(258 days)
The iQ 2 and Phantom 2 Nasal Mask is intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O to 30 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital or institutional environment.
The Sleepnet iQ 2 and Phantom 2 Nasal masks are patient interfaces for use with positive pressure equipment, i.e., CPAP and bi-level. They incorporate an exhaust port in the shell. The 2 styles are similar: Same patient population and Indications for Use, Same headgear, Same headgear connector components, Same tubing assembly, Same materials and manufacturing processes. They differ only in: Mask shell shape, Gel cushion shape.
This is a 510(k) summary for the iQ 2 and Phantom 2 Nasal Mask, which is a medical device and not an AI/ML product. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and studies for an AI/ML device.
The document discusses the substantial equivalence of the iQ 2 and Phantom 2 Nasal Mask to a predicate device (iQ Nasal Mask) based on non-clinical testing for biocompatibility and performance bench testing against standards like ISO 17510-2 and ISO 5356-1.
Here's a breakdown of what the document does provide, and why it doesn't fit your AI/ML criteria:
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A table of acceptance criteria and the reported device performance:
- The document provides a "Table of Comparison to Predicate" (page 5) which lists various attributes like product classification, indications for use, patient population, technical characteristics, and performance characteristics (Exhaust flow, Dead space, Resistance to flow, Sound pressure and Sound power level).
- However, these are comparison points to a predicate device, not pre-defined acceptance criteria for an AI/ML model's performance metrics (like accuracy, sensitivity, specificity, AUC). For performance characteristics like "Exhaust flow" there's a comparison to the predicate, and for "Resistance to flow" and "Sound pressure/power level" it states there are "no acceptance criteria" in the relevant ISO standard but notes similarities or differences to the predicate.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document describes physical device testing, not data-driven model testing.
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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): Not applicable. "Ground truth" in the context of AI/ML diagnostic performance is not relevant here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 is not an AI-assisted device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the physical device performance would be the results of the bench tests against established standards.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the regulatory clearance of a physical medical device (nasal mask) based on substantial equivalence to a predicate device and adherence to relevant performance standards through bench testing, not a study of an AI/ML device.
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January 10, 2022
Sleepnet Corporation % Paul Dryden President ProMedic. LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704
Re: K211274
Trade/Device Name: iQ 2 and Phantom 2 Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: December 10, 2021 Received: December 13, 2021
Dear Paul Dryden:
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 Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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-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 Advice (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,
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211274
Device Name iQ 2 and Phantom 2 Nasal Mask
Indications for Use (Describe)
The iQ 2 and Phantom 2 Nasal Mask is intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O to 30 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital or institutional environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Sponsor:
| Sleepnet Corporation5 Merrill Industrial Drive | Tel - 603-758-6625 |
|---|---|
| Hampton, NH 03842 | Fax - 603-758-6699 |
| Sponsor Contact: | Jennifer Kennedy - Director of Regulatory and Quality |
| Submission Correspondent: | Paul DrydenProMedic, LLC |
| Proprietary or Trade Name: | iQ 2 and Phantom 2 Nasal Mask |
| Common/Usual Name: | Patient interface for CPAP |
| Regulation Number:Regulation Code:Product Code:Regulatory Class: | 21CFR 868.5905Non-continuous ventilator (IPPB)BZDII |
| Device: | iQ 2 and Phantom 2 Nasal Mask |
| Predicate Device:Regulation Number:Regulation Code:Product Code:Regulatory Class: | K021534 - Sleepnet iQ Nasal mask21CFR 868.5905Non-continuous ventilator (IPPB)BZDII |
Device Description:
The Sleepnet iQ 2 and Phantom 2 Nasal masks are patient interfaces for use with positive pressure equipment, i.e., CPAP and bi-level. They incorporate an exhaust port in the shell.
The 2 styles are similar:
- Same patient population and Indications for Use ●
- . Same headgear
- . Same headgear connector components
- Same tubing assembly ●
- Same materials and manufacturing processes
They differ only in:
- Mask shell shape
- Gel cushion shape .
Indications for Use:
The iQ 2 and Phantom 2 Nasal Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O to 30 cmH2O. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital or institutional environment.
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510(k) Summary Page 2 of 6 10-Jan-22
Patient Population: For adults (>30 kg)
Environment of Use: Home or hospital / institutional environments
Substantial Equivalence Discussion:
The Sleepnet iQ 2 and Phantom 2 Nasal masks are viewed as substantially equivalent to the predicate device because:
Indications -
- The masks are to be used on adult patients (>30 kg) for whom positive airway pressure ● therapy has been prescribed.
- Similar to the predicate. ●
Patient Population -
- The masks are to be used on adult patients (>30 kg) for whom positive airway pressure ● therapy has been prescribed.
- Similar to the predicate. ●
Environment of Use -
- The masks are intended for use in the home or hospital/institutional environment. ●
- Similar to the predicate. ●
Technological Characteristics -
- Similar technology to the predicate.
Non-clinical testing
Biocompatibility -
- Some materials have been identified as identical to similar Sleepnet masks and a material certification provided. For the head strap, following testing were performed:
- o ISO 10993-5:2009 Cytotoxicity MEM
- o ISO 10993-10:2010 Sensitization and Irritation.
Performance bench testing
The following performance tests were performed as per ISO 17510-2- Medical Devices - Sleep Apnoea Breathing Therapy - Masks And Application Accessories:
- Internal Volume / Dead space
- Exhaust flow .
- Resistance to Flow .
- Mechanical Drop test
ISO 5356-1 ISO 5356-1:1996 - Anaesthetic and Respiratory Equipment -- Conical Connectors --Part 1: Cones And Socket
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K211274 510(k) Summary Page 3 of 6 10-Jan-22
Table of Comparison to Predicate
| Attributes | Subject –iQ 2 and Phantom 2 nasal mask | Predicate –iQ nasal mask | Explanation of Differences |
|---|---|---|---|
| 510(k) | K211274 | K021534 | - |
| Product ClassificationCFR | BZDCFR 868.5905 | BZDCFR 868.5905 | Identical |
| Indications for Use | The iQ2 and Phantom 2 Nasal Mask is intendedto be used with positive airway pressure devices,such as CPAP or bi-level, operating at or above 3cm H2O to 30 cmH2O. The mask is to be used onadult patients (>30kg) for whom positive airwaypressure therapy has been prescribed. The mask isintended for single-patient multi-use in the home,hospital or institutional environment. | The Sleepnet Corporation iQ® nasal mask isintended to be used with positive airway pressuredevices, such as CPAP, operating at or above 3 cmH2O for the treatment of adult obstructive sleepapnea.The mask is intended for single patient use, ormultiple patient use with proper high leveldisinfection. The mask may be used in the home orhospital/institutional environment. The mask is tobe used on adult patients (>30kg) for whom positiveairway pressure therapy has been prescribed. | SimilarThe predicate included singlepatient and multiple patient use,whereas the subject devices willbe single patient use only. |
| Patient Population | Adult (>30 kg) | Adult (>30 kg) | Identical |
| Patient type | Patients for whom positive airway pressuretherapy has been prescribed | Patients for whom positive airway pressure therapyhas been prescribed | Identical |
| Prescriptive | Yes | Yes | Identical |
| Principle of Operation | Device provides a seal over the nose to allow fordelivery of pressurized air from a positive airwaypressure device. Device has an exhalation port forflushing out exhaled CO2.The device is passive until connected to thepositive pressure device. | Device provides a seal over the nose to allow fordelivery of pressurized air from a positive airwaypressure device. Device has an exhalation port forflushing out exhaled CO2.The device is passive until connected to the positivepressure device. | Identical |
| Attributes | Subject –iQ 2 and Phantom 2 nasal mask | Predicate –iQ nasal mask | Explanation of Differences |
| Therapy Pressure | 3 cm H2O to 30 cm H2O. | 3 cm H2O to 20 cm H2O. | Similar. The lower limits areidentical. The upper limits isdetermined by the equipment towhich the mask is attached.Most CPAP machines todayhave a higher upper limit of 30cm H2O |
| Anatomical site | Seals around nose | Seals around nose | Identical |
| User Interface toadminister therapy | Masks have a standard 22mm connection thatconnects to 22mm CPAP/bi-level circuits. | Masks has a standard 22mm connection thatconnects to 22mm CPAP/bi-level circuits. | Identical |
| Contraindications | None | None | Identical |
| Environment of Use | The masks are intended for use in the home orhospital/institutional environment. | The masks are intended for use in the home orhospital/institutional environment. | Identical |
| Duration of Use | Single patient, multi-use | Single patient, multi-useMulti-patient, multi-use | SimilarRemoved multi-patient use forthe subject device. |
| Useful life | Mask cushion - 1 monthSwivel frame/tube set - 3 monthsHeadgear and magnetic clips - 6 months | 6 months | Components of the subjectdevice will be offeredindividually as replacements |
| Shelf life | 5 years | No shelf life stated. | Similar5 year shelf life has beenvalidated for the subject devices. |
| Non-sterile | Yes | Yes | Identical |
| Cleaning methods | Mild Soap and warm water | Mild detergent and warm water | Cleaning method is identical tothe predicate as previouslycleared |
| Features | |||
| Available sizes | 1 | 1 | Identical |
| Shape | Similar | Similar | Similar |
| Attributes | Subject –iQ 2 and Phantom 2 nasal mask | Predicate –iQ nasal mask | Explanation of Differences |
| Incorporates an Exhaustport | Yes | Yes | Identical |
| Components of the mask | • Mask cushiono Mask shell with vent holeso Gel bladder• Headgear• Swivel frame/tube set (tubing assembly) | • Mask shell• Gel bladder• Vented elbow• Headgear• Tubing | Similar |
| Shell design | Soft | Soft | Similar |
| Patient Contact perISO 10993-1 | Skin contact, Skin andExternally Communicating with tissue (airpathway)Permanent contact | Skin contact, Skin andExternally Communicating with tissue (airpathway)Permanent contact | Some materials are identical andthe headgear is new and testedper ISO 10993-1 |
| Performance Characteristics | |||
| Exhaust flow (vent flow) | Exhaust flow (lpm) | Similar.The exhaust flow of thepredicate is slightly higher.There are no acceptance criteriafor exhaust flow in ISO17510:2015. | |
| Pressure(cm H2O) | iQ 2 | Phantom 2 | |
| 4 | 18.2 | 18.9 | |
| 8 | 26.3 | 27.5 | |
| 12 | 34.6 | 35.2 | |
| 16 | 39.6 | 39.2 | |
| 20 | 44.0 | 45.3 | |
| 24 | 49.8 | 50.6 | |
| 28 | 53.4 | 55.3 | |
| 30 | 55.6 | 56.8 | |
| Pressure(cm H2O) | Exhaust flow (lpm) | ||
| 4 | 22.1 | ||
| 8 | 28.7 | ||
| 12 | 37.1 | ||
| 16 | 44.3 | ||
| 20 | 49.8 | ||
| 24 | 54.2 | ||
| 28 | 58.7 | ||
| 30 | 60.4 | ||
| Dead space | iQ 2 –Mask – 47.3 mlTubing – 68.33 ml | Mask – 68.6 mlTubing – 62 ml | Similar |
| Phantom 2 –Mask – 30.7 mlTubing – 68.33 ml |
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K211274 510(k) Summary Page 4 of 6
10-Jan-22
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K211274 510(k) Summary
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K211274 510(k) Summary Page 6 of 6 10-Jan-22
| Resistance to flow(pressure drop) | Flow rate(lpm) | Pressure drop (cm H2O) | Flow rate(lpm) | Pressure drop(cm H2O) | ||
|---|---|---|---|---|---|---|
| 50 | 0.443 | 0.447 | 50 | 0.86 | The subject devices have a lowerpressure drop compared to thepredicate. There are noacceptance criteria for pressuredrop in ISO 17510:2015. Thepressure drop for a device isdisclosed in the labeling Thisaids therapists in deciding theappropriate pressure settingbased on the desired therapypressure for the patient. | |
| 100 | 2.043 | 2.057 | 100 | 3.06 | ||
| Sound pressure and Soundpower level | iQ 2 -Sound pressure - 30.32 dBSound power - 33.33 dBPhantom 2 -Sound pressure – 30.49 dBSound power - 33.50 dB | Sound pressure – 29.90 dBSound power – 37.90 dB | Similar.There are no acceptance criteriaspecified in ISO 17510:2015 forsound levels. | |||
| Operating Range | Operating Temperature: Do not expose the mask to temperatures above 122°F (50°C). | Similar |
Substantial Equivalence Conclusion:
The iQ2 and Phantom 2 Nasal masks have similar indications, technological characteristics and principles of operation and performance to the predicate and performance testing demonstrates that the proposed device is substantially equivalent to the predicate.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).