(335 days)
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
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.
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 H₂O | |||||
| 100 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 H₂O | |||||
| 100 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.
§ 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).