The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilator failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency.

For single patient use in the Hospital environment

The mask is to be used on patients who are appropriate candidates for noninvasive ventilation.

The small size is intended to be used for children (from 7 years and > 20kg) while the sizes medium/large/ extra-large/ extra-extra-large are intended to be used for adolescents or adults >30 kg

Device Description

FAMILY OF DIMAR DIMAX NIV MASKS consists of two main types of a patient interface:

DIMAX ZERO
DIMAX

The DIMAX ZERO MASK is a "total face" MASK that totally covers eyes, nose and mouth. The DIMAX ZERO MASK is provided for SINGLE USE.

Below a short summary of the technical features of the DIMAX ZERO MASK:

The MASK can be connected to 2 different connectors: 1 for gas inlet and the other one for ● the exhaust gas outlet (the mask can also work with 1 connector, with the hole for the second connector - gas outlet- capped);
The MASK is fixed to the head of the patient through a 5 fixing points headgear;
A silicon gasket allows the mask to adapt to the patient's face and avoid air leaks;
2 specific luer ports are available for the control of the pressure through a manometer;
The DIMAX ZERO MASK is provided not sterile in a plastic pouch. In each pouch are included the following connectors (22 mm connectors conforming to ISO 5356-1) and components:
- 22F Non-Vented connector; O
- 22F Vented connector with flop; O
- 22F Non-Vented connector with FBS port; O
- 22M-22M adapter; O
- o 22F-22F adapter;
- о 22F сар.

The DIMAX MASK is a "Total Face" MASK that totally covers eyes, nose and mouth. The DIMAX MASK is provided for SINGLE USE.

Below a short summary of the technical features of the DIMAX MASK:

The MASK can be connected through the same connector for both gas inlet and exhaust gas ● outlet;
The MASK is fixed to the head of the patient through a 5 fixing points headgear;
A silicon gasket allows the mask to adapt to the patient's face and avoid air leaks;
2 specific luer ports are available for the control of the pressure through a manometer;
The DIMAX MASK is provided not sterile in a plastic pouch. In each pouch are included the following connectors (22 mm connectors conforming to ISO 5356-1) and components:
- O 22F Non-Vented connector;
- O 22F Vented connector with flop;
- O 22F Non-Vented connector with FBS port.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for the "FAMILY OF DIMAR DIMAX NIV MASKS" (subject device) in comparison to predicate devices, primarily the Performax SE Total Face Mask (K072588) and Respironics Total Face Mask (K992969).

Here's the breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria / Performance Metric	Subject Device Performance (DIMAX MASK)	Subject Device Performance (DIMAX ZERO MASK)	Predicate Device (K072588) Performance	Predicate Device (K992969) Performance	Equivalence Discussion
I. Intended Use	Provides a patient interface for non-invasive ventilation; accessory to ventilators; for single-patient use in hospital; for children (>7 yrs, >20kg) and adolescents/adults (>30kg).	Same as DIMAX MASK	Provides a patient interface for non invasive ventilation; accessory to ventilators; for multi-patient reuse in hospital/institutional environment; weighing > 30 kg.	Interface for Respironics CPAP or BiPAP therapy; single patient use in home or hospital/institutional environment; for adult patients (>30kg).	Equivalent intended use to the predicate devices.
II. Environment	Hospital environment only.	Same as DIMAX MASK	Hospital/institutional environment only.	Home or Hospital/institutional environment.	Equivalent environment to predicate devices.
III. Reuse	Single Use	Single Use	Multi Patient	Single Patient	Equivalent to secondary predicate device.
IV. Principles of Operation	Interface to ventilators for CPAP or positive pressure ventilation, held by adjustable headgear.	Same as DIMAX MASK	Interface to ventilators for CPAP or positive pressure ventilation, held by adjustable headgear.	Interface for CPAP or BiPAP therapy, held by adjustable headgear.	Equivalent principle of operation to predicate devices.
V. Type of Patient	From 7 years > 20kg (small size); Adult >30 kg (medium/large/ extra-large / extra-extra-large sizes).	Same as DIMAX MASK	From 7 years > 20kg (small size); Adult >30 Kg (large / extra-large sizes).	From 7 years > 20kg (small size); Adult >30 Kg (large / extra-large sizes).	Equivalent type of patient to predicate devices.
VI. Patient Support System	Positive Pressure Ventilation	Positive Pressure Ventilation	Positive Pressure Ventilation	Positive Pressure Ventilation	Equivalent patient support system to predicate devices.
VII. Available Sizes	S, M, L, XL, XXL	S, M, L, XL, XXL	S, L, XL	S, L, XL	Equivalent sizes to predicate devices.
VIII. Dead Space Volume	S: 396 ml; M: 698 ml; L: 710 ml; XL: 769 ml; XXL: 1053 ml.	S: 396 ml; M: 698 ml; L: 710 ml; XL: 769 ml; XXL: 1053 ml.	Small = 375 ml; Large = 550 ml; Extra Large = 717 ml.	Small = 375 ml; Large = 550 ml; Extra Large = 717 ml.	Equivalent dead space volumes to predicate devices.
IX. Interface to avoid leaking	Silicon seal	Silicon seal	Silicon seal	Silicon seal	Equivalent to predicate devices.
X. Tubing connection points	Compliant to ISO 5356-1	Compliant to ISO 5356-1	Compliant to ISO 5356-1	Compliant to ISO 5356-1	Equivalent to predicate devices.
XI. Minimum Therapy Pressure	4 cm H2O	4 cm H2O	4 cm H2O	4 cm H2O	Equivalent to predicate devices.
XII. Resistance to Flow	S and XXL:50 SLPM: 0.2 cm H₂O100 SLPM: 0.5 cm H₂O	Not explicitly stated, inferred to be similar to DIMAX MASK unless otherwise noted.	Unknown	EE elbow:50 SLPM: 0.52 cm H₂O100 SLPM: 1.07 cm H₂O	Equivalent resistance to flow to secondary predicate device.
XIII. Rebreathing (test 1) - Comparative tests NC	S: 4 cm H₂O = 34%, 5 cm H₂O = 31%, 10 cm H₂O = 21.5%XL: 4 cm H₂O = 35.8%, 5 cm H₂O = 33.1%, 10 cm H₂O = 25.1%XXL: 4 cm H₂O = 39%, 5 cm H₂O = 35.5%, 10 cm H₂O = 32.8%	S: 4 cm H₂O = 23.3%, 5 cm H₂O = 19.6%, 10 cm H₂O = 18.6%XL: 4 cm H₂O = 23.8%, 5 cm H₂O = 20.5%, 10 cm H₂O = 13.4%XXL: 4 cm H₂O = 24.5%, 5 cm H₂O = 20.3%, 10 cm H₂O = 16.2%	Unknown	S: 4 cm H₂O = 55.1%, 5 cm H₂O = 50.4%, 10 cm H₂O = 43.4%XL: 4 cm H₂O = 40.3%, 5 cm H₂O = 35.8%, 10 cm H₂O = 34.3%	Equivalent rebreathing to secondary predicate device.
XIV. Rebreathing (test 2) - Comparative tests SFC	S = 89.7%; XL = 91.1%; XXL = 101.6%	S = 83.7%; XL = 82.3%; XXL = 90.7%	Unknown	S = 98.2%; XL = 103.5%	Equivalent rebreathing to secondary predicate device.
XV. Rebreathing (test 3) - Comparative tests SFC	S = 99%; XL = 101.1%; XXL = 102.8%	S = 93.3%; XL = 103.3%; XXL = 104.2%	Unknown	S = 95.8%; XL = 104.6%	Equivalent rebreathing to secondary predicate device.
XVI. Biocompatibility	Meets ISO 10995-5, ISO 10993-10, ISO 10993-23, ISO 10993-11, ISO 18562-2, ISO 18562-3, ISO 18562-4.	Meets ISO 10995-5, ISO 10993-10, ISO 10993-23, ISO 10993-11, ISO 18562-2, ISO 18562-3, ISO 18562-4.	Not explicitly stated in this document but implied to meet relevant biological safety standards.	Not explicitly stated in this document but implied to meet relevant biological safety standards.	Not explicitly compared in the table but indicated as meeting requirements.
XVII. Other Technical Features	5 fixing points headgear, silicon gasket, 2 luer ports for pressure control.	5 fixing points headgear, silicon gasket, 2 luer ports for pressure control.	Not explicitly detailed in the table provided, but assumed similar for functional equivalence.	Not explicitly detailed in the table provided, but assumed similar for functional equivalence.	Overall technical features are comparable.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size for the test sets. The performance data presented (e.g., resistance to flow, rebreathing) are quantitative measurements.
The data provenance (country of origin, retrospective/prospective) is not mentioned. The submitter is DIMAR S.P.A. located in Italy, which might suggest the testing was conducted in Italy, but this is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a medical device (NIV mask), not an AI/software device that requires expert ground truth for classification or diagnosis. The performance tests are based on physical and functional measurements against established standards (e.g., ISO 17510:2015, ISO 5356-1, ISO 10993 series, ISO 18562 series). Therefore, there is no mention of experts establishing a "ground truth" in the diagnostic sense. The "truth" is determined by compliance with the referenced standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The tests performed are objective measurements against recognized standards for medical device performance (e.g., resistance to flow, rebreathing, biocompatibility). There is no "adjudication" in the context of expert review or consensus for this type of device testing.

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 hard-good medical device (NIV mask), not an AI/software device. No human reader or AI assistance studies are mentioned or relevant to its performance evaluation for market clearance.

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

Not applicable. This is a hard-good medical device (NIV mask), not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is compliance with established international standards for medical devices, specifically:

Physical and Functional Performance: ISO 17510:2015 (Medical devices – Sleep apnea breathing therapy - Masks and application accessories), ISO 5356-1 (Anaesthetic and respiratory equipment — Conical connectors), and internal working pressure/filter connection/construction requirements.
Biocompatibility: ISO 10993 series (Biological evaluation of medical devices) and ISO 18562 series (Biocompatibility evaluation of breathing gas pathways).

8. The sample size for the training set

Not applicable. This is a hard-good medical device and does not involve a training set as would be used for an AI/software algorithm.

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

Not applicable. There is no training set for this type of medical device.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

August 14, 2024

Dimar S.p.A % Maurizio Pantaleoni Senior Consultant Maytal Doo Kneza Milosa, 79 Belgrade, Serbia 11000 Serbia

Re: K232836

Trade/Device Name: Family of DIMAR DMAX NIV masks Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: CBK, BZD Dated: July 9, 2024 Received: July 15, 2024

Dear Maurizio Pantaleoni:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia,

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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) K232836

Device Name FAMILY OF DIMAR DIMAX NIV MASKS

Indications for Use (Describe)

FAMILY OF DIMAR DIMAX NIV MASKS is intended to provide a patient interface for application of noninvasive ventilation.

For single patient use in the Hospital environment

The mask is to be used on patients who are appropriate candidates for noninvasive ventilation.

The small size is intended to be used for children (from 7 years and > 20kg) while the sizes medium/large/ extra-large/ extra-extra-large are intended to be used for adolescents or adults >30 kg

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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1. General Information

This 510(k) Summary is being submitted as required by 21 CFR 807.92

Submitter :	DIMAR S.P.A. is located at:Via G. Galilei, 641036 MedollaModenaITALY
Contact:	Maurizio PantaleoniMaytal DooKneza Miloza 7911000 Beograd (Serbia)Tel. +381 11 3340700Mob. +39 3484435155Email: maurizio.pantaleoni@maytal.eu
Summary Preparation Date:	August 13, 2024

2.	Name & Classification
	Device Name:	FAMILY OF DIMAR DIMAX NIV MASKS
	Regulation Name:	Continuous Ventilator
	Regulation Number:	868.5895
	Product Code:	CBK
	Secondary Product code	BZD
	CLASS:	II

3. Predicate Devices

The FAMILY OF DIMAR DIMAX MASKS is substantially equivalent to the following devices legally marketed in the U.S. market:

Applicant	Device Name	510(k) Number
Respironics Inc.	Performax SE Total Face Mask(primary predicate device)	K072588
	Respironics Inc.	Respironics Total Face Mask(secondary predicate device)

4. Indications for Use

FAMILY OF DIMAR DIMAX NIV MASKS is intended to provide a patient interface for application of noninvasive ventilation.

For single patient use in the Hospital environment.

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The mask is to be used on patients who are appropriate candidates for non-invasive ventilation. The small size is intended to be used for children (from 7 years and > 20kg) while the sizes medium/large/ extra-large/extra-extra-large are intended to be used for adolescents or adults >30 kg.

5. Device Description

FAMILY OF DIMAR DIMAX NIV MASKS consists of two main types of a patient interface:

DIMAX ZERO
DIMAX

The DIMAX ZERO MASK is a "total face" MASK that totally covers eyes, nose and mouth. The DIMAX ZERO MASK is provided for SINGLE USE.

Below a short summary of the technical features of the DIMAX ZERO MASK:

The MASK can be connected to 2 different connectors: 1 for gas inlet and the other one for ● the exhaust gas outlet (the mask can also work with 1 connector, with the hole for the second connector - gas outlet- capped);
The MASK is fixed to the head of the patient through a 5 fixing points headgear;
A silicon gasket allows the mask to adapt to the patient's face and avoid air leaks;
2 specific luer ports are available for the control of the pressure through a manometer;
The DIMAX ZERO MASK is provided not sterile in a plastic pouch. In each pouch are included the following connectors (22 mm connectors conforming to ISO 5356-1) and components:
- 22F Non-Vented connector; O
- 22F Vented connector with flop; O
- 22F Non-Vented connector with FBS port; O
- 22M-22M adapter; O
- o 22F-22F adapter;
- о 22F сар.

The DIMAX MASK is a "Total Face" MASK that totally covers eyes, nose and mouth. The DIMAX MASK is provided for SINGLE USE.

Below a short summary of the technical features of the DIMAX MASK:

The MASK can be connected through the same connector for both gas inlet and exhaust gas ● outlet;
The MASK is fixed to the head of the patient through a 5 fixing points headgear;
A silicon gasket allows the mask to adapt to the patient's face and avoid air leaks;
2 specific luer ports are available for the control of the pressure through a manometer;
The DIMAX MASK is provided not sterile in a plastic pouch. In each pouch are included the following connectors (22 mm connectors conforming to ISO 5356-1) and components:
- O 22F Non-Vented connector;
- O 22F Vented connector with flop;
- O 22F Non-Vented connector with FBS port.

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PRODUCTNAME	SUBJECT DEVICE: FAMILY OFDIMAR DIMAX NIV MASKS		PREDICATE DEVICE(primary)	PREDICATE DEVICE(secondary)	EquivalenceDiscussion
	DIMAX MASK	DIMAX ZERO MASK	Performax SE Total FaceMask (K072588)	Respironics Total FaceMask (K992969)
APPLICANT	DIMAR S.P.A.		Respironics	Respironics	/
K NUMBER			K072588	K992969	/
CLASSIFICATION
DEV. CLASS		II	II	II	IdenticalClassification
PANEL		ANESTHESIOLOGY DEVICES	ANESTHESIOLOGYDEVICES	ANESTHESIOLOGYDEVICES	IdenticalPanel
REGULATIONNUMBER	868.5895 - Continuous Ventilator		868.5895 - ContinuousVentilator	868.5905 Noncontinuousventilator (IPPB)	IdenticalRegulationNumber toprimarypredicate
PRODUCTCODE	CBK	BZD	CBK	BZD	Identical CBKproduct codeto primarypredicateIdentical BZDproduct codeto secondarypredicate
INTENDED USE
INDICATIONSFOR USE:	FAMILY OF DIMAR DIMAX NIV MASKS isintended to provide a patient interfacefor application of non-invasiveventilation.The mask is to be used as an accessoryto ventilators which have adequatealarms and safety systems for ventilatorfailure, and which are intended toadminister CPAP or positive pressureventilation for treatment of respiratoryfailure, respiratory insufficiency.For single patient use in the HospitalenvironmentThe mask is to be used on patients whoare appropriate candidates for non-invasive ventilation.The small size is intended to be used forchildren (from 7 years and > 20kg) whilethe sizes medium/large/ extra-large/extra-extra-large are intended tobe used for adolescents or adults >30 kg		The Performax SE Total FaceMask is intended to providea patient interface forapplication of non invasiveventilation.The mask is to be used as anaccessory to ventilatorswhich have adequatealarms and safety systemsfor ventilator failure, andwhich are intended toadminister CPAP or positivepressure ventilation fortreatment of respiratoryfailure, respiratoryinsufficiency or obstructivesleep apnea.The mask is for multi-patient reuse on patientsweighing > 30 kg, who areappropriate candidates fornon invasive ventilation, inthe hospital/institutionalenvironment only.	The Respironics Total FaceMask is intended to providean interface for applicationof Respironics CPAP orBiPAP therapy to patientsFor single patient use in thehome orHospital/institutionalenvironment. The mask is tobe used on adult patients (>30kg) for whom CPAP orBiPAP therapy has beenprescribed using aRespironics CPAP or BiPAPsystem	Equivalentintended useto thepredicatedevices
PRODUCT NAME	SUBJECT DEVICE: FAMILY OF DIMAR DIMAX NIV MASKS		PREDICATE DEVICE (primary)	PREDICATE DEVICE (secondary)	Equivalence Discussion
	DIMAX MASK	DIMAX ZERO MASK
ENVIRONMENT	Hospital environment only.		Performax SE Total Face Mask (K072588)Hospital/institutional environment only	Home orHospital/institutional environment	Equivalent environment to predicate devices
REUSE		Single Use	Multi Patient	Single Patient	Equivalent to secondary predicate device
THERAPY FEATURES
Principles of Operation		Devices intended to provide an interface to ventilators which are intended to administer CPAP or positive pressure ventilation directed to the patient's nostril and mouth and that are held in place with adjustable headgear that straps the mask to the face	Devices intended to provide an interface to ventilators which are intended to administer CPAP or positive pressure ventilation directed to the patient's nostril and mouth and that are held in place with adjustable headgear that straps the mask to the face	Devices intended to provide an interface for application of Respironics CPAP or BiPAP therapy to patients directed to the patient's nostril and mouth and that are held in place with adjustable headgear that straps the mask to the face	Equivalent principle of operation to predicate devices
Type of Patient		From 7 years > 20kg (small size)Adult >30 kg (medium/large/ extra-large / extra-extra-large sizes)	From 7 years > 20kg (small size)Adult >30 Kg (large / extra-large sizes)	From 7 years > 20kg (small size)Adult >30 Kg (large / extra-large sizes)	Equivalent type of patient to predicate devices
Patient Support System		Positive Pressure Ventilation	Positive Pressure Ventilation	Positive Pressure Ventilation	Equivalent patient support system to predicate devices
TECHNICAL FEATURES
Available Sizes		SMLXLXXL	SLXL	SLXL	Equivalent sizes to predicate devices
Dead Space Volume		S: 396 mlM: 698 mlL: 710 mlXL: 769 mlXXL: 1053 ml	Small = 375 mlLarge = 550 mlExtra Large = 717 ml	Small = 375 mlLarge = 550 mlExtra Large = 717 ml	Equivalent dead space volumes to predicate devices.
Interface to avoid leaking		Silicon seal	Silicon seal	Silicon seal	Equivalent to predicate devices
PRODUCTNAME	SUBJECT DEVICE: FAMILY OFDIMAR DIMAX NIV MASKS		PREDICATE DEVICE(primary)	PREDICATE DEVICE(secondary)	EquivalenceDiscussion
	DIMAX MASK	DIMAX ZEROMASK	Performax SE Total FaceMask (K072588)	Respironics Total FaceMask (K992969)
Tubingconnectionpoints	Connection points compliant toISO 5356-1		Connection pointscompliant to ISO 5356-1	Connection pointscompliant to ISO 5356-1	Equivalent topredicatedevices
MinimumTherapyPressure	4 cm H2O		4 cm H2O	4 cm H2O	Equivalent topredicatedevices
PERFORMANCES
ResistanceFlow	S and XXL50 SLPM: 0.2 cm H₂O100 SLPM:0.5 cm H2O		Unknown	Resistance Flow for EEelbow50 SLPM: 0.52 cm H₂O100 SLPM:1.07 cm H₂O	Equivalentresistance toflow tosecondarypredicatedevice
	S4 cm H₂O = 34%5 cm H₂O = 31%10 cm H₂O = 21,5%	S4 cm H₂O = 23,3%5 cm H₂O = 19,6%10 cm H₂O = 18,6%	Unknown	S4 cm H₂O = 55,1%5 cm H₂O = 50,4%10 cm H₂O = 43,4%	Equivalentrebreathing tosecondarypredicatedevice
Rebreathing(test 1)Comparativetests NC	XL4 cm H₂O = 35.8%5 cm H₂O = 33.1%10 cm H₂O = 25.1%	XL4 cm H₂O = 23.8%5 cm H₂O = 20.5%10 cm H₂O = 13.4%		XL4 cm H₂O = 40.3%5 cm H₂O = 35.8%10 cm H₂O= 34.3%
	XXL4 cm H₂O = 39%5 cm H₂O = 35.5%10 cm H₂O = 32.8%	XXL4 cm H₂O = 24.5%5 cm H₂O = 20.3%10 cm H₂O = 16.2%
Rebreathing(test 2)Comparativetests SFC	S = 89,7%XL = 91.1%XXL = 101.6%	S = 83.7%XL = 82.3%XXL = 90.7%	Unknown	S = 98,2%XL = 103.5%	Equivalentrebreathing tosecondarypredicatedevice
Rebreathing(test 3)Comparativetests SFC	S = 99%XL = 101.1%XXL = 102.8%	S = 93.3%XL = 103.3%XXL = 104.2%	Unknown	S = 95,8%XL = 104.6%	Equivalentrebreathing tosecondarypredicatedevice

6. Comparison with the predicate devices

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7. Performance Data

A program of design verification and validation testing was performed that includes the following:

Connections and ports (This device has been tested to ISO 17510:2015 Medical devices – Sleep apnea breathing therapy - Masks and application accessories);
Working pressure test ;
Filter connection;
Access to patient for airway management;
Resistance to flow (resistance Flow ): This device has been tested to ISO 17510:2015 Medical devices - Sleep apnea breathing therapy - Masks and application accessories;
. Breathing during single fault condition: This device has been tested to ISO 17510:2015 Medical devices - Sleep apnea breathing therapy - Masks and application accessories;
. Protection against CO2 rebreathing: This device has been tested to ISO 17510:2015 Medical devices - Sleep apnea breathing therapy - Masks and application accessories;

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. Construction Requirements;
Noise test.

For Biocompatibility, this device has been tested to:

ISO 10995-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro ● cytotoxicity
. ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
. ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for system toxicity (pyrogenicity and acute systemic toxicity)
. 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 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate

Results of the evaluations demonstrate that the subject device meets the safety and performance requirements as per its indication for use.

8. Clinical data

N/A

Conclusions 9.

In light of above summarized evidences and based on classification, intended use, technical features and performance data, the subject device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).