Therapy Mask 3100 NC/SP

K231313 · Respironics, Inc. · BZD · Jul 28, 2023 · Anesthesiology

Device Facts

• Record ID: K231313
• Device Name: Therapy Mask 3100 NC/SP
• Applicant: Respironics, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Jul 28, 2023
• Decision: SESE
• Submission Type: Special
• 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

Therapy Mask 3100 NC/SP is a nasal mask interface for CPAP or bi-level therapy. Device consists of a nasal cushion (cradle or silicone pillows), two-point headgear, and a mask frame with an exhalation port. Frame and cushion connect magnetically; magnets have opposite polarity to prevent incorrect assembly. Device includes a 10 mm pig tail tube with an ISO 5356-1 compliant 22 mm male conical swivel connector for attachment to therapy device tubing. Used in home (single-patient) or hospital (multi-patient) settings. Operated by patients or clinicians. Provides a sealed interface to deliver prescribed positive airway pressure. Benefits include non-invasive respiratory support for patients with sleep-disordered breathing. Labeling updates include expanded contraindications and increased safety distance (6 inches) for magnetic field exposure to protect patients and those in close proximity.

Clinical Evidence

No clinical data or non-clinical performance testing was required for this submission, as the changes were limited to labeling updates and did not impact device design, performance, or specifications.

Technological Characteristics

Nasal mask with silicone cushion and headgear. Features magnetic assembly with 400 mT field strength. Includes 10 mm pig tail tubing with ISO 5356-1 22 mm connector. Designed per ISO 17510, ISO 5356-1, ISO 10993 series (biocompatibility), ISO 18562 series (gas pathway), ISO 14971 (risk management), and ISO 17664 (processing). Non-sterile. Pressure range 4-30 cm H2O.

Indications for Use

Indicated for patients >7 years old (>40 lbs) requiring CPAP or bi-level therapy. Contraindicated for patients, caregivers, or household members with implanted devices sensitive to magnets, including pacemakers, ICDs, neurostimulators, metallic implants, CSF shunts, aneurysm clips, metallic cranial plates/screws, ocular implants, cochlear implants, insulin pumps, and other MR-unsafe metallic devices.

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

• Therapy Mask 3100 NC/SP (K210386)

Submission Summary (Full Text)

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28 July 2023

Respironics Inc. Shipra Gulati Principal Regulatory Affairs Engineer 1001 Murry Ridge Lane Murrysville, Pennsylvania 15668

Re: K231313

Trade/Device Name: Therapy Mask 3100 NC/SP Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: June 30, 2023 Received: June 30, 2023

Dear Shipra Gulati:

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

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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 (OS) 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 -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 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K231313

Device Name Therapy Mask 3100 NC/SP

#### 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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| Date 510(k) Summary Prepared | July 27, 2023 |
|----------------------------------|---------------------------------------------------------------------------------------------------------|
| 510(k) Owner | Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 |
| Official Contact | Shipra Gulati<br>Principal Regulatory Affairs Engineer<br>P: 617.650.7502<br>E: [e-mail] |
| Establishment Registration # | 2518422 |
| Proprietary Name | Therapy Mask 3100 NC/SP |
| 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 |
| Predicate Device | Therapy Mask 3100 NC/SP (K210386) |

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### Device Description

The Therapy Mask 3100 NC/SP consists of a minimal contact nasal mask cushion/SP: silicone pillows cushion), a two-point headgear, and a mask frame with exhalation port. The mask frame contains enclosed magnets and connects to the nasal mask cushion (NC/SP) magnetically for easy and secure assembly/disassembly by the user. The nasal mask cushion enclosed magnets and the mask frame enclosed magnets are of opposite polarity to prevent incorrect assembly of the mask. The Therapy Mask 3100 NC/SP has a pig tail tube in front mask.

The nasal cushion seals around the bottom of the patient's nose. Nasal cushion (NC) has five sizes: extra small (XS), small (S), medium (M), medium wide (MW), and large (L). The silicone pillows cushion tips seal at the entrance to the nares and the pillows cushion base sits under the silicone pillows cushion (SP) has five sizes: extra small (XS), small (S), medium (M), medium wide (MW), large (L). The headgear has one size and includes adjustment sliders to allow for a large or small fitting on the patient's head. The mask frame is one size and connects to the mask frame connects to the mask cushion magnetically for easy and secure assembly/disassembly by the user.

The Therapy Mask 3100 NC/SP has a 10 mm pig tail tube in front mask. The 10 mm pig tail tubing contains built-in exhalation at the top of the tube where the pig tail tubing connects to the pig tail tubing will also include an ISO 5356-1 compliant, 22 mm male conical swivel connector. The male connector will connector will connect directly to ISO 5356-1 compliant, 22 mm female connector used on therapy device tubing. The male conical swivel connector is detachable from the pig tail tubing, via a quick disconnect feature. When the male concector is detached, the pig tail tubing connects to 12 mm therapy device tubing directly.

The Therapy Mask 3100 NC/SP is designed to be easily disassembled for cleaning or replacement purposes. The components may be cleaned by the patient in the home (single patient - multiple use) or cleaned and disinfected by the professional in the hospital/institutional environment (multiple patient – multiple use).

### 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 hospitalinstitutional environment. The mask is to be used on patients >7 years old (>40 lbs) for whom CPAP or bi-level therapy has been prescribed.

#### Subject Device Compared to the Predicate Device

The subject device, the Therapy Mask 3100 NC/SP, has the following similarities to the previously cleared predicate device, Therapy Mask 3100 NC/SP (K210386):

- . 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 Therapy Mask 3100 NC/SP device in this substantially equivalent to the predicate device.

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# Comparison Table of Predicate and Subject Device

| Feature /<br>Function | Predicate Device:<br>Magneto Nasal Mask(K210386) | Subject Device:<br>Therapy Mask 3100 NC/SP<br>(K231313) | Similarities and/or<br>Differences |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | BZD | BZD | Same |
| Intended Use | This mask is intended to provide an<br>interface for application of CPAP or<br>bi-level therapy to patients. The<br>mask is for single patient use in the<br>home and multi-patient use in the<br>hospital/institutional environment.<br>The mask is to be used on patients<br>>7 years old (>40 lbs) for whom<br>CPAP or bi-level therapy has been<br>prescribed. | This mask is intended to provide an<br>interface for application of CPAP or<br>bi-level therapy to patients. The<br>mask is for single patient use in the<br>home and multi-patient use in the<br>hospital/institutional environment.<br>The mask is to be used on patients<br>>7 years old (>40 lbs) for whom<br>CPAP or bi-level therapy has been<br>prescribed. | Same |
| Indications for use | This mask is intended to provide an<br>interface for application of CPAP or<br>bi-level therapy to patients. The<br>mask is for single patient use in the<br>home and multi-patient use in the<br>hospital/ institutional environment.<br>The mask is to be used on patients<br>> 7 years old (> 40 lbs) for whom<br>CPAP or bi-level therapy has been<br>prescribed. | This mask is intended to provide an<br>interface for application of CPAP or<br>bi-level therapy to patients. The<br>mask is for single patient use in the<br>home and multi-patient use in the<br>hospital/institutional environment.<br>The mask is to be used on patients<br>>7 years old (>40 lbs) for whom<br>CPAP or bi-level therapy has been<br>prescribed. | Same |
| Feature /<br>Function | Predicate Device:<br>Magneto Nasal Mask(K210386) | Subject Device:<br>Therapy Mask 3100 NC/SP<br>(K231313) | Similarities and/or<br>Differences |
| Contraindications | Use of this mask is contraindicated<br>in patients with the following<br>metallic implants: brain shunts,<br>aneurysm clips, splinters in the<br>eyes, and certain neurostimulators<br>used in and around the head and<br>neck. | Use of the mask is contraindicated<br>for patients and their household<br>members, caregivers, and bed<br>partners that may be in close<br>vicinity to patients using the masks,<br>that have implanted devices that<br>may be affected by magnets,<br>including but not limited to:<br>PacemakersImplantable cardioverter<br>defibrillators (ICD)NeurostimulatorsMagnetic metallic<br>implants/electrodes/valves<br>placed in upper limbs, torso, or<br>higher (i.e., neck and head)Cerebral spinal fluid (CSF)<br>shunts (e.g., ventriculo<br>peritoneal (VP) shunt)Aneurysm clipsEmbolic coilsIntracranial aneurysm<br>intravascular flow disruption<br>devicesMetallic cranial plates, screws,<br>burr hole covers, and bone<br>substitute devicesMetallic splinters in the eyeOcular implants (e.g., glaucoma<br>implants, retinal implants)Certain contact lenses with<br>metalImplants to restore hearing or<br>balance that have an implanted<br>magnet (such as cochlear<br>implants, implanted bone<br>conduction hearing devices,<br>and auditory brainstem<br>implants)Magnetic denture attachmentsMetallic gastrointestinal clipsMetallic stents (e.g., aneurysm,<br>coronary, tracheobronchial,<br>biliary)Implantable ports and pumps<br>(e.g., insulin pumps) | The updated<br>contraindications<br>provide a more<br>detailed list of<br> |
| Feature /<br>Function | Predicate Device:<br>Magneto Nasal Mask(K210386) | Subject Device:<br>Therapy Mask 3100 NC/SP<br>(K231313) | Similarities and/or<br>Differences |
| | | Hypoglossal nerve stimulators Devices labeled as MR<br>(Magnetic Resonance) unsafe Magnetic metallic implants not<br>labeled for MR or not evaluated<br>for safety in a magnetic field | |
| Additional Labeling<br>update | Current warning<br>Magnets are used in the mask. The<br>magnetic field strength is 400 mT.<br>Ensure the mask is kept at least 2<br>inches (5 cm) away from any active<br>medical implant or medical device<br>that can be impacted by the<br>magnetic field (e.g., pacemaker,<br>defibrillators, neurostimulators,<br>cochlear implants, hearing aids) to<br>avoid possible effects from<br>localized magnetic fields. | Updated Warning<br>Magnets with a magnetic field<br>strength of 400 mT are used in the<br>mask. With the exception of the<br>devices identified in the<br>contraindication, ensure the mask is<br>kept at least 6 inches (approx.<br>15.24 cm) away from any other<br>medical implants or medical devices<br>that can be impacted by the<br>magnetic fields to avoid possible<br>effects from localized magnetic<br>fields. This includes household<br>members, caregivers, and bed<br>partners that may be in close<br>vicinity to patients that use the<br>masks. | The updated<br>warning extended<br>the mask use<br>distance to avoid<br>possible effects<br>from localized<br>magnetic fields.<br>This extended<br>mask use distance<br>will enhance the<br>patient safety when<br>using the masks<br>that contain<br>magnets. The<br>updated warning<br>includes possible<br>impacted<br>populations (e.g.,<br>household<br>members,<br>caregivers, and bed<br>partners) that may<br>be in close vicinity<br>to patients that use<br>the masks. |
| Patient Population | Patients >7 years (>40 lbs) | Patients >7 years (>40 lbs) | Same |
| Functional<br>Indication | Interface for application of CPAP or<br>bi-level therapy to patients | Interface for application of CPAP or<br>bi-level therapy to patients | Same |
| Environment of<br>Use | home or hospital/institutional<br>environment | home or hospital/institutional<br>environment | Same |
| Patient Usage<br>Type | Single patient use or multi-patient<br>use | Single patient use or multi-patient<br>use | Same |
| Anatomical Sites | Nose | Nose | Same |
| Provided Sterile or<br>Non-Sterile | Non-sterile | Non-sterile | Same |
| Pressure Range<br>Specification | 4 cm H2O to 30 cm H2O | 4 cm H2O to 30 cm H2O | Same |
| Feature / | Predicate Device: | Subject Device: | Similarities and/or |
| Function | Magneto Nasal Mask(K210386) | Therapy Mask 3100 NC/SP<br>(K231313) | Differences |
| Deadspace | Nasal Cradle Cushion:<br>Extra small size - 13.6 ml | Under the nose nasal cushion size:<br>Extra small size - 13.6 ml | Same |
| Volume | Small size - 17.9 ml<br>Medium size - 18.5 ml<br>Medium wide size - 16.9 ml<br>Large size - 23.7 ml | Small size - 17.9 ml<br>Medium size - 18.5 ml<br>Medium wide size - 16.9 ml<br>Large size - 23.7 ml | Note: Nasal Pillows<br>Cushion has been<br>re-named as<br>Silicone Pillows |
| | Nasal Pillows Cushion:<br>Extra small size – 11.4 ml<br>Small size - 11.6 ml<br>Medium size - 12.0 ml<br>Medium wide size - 13.0 ml<br>Large size - 12.4 ml | Silicone Pillows Cushion:<br>Extra small size – 11.4 ml<br>Small size - 11.6 ml<br>Medium size – 12.0 ml<br>Medium wide size - 13.0 ml<br>Large size - 12.4 ml | Cushion to better<br>differentiate<br>between product<br>lines. There is no<br>change in design,<br>materials, or use. |
| Pressure Drop | Nasal Cradle Cushion:<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>Nasal Pillows Cushion:<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<br>Medium size –<br>1.5 cm H2O @ 50 SLPM<br>6.1 cm H2O @ 100 SLPM<br>Medium wide size -<br>1.6 cm H2O @ 50 SLPM<br>6.3 cm H2O @ 100 SLPM<br>Large size -<br>1.8 cm H2O @ 50 SLPM<br>6.8 cm H2O @ 100 SLPM | Under the nose nasal cushion size:<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>Silicone Pillows Cushion:<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<br>Medium size -<br>1.5 cm H2O @ 50 SLPM<br>6.1 cm H2O @ 100 SLPM<br>Medium wide size -<br>1.6 cm H2O @ 50 SLPM<br>6.3 cm H2O @ 100 SLPM<br>Large size -<br>1.8 cm H2O @ 50 SLPM<br>6.8 cm H2O @ 100 SLPM | Same<br>Note: Nasal Pillows<br>Cushion has been<br>re-named as<br>Silicone Pillows<br>Cushion to<br>differentiate<br>between product<br>lines. There is no<br>change in design,<br>materials, or use. |
| Sound Power and<br>Pressure Level | A-weighted Sound Power Level -<br>28 dBA<br>A-weighted Sound Pressure Level | A-weighted Sound Power Level –<br>28 dBA<br>A-weighted Sound Pressure Level | Same |
| | @1m: - 20 dBA | @1m: — 20 dBA | |
| Feature / | Predicate Device: | Subject Device: | Similarities and/or |
| Function | Magneto Nasal Mask(K210386) | Therapy Mask 3100 NC/SP<br>(K231313) | Differences |
| Total Mask Leak | 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 | 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…