(335 days)
Not Found
No
The device description and performance studies focus on the physical components and standard performance characteristics of a NIV mask, with no mention of AI or ML capabilities.
No
This device is a patient interface (mask) used as an accessory to ventilators for noninvasive ventilation, specifically for applying CPAP or positive pressure ventilation. While it facilitates therapy, it does not administer the therapy itself; the ventilator does.
No
Explanation: This device is a mask for noninvasive ventilation, intended to provide a patient interface for the application of ventilation. It does not perform any diagnostic functions like analyzing patient data to identify a disease or condition.
No
The device description clearly outlines physical components like masks, headgear, gaskets, and connectors, indicating it is a hardware medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is a "patient interface for application of noninvasive ventilation." This means it's used to deliver air or oxygen to a patient's respiratory system.
- Device Description: The description details a mask and its components designed to connect to a ventilator and fit onto a patient's face.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are specifically designed for these types of tests.
This device is a medical device used for therapeutic purposes (ventilation), not for in vitro diagnostic testing.
N/A
Intended Use / 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
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
Product codes (comma separated list FDA assigned to the subject device)
CBK, BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
children (from 7 years and > 20kg), adolescents or adults >30 kg
Intended User / Care Setting
Hospital 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)
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;
- . 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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,
2
Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
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, 6
41036 Medolla
Modena
ITALY |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Maurizio Pantaleoni
Maytal Doo
Kneza Miloza 79
11000 Beograd (Serbia)
Tel. +381 11 3340700
Mob. +39 3484435155
Email: 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.
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.
5
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.
6
| PRODUCT
NAME | SUBJECT DEVICE: FAMILY OF
DIMAR DIMAX NIV MASKS | | PREDICATE DEVICE
(primary) | PREDICATE DEVICE
(secondary) | Equivalence
Discussion |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| | DIMAX MASK | DIMAX ZERO MASK | Performax SE Total Face
Mask (K072588) | Respironics Total Face
Mask (K992969) | |
| APPLICANT | DIMAR S.P.A. | | Respironics | Respironics | / |
| K NUMBER | | | K072588 | K992969 | / |
| CLASSIFICATION | | | | | |
| DEV. CLASS | | II | II | II | Identical
Classification |
| PANEL | | ANESTHESIOLOGY DEVICES | ANESTHESIOLOGY
DEVICES | ANESTHESIOLOGY
DEVICES | Identical
Panel |
| REGULATION
NUMBER | 868.5895 - Continuous Ventilator | | 868.5895 - Continuous
Ventilator | 868.5905 Noncontinuous
ventilator (IPPB) | Identical
Regulation
Number to
primary
predicate |
| PRODUCT
CODE | CBK | BZD | CBK | BZD | Identical CBK
product code
to primary
predicate
Identical BZD
product code
to secondary
predicate |
| INTENDED USE | | | | | |
| INDICATIONS
FOR USE: | FAMILY OF DIMAR DIMAX NIV MASKS is
intended to provide a patient interface
for application of non-invasive
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 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 | | The Performax SE Total Face
Mask is intended to provide
a patient interface for
application of non invasive
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 or obstructive
sleep apnea.
The mask is for multi-
patient reuse on patients
weighing > 30 kg, who are
appropriate candidates for
non invasive ventilation, in
the hospital/institutional
environment only. | The Respironics Total Face
Mask is intended to provide
an interface for application
of Respironics CPAP or
BiPAP therapy to patients
For single patient use in the
home or
Hospital/institutional
environment. The mask is to
be used on adult patients (>
30kg) for whom CPAP or
BiPAP therapy has been
prescribed using a
Respironics CPAP or BiPAP
system | Equivalent
intended use
to the
predicate
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)
Hospital/institutional environment only | Home or
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)
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 | | S
M
L
XL
XXL | S
L
XL | S
L
XL | Equivalent sizes to predicate devices |
| Dead Space Volume | | 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. |
| Interface to avoid leaking | | Silicon seal | Silicon seal | Silicon seal | Equivalent to predicate devices |
| PRODUCT
NAME | SUBJECT DEVICE: FAMILY OF
DIMAR DIMAX NIV MASKS | | PREDICATE DEVICE
(primary) | PREDICATE DEVICE
(secondary) | Equivalence
Discussion |
| | DIMAX MASK | DIMAX ZERO
MASK | Performax SE Total Face
Mask (K072588) | Respironics Total Face
Mask (K992969) | |
| Tubing
connection
points | Connection points compliant to
ISO 5356-1 | | Connection points
compliant to ISO 5356-1 | Connection points
compliant to ISO 5356-1 | Equivalent to
predicate
devices |
| Minimum
Therapy
Pressure | 4 cm H2O | | 4 cm H2O | 4 cm H2O | Equivalent to
predicate
devices |
| PERFORMANCES | | | | | |
| Resistance
Flow | S and XXL
50 SLPM: 0.2 cm H₂O
100 SLPM:0.5 cm H2O | | Unknown | Resistance Flow for EE
elbow
50 SLPM: 0.52 cm H₂O
100 SLPM:1.07 cm H₂O | Equivalent
resistance to
flow to
secondary
predicate
device |
| | S
4 cm H₂O = 34%
5 cm H₂O = 31%
10 cm H₂O = 21,5% | S
4 cm H₂O = 23,3%
5 cm H₂O = 19,6%
10 cm H₂O = 18,6% | Unknown | S
4 cm H₂O = 55,1%
5 cm H₂O = 50,4%
10 cm H₂O = 43,4% | Equivalent
rebreathing to
secondary
predicate
device |
| Rebreathing
(test 1)
Comparative
tests NC | XL
4 cm H₂O = 35.8%
5 cm H₂O = 33.1%
10 cm H₂O = 25.1% | XL
4 cm H₂O = 23.8%
5 cm H₂O = 20.5%
10 cm H₂O = 13.4% | | XL
4 cm H₂O = 40.3%
5 cm H₂O = 35.8%
10 cm H₂O= 34.3% | |
| | XXL
4 cm H₂O = 39%
5 cm H₂O = 35.5%
10 cm H₂O = 32.8% | XXL
4 cm H₂O = 24.5%
5 cm H₂O = 20.3%
10 cm H₂O = 16.2% | | | |
| 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 |
| 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 |
6. Comparison with the predicate devices
7
8
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;
9
- . 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.