(22 days)
No
The description focuses on the physical design and intended use of a nasal mask for positive airway pressure therapy, with no mention of AI or ML capabilities. The submission is primarily for updating warnings and contraindications related to magnets.
No
The device is a mask that delivers pressurized air from a positive airway pressure device; it is not a therapeutic device itself, but rather a component used with therapeutic devices like CPAP or bi-level machines.
No
The device is a nasal mask intended to deliver pressurized air for positive airway pressure therapy, not to diagnose a medical condition.
No
The device description clearly states it is a physical mask intended to be used with positive airway pressure devices, not a software application.
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 adult patients with prescribed positive airway pressure therapy. This is a therapeutic device, not a diagnostic one.
- Device Description: The device provides a seal over the nose to deliver pressurized air and has an exhalation port. It is a passive device until connected to a positive pressure device. This description aligns with a medical device used for therapy, not for analyzing samples from the body.
- No mention of in vitro analysis: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) which is a core characteristic of IVD devices.
- Anatomical Site: The device interacts with the face (seals around the nose), which is an external anatomical site for delivering therapy, not for collecting or analyzing internal samples.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to facilitate the delivery of positive airway pressure therapy, which is a treatment.
N/A
Intended Use / Indications for Use
The iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at 3 cmH2O to 30 cmH2O. The masks are to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The masks are 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 Vented masks are nearly identical to the Predicate Sleepnet iQ 2 and Phantom 2 Nasal Mask (K211274).
The subject of this submission is:
· Addition of a contraindication related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask
• Update to the warning related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face (seals around nose)
Indicated Patient Age Range
Adult (>30 kg)
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)
No new performance testing was conducted on the subject device, since the device designs are identical to the predicates. The performance test results from the predicate device were leveraged for the subject device.
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 logo of the U.S. Food & 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 15, 2024
Sleepnet Corporation % Paul Dryden President ProMedic Consulting LLC 131 Bay Point Dr NE St. Ptersburg, Florida 33704
Re: K241469
Trade/Device Name: iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: May 23, 2024 Received: May 24, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 -S
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241469
Device Name
iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask
Indications for Use (Describe)
The iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at 3 cmH2O to 30 cmH2O. The masks are to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The masks are 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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4
| Sponsor:
Sleepnet Corporation
5 Merrill Industrial Drive
| Hampton, NH 03842 | Tel - 603-758-6625 |
|---|---|
| Sponsor Contact: | Jennifer Kennedy - Director of Regulatory and Quality |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| Proprietary or Trade Name: | iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask |
| Common/Usual Name: | Patient interface for CPAP |
| Regulation Number: | |
| Regulation Code: | |
| Product Code: | 21CFR 868.5905 |
| Non-continuous ventilator (IPPB) | |
| BZD | |
| Device: | iQ 2 and Phantom 2 Nasal Vented Mask |
| Predicate Device: | |
| Regulation Number: | |
| Regulation Code: | |
| Product Code: | K211274 - Sleepnet iQ 2 and Phantom 2 Nasal Mask |
| 21CFR 868.5905 | |
| Non-continuous ventilator (IPPB) | |
| BZD |
Device Description:
The Sleepnet iQ 2 and Phantom 2 Nasal Vented masks are nearly identical to the Predicate Sleepnet iQ 2 and Phantom 2 Nasal Mask (K211274).
The subject of this submission is:
· Addition of a contraindication related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask
• Update to the warning related to magnets on the iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask
Indications for Use:
The iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at 3 cmH2O to 30 cmH2O. The masks are to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The masks are intended for single-patient multi-use in the home, hospital or institutional environment.
Patient Population: For adults (>30 kg)
Environment of Use: Home or hospital / institutional environments
Substantial Equivalence Discussion:
5
The Sleepnet iQ 2 and Phantom 2 Nasal Vented masks are viewed as substantially equivalent to the predicate device because:
Indications -
- We have updated the device name and removed "or above" in the Indications for Use which are similar.
- Similar to the predicate - K211274.
Patient Population -
- The masks are to be used on adult patients (>30 kg) for whom positive airway pressure ● therapy has been prescribed.
- Identical to the predicate K211274. ●
Environment of Use -
- The masks are intended for use in the home or hospital/institutional environment.
- Identical to the predicate K211274. ●
Technological Characteristics -
- Identical technology to the predicate K211274. ●
Non-Clinical Testing Summary -
Bench testing -
No new performance testing was conducted on the subject device, since the device designs are identical to the predicates.
Discussion - The performance test results from the predicate device were leveraged for the subject device.
Biocompatibility -
There has been no change in the materials – the subject and predicate device utilize the same materials.
Discussion - The biocompatibility test results from the predicate device were leveraged for the subject device.
Reprocessing -
There has been no change in the reprocessing - the subject and predicate device utilize the same reprocessing instructions.
Discussion - The reprocessing test results from the predicate device were leveraged for the subject device.
We have demonstrated that the proposed device is equivalent to the predicate, K211274.
6
K241469 510(k) Summary Page 3 of 7 15-Jun-24
Table of Comparison to Predicate
| Attributes | Subject -
iQ 2 Nasal Vented Mask and | Predicate -
iQ 2/ Phantom 2 Nasal Mask | Explanation of Differences |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| | Phantom 2 Nasal Vented Mask | | |
| 510(k) | K241469 | K211274 | |
| Product
Classification
CFR | BZD
CFR 868.5905 | BZD
CFR 868.5905 | Identical |
| Indications for Use | The iQ 2 Nasal Vented Mask and Phantom 2
Nasal Vented Mask are intended to be used with
positive airway pressure devices, such as CPAP
or bi-level, operating at 3 cmH2O to 30 cmH2O.
The masks are to be used on adult patients (>30
kg) for whom positive airway pressure therapy
has been prescribed. The masks are intended for
single-patient multi-use in the home, hospital or
institutional environment. | The iQ 2/ 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. 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. | Similar
Removed "or above" for clarity |
| 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 |
| Contraindication and
Warnings | New Contraindication
Do not use this mask if you or anyone (example:
household members, bed partners, caregivers, etc.)
in close physical contact with your mask has an
active medical implant or metallic implant that will
interact with magnets. Implant examples include,
but are not limited to, pacemakers, implantable | There were no contraindications in K211274. | New as per recall event #94169
Original K211274 labeling
available in Section
006_Labeling. |
| | | | |
| | cardioverter defibrillators (ICD), neurostimulators,
aneurysm clips, metallic stents, ocular implants,
insulin/infusion pumps, cerebral spinal fluid (CSF)
shunts, embolic coils, metallic splinter, implants to
restore hearing or balance with implanted magnets
(such as cochlear implants), flow disruption
devices, contact lenses with metal, dental implants,
metallic cranial plates, screws, burr hole covers,
bone substitute device, magnetic metallic
implants/electrodes/valves placed in upper limbs,
torso, or higher, etc. If you have any questions
regarding the implant, consult your physician or
the manufacturer of your implant.
Updated Warning
Magnets are used in the mask and headgear clips
with a field strength of 380mT. With the exception
of the devices identified in the contraindication,
ensure that the mask is kept at least 6 inches
(approx.16 cm) away from any other medical
implants or medical devices that can be impacted by
the magnetic fields to avoid possible effects from
localized magnetic fields. For instance, the
functioning of implants may change, or implants
may move within the body due to magnetic
attraction/repulsion. This applies to you or anyone
in close physical contact with your mask. | Magnet Warning
Magnets are used in the swivel frame/tube set and
the headgear clips. The magnetic field strength is
380 mT. Ensure that the magnets are kept at least
2.25 inches (6 cm) away from any active medical
implant or medical device that can be impacted by
the magnetic field (e.g., pacemaker, defibrillators,
neurostimulators, cochlear implants, hearing aids)
to avoid possible effects from localized magnetic
fields | |
| Therapy Pressure
Range | 3 cm H2O to 30 cm H2O. | 3 cm H2O to 30 cm H2O. | Identical |
| Anatomical site | Face (seals around nose) | Face (seals around nose) | Identical |
| | | | |
| User Interface
to administer
therapy | Masks have a standard 22mm connection that
connects to 22mm CPAP/bi-level circuits. | Masks have a standard 22mm connection that
connects to 22mm CPAP/bi-level circuits. | 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 |
| Attributes | Subject -
iQ 2/ Phantom 2 nasal vented mask | Predicate -
iQ 2/ Phantom 2 nasal mask | Explanation of Differences |
| Useful life | Mask cushion - 1 month
Swivel frame/tube set - 3 months Headgear
and magnetic clips – 6 months | Mask cushion - 1 month
Swivel frame/tube set - 3 months Headgear
and magnetic clips - 6 months | Identical |
| Shelf life | 5 years. | 5 years. | Identical |
| Non-sterile | Yes | Yes | Identical |
| Cleaning methods | Mild Soap (such as Ivory) and warm water | Mild Soap (such as Ivory) and warm water | Identical |
| Available sizes | 1 | 1 | Identical |
| Shape | Identical | Identical | Identical |
| Incorporates an Exhaust port | Yes | Yes | Identical |
| Components of the mask | Mask cushion Mask shell Gel bladder Headgear
Swivel frame/tube set (tubing assembly) | Mask cushion Mask shell Gel bladder Headgear
Swivel frame/tube set (tubing assembly) | Identical |
| Shell design | Soft | Soft | Identical |
7
K241469 510(k) Summary
8
K241469 510(k) Summary
| Duration of Use | Single patient, multi-use |
|---|---|
| Single patient, multi-use | |
| Identical |
9
K241469 510(k) Summary Page 6 of 7
15-Jun-24
| Attributes | Subject -
iQ 2/ Phantom 2 nasal vented mask | | | Predicate -
iQ 2/ Phantom 2 nasal mask | | | Explanation of Differences |
|-----------------------------------------|------------------------------------------------------------------------------------------------------|------------------------|-----------|------------------------------------------------------------------------------------------------------|------------------------|-----------|----------------------------|
| 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 | | | Identical |
| Exhaust Flow | Pressure
(cm H2O) | Exhaust flow (lpm) | | Pressure
(cm H2O) | Exhaust flow (lpm) | | Identical |
| | | iQ 2 | Phantom 2 | | iQ 2 | Phantom 2 | |
| | 4 | 18.2 | 18.9 | 4 | 18.2 | 18.9 | |
| | 8 | 26.3 | 27.5 | 8 | 26.3 | 27.5 | |
| | 12 | 34.3 | 35.2 | 12 | 34.3 | 35.2 | |
| | 16 | 39.6 | 39.2 | 16 | 39.6 | 39.2 | |
| | 20 | 44.0 | 45.3 | 20 | 44.0 | 45.3 | |
| | 24 | 49.8 | 50.6 | 24 | 49.8 | 50.6 | |
| | 28 | 53.4 | 55.3 | 28 | 53.4 | 55.3 | |
| | 30 | 55.6 | 56.8 | 30 | 55.6 | 56.8 | |
| Dead space | iQ 2 –
Mask – 47.3 ml
Tubing – 68.33 ml | | | iQ 2 –
Mask – 47.3 ml
Tubing – 68.33 ml | | | Identical |
| | Phantom 2 –
Mask – 30.7 ml
Tubing – 68.33 ml | | | Phantom 2 –
Mask – 30.7 ml
Tubing – 68.33 ml | | | |
| Resistance to flow (pressure
drop) | Flow rate
(lpm) | Pressure drop (cm H2O) | | Flow rate
(lpm) | Pressure drop (cm H2O) | | Identical |
| | | iQ 2 | Phantom 2 | | iQ 2 | Phantom 2 | |
| | 50 | 0.45 | 0.45 | 50 | 0.45 | 0.45 | |
| | 100 | 2.05 | 2.06 | 100 | 2.05 | 2.06 | |
| Sound pressure and Sound
power level | iQ 2 –
Sound pressure - 30.32 dB
Sound power - 33.33 dB | | | iQ 2 –
Sound pressure - 30.32 dB
Sound power - 33.33 dB | | | Identical |
| | Phantom 2 –
Sound pressure – 30.49 dB Sound power –
33.50 dB | | | Phantom 2 –
Sound pressure – 30.49 dB Sound power –
33.50 dB | | | |
10
K241469 510(k) Summary Page 7 of 7 15-Jun-24
Substantial Equivalence Conclusion:
The iQ 2 Nasal Vented Mask and Phantom 2 Nasal Ventical indications, technological characteristics and principles of operation and performance to the predicate and performance testing demonstrates that the subject device is use the predicate.