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 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Magneto Nasal Mask." It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence.

This document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format typically required for performance studies of AI/ML-driven medical devices. The Magneto Nasal Mask is a physical medical device (a mask for CPAP/bi-level therapy), not an AI/ML software device.

Therefore, many of the requested categories in the prompt (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary for a physical medical device.

However, I can extract the closest analogous information regarding performance testing and acceptance criteria for this physical device.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for this physical device are primarily based on demonstrating equivalence to the predicate device and meeting relevant international standards for safety and performance. The "reported device performance" refers to the measurements taken for the Magneto Nasal Mask compared to the predicate.

Note: The acceptance criteria are largely implied by compliance with standards (e.g., ISO 17510 for masks, ISO 10993 for biocompatibility) and demonstrating that differences from the predicate do not raise new questions of safety and effectiveness. Specific numerical "acceptance criteria" are not explicitly stated as pass/fail thresholds in this summary for most metrics, but rather performance values are presented for comparison.

Metric (Acceptance Criteria Implicitly derived from standards and predicate comparison)	Reported Device Performance (Magneto Nasal Mask)	Predicate Device Performance (Simple T Youth Nasal Mask, K140268)
Deadspace Volume	Nasal Cradle Cushion:- Extra small: 13.6 ml- Small: 17.9 ml- Medium: 18.5 ml- Medium wide: 16.9 ml- Large: 23.7 mlNasal Pillows Cushion:- Extra small: 11.4 ml- Small: 11.6 ml- Medium: 12.0 ml- Medium wide: 13.0 ml- Large: 12.4 ml	- Small size: 37.4 ml- Medium size: 48.7 ml- Large size: 72.8 ml
Pressure Drop	Nasal Cradle Cushion:- XS: 1.7 cm H₂O @ 50 SLPM, 6.3 cm H₂O @ 100 SLPM- S: 1.5 cm H₂O @ 50 SLPM, 6.5 cm H₂O @ 100 SLPM- M: 1.4 cm H₂O @ 50 SLPM, 6.1 cm H₂O @ 100 SLPM- MW: 1.6 cm H₂O @ 50 SLPM, 6.1 cm H₂O @ 100 SLPM- L: 1.5 cm H₂O @ 50 SLPM, 5.3 cm H₂O @ 100 SLPMNasal Pillows Cushion:- XS: 1.9 cm H₂O @ 50 SLPM, 7.5 cm H₂O @ 100 SLPM- S: 2.0 cm H₂O @ 50 SLPM, 7.2 cm H₂O @ 100 SLPM- M: 1.5 cm H₂O @ 50 SLPM, 6.1 cm H₂O @ 100 SLPM- MW: 1.6 cm H₂O @ 50 SLPM, 6.3 cm H₂O @ 100 SLPM- L: 1.8 cm H₂O @ 50 SLPM, 6.8 cm H₂O @ 100 SLPM	- 0.8 cm H₂O @ 50 SLPM- 3.1 cm H₂O @ 100 SLPM
A-weighted Sound Power Level	28 dBA	26.5 dBA
A-weighted Sound Pressure Level	20 dBA	18.5 dBA
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	- 19.8 SLPM @ 5 cm H₂O- 29.5 SLPM @ 10 cm H₂O- 43.6 SLPM @ 20 cm H₂O
Biocompatibility	Compliant with ISO 10993 series and ISO 18562 series. (No specific numerical performance reported, only compliance)	(Implied compliance, not explicitly detailed in the predicate comparison for this summary)
Cleaning & Disinfection Validation	Validated (Cleaning residuals, disinfection residuals confirmed). (No specific numerical performance reported, only validation status)	(Methods outlined for predicate, no direct comparison of validation results)
Magnetic Strength	Tested (No specific numerical performance reported, only tested status)	(Not mentioned for predicate, but implies acceptable levels to prevent interference while providing secure connection)
CO2 Rebreathing	Tested (No specific numerical performance reported, only tested status)	(Not mentioned for predicate, implies meeting safety standards for CO2 washout)
Resistance (Pre & Post Cleaning/Disinfection)	Tested (derived from pressure drop, implies within acceptable limits after reprocessing)	(Covered by pressure drop for predicate, implies acceptable limits after reprocessing)
Conical Connectors	Complies with ISO 5356-1:2015 (No specific numerical performance reported, only compliance)	(Implied compliance for predicate, not explicitly detailed)

Study Proving Device Meets Acceptance Criteria:

A series of non-clinical tests were performed to verify the safety and effectiveness of the device and demonstrate substantial equivalence to the predicate device. These tests assessed various physical and performance characteristics of the mask.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated in terms of number of masks or specific test replicates for each performance metric, but the tests were conducted on the "Magneto Nasal Mask."
Data Provenance: The tests were performed by the manufacturer, Respironics, Inc., to verify the device modifications. This is retrospective testing done on manufactured devices. The country of origin of the data is implicitly the USA, where Respironics is based and where the FDA submission occurred.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical medical device, not an AI/ML software. "Ground truth" in the AI/ML sense (e.g., expert annotation of images) is not used. Performance is assessed through objective physical and functional measurements against standards and predicate device data.

4. Adjudication method for the test set

Not applicable. This is a physical medical device, not an AI/ML software. Performance is measured objectively according to specified test protocols for physical devices.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device, not an AI/ML software. No human readers or AI assistance are involved in interpreting its output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an AI/ML software.

7. The type of ground truth used

The "ground truth" for this medical device is established by:

International standards (e.g., ISO 17510 for mask performance, ISO 10993 for biocompatibility).
Performance data of the legally marketed predicate device (Simple T Youth Nasal Mask, K140268).
Engineering specifications and safety requirements for medical devices.
The tests themselves produce objective physical measurements.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML software. It does not use a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an AI/ML software.

Summary

{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 (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)

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)

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.1001 Murry Ridge LaneMurrysville, PA 15668
Official Contact	Anna DanleySenior Regulatory Affairs EngineerP: (412)-542-3513E: 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 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 NasalMaskManufacturer:Respironics, Inc.510(k) Number: K140268	Subject Device:Magneto Nasal MaskManufacturer:Respironics, Inc.510(k) Number: K210386	Similaritiesand/orDifferences
Product Code	BZD	BZD	Unchanged fromK140268.
Intended Use	The Simple T Youth NasalMask is intended to providean interface for applicationof CPAP or bi-level therapyto patients. The mask isfor single patient use in thehome or multi-patient usein the hospital/institutionalenvironment. The mask isto be used by patients 7years or older (>40lbs) for	This mask is intended toprovide an interface forapplication of CPAP or bi-level therapy to patients.The mask is for singlepatient use in the home andmulti-patient use in thehospital/institutionalenvironment. The mask isto be used on patients > 7	Unchanged fromK140268.
Feature/Function	Predicate Device:	Subject Device:	Similaritiesand/orDifferences
	Simple T Youth NasalMask	Magneto Nasal Mask
	Manufacturer:Respironics, Inc.	Manufacturer:Respironics, Inc.
	510(k) Number: K140268	510(k) Number: K210386
	whom CPAP or bi-leveltherapy has beenprescribed.	years old (> 40 lbs) forwhom CPAP or bi-leveltherapy has beenprescribed.
Patient Population	Patients 7 years or older(>40 lbs)	Patients >7 years (>40 lbs)	Unchanged fromK140268.
FunctionalIndication	Interface for application ofCPAP or bi-level therapy topatients	Interface for application ofCPAP or bi-level therapy topatients	Unchanged fromK140268.
Environment ofUse	home orhospital/institutionalenvironment	home orhospital/institutionalenvironment	Unchanged fromK140268.
Patient UsageType	Single patient use or multi-patient use	Single patient use or multi-patient use	Unchanged fromK140268.
Anatomical Sites	Nose	Nose	Unchanged fromK140268.
Provided Sterile orNon-Sterile	Non-sterile	Non-sterile	Unchanged fromK140268.
Pressure RangeSpecification	4 cm H2O to 30 cm H2O	4 cm H2O to 30 cm H2O	Unchanged fromK140268.
DeadspaceVolume	Small size – 37.4 mlMedium size – 48.7 mlLarge size – 72.8 ml	Nasal Cradle Cushion:Extra small size – 13.6 mlSmall size – 17.9 mlMedium size – 18.5 mlMedium wide size – 16.9 mlLarge size - 23.7 mlNasal Pillows Cushion:Extra small size – 11.4 ml	The deadspacevalues of thesubject deviceare lower than thepredicate device.
Feature/Function	Predicate Device:	Subject Device:	Similaritiesand/orDifferences
	Simple T Youth NasalMask	Magneto Nasal Mask
	Manufacturer:Respironics, Inc.	Manufacturer:Respironics, Inc.
	510(k) Number: K140268	510(k) Number: K210386
		Small size – 11.6 mlMedium size – 12.0 mlMedium wide size – 13.0 mlLarge size - 12.4 ml
Pressure Drop	0.8 cm H2O @ 50 SLPM3.1 cm H2O @ 100 SLPM	Nasal Cradle Cushion:Extra small size –1.7 cm H2O @ 50 SLPM6.3 cm H2O @ 100 SLPMSmall size –1.5 cm H2O @ 50 SLPM6.5 cm H2O @ 100 SLPMMedium size –1.4 cm H2O @ 50 SLPM6.1 cm H2O @ 100 SLPMMedium wide size –1.6 cm H2O @ 50 SLPM6.1 cm H2O @ 100 SLPMLarge size –1.5 cm H2O @ 50 SLPM5.3 cm H2O @ 100 SLPMNasal Pillows Cushion:Extra small size –1.9 cm H2O @ 50 SLPM7.5 cm H2O @ 100 SLPMSmall size –2.0 cm H2O @ 50 SLPM7.2 cm H2O @ 100 SLPM	The pressuredrop values of thesubject deviceare different tothe predicatedevice. There areno performancerequirements forpressure drop.The pressuredrop for a deviceis disclosed inlabelingconsistent withISO 17510:2015requirements.
Feature/Function	Predicate Device:	Subject Device:	Similaritiesand/orDifferences
	Simple T Youth NasalMaskManufacturer:Respironics, Inc.510(k) Number: K140268	Magneto Nasal MaskManufacturer:Respironics, Inc.510(k) Number: K210386
		Medium size –1.5 cm H₂O @ 50 SLPM6.1 cm H₂O @ 100 SLPMMedium wide size –1.6 cm H₂O @ 50 SLPM6.3 cm H₂O @ 100 SLPMLarge size –1.8 cm H₂O @ 50 SLPM6.8 cm H₂O @ 100 SLPM
Sound Power andPressure Level	A-weighted Sound PowerLevel – 26.5 dBAA-weighted SoundPressure Level – 18.5 dBA	A-weighted Sound PowerLevel – 28 dBAA-weighted Sound PressureLevel – 20 dBA	The sound levelsof the subjectdevice aredifferent from thepredicate devicebut do not raisedifferentquestions ofsafety andeffectiveness.The sound levelsare disclosed inlabelingconsistent withISO 17510:2015requirements.
Total Mask Leak	19.8 SLPM @ 5 cm H₂O29.5 SLPM @ 10 cm H₂O43.6 SLPM @ 20 cm H₂O	9.2 SLPM @ 4 cm H₂O10.8 SLPM @ 5 cm H₂O17.2 SLPM @ 10 cm H₂O26.7 SLPM @ 20 cm H₂O34.6 SLPM @ 30 cm H₂O	The total maskleak values arelower than thepredicate device.
Feature/Function	Predicate Device:	Subject Device:	Similaritiesand/orDifferences
	Simple T Youth NasalMask	Magneto Nasal Mask
	Manufacturer:Respironics, Inc.	Manufacturer:Respironics, Inc.
	510(k) Number: K140268	510(k) Number: K210386
	ReprocessingMethods	Air path and non-air pathcomponents – Cleaningwith liquid dish detergent
	Air path components –High level chemical andthermal disinfection	Air path components – Highlevel chemical and thermaldisinfection
		Non-air path components –Low level chemical andthermal disinfection
Mask Weight	No mask weight stated	XS Pillow Mask 37.3 gS Pillow Mask 37.4 gM Pillow Mask 37.6 gMW Pillow Mask 37.7 gL Pillow Mask 37.8 gXS Cradle Mask 39.3 gS Cradle Mask 40.8 gM Cradle Mask 41.6 gMW Cradle Mask 40.9 gL Cradle Mask 43.1 g	No mask weightwas provided forthe predicatedevice.
Exhalation/Exhaust	Built-in exhalation throughthe mask elbow	Built-in exhalation throughthe mask tubing	The subjectdevice includesexhalation in themask tubinginstead of aseparate elbowwith built-inexhalation.
Storage Conditions	Temperature: -4° to 140° F(-20° to +60° C)Relative Humidity: 15% to95%	Temperature: -4° to 140° F(-20° to +60° C)Relative Humidity: 15% to95%	Unchanged fromK140268.

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.

Regulation Number and Section

§ 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).