(169 days)
Not Found
No
The document describes a sensor and cables for measuring respiratory effort using standard RIP technology. It explicitly states "No signal processing is done in RIP Belts" and "No signal processing done in Third Party RIP Belt Cables". There is no mention of AI or ML in the text.
No
The device is described as an accessory for sleep/polysomnography (PSG) systems, intended for measuring respiratory effort signals, not for providing therapy or treatment.
Yes
The device is intended for "measuring of respiratory effort signals" as an accessory for sleep/polysomnography (PSG) systems, which are used for diagnosing sleep disorders. While the belts themselves only measure signals, they are part of a larger system used clinically for diagnostic purposes.
No
The device description clearly states that the Nox RIP Belts are "respiratory effort sensors" and the Nox RIP Belt Cables are used to "connect between the respiratory effort sensor (RIP belts) and the applicable sleep recorder/polysomnography (PSG) system." This indicates the device includes physical hardware components (belts and cables) that are essential to its function of measuring respiratory effort. The summary also details hardware-specific testing like EMC testing and compliance with hardware standards (AAMI/ANSI/ES 60601-1).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure respiratory effort signals. This is a physiological measurement taken directly from the patient's body.
- Mechanism of Action: The device uses Respiratory Inductance Plethysmography (RIP) technology to measure changes in inductance related to breathing. This is a physical measurement, not a test performed on a sample taken from the body.
- Lack of Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, disease, or condition. This device does not analyze any such samples.
The device is an accessory for sleep/polysomnography (PSG) systems, which are used to monitor various physiological parameters during sleep. While the information gathered by the RIP belts contributes to a diagnosis or assessment, the belts themselves are measuring a physical signal from the patient, not performing an in vitro diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The Nox RIP Belts are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems.
The Nox RIP Belts are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient 's home.
The RIP Belt Cables are intended to interconnect Nox RIP belts (respiratory effort sensors) and Nox sleep devices, to allow measuring of respiratory effort signals.
The RIP Belt Cables are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient´s home.
The Third Party RIP Belt Cables are intended to allow measuring of respiratory effort signals by interconnecting Nox RIP belts (respiratory effort sensors) and sleep devices with oscillation circuitry capable of measuring inductance between 1 and 5 µH.
The Third Party RIP Belt Cables are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home.
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
The Nox RIP Belts are respiratory effort sensors that are intended to function as an accessory with sleep/polysomnography (PSG) systems. The RIP Belts measure respiratory effort signals based on Respiratory Inductance Plethysmography (RIP) technology, which is the gold standard technology for respiratory effort belts.
Two RIP belts are used to measure the respiratory effort of the patient. One belt is placed around the patient's abdomen and the other around the patient's thorax. Both abdomen and thorax belts are identical.
The Nox RIP Belt Cables are used to connect between the respiratory effort sensor (RIP belts) and the applicable sleep recorder/polysomnography (PSG) system.
There are two product groups for the Nox RIP Belt Cables; RIP Belt Cables and Third Party RIP Belt Cables.
The RIP Belt Cables are designed for use with Nox recorders only. Those are abdomen cables only because the thorax belt is attached directly to the Nox recorders.
The Third Party RIP Belt Cables are designed for use with third party recorders. The Third Party RIP Belt Cables come in pairs for abdomen and thorax.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen and Thorax
Indicated Patient Age Range
greater than 2 years of age
Intended User / Care Setting
hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient´s home.
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)
Thorough internal testing has demonstrated that the Nox RIP Belts and Nox RIP Belt Cables are suitable for their intended use.
The design of the Nox RIP Belts and Nox RIP Belt Cables was tested, verified and validated throughout the design process according to product requirement specifications and intended use.
The Nox RIP Belts and Nox RIP Belt Cables comply with the following standards:
- ISO 14971 Second edition 2007, Medical devices Application of risk management to . medical devices
- . ISO 15223-1:2012, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied
- . AAMI/ANSI/ES 60601-1:2005, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- . IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- AAMI/ANSI/IEC 62366:2007/(R)2013, Medical devices Application of usability . engineering to medical devices
Additionally, the Third Party RIP Belt Cables comply with
- 21 CFR 898 FDA PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND . PATIENT CABLES:2014
Verification
Nox RIP Belts and Nox RIP Belt Cables were tested towards test protocols written to cover all product requirement specifications. The test results demonstrate that the design output conforms to design input and that the device fulfills all physical characteristics, performance criteria, functional requiremental requirements, interface requirements, packaging and labeling requirements as well as safety and reliability requirements defined.
Risk Analysis
Risk analysis was performed for RIP Belts and RIP Belt Cables according to the standard: ISO 14971 - Medical devices - Application of risk management to medical devices, appropriate measures have been implemented and their effectiveness verified and validated.
Standards Testing
Assessment has been conducted for RIP Belts and RIP Belt Cables towards the standard AAMI/ANSI/ES 60601-1:2005. The result of this assessment is that the RIP Belt Cables are in compliance with the standard AAMI/ANSI/ES 60601-1:2005.
EMC Testing
Assessment has been conducted for RIP Belts and RIP Belt Cables towards the electromagnetic compatibility standard IEC 60601-1-2 Edition 3: 2007-03 to ensure compatibility with requirements addressing electrostatic discharge (ESD), electromagnetic disturbances, magnetic fields, electrical fast transients and bursts, and surge. The result of this assessment is that the RIP Belts and RIP Belt Cables are in compliance with the standard IEC 60601-1-2 Edition 3: 2007-03.
Usability
The RIP Belts and RIP Belt Cables were designed to minimize use errors and use-associated risks according to the usability engineering standard AAMI/ANSI/IEC 62366:2007/(R)2013. Usability testing resulted in all usability goals passed.
Signal Quality and Comparison Testing
Signal integrity tests were conducted for the Nox RIP Belts and Nox RIP Belt Cables with focus on signal to noise ratio, signal range, bandwidth and linearity and the test results compared to the signal integrity test conducted for the predicate QDC-PRO AND NOX-RIP.
The results from these signal integrity tests and comparison demonstrate that the Nox RIP Belts and Nox RIP Belt Cables signals are clinically equivalent to that of the predicate QDC-PRO AND NOX RIP.
Conclusion
Based on the testing, risk analysis and verification activates described above and detailed comparison to the predicate device provided in Table 2 above, it is the conclusion of Nox Medical that the Nox RIP Belts and Nox RIP Belt Cables are substantially equivalent to device already on the market (cleared by the 510(k) process) and present no new concerns about safety and effectiveness.
The Nox RIP Belts and Nox RIP Belt Cables are therefore substantial equivalent to the predicate QDC-PRO AND NOX-RIP from Nox Medical (K124062).
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2015
Nox Medical ehf C/O Kolbrun E Ottosdottir Director of Quality & Regulatory Katrinartuni 2 IS-105 Reykjavik ICELAND
Re: K151361
Trade/Device Name: Nox RIP Belts and Nox RIP Belt Cables Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: Class II Product Code: MNR Dated: October 2, 2015 Received: October 5, 2015
Dear Mr. Ottosdottir:
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.
1
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 (reporting of medical device-related 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.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indication for Use
510(k) Number (if known): K151361
Device Name: Nox RIP Belts
Indications for Use (Describe):
The Nox RIP Belts are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems.
The Nox RIP Belts are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient 's home.
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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Indication for Use
510(k) Number (if known): K151361
Device Name: RIP Belt Cables
Indications for Use (Describe):
The RIP Belt Cables are intended to interconnect Nox RIP belts (respiratory effort sensors) and Nox sleep devices, to allow measuring of respiratory effort signals.
The RIP Belt Cables are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient´s home.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
Indication for Use
510(k) Number (if known): K151361
Device Name: Third Party RIP Belt Cables
Indications for Use (Describe):
The Third Party RIP Belt Cables are intended to allow measuring of respiratory effort signals by interconnecting Nox RIP belts (respiratory effort sensors) and sleep devices with oscillation circuitry capable of measuring inductance between 1 and 5 µH.
The Third Party RIP Belt Cables are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home.
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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
5
510(k) Summary
Submitter
Nox Medical ehf Katrinartuni 2 IS-105 Reykjavik Iceland Tel: +354 570 7170
Establishment Registration Number: 3007389703
Contact person
Kolbrun E Ottosdottir Katrinartuni 2 IS-105 Reykjavik Iceland Email: keo@noxmedical.com Direct tel: +354 570 7173
Preparation Date
06 November 2015
Device Details
| Trade Name: | Nox RIP Belts | Nox RIP Belt Cables |
|---|---|---|
| Product Groups | ||
| RIP Belt Cables | Third Party RIP Belt Cables | |
| Common Name: | Respiratory Effort | |
| Sensor | Respiratory Effort Sensor | |
| Classification | ||
| Name: | Ventilatory Effort | |
| Recorder | Ventilatory Effort Recorder | |
| Regulation | ||
| Number: | 868.2375 | 868.2375 |
| Product Code: | MNR | MNR |
| Device Class | Class II | Class II |
| Classification | ||
| Panel: | Anesthesiology | Anesthesiology |
6
Predicate Device
QDC-PRO AND NOX-RIP from Nox Medical ehf Product Code: MNR 510(k) Number: K124062
This predicate has not been subject to a design-related recall.
Note1: Please note that the Nox RIP Belts will be regarded as a subsystem of the predicate, QDC-PRO AND NOX-RIP. The QDC-PRO AND NOX-RIP includes a recorder and several accessories but only the RIP belts will be addressed in the comparison between the new device and the predicate.
Note2: Please note that the Nox RIP Belt Cables will be regarded as a subsystem of the predicate, QDC-PRO AND NOX-RIP. The QDC-PRO AND NOX-RIP includes a recorder and several accessories but only the RIP belt cable will be addressed in the comparison between the new device and the predicate.
7
Device Description
The Nox RIP Belts are respiratory effort sensors that are intended to function as an accessory with sleep/polysomnography (PSG) systems. The RIP Belts measure respiratory effort signals based on Respiratory Inductance Plethysmography (RIP) technology, which is the gold standard technology for respiratory effort belts.
Two RIP belts are used to measure the respiratory effort of the patient. One belt is placed around the patient's abdomen and the other around the patient's thorax. Both abdomen and thorax belts are identical.
The Nox RIP Belt Cables are used to connect between the respiratory effort sensor (RIP belts) and the applicable sleep recorder/polysomnography (PSG) system.
There are two product groups for the Nox RIP Belt Cables; RIP Belt Cables and Third Party RIP Belt Cables.
The RIP Belt Cables are designed for use with Nox recorders only. Those are abdomen cables only because the thorax belt is attached directly to the Nox recorders.
The Third Party RIP Belt Cables are designed for use with third party recorders. The Third Party RIP Belt Cables come in pairs for abdomen and thorax.
8
Intended Use
Nox RIP Belts
The Nox RIP Belts are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems.
The Nox RIP Belts are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home.
RIP Belt Cables
The RIP Belt Cables are intended to interconnect Nox RIP belts (respiratory effort sensors) and Nox sleep devices, to allow measuring of respiratory effort signals.
The RIP Belt Cables are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home.
Third Party RIP Belt Cables
The Third Party RIP Belt Cables are intended to allow measuring of respiratory effort signals by interconnecting Nox RIP belts (respiratory effort sensors) and sleep devices with oscillation circuitry capable of measuring inductance between 1 and 5 µH.
The Third Party RIP Belt Cables are indicated for use on patients greater than 2 years of age.
The intended environments are hospitals, institutions, sleep clinics, or other test environments, including the patient's home.
Technological Characteristics and Comparison with Predicate
Nox RIP Belts
The comparison table below is provided as a summary of the intended use and most relevant characteristics of the Nox RIP Belts relative to the predicate device.
Please note that the Nox RIP Belts will be regarded as a subsystem of the predicate. ODC-PRO AND NOX-RIP. The ODC-PRO AND NOX-RIP includes a recorder and several accessories but only the RIP belts will be addressed in the comparison between the new device and the predicate.
9
| Characteristic | QDC - PRO AND NOX-RIP (K124062) | Nox RIP Belts | Comparison Result |
|---|---|---|---|
| General | |||
| Intended Use | The QDC-PRO device is a sensor unit intended for measuring of physiological signals during sleep. The signals measured are processed in the QDC-PRO device and the resulting signals made available at the output connector for acquisition by a third party Polysomnography (PSG)/sleep recorder. | The Nox RIP Belts are intended for measuring of respiratory effort signals. They function as accessories for sleep/polysomnography (PSG) systems. | Equivalent |
| See Note 1 below | |||
| Intended Environments | The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments. | The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient´s home. | Equivalent |
| See Note 2 below | |||
| Patient Population | The QDC-PRO AND NOX-RIP are indicated for use in patients greater than 2 years of age. | The Nox RIP Belts are indicated for use on patients greater than 2 years of age. | Identical |
| Prescription Use | Yes | Yes | Identical |
| Type of Modules | RIP belts are disposable | RIP belts are disposable | Identical |
| Various Belt Sizes | Yes | Yes | Identical |
| Physical/Material | |||
| RIP Belts Material | Elastic: Polyester/Dorlastan (not made with natural rubber latex), tin plated copper wire | ||
| Connector: ABS plastic | Elastic: Polyester/Dorlastan (not made with natural rubber latex), tin plated copper wire | ||
| Connector: ABS plastic | Identical | ||
| Disposable Components | Disposable respiratory effort sensor/RIP belts. | Disposable respiratory effort sensor/RIP belts. | Identical |
| Functional | |||
| Connection to Patient | RIP Belts are attached to patient | RIP Belts are attached to patient | Identical |
| Type of Equipment to Be Connected to | Sleep recorder and RIP Belt Cable | Sleep recorder and RIP Belt Cable | Identical |
| Connector Type | RIP belts have connector for to connect to Nox proprietary RIP snaps | RIP belts have connector for to connect to Nox proprietary RIP snaps | Identical |
| Signals and Sensors | |||
| Signals Measured | Respiratory Effort (Abdomen and Thorax) | Respiratory Effort (Abdomen and | |
| Thorax) | Identical | ||
| Respiratory Effort | |||
| Technology | RIP (Respiratory Inductive Plethysmography) | ||
| technology | RIP (Respiratory Inductive | ||
| Plethysmography) technology | Identical | ||
| Signal Processing | No signal processing is done in RIP Belts | No signal processing is done in | |
| RIP Belts | Identical | ||
| Power and Isolation | |||
| Power Source | No power source. RIP Belts contain only | ||
| passive components | No power source. RIP Belts | ||
| contain only passive components | Identical | ||
| Isolation | No component included in the RIP Belts that | ||
| are relied on as means of protection | No component included in the | ||
| RIP Belts that are relied on as | |||
| means of protection | Identical | ||
| Standards | |||
| AAMI/ANSI/ES | |||
| 60601-1 | Yes | Yes | Identical |
| IEC 60601-1-2 | Yes | Yes | Identical |
Table 1 Comparison Summary of the New Device (Nox RIP Belts) and Predicate Device
10
Note 1: Nox RIP Belts are intended for measuring of respiratory effort signals and function as accessories for sleep systems. The predicate, ODC-PRO AND NOX RIP, is intended for measuring of physiological signals during sleep. Respiratory effort is one example of physiological signals and both the new device and the predicate measure the signals during sleep. Furthermore, the predicate RIP belts are intended for measuring respiratory effort signals as an accessory to the ODC-PRO recorder. Therefore the indication for use can be reqarded the same.
Note 2: The intended environment depends on the classification of the sleep recorder to be used with the Nox RIP Belts. The predicate device, ODC-PRO AND NOX-RIP, is intended to be used with a third party polysomnography (PSG) recorder. PSG studies are rarely performed in home environment and therefore it is not listed in the intended environments for the predicate. Simpler sleep recorders like polygraph (PG) recorders are commonly used at patients' home. The Nox RIP Belts may be used with any type of sleep recorders/PSG recorders including PG recorders. Therefore, the home environment was added for the Nox RIP Belts. If a sleep recorder is intended for home use, the type of RIP Belts does not change or influence the intended environment of the recorder. The home inclusion to the environment of use does therefore not pose any new safety and effectiveness concerns for the Nox RIP Belts. Additionally, risk analysis, verification and validation results demonstrate that the use of Nox RIP Belts in the home environment does not raise any new concerns regarding the intended use, safety or efficiency. Furthermore, these are prescription devices and are always used under supervision of a licensed medical practitioner. The intended environments are therefore deemed equivalent.
The result of the above comparison is that the indication for use, patient population and intended environments for the Nox RIP Belts can be regarded the same as that of the predicate QDC-PRO AND NOX-RIP device.
The comparison above demonstrates that all major technological characteristics, including features, materials, and principles of operation of the Nox RIP Belts are identical to the predicate QDC-PRO AND NOX RIP.
11
Nox RIP Belt Cables
The comparison table below is provided as a summary of the intended use and most relevant characteristics of the Nox RIP Belt Cables relative to the predicate device.
Please note that the Nox RIP Belt Cables will be regarded as a subsystem of the predicate, QDC-PRO AND NOX-RIP. The QDC-PRO AND NOX-RIP includes a recorder and several accessories but only the RIP belt cable will be addressed in the comparison between the new device and the predicate.
12
| Characteristic | QDC - PRO AND NOX-
RIP (K124062) | Nox RIP Belt Cables | | |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | | RIP Belt Cables | Third Party RIP Belt
Cables | Comparison Results |
| | | General | | |
| Intended Use | The QDC-PRO device is
a sensor unit intended
for measuring of
physiological signals
during sleep. The signals
measured are processed
in the QDC-PRO device
and the resulting signals
made available at the
output connector for
acquisition by a third
party Polysomnography
(PSG)/sleep recorder. | The RIP Belt Cables are
intended to interconnect
Nox RIP belts
(respiratory effort
sensors) and Nox sleep
devices, to allow
measuring of respiratory
effort signals. | The Third Party RIP Belt
Cables are intended to
allow measuring of
respiratory effort signals
by interconnecting Nox
RIP belts (respiratory
effort sensors) and sleep
devices with oscillation
circuitry capable of
measuring inductance
between 1 and 5 μH. | Equivalent
See Note 3 below |
| Intended
Environments | The intended
environments are
hospitals, institutions,
sleep centers, sleep
clinics, or other test
environments. | The intended
environments are
hospitals, institutions,
sleep centers, sleep
clinics, or other test
environments, including
the patient's home. | The intended
environments are
hospitals, institutions,
sleep centers, sleep clinics,
or other test
environments, including
the patient's home. | Equivalent
See Note 4 below |
| Patient
Population | The QDC-PRO AND
NOX-RIP are indicated
for use in patients
greater than 2 years of
age. | The RIP Belt Cables are
indicated for use on
patients greater than 2
years of age. | The Third Party RIP Belt
Cables are indicated for
use on patients greater
than 2 years of age. | Identical |
| Prescription
Use | Yes | Yes | Yes | Identical |
| Type of Modules | RIP Belt Cable for
connection to recorder
and RIP belts | RIP Belt Cable for
connection to recorder
and RIP belts | RIP Belt Cables for
connection to recorder and
RIP belts | Identical |
| Physical / Material | | | | |
| RIP Cables
Material | ● PVC – wire jacket
● PC with 10% glass
fiber – belt end
● PC with 10% glass
fiber – device end
● Gold plated
stainless steel -
snaps
● TPE - strain relief | ● PVC – wire jacket
● ABS/PC - belt end
● ABS/PC - device
end
● Gold plated
stainless steel -
snaps
● TPE - strain relief | ● PVC – wire jacket
● ABS/PC - belts end
● TPE-ET - device end
strain relief
● Gold plated stainless
steel - snaps
● TPE-ET - strain relief
Note: TPE-ET is also
known as Riteflex® | Equivalent
See Note 5 below |
| Disposable | RIP Belt Cable is | RIP Belt Cable is | Third Party RIP Belt Cables | Identical |
| Components | reusable | reusable | are reusable | |
| Functional | | | | |
| Connection to
Patient | RIP Belt Cable is
attached to patient via
connection to RIP belts | RIP Belt Cable is
attached to patient via
connection to RIP belts | Third Party RIP Belt Cables
are attached to patient via
connection to RIP belts | Identical |
| Type of
Equipment to
Be Connected
to | Interconnect sleep
recorder and respiratory
effort sensor (RIP belt) | Interconnect sleep
recorder and respiratory
effort sensor (RIP belt) | Interconnect sleep
recorder and respiratory
effort sensor (RIP belt) | Identical |
| Belt Cable
Connectors -
Recorder End | Proprietary connector for
Nox RIP snaps | Proprietary connector for
Nox RIP snaps | Touch proof 1 mm 2 pin
female connector | Equivalent
See Note 6 below |
| Belt Cable
Connectors -
Belt End | Gold coated proprietary
metal snaps | Gold coated proprietary
metal snaps | Gold coated proprietary
metal snaps | Identical |
| Signals and Sensors | | | | |
| Signal
Processing | No signal processing
done in RIP Belt Cable | No signal processing
done in RIP Belt Cable | No signal processing done
in Third Party RIP Belt
Cables | Identical |
| Power and Isolation | | | | |
| Power Source | No power source. RIP
Belt Cable contains only
passive components | No power source. RIP
Belt Cable contains only
passive components | No power source. Third
Party RIP Belt Cables
contain only passive
components | Identical |
| Isolation | No component included
in the RIP Belt Cable
that is relied on as
means of protection | No component included
in the RIP Belt Cable
that is relied on as
means of protection | No component included in
the Third Party RIP Belt
Cables that is relied on as
means of protection | Identical |
| Standards | | | | |
| AAMI/ANSI/ES
60601-1 | Yes | Yes | Yes | Identical |
| IEC 60601-1-2 | Yes | Yes | Yes | Identical |
Table 2 Comparison Summary of the New Device (Nox RIP Belt Cables) and Predicate Device
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Note 3: Nox RIP Belt Cables are intended to allow measuring of respiratory effort signals and function as accessories for sleep systems. The predicate, QDC-PRO AND NOX RIP, is intended for measuring of physiological signals during sleep. Respiratory effort is one example of physiological signals and both the new device and the predicate allow measuring of the signals during sleep. Furthermore, the predicate RIP belt cable is intended to interconnect RIP belts and the QDC-PRO recorder to allow measuring of respiratory effort signals. Therefore the indication for use can be regarded the same.
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Note 4: The intended environment depends on the classification of the sleep recorder to be used with the Nox RIP Belt Cables. The predicate device, ODC-PRO AND NOX-RIP, is intended to be used with a third party polysomnography (PSG) recorder. Simpler sleep recorders like polygraph (PG) recorders are commonly used at patients' home. The Nox RIP Belt Cables may be used with any type of sleep recorders/PSG recorders including PG recorders. Therefore, the home environment was added for the Nox RIP Belt Cables. If a sleep recorder is intended for home use, the type of RIP belt cables does not change or influence the intended environment of the recorder. The home inclusion to the environment of use does therefore not pose any new safety and effectiveness concerns for the Nox RIP Belt Cables. Additionally, risk analysis, verification and validation results demonstrate that the use of Nox RIP Belt Cables in the home environment does not raise any new concerns regarding the intended use, safety or efficiency. Furthermore, these are prescription devices and are always used under supervision of a licensed medical practitioner. The intended environments are therefore deemed equivalent.
Note 5: The RIP Belt Cables and Third Party RIP Belt Cables are compliant to standard AAMI/ANSI ES/60601-1. Furthermore, verification testing and risk analysis show that minor difference in material does not raise new questions about safety and effectiveness. The material of the new devices and the predicate can thus be regarded as equivalent.
Note 6: All cables, both new and predicate, are compliant with standard AAMI/ANSI ES/60601-1. Furthermore, verification testing, signal integrity comparison and risk analysis show that different connectors do not raise new questions about safety and effectiveness. The recorder end connectors can thus be regarded as equivalent.
The result of the above comparison is that the indication for use, patient population and intended environments for the Nox RIP Belt Cables can be regarded the same as that of the predicate QDC-PRO AND NOX-RIP device.
Furthermore, the comparison above shows that there are no significant differences in major technological characteristics, including features, materials, and principles of operation of Nox RIP Belt Cables compared to the predicate. The minor differences between the new and predicate device do not raise any new questions regarding safety and effectiveness. It can therefore be determined that Nox RIP Belt Cables have the same major technological characteristics as the predicate device, QDC-PRO AND NOX RIP.
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Performance Testing Summary
Thorough internal testing has demonstrated that the Nox RIP Belts and Nox RIP Belt Cables are suitable for their intended use.
The design of the Nox RIP Belts and Nox RIP Belt Cables was tested, verified and validated throughout the design process according to product requirement specifications and intended use.
The Nox RIP Belts and Nox RIP Belt Cables comply with the following standards:
- ISO 14971 Second edition 2007, Medical devices Application of risk management to . medical devices
- . ISO 15223-1:2012, Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied
- . AAMI/ANSI/ES 60601-1:2005, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- . IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
- AAMI/ANSI/IEC 62366:2007/(R)2013, Medical devices Application of usability . engineering to medical devices
Additionally, the Third Party RIP Belt Cables comply with
- 21 CFR 898 FDA PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND . PATIENT CABLES:2014
Verification
Nox RIP Belts and Nox RIP Belt Cables were tested towards test protocols written to cover all product requirement specifications. The test results demonstrate that the design output conforms to design input and that the device fulfills all physical characteristics, performance criteria, functional requiremental requirements, interface requirements, packaging and labeling requirements as well as safety and reliability requirements defined.
Risk Analysis
Risk analysis was performed for RIP Belts and RIP Belt Cables according to the standard: ISO 14971 - Medical devices - Application of risk management to medical devices, appropriate measures have been implemented and their effectiveness verified and validated.
Standards Testing
Assessment has been conducted for RIP Belts and RIP Belt Cables towards the standard AAMI/ANSI/ES 60601-1:2005. The result of this assessment is that the RIP Belt Cables are in compliance with the standard AAMI/ANSI/ES 60601-1:2005.
EMC Testing
Assessment has been conducted for RIP Belts and RIP Belt Cables towards the electromagnetic compatibility standard IEC 60601-1-2 Edition 3: 2007-03 to ensure compatibility with requirements addressing electrostatic discharge (ESD), electromagnetic disturbances, magnetic fields, electrical fast transients and bursts, and surge. The result of this assessment is that the RIP Belts and RIP Belt Cables are in compliance with the standard IEC 60601-1-2 Edition 3: 2007-03.
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Usability
The RIP Belts and RIP Belt Cables were designed to minimize use errors and use-associated risks according to the usability engineering standard AAMI/ANSI/IEC 62366:2007/(R)2013. Usability testing resulted in all usability goals passed.
Signal Quality and Comparison Testing
Signal integrity tests were conducted for the Nox RIP Belts and Nox RIP Belt Cables with focus on signal to noise ratio, signal range, bandwidth and linearity and the test results compared to the signal integrity test conducted for the predicate QDC-PRO AND NOX-RIP.
The results from these signal integrity tests and comparison demonstrate that the Nox RIP Belts and Nox RIP Belt Cables signals are clinically equivalent to that of the predicate QDC-PRO AND NOX RIP.
Conclusion
Based on the testing, risk analysis and verification activates described above and detailed comparison to the predicate device provided in Table 2 above, it is the conclusion of Nox Medical that the Nox RIP Belts and Nox RIP Belt Cables are substantially equivalent to device already on the market (cleared by the 510(k) process) and present no new concerns about safety and effectiveness.
The Nox RIP Belts and Nox RIP Belt Cables are therefore substantial equivalent to the predicate QDC-PRO AND NOX-RIP from Nox Medical (K124062).