(169 days)
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.
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.
The provided document is a 510(k) premarket notification for Nox RIP Belts and Nox RIP Belt Cables. The core of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to set new performance acceptance criteria through a clinical study in the same way an AI-driven diagnostic might.
Therefore, the acceptance criteria and study described here are focused on demonstrating that the new devices perform equivalently to the predicate, and comply with relevant safety standards.
Here's an attempt to extract the information you requested, based on the provided text, while noting the differences in context for a traditional medical device accessory vs. an AI diagnostic:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a submission for device accessories (RIP belts and cables) demonstrating substantial equivalence to a predicate, the "acceptance criteria" are primarily related to meeting performance specifications and safety standards, and showing clinical equivalence to the predicate's signal quality. There aren't specific metrics like sensitivity/specificity for disease detection.
| Criteria Type | Acceptance Criteria (Met by) | Reported Device Performance (Demonstrated by) |
|---|---|---|
| Safety & Standards | Compliance with relevant standards. | Demonstrated compliance with: - ISO 14971 (Risk Management)- ISO 15223-1 (Symbols)- AAMI/ANSI/ES 60601-1 (Basic Safety & Essential Performance)- IEC 60601-1-2 (EMC)- AAMI/ANSI/IEC 62366 (Usability Engineering)- 21 CFR 898 (for Third Party RIP Belt Cables) |
| Functional | Conformance to design input/specifications. | Verification testing: Design output conforms to design input, fulfilling all physical characteristics, performance, functional, interface, packaging, labeling, safety, and reliability requirements. |
| Usability | Minimize use errors and risks. | Usability testing resulted in all usability goals passed. |
| Signal Quality | Clinically equivalent signal to predicate. | Signal integrity tests (signal-to-noise ratio, signal range, bandwidth, linearity) for new devices compared to predicate (QDC-PRO AND NOX-RIP) demonstrated clinical equivalence. |
| Risk Management | Risks appropriately managed. | Risk analysis performed according to ISO 14971; appropriate measures implemented and their effectiveness verified/validated. |
| Material/Physical Equivalence | Materials do not raise new safety/effectiveness concerns. | Verification testing and risk analysis show minor differences in material do not raise new questions about safety and effectiveness (for RIP Belt Cables). |
| Connector Equivalence | Different connectors do not raise new safety/effectiveness concerns. | Verification testing, signal integrity comparison, and risk analysis show different connectors do not raise new questions about safety and effectiveness (for RIP Belt Cables). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data or clinical images for an algorithm. The testing described is primarily bench testing, engineering verification, and validation against product requirements and standards.
- Sample Size for Test Set: Not applicable in the context of patient-specific data for algorithm performance. The "samples" would be the manufactured devices (RIP Belts and Cables) themselves. The number of devices tested is not specified, but it implies a statistically sound sample for verification and validation activities.
- Data Provenance: Not applicable for patient data. The provenance of the testing results is "thorough internal testing" conducted by Nox Medical ehf.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As a medical device accessory focused on signal measurement and equivalence to a predicate, the "ground truth" is established by direct physical/electrical measurements against known standards and the predicate device's performance, rather than expert interpretation of a clinical finding.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication mentioned, as the nature of the device (respiratory effort sensors) involves direct measurement and comparison, not subjective interpretation.
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
Not applicable. This device is a sensor and cable accessory, not an AI diagnostic tool that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device does not involve an algorithm with standalone performance. It measures respiratory effort signals, which are then used by sleep/polysomnography (PSG) systems, presumably to be interpreted by healthcare professionals.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the performance evaluation of these accessories primarily consists of:
- Engineering Specifications and Standard Compliance: Adherence to established ISO and IEC standards for medical devices (e.g., electrical safety, EMC, risk management, usability).
- Predicate Device Performance: The QDC-PRO AND NOX-RIP (K124062) device serves as the benchmark for "clinical equivalence" of signal quality. New devices' signals were compared against the predicate's signals using metrics like signal-to-noise ratio, signal range, bandwidth, and linearity.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this device does not involve machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device.
{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 EffortSensor | Respiratory Effort Sensor |
| ClassificationName: | Ventilatory EffortRecorder | Ventilatory Effort Recorder |
| RegulationNumber: | 868.2375 | 868.2375 |
| Product Code: | MNR | MNR |
| Device Class | Class II | Class II |
| ClassificationPanel: | 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. | EquivalentSee 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. | EquivalentSee 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 wireConnector: ABS plastic | Elastic: Polyester/Dorlastan (not made with natural rubber latex), tin plated copper wireConnector: 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 andThorax) | Identical |
| Respiratory EffortTechnology | RIP (Respiratory Inductive Plethysmography)technology | RIP (Respiratory InductivePlethysmography) technology | Identical |
| Signal Processing | No signal processing is done in RIP Belts | No signal processing is done inRIP Belts | Identical |
| Power and Isolation | |||
| Power Source | No power source. RIP Belts contain onlypassive components | No power source. RIP Beltscontain only passive components | Identical |
| Isolation | No component included in the RIP Belts thatare relied on as means of protection | No component included in theRIP Belts that are relied on asmeans of protection | Identical |
| Standards | |||
| AAMI/ANSI/ES60601-1 | 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 BeltCables | Comparison Results | ||
| General | ||||
| Intended Use | The QDC-PRO device isa sensor unit intendedfor measuring ofphysiological signalsduring sleep. The signalsmeasured are processedin the QDC-PRO deviceand the resulting signalsmade available at theoutput connector foracquisition by a thirdparty Polysomnography(PSG)/sleep recorder. | The RIP Belt Cables areintended to interconnectNox RIP belts(respiratory effortsensors) and Nox sleepdevices, to allowmeasuring of respiratoryeffort signals. | The Third Party RIP BeltCables are intended toallow measuring ofrespiratory effort signalsby interconnecting NoxRIP belts (respiratoryeffort sensors) and sleepdevices with oscillationcircuitry capable ofmeasuring inductancebetween 1 and 5 μH. | EquivalentSee Note 3 below |
| IntendedEnvironments | The intendedenvironments arehospitals, institutions,sleep centers, sleepclinics, or other testenvironments. | The intendedenvironments arehospitals, institutions,sleep centers, sleepclinics, or other testenvironments, includingthe patient's home. | The intendedenvironments arehospitals, institutions,sleep centers, sleep clinics,or other testenvironments, includingthe patient's home. | EquivalentSee Note 4 below |
| PatientPopulation | The QDC-PRO ANDNOX-RIP are indicatedfor use in patientsgreater than 2 years ofage. | The RIP Belt Cables areindicated for use onpatients greater than 2years of age. | The Third Party RIP BeltCables are indicated foruse on patients greaterthan 2 years of age. | Identical |
| PrescriptionUse | Yes | Yes | Yes | Identical |
| Type of Modules | RIP Belt Cable forconnection to recorderand RIP belts | RIP Belt Cable forconnection to recorderand RIP belts | RIP Belt Cables forconnection to recorder andRIP belts | Identical |
| Physical / Material | ||||
| RIP CablesMaterial | ● PVC – wire jacket● PC with 10% glassfiber – belt end● PC with 10% glassfiber – device end● Gold platedstainless steel -snaps● TPE - strain relief | ● PVC – wire jacket● ABS/PC - belt end● ABS/PC - deviceend● Gold platedstainless steel -snaps● TPE - strain relief | ● PVC – wire jacket● ABS/PC - belts end● TPE-ET - device endstrain relief● Gold plated stainlesssteel - snaps● TPE-ET - strain reliefNote: TPE-ET is alsoknown as Riteflex® | EquivalentSee 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 toPatient | RIP Belt Cable isattached to patient viaconnection to RIP belts | RIP Belt Cable isattached to patient viaconnection to RIP belts | Third Party RIP Belt Cablesare attached to patient viaconnection to RIP belts | Identical |
| Type ofEquipment toBe Connectedto | Interconnect sleeprecorder and respiratoryeffort sensor (RIP belt) | Interconnect sleeprecorder and respiratoryeffort sensor (RIP belt) | Interconnect sleeprecorder and respiratoryeffort sensor (RIP belt) | Identical |
| Belt CableConnectors -Recorder End | Proprietary connector forNox RIP snaps | Proprietary connector forNox RIP snaps | Touch proof 1 mm 2 pinfemale connector | EquivalentSee Note 6 below |
| Belt CableConnectors -Belt End | Gold coated proprietarymetal snaps | Gold coated proprietarymetal snaps | Gold coated proprietarymetal snaps | Identical |
| Signals and Sensors | ||||
| SignalProcessing | No signal processingdone in RIP Belt Cable | No signal processingdone in RIP Belt Cable | No signal processing donein Third Party RIP BeltCables | Identical |
| Power and Isolation | ||||
| Power Source | No power source. RIPBelt Cable contains onlypassive components | No power source. RIPBelt Cable contains onlypassive components | No power source. ThirdParty RIP Belt Cablescontain only passivecomponents | Identical |
| Isolation | No component includedin the RIP Belt Cablethat is relied on asmeans of protection | No component includedin the RIP Belt Cablethat is relied on asmeans of protection | No component included inthe Third Party RIP BeltCables that is relied on asmeans of protection | Identical |
| Standards | ||||
| AAMI/ANSI/ES60601-1 | 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
{13}------------------------------------------------
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.
{14}------------------------------------------------
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.
{15}------------------------------------------------
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.
{16}------------------------------------------------
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).
§ 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).