K Number
K231313
Device Name
Therapy Mask 3100 NC/SP
Manufacturer
Date Cleared
2023-07-28

(84 days)

Product Code
Regulation Number
868.5905
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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).
More Information

Not Found

No
The device description focuses on the physical components and mechanical function of a CPAP/bi-level therapy mask. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.

No

This device is a mask intended to provide an interface for the application of CPAP or bi-level therapy, meaning it is an accessory used with a therapeutic device, not a therapeutic device itself.

No

The device is a mask for CPAP/bi-level therapy, which is a treatment, not a diagnostic procedure. Its stated purpose is to provide an interface for the application of therapy that has already been prescribed.

No

The device description clearly outlines physical components such as a mask cushion, headgear, mask frame, and tubing, indicating it is a hardware device.

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 applying CPAP or bi-level therapy to patients. This is a therapeutic application, not a diagnostic one.
  • Device Description: The description details a mask, headgear, and tubing for delivering air pressure. There is no mention of analyzing biological samples or providing diagnostic information.
  • Lack of IVD Characteristics: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.

The device is clearly intended for respiratory therapy, not for in vitro diagnostic testing.

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 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).

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

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)

No non-clinical and/or clinical tests summaries are submitted with this CBE submission. These labeling changes do not affect the product performance related to design outputs or specifications; therefore, additional design validation of product performance requirements was not required to implement this change.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Therapy Mask 3100 NC/SP (K210386)

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 and 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.

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

1

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

Enclosure

2

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 PreparedJuly 27, 2023
510(k) OwnerRespironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668
Official ContactShipra Gulati
Principal Regulatory Affairs Engineer
P: 617.650.7502
E: SRC.RA.Dept@philips.com
Establishment Registration #2518422
Proprietary NameTherapy Mask 3100 NC/SP
Common/Usual NameNasal Mask
ClassificationClass II device
Classification PanelAnesthesiology
Classification Reference21 CFR 868.5905
Classification Name/Product CodeVentilator, non-continuous (respirator)/BZD
Predicate DeviceTherapy 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 /
Function | Predicate Device:
Magneto Nasal Mask(K210386) | Subject Device:
Therapy Mask 3100 NC/SP
(K231313) | Similarities and/or
Differences |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | BZD | BZD | Same |
| 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. | 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. | Same |
| 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. | 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. | Same |
| Feature /
Function | Predicate Device:
Magneto Nasal Mask(K210386) | Subject Device:
Therapy Mask 3100 NC/SP
(K231313) | Similarities and/or
Differences |
| Contraindications | Use of this mask is contraindicated
in patients with the following
metallic implants: brain shunts,
aneurysm clips, splinters in the
eyes, and certain neurostimulators
used in and around the head and
neck. | Use of the mask is contraindicated
for patients and their household
members, caregivers, and bed
partners that may be in close
vicinity to patients using the masks,
that have implanted devices that
may be affected by magnets,
including but not limited to:
PacemakersImplantable cardioverter
defibrillators (ICD)NeurostimulatorsMagnetic metallic
implants/electrodes/valves
placed in upper limbs, torso, or
higher (i.e., neck and head)Cerebral spinal fluid (CSF)
shunts (e.g., ventriculo
peritoneal (VP) shunt)Aneurysm clipsEmbolic coilsIntracranial aneurysm
intravascular flow disruption
devicesMetallic cranial plates, screws,
burr hole covers, and bone
substitute devicesMetallic splinters in the eyeOcular implants (e.g., glaucoma
implants, retinal implants)Certain contact lenses with
metalImplants to restore hearing or
balance that have an implanted
magnet (such as cochlear
implants, implanted bone
conduction hearing devices,
and auditory brainstem
implants)Magnetic denture attachmentsMetallic gastrointestinal clipsMetallic stents (e.g., aneurysm,
coronary, tracheobronchial,
biliary)Implantable ports and pumps
(e.g., insulin pumps) | The updated
contraindications
provide a more
detailed list of
|
| Feature /
Function | Predicate Device:
Magneto Nasal Mask(K210386) | Subject Device:
Therapy Mask 3100 NC/SP
(K231313) | Similarities and/or
Differences |
| | | Hypoglossal nerve stimulators Devices labeled as MR
(Magnetic Resonance) unsafe Magnetic metallic implants not
labeled for MR or not evaluated
for safety in a magnetic field | |
| Additional Labeling
update | Current warning
Magnets are used in the mask. The
magnetic field strength is 400 mT.
Ensure the mask is kept at least 2
inches (5 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. | Updated Warning
Magnets with a magnetic field
strength of 400 mT are used in the
mask. With the exception of the
devices identified in the
contraindication, ensure the mask is
kept at least 6 inches (approx.
15.24 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. This includes household
members, caregivers, and bed
partners that may be in close
vicinity to patients that use the
masks. | The updated
warning extended
the mask use
distance to avoid
possible effects
from localized
magnetic fields.
This extended
mask use distance
will enhance the
patient safety when
using the masks
that contain
magnets. The
updated warning
includes possible
impacted
populations (e.g.,
household
members,
caregivers, and bed
partners) that may
be in close vicinity
to patients that use
the masks. |
| Patient Population | Patients >7 years (>40 lbs) | Patients >7 years (>40 lbs) | Same |
| Functional
Indication | Interface for application of CPAP or
bi-level therapy to patients | Interface for application of CPAP or
bi-level therapy to patients | Same |
| Environment of
Use | home or hospital/institutional
environment | home or hospital/institutional
environment | Same |
| Patient Usage
Type | Single patient use or multi-patient
use | Single patient use or multi-patient
use | Same |
| Anatomical Sites | Nose | Nose | Same |
| Provided Sterile or
Non-Sterile | Non-sterile | Non-sterile | Same |
| Pressure Range
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
(K231313) | Differences |
| Deadspace | Nasal Cradle Cushion:
Extra small size - 13.6 ml | Under the nose nasal cushion size:
Extra small size - 13.6 ml | Same |
| Volume | Small size - 17.9 ml
Medium size - 18.5 ml
Medium wide size - 16.9 ml
Large size - 23.7 ml | Small size - 17.9 ml
Medium size - 18.5 ml
Medium wide size - 16.9 ml
Large size - 23.7 ml | Note: Nasal Pillows
Cushion has been
re-named as
Silicone Pillows |
| | Nasal Pillows Cushion:
Extra small size – 11.4 ml
Small size - 11.6 ml
Medium size - 12.0 ml
Medium wide size - 13.0 ml
Large size - 12.4 ml | Silicone Pillows Cushion:
Extra small size – 11.4 ml
Small size - 11.6 ml
Medium size – 12.0 ml
Medium wide size - 13.0 ml
Large size - 12.4 ml | Cushion to better
differentiate
between product
lines. There is no
change in design,
materials, or use. |
| Pressure Drop | 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
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 | Under the nose nasal cushion size:
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
Silicone 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
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 | Same
Note: Nasal Pillows
Cushion has been
re-named as
Silicone Pillows
Cushion to
differentiate
between product
lines. There is no
change in design,
materials, or use. |
| Sound Power and
Pressure Level | A-weighted Sound Power Level -
28 dBA
A-weighted Sound Pressure Level | A-weighted Sound Power Level –
28 dBA
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
(K231313) | Differences |
| Total Mask Leak | 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 | 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 | Same |
| Reprocessing
Methods | Air path and non-air path
components - Cleaning with liquid
dish detergent | Air path and non-air path
components - Cleaning with liquid
dish detergent | Same |
| | 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 | Non-air path components - Low
level chemical and thermal
disinfection | |
| Mask Weight | 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 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 | Same |
| | 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 | 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 | |
| Exhalation/Exhaust | Built-in exhalation through the
mask tubing | Built-in exhalation through the mask
tubing | Same |
| Storage Conditions | Temperature: -4° to 140° F (-20° to
+60°C) | Temperature: -4° to 140° F (-20° to
+60°C) | Same |
| | Relative Humidity: 15% to 95% | Relative Humidity: 15% to 95% | |

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7

8

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Note: 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 and/ or Clinical tests

No non-clinical and/or clinical tests summaries are submitted with this CBE submission. These labeling changes do not affect the product performance related to design outputs or specifications; therefore, additional design validation of product performance requirements was not required to implement this change.

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Standards

The Therapy Mask 3100 NC/SP 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, carcinoqenicity and . reproductive toxicity
  • ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
  • 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
  • . 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: 2021 Medical devices – Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements

Conclusion

The performance and technological characteristics of the Therapy Mask 3100 NC/SP (K231313) are substantially equivalent to those of the Therapy Mask 3100 NC/SP (K210386). The differences described above do not raise new questions of safety and effectiveness.