| Storage RelativeHumidity | 10%-95% RH non-condensing | 0 - 93% RH non-condensing | |
| Pressure | Not Specified | 70.0 kPa to 106 kPa | |
| OutputSpecifications | Output Signal | 0 V to 1 V (± 0.1 V) | 0 V to 0.78 V (± 10%) |
| PositionsDetected | Right SideLeft SideSupineProneUpright (Sitting) | Right SideLeft SideSupineProneSitting (Upright) |
Body Position Sensor Comparison
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RIP Sensor Comparison
| RIP Sensor Comparison | Ambu RIPmate | Neurotronics SerenityRIP Sensor | |
|---|---|---|---|
| Image | |||
| Belt Length | Adjustable24"to 79"(60 cm to 200 cm) | AdjustableSmall 15" to 27"(38.1 cm to 68.58 cm)Medium 21" to 45"(53.34 cm to 114.3 cm)Large 32" to 78"(81.28 cm to 198.12 cm) | |
| Belt Material | Elastic Band withInsulated wire | Elastic Band withInsulated wire | |
| Cable Length | 2.05 m | 0.6m ± 2 cmor2.0m ± 5 cm | |
| Cable Material | PVC jacketed; ZIP-stylecord | PVC jacketed; ZIP-stylecord | |
| Module | Box: ABSCable: PVC jacketed;ZIP-style cord | Box: ABSCable: PVC jacketed;ZIP-style cord | |
| Battery | 3V Lithium | 3V Lithium | |
| Battery Life | Estimated 3000 hours | > 3000 hours | |
| OperatingTemperature | 40°F - 120°F(5°C-50°C) | 50°F - 104°F(10°C - 40°C) | |
| Operating RelativeHumidity | 15%-95%RH non-condensing | 0 - 93% RH non-condensing | |
| EnvironmentalSpecifications | StorageTemperature | 0°F-120°F(-20°C-50°C) | -4°F - 140°F(-20°C - 60°C) |
| Storage RelativeHumidity | 10%-95% RH non-condensing | 0 - 93% RH non-condensing | |
| Pressure | 50.33 kPa – 199.48 kPa | 70.0 kPa - 106 kPa | |
| OutputSpecifications | Output Signal | Maximum: ±5mV | Maximum: NotSpecified.Nominal: ~ ±1mv |
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5.8.3 Performance Data
5.8.4 Testing Data
Each referenced document identifies the methodology, criteria, and results for assessing performance and safety characteristics of the applicable device in compliance with Neurotronics design control processes. See section 11.6 Verification for testing related information. Neither the Braebon Ultima Body Position Sensor or the Ambu RIPmate are found to publish testing to a standard. The design for both the Neurotronics Serenity Body Position Sensor and the Neurotronics Serenity RIP Sensor are tested to 60601-1 C1:2009/(R)2012 And A2:2010/(R)2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
| Test | Test Method Summary | Results |
|---|---|---|
| 60601-1 Medical ElectricalEquipment - Part 1:General Requirements forBasic Safety and EssentialPerformance | Humidity PreconditioningDetermination of Applied Partand Accessible PartsLegibility of MarkingDurability of MarkingPatient Leakage CurrentDielectric Voltage WithstandResistance to HeatExcessive TemperatureIngress of Liquids – IEC 60529Cleaning, Disinfection andSterilization of ME Equipmentand ME SystemsEnclosure Mechanical StrengthPushImpactDrop Test Hand-Held MEEquipmentMold Stress Relief | All samples passed theacceptance criteria.Neither the Braebon UltimaBody Position Sensor or theAmbu RIPmate were found topublish testing to a basicsafety standard. |
| IEC 60601-1-2 MedicalElectrical Equipment - Part1-2: General Requirementsfor Safety - CollateralStandard: ElectromagneticCompatibility | Radiated Emissions CISPR11ed5.0 (with A1:2010)Electro-Static DischargeImmunity Test IEC 61000-4-2ed2.0 (2008-12)Conducted, Radio-Frequency,Electromagnetic Immunity TestIEC 61000-4-6 ed2.0 (withA1:2004+A2:2006)Power Frequency MagneticField Immunity Test IEC 61000-4-8 ed2.0 (2009-09) | All samples passed theacceptance criteria.Neither the Braebon UltimaBody Position Sensor or theAmbu RIPmate were found topublish testingelectromagnetic compatibility. |
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| Body Position SensorVerification | Position testDielectric strengthTransition and HysteresisOutput ImpedanceOperational Battery LifeCalculationDimensional AnalysisOutput NoiseConnector TestsStrap Fasten/Unfasten CycleWire Construction TestOperational Battery VoltageRange Test | All samples passed theacceptance criteria.Neither the Braebon UltimaBody Position Sensor or theAmbu RIPmate were found topublish testing details. |
|---|---|---|
| Reference DeviceComparison | Body Position SensorReference Comparison TestRIP Sensor Reference DeviceComparison | Comparison testing showsequivalent performance of theSerenity sensors and thereference devices, using thesame host systemconfigurations.Neither the Braebon UltimaBody Position Sensor or theAmbu RIPmate were found topublish comparisoninformation. |
| Biocompatibility | Not Applicable | Neither the Braebon UltimaBody Position Sensor or theAmbu RIPmate were found topublish biocompatability. |
| Sterility | Not applicable | Neither the Braebon UltimaBody Position Sensor or theAmbu RIPmate were found topublish sterility information. |
CONCLUSION 5.9
Based on the results of the Intended Use Comparison, the Technical Comparison, and Testing Data, it is believed that the Serenity Body Position Sensor and Serenity RIP Sensors present no new questions of safety and effectiveness and, are substantially equivalent to the identified predicate. Both sensors have similar physical, electrical, and environmental designs. Both share the same intended use.
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).