(258 days)
Not Found
No
The document describes a physical mask and its components, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a mask for positive airway pressure devices, which are therapeutic devices themselves. The mask itself is an accessory that interfaces with the patient and the therapeutic device, rather than providing therapy directly.
No
The device description clearly states it is a patient interface (mask) for use with positive pressure equipment (CPAP/bi-level), not for diagnostic purposes.
No
The device description clearly states it is a "patient interface" and describes physical components like a mask shell, gel cushion, headgear, and tubing assembly. The performance studies also focus on physical characteristics and mechanical testing, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be used with positive airway pressure devices for treating sleep apnea. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a patient interface (mask) for delivering positive pressure. It does not perform any tests on biological samples.
- Lack of Diagnostic Function: There is no mention of the device analyzing samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the mask (volume, flow, resistance, etc.) and biocompatibility, which are relevant to a therapeutic device, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / 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 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.
Product codes
BZD
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Seals around nose
Indicated Patient Age Range
adult patients (>30kg)
Intended User / Care Setting
single-patient multi-use in the home, hospital or institutional environment.
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)
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:
- ISO 10993-5:2009 Cytotoxicity MEM
- 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
Key results:
- Exhaust flow: Subject devices have slightly lower exhaust flow than predicate but similar. No acceptance criteria in ISO 17510:2015.
- iQ 2 (lpm): 18.2 (4 cm H2O) to 55.6 (30 cm H2O)
- Phantom 2 (lpm): 18.9 (4 cm H2O) to 56.8 (30 cm H2O)
- Predicate (lpm): 22.1 (4 cm H2O) to 60.4 (30 cm H2O)
- Dead space:
- iQ 2: Mask – 47.3 ml, Tubing – 68.33 ml
- Phantom 2: Mask – 30.7 ml, Tubing – 68.33 ml
- Predicate: Mask – 68.6 ml, Tubing – 62 ml
- Similar.
- Resistance to flow (pressure drop): Subject devices have lower pressure drop compared to the predicate. No acceptance criteria in ISO 17510:2015.
- Subject (iQ 2 and Phantom 2) pressure drop (cm H2O): 0.443 (50 lpm) to 2.057 (100 lpm)
- Predicate pressure drop (cm H2O): 0.86 (50 lpm) to 3.06 (100 lpm)
- Sound pressure and Sound power level: Similar. No acceptance criteria specified in ISO 17510:2015.
- iQ 2: Sound pressure - 30.32 dB, Sound power - 33.33 dB
- Phantom 2: Sound pressure – 30.49 dB, Sound power - 33.50 dB
- Predicate: Sound pressure – 29.90 dB, Sound power – 37.90 dB
- Operating Range: Operating Temperature: Do not expose the mask to temperatures above 122°F (50°C). Similar.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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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3
Sponsor:
| Sleepnet Corporation
| 5 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 Dryden |
| ProMedic, 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 868.5905 |
| Non-continuous ventilator (IPPB) | |
| BZD | |
| II | |
| Device: | iQ 2 and Phantom 2 Nasal Mask |
| Predicate Device: | |
| Regulation Number: | |
| Regulation Code: | |
| Product Code: | |
| Regulatory Class: | K021534 - Sleepnet iQ Nasal mask |
| 21CFR 868.5905 | |
| Non-continuous ventilator (IPPB) | |
| BZD | |
| II |
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.
4
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
5
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 Classification
CFR | BZD
CFR 868.5905 | BZD
CFR 868.5905 | Identical |
| Indications for Use | The iQ2 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 (>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 Corporation iQ® nasal mask is
intended to be used with positive airway pressure
devices, such as CPAP, operating at or above 3 cm
H2O for the treatment of adult obstructive sleep
apnea.
The mask is intended for single patient use, or
multiple patient use with proper high level
disinfection. The mask may be used in the home or
hospital/institutional environment. The mask is to
be used on adult patients (>30kg) for whom positive
airway pressure therapy has been prescribed. | Similar
The predicate included single
patient and multiple patient use,
whereas the subject devices will
be single patient use only. |
| Patient Population | Adult (>30 kg) | Adult (>30 kg) | Identical |
| Patient type | Patients for whom positive airway pressure
therapy has been prescribed | Patients for whom positive airway pressure therapy
has been prescribed | Identical |
| Prescriptive | Yes | Yes | Identical |
| Principle of Operation | Device provides a seal over the nose to allow for
delivery of pressurized air from a positive airway
pressure device. Device has an exhalation port for
flushing out exhaled CO2.
The device is passive until connected to the
positive pressure device. | Device provides a seal over the nose to allow for
delivery of pressurized air from a positive airway
pressure device. Device has an exhalation port for
flushing out exhaled CO2.
The device is passive until connected to the positive
pressure 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 are
identical. The upper limits is
determined by the equipment to
which the mask is attached.
Most CPAP machines today
have a higher upper limit of 30
cm H2O |
| Anatomical site | Seals around nose | Seals around nose | Identical |
| User Interface to
administer therapy | Masks have a standard 22mm connection that
connects to 22mm CPAP/bi-level circuits. | Masks has a standard 22mm connection that
connects to 22mm CPAP/bi-level circuits. | Identical |
| Contraindications | None | None | Identical |
| Environment of Use | The masks are intended for use in the home or
hospital/institutional environment. | The masks are intended for use in the home or
hospital/institutional environment. | Identical |
| Duration of Use | Single patient, multi-use | Single patient, multi-use
Multi-patient, multi-use | Similar
Removed multi-patient use for
the subject device. |
| Useful life | Mask cushion - 1 month
Swivel frame/tube set - 3 months
Headgear and magnetic clips - 6 months | 6 months | Components of the subject
device will be offered
individually as replacements |
| Shelf life | 5 years | No shelf life stated. | Similar
5 year shelf life has been
validated 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 to
the predicate as previously
cleared |
| 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 Exhaust
port | Yes | Yes | Identical |
| Components of the mask | • Mask cushion
o Mask shell with vent holes
o 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 per
ISO 10993-1 | Skin contact, Skin and
Externally Communicating with tissue (air
pathway)
Permanent contact | Skin contact, Skin and
Externally Communicating with tissue (air
pathway)
Permanent contact | Some materials are identical and
the headgear is new and tested
per ISO 10993-1 |
| Performance Characteristics | | | |
| Exhaust flow (vent flow) | Exhaust flow (lpm) | | Similar.
The exhaust flow of the
predicate is slightly higher.
There are no acceptance criteria
for exhaust flow in ISO
17510:2015. |
| | 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 ml
Tubing – 68.33 ml | Mask – 68.6 ml
Tubing – 62 ml | Similar |
| | Phantom 2 –
Mask – 30.7 ml
Tubing – 68.33 ml | | |
6
K211274 510(k) Summary Page 4 of 6
10-Jan-22
7
K211274 510(k) Summary
8
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 lower
pressure drop compared to the
predicate. There are no
acceptance criteria for pressure
drop in ISO 17510:2015. The
pressure drop for a device is
disclosed in the labeling This
aids therapists in deciding the
appropriate pressure setting
based on the desired therapy
pressure for the patient. |
| | 100 | 2.043 | 2.057 | 100 | 3.06 | |
| Sound pressure and Sound
power level | iQ 2 -
Sound pressure - 30.32 dB
Sound power - 33.33 dB
Phantom 2 -
Sound pressure – 30.49 dB
Sound power - 33.50 dB | | | Sound pressure – 29.90 dB
Sound power – 37.90 dB | | Similar.
There are no acceptance criteria
specified in ISO 17510:2015 for
sound 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.