(194 days)
No
The device description and intended use focus on basic physiological signal measurement and output, with no mention of AI/ML for analysis or interpretation. The analysis is performed by a qualified sleep clinician.
No.
The device measures and outputs respiratory effort and body position for diagnostic purposes in sleep studies, and it is not intended for treatment or life monitoring.
No
The device measures and outputs physiological signals (respiratory effort and body position) for archival in a polysomnography study. It is an accessory to a polysomnography system, and the data is then analyzed by a qualified sleep clinician "to aid in the diagnosis of sleep disorders." The device itself does not make a diagnosis.
No
The device description explicitly mentions physical sensors (3-axis accelerometer, respiratory inductance plethysmography) and hardware components (adjustable elastic belt, RIP driver) that are worn by the patient and connect to an amplifier. The performance studies also detail testing related to hardware characteristics like mechanical strength, ingress of liquids, and electrical safety.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Serenity RIP and Serenity Body Position Sensors measure physiological signals (respiratory effort and body position) directly from the patient's body. They do not analyze samples taken from the body.
- Intended Use: The intended use is to measure and output these signals for archival in a polysomnography study, which is then analyzed by a clinician to aid in the diagnosis of sleep disorders. This is a process of collecting physiological data from the living patient, not analyzing samples in vitro.
Therefore, the device falls under the category of medical devices used for physiological monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OLV
Device 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
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.
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
adults and children
Intended User / Care Setting
healthcare professionals within a hospital, laboratory, clinic, or nursing home; or outside of a medical facility under the direction of a medical professional.
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)
| Test | Test Method Summary | Results |
|---|---|---|
| 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance | 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. Neither the Braebon Ultima Body Position Sensor or the Ambu RIPmate were found to publish testing to a basic safety standard. |
| IEC 60601-1-2 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility | Radiated Emissions CISPR11 ed5.0 (with A1:2010) Electro-Static Discharge Immunity Test IEC 61000-4-2 ed2.0 (2008-12) Conducted, Radio-Frequency, Electromagnetic Immunity Test IEC 61000-4-6 ed2.0 (with A1:2004+A2:2006) Power Frequency Magnetic Field Immunity Test IEC 61000-4-8 ed2.0 (2009-09) | All samples passed the acceptance criteria. Neither the Braebon Ultima Body Position Sensor or the Ambu RIPmate were found to publish testing electromagnetic compatibility. |
| Body Position Sensor Verification | 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. Neither the Braebon Ultima Body Position Sensor or the Ambu RIPmate were found to publish testing details. |
| Reference Device Comparison | Body Position Sensor Reference Comparison Test RIP Sensor Reference Device Comparison | Comparison testing shows equivalent performance of the Serenity sensors and the reference devices, using the same host system configurations. Neither the Braebon Ultima Body Position Sensor or the Ambu RIPmate were found to publish comparison information. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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).
0
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.
1
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
2
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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3
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 C2 | |||
| Gainesville, FL 32606 | Fax: | 815.550.2871 | |
| Name: | |||
| Email: | David Pezet | ||
| quality@neurotronics.com | Title: | ||
| Phone: | Quality Manage | ||
| 352.372.9955 |
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
4
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
| Produc
t Code | Device | Regulation Description | Regulation
Number |
|------------------|-------------------------------------------------------|------------------------|----------------------|
| OLV | Standard Polysomnograph
With Electroencephalograph | Electroencephalograph | 882.1400 |
Serenity RIP Sensor
| Product
Code | Device | Regulation Description | Regulation
Number |
|-----------------|-------------------------------------------------------|------------------------|----------------------|
| OLV | Standard Polysomnograph
With 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 | Product
Codes | 510(K) |
|-----------------------|-------------------------------------------------|------------|------------------|---------|
| Neurotronics, Inc. | Nomad Sleep System
Recorder, Model PMU800 | 882.1835 | GWL, DQA,
MNR | K092699 |
| Braebon Medical Corp. | Ultima Body Position
Sensor | 882.5050 | LEL | K981969 |
| Ambu A/S | RIPmate; Sleepmate
Respiratory Effort Sensor | 868.2375 | BZQ | K903300 |
5
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
6
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.
7
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.
8
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. "
9
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.
10
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 Body
Position Sensor | Neurotronics Serenity
Body Position Sensor |
|------------------------------------------|-----------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|
| Image: [body position sensor comparison] | | Image: [Braebon Ultima Body Position Sensor] | Image: [Neurotronics Serenity Body Position Sensor] |
| Physical
Properties | Battery | 3V Lithium | 3V Lithium |
| | Battery Life | ~2 years | > 2 years |
| Environmental
Specifications | Operating
Temperature | 41°F - 90°F
(5°C-32°C) | 50°F - 104°F
(10°C - 40°C) |
| | Operating
Relative
Humidity | 10% to 95% RH non-
condensing | 0 to 93% RH non-
condensing |
| | Storage
Temperature | 32°F to 140°F
(0°C to 60°C) | -4°F to 140°F
(-20°C to 60°C) |
| | Storage Relative
Humidity | 10%-95% RH non-
condensing | 0 - 93% RH non-condensing |
| | Pressure | Not Specified | 70.0 kPa to 106 kPa |
| Output
Specifications | Output Signal | 0 V to 1 V (± 0.1 V) | 0 V to 0.78 V (± 10%) |
| | Positions
Detected | Right Side
Left Side
Supine
Prone
Upright (Sitting) | Right Side
Left Side
Supine
Prone
Sitting (Upright) |
Body Position Sensor Comparison
11
RIP Sensor Comparison
| RIP Sensor Comparison | Ambu RIPmate | Neurotronics Serenity
RIP Sensor | |
|---------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| | Image | | |
| Belt Length | Adjustable
24"to 79"
(60 cm to 200 cm) | Adjustable
Small 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 with
Insulated wire | Elastic Band with
Insulated wire | |
| Cable Length | 2.05 m | 0.6m ± 2 cm
or
2.0m ± 5 cm | |
| Cable Material | PVC jacketed; ZIP-style
cord | PVC jacketed; ZIP-style
cord | |
| Module | Box: ABS
Cable: PVC jacketed;
ZIP-style cord | Box: ABS
Cable: PVC jacketed;
ZIP-style cord | |
| Battery | 3V Lithium | 3V Lithium | |
| Battery Life | Estimated 3000 hours | > 3000 hours | |
| | Operating
Temperature | 40°F - 120°F
(5°C-50°C) | 50°F - 104°F
(10°C - 40°C) |
| | Operating Relative
Humidity | 15%-95%
RH non-condensing | 0 - 93% RH non-
condensing |
| Environmental
Specifications | Storage
Temperature | 0°F-120°F
(-20°C-50°C) | -4°F - 140°F
(-20°C - 60°C) |
| | Storage Relative
Humidity | 10%-95% RH non-
condensing | 0 - 93% RH non-
condensing |
| | Pressure | 50.33 kPa – 199.48 kPa | 70.0 kPa - 106 kPa |
| Output
Specifications | Output Signal | Maximum: ±5mV | Maximum: Not
Specified.
Nominal: ~ ±1mv |
12
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 Electrical | ||
| Equipment - Part 1: | ||
| General Requirements for | ||
| Basic Safety and Essential | ||
| Performance | 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. | ||
| Neither the Braebon Ultima | ||
| Body Position Sensor or the | ||
| Ambu RIPmate were found to | ||
| publish testing to a basic | ||
| safety standard. | ||
| IEC 60601-1-2 Medical | ||
| Electrical Equipment - Part | ||
| 1-2: General Requirements | ||
| for Safety - Collateral | ||
| Standard: Electromagnetic | ||
| Compatibility | Radiated Emissions CISPR11 | |
| ed5.0 (with A1:2010) | ||
| Electro-Static Discharge | ||
| Immunity Test IEC 61000-4-2 | ||
| ed2.0 (2008-12) | ||
| Conducted, Radio-Frequency, | ||
| Electromagnetic Immunity Test | ||
| IEC 61000-4-6 ed2.0 (with | ||
| A1:2004+A2:2006) | ||
| Power Frequency Magnetic | ||
| Field Immunity Test IEC 61000- | ||
| 4-8 ed2.0 (2009-09) | All samples passed the | |
| acceptance criteria. | ||
| Neither the Braebon Ultima | ||
| Body Position Sensor or the | ||
| Ambu RIPmate were found to | ||
| publish testing | ||
| electromagnetic compatibility. |
13
| Body Position Sensor
Verification | 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.
Neither the Braebon Ultima
Body Position Sensor or the
Ambu RIPmate were found to
publish testing details. |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Device
Comparison | Body Position Sensor
Reference Comparison Test
RIP Sensor Reference Device
Comparison | Comparison testing shows
equivalent performance of the
Serenity sensors and the
reference devices, using the
same host system
configurations.
Neither the Braebon Ultima
Body Position Sensor or the
Ambu RIPmate were found to
publish comparison
information. |
| Biocompatibility | Not Applicable | Neither the Braebon Ultima
Body Position Sensor or the
Ambu RIPmate were found to
publish biocompatability. |
| Sterility | Not applicable | Neither the Braebon Ultima
Body Position Sensor or the
Ambu RIPmate were found to
publish 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.