Family of DIMAR DMAX NIV masks

K232836 · Dimar S.P.A. · CBK · Aug 14, 2024 · Anesthesiology

Device Facts

• Record ID: K232836
• Device Name: Family of DIMAR DMAX NIV masks
• Applicant: Dimar S.P.A.
• Product Code: CBK · Anesthesiology
• Decision Date: Aug 14, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Patient interface for noninvasive ventilation (NIV); total face mask covering eyes, nose, and mouth. Connects to ventilators via 22mm ports (ISO 5356-1) for gas inlet/exhaust. Features silicon gasket for facial seal; 5-point headgear for fixation; luer ports for pressure monitoring. Used in hospital environments by clinicians. Provides positive pressure ventilation to treat respiratory failure/insufficiency. Benefits patient by maintaining airway pressure and supporting breathing. Single-patient use; provided non-sterile.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ISO 17510:2015 (connections, resistance to flow, CO2 rebreathing, single fault condition) and biocompatibility testing (ISO 10993-5, -10, -11, -23; ISO 18562-2, -3, -4).

Technological Characteristics

Total face mask; silicon gasket seal; 5-point headgear. 22mm connectors (ISO 5356-1). Luer ports for pressure monitoring. Single-patient use. Non-sterile. Biocompatibility per ISO 10993 and ISO 18562. Mechanical device; no software or electronics.

Indications for Use

Indicated for patients requiring noninvasive ventilation (CPAP or positive pressure) for respiratory failure or insufficiency. Small size for children (≥7 years, >20kg); medium/large/extra-large/extra-extra-large for adolescents/adults >30kg. Hospital use only.

Regulatory Classification

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.

Predicate Devices

• Performax SE Total Face Mask (K072588)
• Respironics Total Face Mask (K992969)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.

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

| 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:<br>Via G. Galilei, 6<br>41036 Medolla<br>Modena<br>ITALY |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Maurizio Pantaleoni<br>Maytal Doo<br>Kneza Miloza 79<br>11000 Beograd (Serbia)<br>Tel. [phone]<br>Mob. [phone]<br>Email: [e-mail] |
| 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<br>(primary predicate device) | K072588 |
| | Respironics Inc. | Respironics Total Face Mask<br>(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.

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.

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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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| PRODUCT<br>NAME | SUBJECT DEVICE: FAMILY OF<br>DIMAR DIMAX NIV MASKS | | PREDICATE DEVICE<br>(primary) | PREDICATE DEVICE<br>(secondary) | Equivalence<br>Discussion |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | DIMAX MASK | DIMAX ZERO MASK | Performax SE Total Face<br>Mask (K072588) | Respironics Total Face<br>Mask (K992969) | |
| APPLICANT | DIMAR S.P.A. | | Respironics | Respironics | / |
| K NUMBER | | | K072588 | K992969 | / |
| CLASSIFICATION | | | | | |
| DEV. CLASS | | II | II | II | Identical<br>Classification |
| PANEL | | ANESTHESIOLOGY DEVICES | ANESTHESIOLOGY<br>DEVICES | ANESTHESIOLOGY<br>DEVICES | Identical<br>Panel |
| REGULATION<br>NUMBER | 868.5895 - Continuous Ventilator | | 868.5895 - Continuous<br>Ventilator | 868.5905 Noncontinuous<br>ventilator (IPPB) | Identical<br>Regulation<br>Number to<br>primary<br>predicate |
| PRODUCT<br>CODE | CBK | BZD | CBK | BZD | Identical CBK<br>product code<br>to primary<br>predicate<br>Identical BZD<br>product code<br>to secondary<br>predicate |
| INTENDED USE | | | | | |
| INDICATIONS<br>FOR USE: | FAMILY OF DIMAR DIMAX NIV MASKS is<br>intended to provide a patient interface<br>for application of non-invasive<br>ventilation.<br><br>The mask is to be used as an accessory<br>to ventilators which have adequate<br>alarms and safety systems for ventilator<br>failure, and which are intended to<br>administer CPAP or positive pressure<br>ventilation for treatment of respiratory<br>failure, respiratory insufficiency.<br><br>For single patient use in the Hospital<br>environment<br><br>The mask is to be used on patients who<br>are appropriate candidates for non-<br>invasive ventilation.<br><br>The small size is intended to be used for<br>children (from 7 years and > 20kg) while<br>the sizes medium/large/ extra-<br>large/extra-extra-large are intended to<br>be used for adolescents or adults >30 kg | | The Performax SE Total Face<br>Mask is intended to provide<br>a patient interface for<br>application of non invasive<br>ventilation.<br><br>The mask is to be used as an<br>accessory to ventilators<br>which have adequate<br>alarms and safety systems<br>for ventilator failure, and<br>which are intended to<br>administer CPAP or positive<br>pressure ventilation for<br>treatment of respiratory<br>failure, respiratory<br>insufficiency or obstructive<br>sleep apnea.<br><br>The mask is for multi-<br>patient reuse on patients<br>weighing > 30 kg, who are<br>appropriate candidates for<br>non invasive ventilation, in<br>the hospital/institutional<br>environment only. | The Respironics Total Face<br>Mask is intended to provide<br>an interface for application<br>of Respironics CPAP or<br>BiPAP therapy to patients<br><br>For single patient use in the<br>home or<br>Hospital/institutional<br>environment. The mask is to<br>be used on adult patients (><br>30kg) for whom CPAP or<br>BiPAP therapy has been<br>prescribed using a<br>Respironics CPAP or BiPAP<br>system | Equivalent<br>intended use<br>to the<br>predicate<br>devices |
| 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)<br>Hospital/institutional environment only | Home or<br>Hospital/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)<br><br>Adult >30 kg (medium/large/ extra-large / extra-extra-large sizes) | From 7 years > 20kg (small size)<br><br>Adult >30 Kg (large / extra-large sizes) | From 7 years > 20kg (small size)<br><br>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 | | S<br>M<br>L<br>XL<br>XXL | S<br>L<br>XL | S<br>L<br>XL | Equivalent sizes to predicate devices |
| Dead Space Volume | | S: 396 ml<br>M: 698 ml<br>L: 710 ml<br>XL: 769 ml<br>XXL: 1053 ml | Small = 375 ml<br><br>Large = 550 ml<br><br>Extra Large = 717 ml | Small = 375 ml<br><br>Large = 550 ml<br><br>Extra Large = 717 ml | Equivalent dead space volumes to predicate devices. |
| Interface to avoid leaking | | Silicon seal | Silicon seal | Silicon seal | Equivalent to predicate devices |
| PRODUCT<br>NAME | SUBJECT DEVICE: FAMILY OF<br>DIMAR DIMAX NIV MASKS | | PREDICATE DEVICE<br>(primary) | PREDICATE DEVICE<br>(secondary) | Equivalence<br>Discussion |
| | DIMAX MASK | DIMAX ZERO<br>MASK | Performax SE Total Face<br>Mask (K072588) | Respironics Total Face<br>Mask (K992969) | |
| Tubing<br>connection<br>points | Connection points compliant to<br>ISO 5356-1 | | Connection points<br>compliant to ISO 5356-1 | Connection points<br>compliant to ISO 5356-1 | Equivalent to<br>predicate<br>devices |
| Minimum<br>Therapy<br>Pressure | 4 cm H2O | | 4 cm H2O | 4 cm H2O | Equivalent to<br>predicate<br>devices |
| PERFORMANCES | | | | |…