(782 days)
Maxxi RIP Sensor is intended for measuring of respiratory effort signals. They function as accessories for sleep/ polysomnography (PSG) systems.
The device is offered in different sizes to be used on adult patients.
The intended environments are hospitals, institutions, sleep centers or sleep clinics.
Maxxi Rip Sensor is a device intended to capture respiratory effort from a patient and output the signal to a PSG device for sleep studies. This signal is captured using an elastic belt fastened around the thorax or abdomen that will exhibit a change in tension as the thorax or abdomen expands or contracts. This change in tension is measured and converted to a signal output by the interface and processed by a PSG device.
The product is composed of 3 major parts, the interface box, the cable and the belt.
Cables are used to connect between the respiratory effort sensor (RIP belts) and the applicable sleep recorder/polysomnography (PSG) system.
The device is offered in different sizes to be used on adult patients.
The Maxxi Rip was validated with Neurovirtual BWMini PSG device recorder only, therefore we don't quarantee compatibility with other devices.
The provided document describes the Neurovirtual Maxxi RIP Sensor, an accessory for sleep/polysomnography (PSG) systems intended for measuring respiratory effort signals. The document outlines performance testing conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Performance Test Protocol | Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Belt Signal Verification | Verify the signal output stretching and releasing the inductive belt in order to get a sine wave form in the output. | The signal must have a clean sine wave form following the belts stimulation. Devices showing the signal output with interferences will be rejected. | The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the signal quality criteria. |
| Belt Dimensions | Verify if the dimensions of the belts in rest are within the acceptable range in accordance with the product specifications. | Smaller adjustment: 900mm, Larger adjustment: 1200mm, Allowance: +-10% | The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the dimensional criteria. |
| Belt Connectivity | Using a multimeter in continuity scale, check if the internal belt wiring has connectivity. | Not allowed false contact, or no connectivity. | The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the connectivity criteria. |
| Belt Visual Conditions | Verify the visual aspects of the product. Any scratches, ruptures, wrong labels, oxidation, packing flaws, and connector conditions will be rejected. | All damage types are not allowed, products with scratches, wire ruptures, wrong labeling, oxidation, packing flaws or connector issues will be rejected and not put to sales. | The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the visual condition criteria. |
| Cable Dimensions | Verify if the cable length is within the acceptable range. | Cable A: 250mm, Cable B: 2000mm, Allowance: +-5% | The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the dimensional criteria. |
| Cable Connectivity | Using a multimeter in continuity scale, check if the cable has connectivity. | Not allowed false contact, or no connectivity. | The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the connectivity criteria. |
| Cable Visual Conditions | Verify the visual aspects of the product. Any scratches, ruptures, wrong labels, oxidation, packing flaws, and connector conditions will be rejected. | All damage types are not allowed, products with scratches, wire ruptures, wrong labeling, oxidation, packing flaws or connector issues will be rejected and not put to sales. | The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the visual condition criteria. |
| Interface Functional Test | Verify if the signal output from the pre-approved belt is working properly. | The signal must have a clean sine wave form following the belts stimulation. Devices showing the signal output with interferences will be rejected. | The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the signal quality criteria. |
| Interface Visual Conditions | Verify the visual aspects of the product. Any scratches, ruptures, wrong labels, oxidation, packing flaws, and connector conditions will be rejected. | All damage types are not allowed, products with scratches, wire ruptures, wrong labeling, oxidation, packing flaws or connector issues will be rejected and not put to sales. | The document states: "Based on the performance test applied to this Maxxi Rip Sensor... we conclude that the quality and performance for the specified Indications for use for this product was reached..." This implies the device met the visual condition criteria. |
| Safety and Effectiveness | Submitted to standard IEC 60601-1 test. | Full compliance with IEC 60601-1. | Resulted in full compliance as reported in the test reports. |
| EMC Testing | Submitted to electromagnetic compatibility test, standard IEC 60601-1-2. | Full compliance with IEC 60601-1-2. | Resulted in full compliance as reported in the test reports. |
| Risk Analysis | Developed according to the ISO14971. | Appropriate actions related to risks found during the development to reach appropriate performance, safety and substantially equivalence with the predicate. | The Maxxi Rip was developed according to ISO14971 for appropriate actions related to risks found during the development. |
| Signal Quality and Comparison | Signal integrity tests were conducted for the Maxxi Rip Sensor with focus on signal to noise ratio, signal range, bandwidth and linearity. | Test results compared to the signal integrity test conducted for the predicate NOX-RIP. (Implied acceptance is comparable performance to predicate) | Signal integrity tests were conducted for the Maxxi Rip Sensor 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 NOX-RIP. No specific performance metrics or direct comparison results are provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "The performance test is executed for certain % amount of the products manufactured." It does not specify the exact sample size for the individual performance tests (Belt Signal Verification, Belt Dimensions, etc.). No information is provided regarding the country of origin of the data, or whether the tests were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable as the performance tests described are for a physical device (Maxxi RIP Sensor) and its components, and do not involve human interpretation or a "ground truth" derived from expert consensus in the clinical sense. The "ground truth" here is the expected physical or electrical characteristic according to specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a physical device testing, not a clinical study involving human assessment of data. The pass/fail criteria are objective measurements.
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. The Maxxi RIP Sensor is a hardware device for measuring respiratory effort. It is not an AI algorithm or a diagnostic tool that involves human readers or assessment of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests (e.g., Belt Dimensions, Cable Connectivity) is based on the pre-defined product specifications and engineering standards (e.g., 900mm-1200mm for belt length, continuity for cables, clean sine wave form for signal). For safety and EMC testing, it is compliance with international standards (IEC 60601-1, IEC 60601-1-2) and risk analysis (ISO14971). For signal quality, it is a comparison to the predicate device, although no specific metrics were reported.
8. The sample size for the training set
Not applicable. This is a hardware device and does not involve machine learning or training sets.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 24, 2019
Neurovirtual USA, INC. Eduardo Faria CEO 2315 NW 107th Ave Suite# 1M27 Doral, Florida 33172
Re: K171304
Trade/Device Name: Maxxi Rip Sensor Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: May 17, 2019 Received: May 22, 2019
Dear Eduardo Faria:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for James J. Lee. Ph.D. Assistant Director DHT1C: Division of ENT. Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171304
Device Name Maxxi Rip Sensor
Indications for Use (Describe)
Maxxi RIP Sensor is intended for measuring of respiratory effort signals. They function as accessories for sleep/ polysomnography (PSG) systems.
The device is offered in different sizes to be used on adult patients.
The intended environments are hospitals, institutions, sleep centers or sleep clinics.
| 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform graphic in shades of orange, followed by the word "NEUROVIRTUAL" in dark blue. A thin, light orange line extends from the waveform graphic over the word "NEUROVIRTUAL".
Neurovirtual USA Inc. 3303 W Commercial Blvd Suite #100 Fort Lauderdale. FL 33309 - USA Phone: (786) 693-8200 – Fax (305) 393-8429
Section 5 510(k) SUMMARY
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A) Submitter's Name: Neurovirtual USA. Inc.
Owner / Operator Registration Number: 9091724 Manufacture Registration Number: 3006136239 -
B) Address: 3303 W Commercial Blvd #100 Fort Lauderdale, FL 33309 USA
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C) Phone and Fax Numbers Phone: (786) 693-8200 Fax: (305) 393-8429
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D) Contact Person: Eduardo J. Faria
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E) Preparation Date: June 21, 2019
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F) Classification Name:
Common / Usual Name: Ventilatory effort recorder Proprietary Name: Maxxi Rip Sensor Product Code: MNR Class: Class II Regulation: 21 CFR 868.2375
G) Device Description
Maxxi Rip Sensor is a device intended to capture respiratory effort from a patient and output the signal to a PSG device for sleep studies. This signal is captured using an elastic belt fastened around the thorax or abdomen that will exhibit a change in tension as the thorax or abdomen expands or contracts. This change in tension is measured and converted to a signal output by the interface and processed by a PSG device.
The product is composed of 3 major parts, the interface box, the cable and the belt.
Cables are used to connect between the respiratory effort sensor (RIP belts) and the applicable sleep recorder/polysomnography (PSG) system.
The device is offered in different sizes to be used on adult patients.
The Maxxi Rip was validated with Neurovirtual BWMini PSG device recorder only, therefore we don't quarantee compatibility with other devices.
H) Substantial Equivalence:
The Maxxi Rip Sensor is equivalent with the following products:
| 510(k) Number | Model | Company |
|---|---|---|
| K151361 | Nox RIP Belts | Nox Medical ehf |
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Image /page/4/Picture/0 description: The image shows the logo for Neurovirtual. The logo features a stylized waveform graphic in shades of orange and yellow on the left. To the right of the graphic is the word "NEUROVIRTUAL" in a bold, sans-serif font, with the "O" in "NEURO" replaced by a solid orange circle.
Neurovirtual USA Inc. 3303 W Commercial Blvd Suite #100 Fort Lauderdale, FL 33309 - USA Phone: (786) 693-8200 – Fax (305) 393-8429
1. Indications for Use:
| Indications for Use Comparison | |
|---|---|
| Neurovirtual | Nox Medical ehf |
| Maxxi Rip Sensor | Nox RIP Belts |
| Maxxi RIP Sensor is intended for measuring ofrespiratory effort signals. They function asaccessories for sleep/polysomnography (PSG)systems. | Nox RIP Belts are intended for measuring ofrespiratory effort signals. They function asaccessories for sleep/polysomnography (PSG)systems. |
| The device is offered in different sizes to be usedon adult patients. | The intended environments are hospitals,institutions, sleep centers, sleep clinics, or othertest environments, including the patient´s home. |
| The intended environments are hospitals,institutions, sleep centers or sleep clinics. |
2. Technological Characteristics Comparison:
The predicate devices used to establish substantial equivalence for the Maxxi Rip Sensor is outlined below. This section of this submission will provide a comparison of design, materials, and technical specifications of the Maxxi Rip Sensor to each of the predicate devices stratified by functional modality.
| Specifications Comparison | |||
|---|---|---|---|
| Device Brand andCommon Name | NeurovirtualMaxxi Rip Sensor | Nox Medical ehfNox RIP Belts | Comments |
| 510(k) Number | K171304 | K151361 | NA |
| Classification | MNR | MNR | Identical |
| Regulation # | 21 CFR 868.2375 | 21 CFR 868.2375 | Identical |
| Classification Name | Ventilatory effort recorder | Ventilatory effort recorder | Identical |
| Patient Population | Indicated for use on patientsgreater than 2 years of age | Indicated for use on patients greaterthan 2 years of age | Identical |
| Prescription Use | YES | YES | Identical |
| Mechanism ofaction/Principle ofoperation | respiratory inductanceplethysmograph | respiratory inductanceplethysmograph | Identical |
| Intended EnvironmentUse | hospitals, institutions, sleepcenters or sleep clinics | hospitals, institutions, sleep centers,sleep clinics, or other testenvironments, including thepatient´s home | Equivalent |
| Type of modules | RIP Belt and Interface | Rip Belt and Interface | Identical |
| Frequency Response | 0-1Hz | Not declared | Equivalent |
| Disposable | RIP Belts: DisposableInterface and Cable: ReusableAdjustable Belt: Reusable | RIP Belts: DisposableInterface and Cable: Reusable | Equivalent |
| Shelf life | 10 years | Not declared | Equivalent |
| Dimensions | 50.80 x 36.50 x 18.90 mm | Not declared | Equivalent |
| Different belt sizes | YES from X-Small to X-Large | YES from X-Small to X-Large | Identical |
| RIP Belt Material | Polyester/DorlastanABS BucklesNylon - Velcro | Polyester/Dorlastan | Equivalent |
| Cables Material | PVC - plastic injection | - PVC - wire jacket | Equivalent |
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Image /page/5/Picture/0 description: The image shows the logo for Neurovirtual. The logo consists of a stylized waveform graphic in shades of orange, followed by the word "NEUROVIRTUAL" in blue. The "O" in Neurovirtual is replaced with a solid orange circle. The waveform graphic is positioned to the left of the text, with a horizontal line extending from the waveform to the beginning of the word "NEUROVIRTUAL".
Neurovirtual USA Inc. 3303 W Commercial Blvd Suite #100 Fort Lauderdale. FL 33309 - USA Phone: (786) 693-8200 – Fax (305) 393-8429
| TPE - device end strain reliefTPU - wire jacketNi plated stainless steel – snaps | ABS/PC - belts endTPE - device end strain reliefGold plated stainless steel - snaps | ||
|---|---|---|---|
| Interface EnclosureMaterial | Plastic ABS enclosureElectronic componentsPrinted Circuit board | ABS plastic | Equivalent |
| Connection to Patient | Around the abdomen or thorax | Around the abdomen or thorax | Identical |
| Type of Equipment toBe Connected to | Sleep recorder | Sleep recorder | Identical |
| Connector Type | Monopolar DIN 42-802touch proof | Nox proprietary RIP snaps | Equivalent |
| Signals Measured | Respiratory Effort (Abdomen andThorax) | Respiratory Effort (Abdomen andThorax) | Identical |
| Respiratory EffortTechnology | RIP (Respiratory InductivePlethysmography)technology | RIP (Respiratory InductivePlethysmography)technology | Identical |
| Power Source | Not intended to be connected tothe power grid | Not intended to be connected to thepower grid | Identical |
| Isolation | No component included in theRIP Belts thatare relied on as means ofprotection | No component included in the RIPBelts thatare relied on as means of protection | Identical |
| Applicable Standards | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | Identical |
| Packing | Plastic bag | Plastic bag | Identical |
Discussion: As showed above the comparison shows that Maxxi Rip Sensor was developed to be substantial equivalent to the predicate, despite the small differences in the intended environment use and material the subject device does meet the performance criteria when compared with the predicate demonstrating substantially equivalence.
I) Performance Testing Summary:
1. Safety and Effectiveness Testing
The Maxxi Rip was submitted to standard IEC 60601-1 test which resulted in full compliance as reported in the test reports.
2. EMC Testing
The Maxxi Rip was submitted to electromagnetic compatibility test, standard IEC 60601-1-2 which resulted in full compliance as reported in the test reports.
3. Risk Analysis
The Maxxi Rip was developed according to the ISO14971 for appropriate actions related to risks found during the development to reach appropriate performance, safety and substantially equivalence with the predicate.
4. Signal Quality and Comparison Testing:
Siqnal integrity tests were conducted for the Maxxi Rip Sensor 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 NOX-RIP.
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Neurovirtual USA Inc. 3303 W Commercial Blvd Suite #100 Fort Lauderdale, FL 33309 - USA Phone: (786) 693-8200 – Fax (305) 393-8429
5. Performance Testing:
The performance test is executed for certain % amount of the products manufactured. This phase is necessary to identify possible flaws with the product and manufacturing process mistakes.
| Performance Testprotocol | Description | Acceptance Criteria |
|---|---|---|
| Belt Signal Verification | Verify the signal output stretching andreleasing the inductive belt in order to geta sine wave form in the output. | The signal must have a clean sine wave formfollowing the belts stimulation. Devices withshowing the signal output with interreferences willbe rejected. |
| Belt Dimensions | Verify if the dimensions of the belts in restare within the acceptable range inaccordance with the productspecifications. | Smaller adjustment: 900mmLarger adjustment: 1200mmAllowance: +-10% |
| Belt Connectivity | Using a multimeter in continuity scale,check if the internal belt wiring hasconnectivity. | Not allowed false contact, or no connectivity. |
| Belt Visual Conditions | Verify the visual aspects of the product.Any scratches, ruptures, wrong labels,oxidation, packing flaws, and connectorconditions will be rejected. | All damage types are not allowed, products withscratches, wire ruptures, wrong labeling, oxidation,packing flaws or connector issues will be rejectedand not put to sales. |
| Cable Dimensions | Verify if the cable length is within theacceptable range. | Cable A: 250mmCable B: 2000mmAllowance: +-5% |
| Cable Connectivity | Using a multimeter in continuity scale,check if the cable has connectivity. | Not allowed false contact, or no connectivity. |
| Cable Visual Conditions | Verify the visual aspects of the product.Any scratches, ruptures, wrong labels,oxidation, packing flaws, and connectorconditions will be rejected. | All damage types are not allowed, products withscratches, wire ruptures, wrong labeling, oxidation,packing flaws or connector issues will be rejectedand not put to sales. |
| Interface functionaltest | Verify if the signal output from the pre-approved belt is working properly. | The signal must have a clean sine wave formfollowing the belts stimulation. Devices withshowing the signal output with interreferences willbe rejected. |
| InterfaceVisual Conditions | Verify the visual aspects of the product.Any scratches, ruptures, wrong labels,oxidation, packing flaws, and connectorconditions will be rejected. | All damage types are not allowed, products withscratches, wire ruptures, wrong labeling, oxidation,packing flaws or connector issues will be rejectedand not put to sales. |
Conclusion: Based on the performance test applied to this Maxxi Rip Sensor and the predicate comparison, we conclude that the quality and performance for the specified Indications for use for this product was reached as well the substantially equivalency to the predicate.
§ 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).