(153 days)
Not Found
No
The device description and performance studies focus on the physical components and basic functional performance of a CPAP mask, with no mention of AI or ML technologies.
No.
The device is a mask that provides an interface for the application of CPAP or bi-level therapy, but it does not generate the therapy itself.
No
Explanation: The device is a mask intended to provide an interface for the application of CPAP or bi-level therapy, which are forms of treatment, not diagnosis. Its purpose is to deliver air to patients, not to detect or identify medical conditions.
No
The device description clearly outlines physical components such as a mask frame, cushions, headgear, and tubing, and the performance studies include testing of physical properties like resistance, leak, and magnetic strength. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide an interface for CPAP or bi-level therapy, which is a medical treatment delivered to a patient's respiratory system. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a mask, cushions, frame, headgear, and tubing – all components used for delivering air pressure to a patient. There is no mention of components or processes related to testing samples from the human body (like blood, urine, tissue, etc.) to diagnose a condition.
- Performance Studies: The performance studies listed focus on the physical and functional aspects of the mask (resistance, leak, CO2 rebreathing, sound, deadspace, magnetic strength, cleaning/disinfection). These are relevant to a therapeutic device, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing samples, reagents, or any other elements typically associated with in vitro diagnostics.
In summary, the device is a medical device used for therapy, not for diagnosing a condition by testing samples outside of the body.
N/A
Intended Use / Indications for Use
This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients > 7 years old (> 40 lbs) for whom CPAP or bi-level therapy has been prescribed.
Product codes
BZD
Device Description
The Magneto Nasal Mask includes two cushion type options: a nasal, cradle cushion and nasal, pillows cushion. The nasal cradle cushion seals around the bottom of the patient's nose, and comes in five sizes (extra small, medium wide, large). The nasal pillows cushion tips seal at the entrance to the nares. The pillows cushion base sits under the nares, and comes in five sizes (extra small, small, medium wide, large). Both of the cushion design options contain enclosed magnets.
The mask frame also contains enclosed magnets, and connects to the mask cushion magnetically for easy and secure assembly by the user. The mask frame comes in one size and connects to the tubing with a snap fit, which allows the frame attached to the tubing.
The fabric headgear goes over the top of the mask frame and around the patient's head. The headgear comes in one size and includes adjustment sliders to allow for a large or small fitting on the patient's head.
The mask includes 10 mm tubing. The 10 mm tubing contains built-in exhalation at the top of the tube where the tubing connects to the mask frame. The tubing also includes an ISO 5356-1 compliant, 22 mm male conical swivel. The tubing swivel connects directly to ISO 5356-1 compliant, 22 mm female connections used on therapy device tubing. The tubing swivel detaches from the mask tubing, via a quick disconnect feature. The tubing connects to 12 mm connections when the tubing swivel is detached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose
Indicated Patient Age Range
7 years old (> 40 lbs)
Intended User / Care Setting
single patient use in the home and multi-patient use in the hospital/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)
Performance testing was performed to verify that the device modifications did not affect the safety and effectiveness of the subject device. Performance testing included:
- Resistance, derived from pressure drop (pre & post cleaning and disinfection)
- Total Mask Leak (pre & post cleaning and disinfection)
- CO2 rebreathing
- A-weighted sound power and pressure levels
- Deadspace
- Magnetic strength
- Cleaning validation
- Cleaning residuals
- Disinfection validation
- Disinfection residuals
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
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July 12, 2021
Respironics, Inc. Anna Danley Senior Regulatory Affairs Engineer 1740 Golden Mile Highway Monroeville. Pennsylvania 15146
Re: K210386
Trade/Device Name: Magneto Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: June 3, 2021 Received: June 3, 2021
Dear Anna Danley:
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 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
1
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 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, 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
2
Indications for Use
510(k) Number (if known) K210386
Device Name Magneto Nasal Mask
Indications for Use (Describe)
This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients > 7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed.
| 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
| Date 510(k) Summary Prepared | July 9, 2021 |
|---|---|
| 510(k) Owner | Respironics, Inc. |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| Official Contact | Anna Danley |
| Senior Regulatory Affairs Engineer | |
| P: (412)-542-3513 | |
| E: anna.danley@philips.com | |
| Establishment Registration # | 2518422 |
| Proprietary Name | Magneto Nasal Mask |
| Common/Usual Name | Nasal Mask |
| Classification | Class II device |
| Classification Panel | Anesthesiology |
| Classification Reference | 21 CFR 868.5905 |
| Classification Name/Product Code | Ventilator, non-continuous (respirator)/BZD |
4
Device Description
The Magneto Nasal Mask includes two cushion type options: a nasal, cradle cushion and nasal, pillows cushion. The nasal cradle cushion seals around the bottom of the patient's nose, and comes in five sizes (extra small, medium wide, large). The nasal pillows cushion tips seal at the entrance to the nares. The pillows cushion base sits under the nares, and comes in five sizes (extra small, small, medium wide, large). Both of the cushion design options contain enclosed magnets.
The mask frame also contains enclosed magnets, and connects to the mask cushion magnetically for easy and secure assembly by the user. The mask frame comes in one size and connects to the tubing with a snap fit, which allows the frame attached to the tubing.
The fabric headqear goes over the top of the mask frame and around the patient's head. The headgear comes in one size and includes adjustment sliders to allow for a large or small fitting on the patient's head.
The mask includes 10 mm tubing. The 10 mm tubing contains built-in exhalation at the top of the tube where the tubing connects to the mask frame. The tubing also includes an ISO 5356-1 compliant, 22 mm male conical swivel. The tubing swivel connects directly to ISO 5356-1 compliant, 22 mm female connections used on therapy device tubing. The tubing swivel detaches from the mask tubing, via a quick disconnect feature. The tubing connects to 12 mm connections when the tubing swivel is detached.
The key benefits of this device to the patient are:
- Ease of use
- Secure magnetic cushion and frame fitting
- Comfort
- Choice through two nasal cushion options
- User appeal and non-intimidating design
Indications for Use Statement
This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home and multi-patient use in the hospital/institutional environment. The mask is to be used on patients > 7 years old (> 40 lbs) for whom CPAP or bi-level therapy has been prescribed.
Similarities and Differences of the Indications for Use
Like the predicate device, Simple T Youth Nasal Mask (K140268), the subject device, the Magneto Nasal Mask, is intended to provide an interface for application of CPAP or bi-level therapy. Both masks provide a connection between the noninvasive positive pressure ventilation device and the patient wearing the mask.
5
Both the predicate and the subject device are to be used on patients > 7 years old (> 40 lbs) for whom CPAP or bi-level therapy has been prescribed. CPAP or bi-level therapy treats Sleep Disordered Breathing and Respiratory Insufficiency caused by central and/or mixed apneas, periodic breathing, and intermittent ventilatory support for individuals who require mechanical ventilation.
Additionally, both the predicate and the subject device are for single patient use in the home or multipatient use in the hospital/institutional environment.
Subject Device Compared to the Predicate Device
The subject device, the Magneto Nasal Mask, has the following similarities to the previously cleared predicate device, Simple T Youth Nasal Mask (K140268):
- Same operating principle
- . Same nasal mask design type
- Same patient population ●
- Same environment of use
- Same patient usage type (single patient use/multi-patient use) .
Respironics, Inc. has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the Magneto Nasal Mask device in this submission is substantially equivalent to the predicate device.
| Feature/Function | Predicate Device:
Simple T Youth Nasal
Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K140268 | Subject Device:
Magneto Nasal Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K210386 | Similarities
and/or
Differences |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | BZD | BZD | Unchanged from
K140268. |
| Intended Use | The Simple T Youth Nasal
Mask is intended to provide
an interface for application
of CPAP or bi-level therapy
to patients. The mask is
for single patient use in the
home or multi-patient use
in the hospital/institutional
environment. The mask is
to be used by patients 7
years or older (>40lbs) for | This mask is intended to
provide an interface for
application of CPAP or bi-
level therapy to patients.
The mask is for single
patient use in the home and
multi-patient use in the
hospital/institutional
environment. The mask is
to be used on patients > 7 | Unchanged from
K140268. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities
and/or
Differences |
| | Simple T Youth Nasal
Mask | Magneto Nasal Mask | |
| | Manufacturer:
Respironics, Inc. | Manufacturer:
Respironics, Inc. | |
| | 510(k) Number: K140268 | 510(k) Number: K210386 | |
| | whom CPAP or bi-level
therapy has been
prescribed. | years old (> 40 lbs) for
whom CPAP or bi-level
therapy has been
prescribed. | |
| Patient Population | Patients 7 years or older
(>40 lbs) | Patients >7 years (>40 lbs) | Unchanged from
K140268. |
| Functional
Indication | Interface for application of
CPAP or bi-level therapy to
patients | Interface for application of
CPAP or bi-level therapy to
patients | Unchanged from
K140268. |
| Environment of
Use | home or
hospital/institutional
environment | home or
hospital/institutional
environment | Unchanged from
K140268. |
| Patient Usage
Type | Single patient use or multi-
patient use | Single patient use or multi-
patient use | Unchanged from
K140268. |
| Anatomical Sites | Nose | Nose | Unchanged from
K140268. |
| Provided Sterile or
Non-Sterile | Non-sterile | Non-sterile | Unchanged from
K140268. |
| Pressure Range
Specification | 4 cm H2O to 30 cm H2O | 4 cm H2O to 30 cm H2O | Unchanged from
K140268. |
| Deadspace
Volume | Small size – 37.4 ml
Medium size – 48.7 ml
Large size – 72.8 ml | Nasal Cradle Cushion:
Extra small size – 13.6 ml
Small size – 17.9 ml
Medium size – 18.5 ml
Medium wide size – 16.9 ml
Large size - 23.7 ml
Nasal Pillows Cushion:
Extra small size – 11.4 ml | The deadspace
values of the
subject device
are lower than the
predicate device. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities
and/or
Differences |
| | Simple T Youth Nasal
Mask | Magneto Nasal Mask | |
| | Manufacturer:
Respironics, Inc. | Manufacturer:
Respironics, Inc. | |
| | 510(k) Number: K140268 | 510(k) Number: K210386 | |
| | | Small size – 11.6 ml
Medium size – 12.0 ml
Medium wide size – 13.0 ml
Large size - 12.4 ml | |
| Pressure Drop | 0.8 cm H2O @ 50 SLPM
3.1 cm H2O @ 100 SLPM | Nasal Cradle Cushion:
Extra small size –
1.7 cm H2O @ 50 SLPM
6.3 cm H2O @ 100 SLPM
Small size –
1.5 cm H2O @ 50 SLPM
6.5 cm H2O @ 100 SLPM
Medium size –
1.4 cm H2O @ 50 SLPM
6.1 cm H2O @ 100 SLPM
Medium wide size –
1.6 cm H2O @ 50 SLPM
6.1 cm H2O @ 100 SLPM
Large size –
1.5 cm H2O @ 50 SLPM
5.3 cm H2O @ 100 SLPM
Nasal Pillows Cushion:
Extra small size –
1.9 cm H2O @ 50 SLPM
7.5 cm H2O @ 100 SLPM
Small size –
2.0 cm H2O @ 50 SLPM
7.2 cm H2O @ 100 SLPM | The pressure
drop values of the
subject device
are different to
the predicate
device. There are
no performance
requirements for
pressure drop.
The pressure
drop for a device
is disclosed in
labeling
consistent with
ISO 17510:2015
requirements. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities
and/or
Differences |
| | Simple T Youth Nasal
Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K140268 | Magneto Nasal Mask
Manufacturer:
Respironics, Inc.
510(k) Number: K210386 | |
| | | Medium size –
1.5 cm H₂O @ 50 SLPM
6.1 cm H₂O @ 100 SLPM
Medium wide size –
1.6 cm H₂O @ 50 SLPM
6.3 cm H₂O @ 100 SLPM
Large size –
1.8 cm H₂O @ 50 SLPM
6.8 cm H₂O @ 100 SLPM | |
| Sound Power and
Pressure Level | A-weighted Sound Power
Level – 26.5 dBA
A-weighted Sound
Pressure Level – 18.5 dBA | A-weighted Sound Power
Level – 28 dBA
A-weighted Sound Pressure
Level – 20 dBA | The sound levels
of the subject
device are
different from the
predicate device
but do not raise
different
questions of
safety and
effectiveness.
The sound levels
are disclosed in
labeling
consistent with
ISO 17510:2015
requirements. |
| Total Mask Leak | 19.8 SLPM @ 5 cm H₂O
29.5 SLPM @ 10 cm H₂O
43.6 SLPM @ 20 cm H₂O | 9.2 SLPM @ 4 cm H₂O
10.8 SLPM @ 5 cm H₂O
17.2 SLPM @ 10 cm H₂O
26.7 SLPM @ 20 cm H₂O
34.6 SLPM @ 30 cm H₂O | The total mask
leak values are
lower than the
predicate device. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities
and/or
Differences |
| | Simple T Youth Nasal
Mask | Magneto Nasal Mask | |
| | Manufacturer:
Respironics, Inc. | Manufacturer:
Respironics, Inc. | |
| | 510(k) Number: K140268 | 510(k) Number: K210386 | |
| | Reprocessing
Methods | Air path and non-air path
components – Cleaning
with liquid dish detergent | |
| | Air path components –
High level chemical and
thermal disinfection | Air path components – High
level chemical and thermal
disinfection | |
| | | Non-air path components –
Low level chemical and
thermal disinfection | |
| Mask Weight | No mask weight stated | XS Pillow Mask 37.3 g
S Pillow Mask 37.4 g
M Pillow Mask 37.6 g
MW Pillow Mask 37.7 g
L Pillow Mask 37.8 g
XS Cradle Mask 39.3 g
S Cradle Mask 40.8 g
M Cradle Mask 41.6 g
MW Cradle Mask 40.9 g
L Cradle Mask 43.1 g | No mask weight
was provided for
the predicate
device. |
| Exhalation/Exhaust | Built-in exhalation through
the mask elbow | Built-in exhalation through
the mask tubing | The subject
device includes
exhalation in the
mask tubing
instead of a
separate elbow
with built-in
exhalation. |
| Storage Conditions | Temperature: -4° to 140° F
(-20° to +60° C)
Relative Humidity: 15% to
95% | Temperature: -4° to 140° F
(-20° to +60° C)
Relative Humidity: 15% to
95% | Unchanged from
K140268. |
Comparison Table of Predicate and Subject Device
6
7
8
9
10
- SLPM is Standard Liters Per Minute. SLPM is a unit of volumetric flow rate of a gas at standard conditions for temperature and pressure (STP)
Non-Clinical Tests
Performance testing was performed to verify that the device modifications did not affect the safety and effectiveness of the subject device. Performance testing included:
- Resistance, derived from pressure drop (pre & post cleaning and disinfection)
- Total Mask Leak (pre & post cleaning and disinfection)
- CO2 rebreathing
- . A-weighted sound power and pressure levels
- . Deadspace
- Magnetic strength ●
- . Cleaning validation
- Cleaning residuals ●
- Disinfection validation ●
- Disinfection residuals ●
Standards
The Magneto Nasal Mask has been designed per the following standards:
- ISO 17510: 2015 Medical Device Sleep Apnoea Breathing Therapy: Masks and Application . Accessories
- . ISO 5356-1: 2015 Anaesthetic and Respiratory Equipment - Conical Connectors: Part 1: Cones and Sockets
- ISO 10993-1: 2018 Biological Evaluation of Medical Devices Part 1: Evaluation and testing ● within a risk management process
- ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, . carcinogenicity and reproductive toxicity
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicitv
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and ● skin sensitization
- ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of . allowable limits for leachable substances
- ISO 18562-1: 2017 Biocompatibility Evaluation of Breathing Gas Pathways In Healthcare . Applications - Part 1: Evaluation and Testing Within A Risk Management Process
- ISO 18562-2:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare ● Applications-Part 2: Tests for Emissions of Particulate Matter
- ISO 18562-3:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare ● Applications-Part 3: Tests for Emissions of Volatile Organic Compounds
- ISO 18562-4:2017 Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare ● Applications-Part 4: Tests for leachables in Condensate
11
- ISO 14971: 2019 Medical devices Application of risk management to medical devices ●
- . ISO 17664: 2017 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices
- ISO 15223-1: 2016 Medical devices Symbols to be used with medical device labels, ● labelling, and information to be supplied - Part 1: General requirements
Clinical Tests
Clinical tests were not required to demonstrate the safety and effectiveness of the Magneto Nasal Mask. All risks have been sufficiently mitigated and product functionality has been adequately assessed by non-clinical tests.
Conclusion
The performance and technological characteristics of the Magneto Nasal Mask are substantially equivalent to those of the Simple T Youth Nasal Mask (K140268). The differences described above do not raise new questions of safety and effectiveness.