Magneto Nasal Mask

K210386 · Respironics, Inc. · BZD · Jul 12, 2021 · Anesthesiology

Device Facts

• Record ID: K210386
• Device Name: Magneto Nasal Mask
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 12, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Nasal mask interface for CPAP/bi-level therapy; delivers pressurized air to patients >7 years old. Features nasal cradle or nasal pillows cushions; magnetic attachment between cushion and frame; fabric headgear with adjustment sliders. Includes 10mm tubing with integrated exhalation port and ISO 5356-1 compliant 22mm swivel connector. Used in home or hospital settings; operated by patient or clinician. Provides secure, non-intimidating interface; facilitates therapy delivery for sleep disordered breathing/respiratory insufficiency.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via bench testing, including resistance, mask leak, CO2 rebreathing, sound levels, deadspace, magnetic strength, and cleaning/disinfection validation.

Technological Characteristics

Nasal mask with cradle or pillows cushions; magnetic frame-cushion coupling. Materials evaluated per ISO 10993 and ISO 18562. Connectivity: ISO 5356-1 compliant 22mm conical swivel. Non-sterile. Designed per ISO 17510:2015, ISO 14971:2019, ISO 17664:2017, and ISO 15223-1:2016.

Indications for Use

Indicated for patients > 7 years old (>40 lbs) requiring CPAP or bi-level therapy for sleep disordered breathing or respiratory insufficiency.

Regulatory Classification

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.

Predicate Devices

• Simple T Youth Nasal Mask (K140268)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

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 ([e-mail]) or phone [phone] 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) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

| Date 510(k) Summary Prepared | July 9, 2021 |
|----------------------------------|------------------------------------------------------------------------------------------------------|
| 510(k) Owner | Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 |
| Official Contact | Anna Danley<br>Senior Regulatory Affairs Engineer<br>P: (412)-542-3513<br>E: [e-mail] |
| 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:<br>Simple T Youth Nasal<br>Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K140268 | Subject Device:<br>Magneto Nasal Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K210386 | Similarities<br>and/or<br>Differences |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | BZD | BZD | Unchanged from<br>K140268. |
| Intended Use | The Simple T Youth Nasal<br>Mask is intended to provide<br>an interface for application<br>of CPAP or bi-level therapy<br>to patients. The mask is<br>for single patient use in the<br>home or multi-patient use<br>in the hospital/institutional<br>environment. The mask is<br>to be used by patients 7<br>years or older (>40lbs) for | This mask is intended to<br>provide an interface for<br>application of CPAP or bi-<br>level therapy to patients.<br>The mask is for single<br>patient use in the home and<br>multi-patient use in the<br>hospital/institutional<br>environment. The mask is<br>to be used on patients > 7 | Unchanged from<br>K140268. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities<br>and/or<br>Differences |
| | Simple T Youth Nasal<br>Mask | Magneto Nasal Mask | |
| | Manufacturer:<br>Respironics, Inc. | Manufacturer:<br>Respironics, Inc. | |
| | 510(k) Number: K140268 | 510(k) Number: K210386 | |
| | whom CPAP or bi-level<br>therapy has been<br>prescribed. | years old (> 40 lbs) for<br>whom CPAP or bi-level<br>therapy has been<br>prescribed. | |
| Patient Population | Patients 7 years or older<br>(>40 lbs) | Patients >7 years (>40 lbs) | Unchanged from<br>K140268. |
| Functional<br>Indication | Interface for application of<br>CPAP or bi-level therapy to<br>patients | Interface for application of<br>CPAP or bi-level therapy to<br>patients | Unchanged from<br>K140268. |
| Environment of<br>Use | home or<br>hospital/institutional<br>environment | home or<br>hospital/institutional<br>environment | Unchanged from<br>K140268. |
| Patient Usage<br>Type | Single patient use or multi-<br>patient use | Single patient use or multi-<br>patient use | Unchanged from<br>K140268. |
| Anatomical Sites | Nose | Nose | Unchanged from<br>K140268. |
| Provided Sterile or<br>Non-Sterile | Non-sterile | Non-sterile | Unchanged from<br>K140268. |
| Pressure Range<br>Specification | 4 cm H2O to 30 cm H2O | 4 cm H2O to 30 cm H2O | Unchanged from<br>K140268. |
| Deadspace<br>Volume | Small size – 37.4 ml<br>Medium size – 48.7 ml<br>Large size – 72.8 ml | Nasal Cradle Cushion:<br>Extra small size – 13.6 ml<br>Small size – 17.9 ml<br>Medium size – 18.5 ml<br>Medium wide size – 16.9 ml<br>Large size - 23.7 ml<br>Nasal Pillows Cushion:<br>Extra small size – 11.4 ml | The deadspace<br>values of the<br>subject device<br>are lower than the<br>predicate device. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities<br>and/or<br>Differences |
| | Simple T Youth Nasal<br>Mask | Magneto Nasal Mask | |
| | Manufacturer:<br>Respironics, Inc. | Manufacturer:<br>Respironics, Inc. | |
| | 510(k) Number: K140268 | 510(k) Number: K210386 | |
| | | Small size – 11.6 ml<br>Medium size – 12.0 ml<br>Medium wide size – 13.0 ml<br>Large size - 12.4 ml | |
| Pressure Drop | 0.8 cm H2O @ 50 SLPM<br>3.1 cm H2O @ 100 SLPM | <i>Nasal Cradle Cushion:</i><br>Extra small size –<br>1.7 cm H2O @ 50 SLPM<br>6.3 cm H2O @ 100 SLPM<br>Small size –<br>1.5 cm H2O @ 50 SLPM<br>6.5 cm H2O @ 100 SLPM<br>Medium size –<br>1.4 cm H2O @ 50 SLPM<br>6.1 cm H2O @ 100 SLPM<br>Medium wide size –<br>1.6 cm H2O @ 50 SLPM<br>6.1 cm H2O @ 100 SLPM<br>Large size –<br>1.5 cm H2O @ 50 SLPM<br>5.3 cm H2O @ 100 SLPM<br><i>Nasal Pillows Cushion:</i><br>Extra small size –<br>1.9 cm H2O @ 50 SLPM<br>7.5 cm H2O @ 100 SLPM<br>Small size –<br>2.0 cm H2O @ 50 SLPM<br>7.2 cm H2O @ 100 SLPM | The pressure<br>drop values of the<br>subject device<br>are different to<br>the predicate<br>device. There are<br>no performance<br>requirements for<br>pressure drop.<br>The pressure<br>drop for a device<br>is disclosed in<br>labeling<br>consistent with<br>ISO 17510:2015<br>requirements. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities<br>and/or<br>Differences |
| | Simple T Youth Nasal<br>Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K140268 | Magneto Nasal Mask<br>Manufacturer:<br>Respironics, Inc.<br>510(k) Number: K210386 | |
| | | Medium size –<br>1.5 cm H₂O @ 50 SLPM<br>6.1 cm H₂O @ 100 SLPM<br><br>Medium wide size –<br>1.6 cm H₂O @ 50 SLPM<br>6.3 cm H₂O @ 100 SLPM<br><br>Large size –<br>1.8 cm H₂O @ 50 SLPM<br>6.8 cm H₂O @ 100 SLPM | |
| Sound Power and<br>Pressure Level | A-weighted Sound Power<br>Level – 26.5 dBA<br><br>A-weighted Sound<br>Pressure Level – 18.5 dBA | A-weighted Sound Power<br>Level – 28 dBA<br><br>A-weighted Sound Pressure<br>Level – 20 dBA | The sound levels<br>of the subject<br>device are<br>different from the<br>predicate device<br>but do not raise<br>different<br>questions of<br>safety and<br>effectiveness.<br>The sound levels<br>are disclosed in<br>labeling<br>consistent with<br>ISO 17510:2015<br>requirements. |
| Total Mask Leak | 19.8 SLPM @ 5 cm H₂O<br>29.5 SLPM @ 10 cm H₂O<br>43.6 SLPM @ 20 cm H₂O | 9.2 SLPM @ 4 cm H₂O<br>10.8 SLPM @ 5 cm H₂O<br>17.2 SLPM @ 10 cm H₂O<br>26.7 SLPM @ 20 cm H₂O<br>34.6 SLPM @ 30 cm H₂O | The total mask<br>leak values are<br>lower than the<br>predicate device. |
| Feature/Function | Predicate Device: | Subject Device: | Similarities<br>and/or<br>Differences |
| | Simple T Youth Nasal<br>Mask | Magneto Nasal Mask | |
| | Manufacturer:<br>Respironics, Inc. | Manufacturer:<br>Respironics, Inc. | |
| | 510(k) Number: K140268 | 510(k) Number: K210386 | |
| | Reprocessing<br>Methods | Air path and non-air path<br>components – Cleaning<br>with liquid dish detergent | |
| | Air path components –<br>High level chemical and<br>thermal disinfection | Air path components – High<br>level chemical and thermal<br>disinfection | |
| | | Non-air path components –<br>Low level chemical and<br>thermal disinfection | |
| Mask Weight | No mask weight stated | XS Pillow Mask 37.3 g<br>S Pillow Mask 37.4 g<br>M Pillow Mask 37.6 g<br>MW Pillow Mask 37.7 g<br>L Pillow Mask 37.8 g<br>XS Cradle Mask 39.3 g<br>S Cradle Mask 40.8 g<br>M Cradle Mask 41.6 g<br>MW Cradle Mask 40.9 g<br>L Cradle Mask 43.1 g | No mask weight<br>was provided for<br>the predicate<br>device. |
| Exhalation/Exhaust | Built-in exhalation through<br>the mask elbow | Built-in exhalation through<br>the mask tubing | The subject<br>device includes<br>exhalation in the<br>mask tubing<br>instead of a<br>separate elbow<br>with built-in<br>exhalation. |
| Storage Conditions | Temperature: -4° to 140° F<br>(-20° to +60° C)<br><br>Relative Humidity: 15% to<br>95% | Temperature: -4° to 140° F<br>(-20° to +60° C)<br><br>Relative Humidity: 15% to<br>95% | Unchanged from<br>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.