(274 days)
The IQ® Ventilation Nasal Mask is to be used as an accessory to CPAP / bi-level positive pressure systems that have adequate alarms and safety systems for positive pressure delivery failure. Use of this product is indicated for use with CPAP / BI-LEVEL POSITIVE PRESSURE SYSTEMS CONTAINING EXHALATION VALVES.
The IQ® Ventilation Nasal mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/institutional environment.
The SleepNet IQ® Ventilation Nasal mask is a standard type nasal mask but with no vent ports in the swivel elbow which allows this mask to be used with CPAP and bi-level positive pressure systems.
The IQ® Ventilation Nasal mask requires that the mask and circuit be connected to a positive pressure (CPAP / bi-level) system with its own exhalation valve having adequate alarms and safety systems for positive pressure delivery failure.
The IQ® Ventilation Nasal mask also utilizes standard headgear, swivel elbow (without vent holes) and a delivery tube.
This document describes a 510(k) submission for the SleepNet IQ® Ventilation Nasal Mask, which is a patient interface intended for use with CPAP/bi-level positive pressure systems containing exhalation valves.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SleepNet IQ® Ventilation Nasal Mask are established by demonstrating substantial equivalence to predicate devices through comparative performance testing. The reported device performance is presented in comparison to these predicate devices. The "acceptance criteria" column reflects the performance of the predicate device that the proposed device aims to be equivalent to or demonstrate comparable performance with.
| Performance Metric | Acceptance Criteria (Predicate: Respironics Contour nasal mask (Deluxe) – K991648 unless specified) | Reported Device Performance (SleepNet IQ® Ventilation Nasal mask) |
|---|---|---|
| Unintentional Leak | ||
| 3 cm H₂O | 2.3 lpm | 1.8 lpm |
| 10 cm H₂O | 5.4 lpm | 4.3 lpm |
| 20 cm H₂O | 9.6 lpm | 7.9 lpm |
| 30 cm H₂O | 15.9 lpm | 13.7 lpm |
| 40 cm H₂O | 25.9 lpm | 22.9 lpm |
| Intentional Leak | ||
| 3 cm H₂O | 1.5 lpm | 1.5 lpm |
| 10 cm H₂O | 3.6 lpm | 3.9 lpm |
| 20 cm H₂O | 5.8 lpm | 6.4 lpm |
| 30 cm H₂O | 7.5 lpm | 8.5 lpm |
| 40 cm H₂O | 9.1 lpm | 10.2 lpm |
| Internal volume / Dead space | 120 ml | 120 ml |
| Pressure Drop | ||
| 0.25 cm H₂O @ 30 lpm | 0.25 cm H₂O @ 30 lpm (Tested with extension tube) | 0.31 cm H₂O @ 30 lpm |
| 1.02 cm H₂O @ 60 lpm | 1.02 cm H₂O @ 60 lpm | 1.28 cm H₂O @ 60 lpm |
| Biocompatibility | Tested to ISO 10993 (Predicate materials) | Tested to ISO 10993 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of human subjects or a clinical study. The performance data presented (e.g., leak rates, pressure drop, internal volume) are results of bench testing (laboratory measurements). Therefore, sample size is not applicable in the human case, and data provenance refers to the laboratory environment where these tests were conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on substantial equivalence through bench testing to established predicate devices, not on human expert ground truth for interpretation of outcomes.
4. Adjudication Method for the Test Set
Not applicable. As this is bench testing, there is no adjudication method in the context of human expert review.
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
No MRMC study was done, as this is a medical device (nasal mask) and not an AI-powered diagnostic or assistive technology. Therefore, effect size related to human reader improvement with AI is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical nasal mask, not an algorithm, so standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on engineering and performance specifications derived from legally marketed predicate devices and international standards (e.g., ISO 10993 for biocompatibility). The claim of substantial equivalence is based on demonstrating comparable physical and functional characteristics.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an algorithm, there is no ground truth established for it.
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MAY 17 2011
510(k) Summary Page 1 of 4 11-May-11
| SleepNet Corporation | Indications for Use | PredicateSleepNet MoJo Non-vented Full face maskK063806 | PredicateSleepNetIQ® Nasal maskK021534 | PredicateRespironics – Contour nasal mask (Deluxe) –K991648 | ProposedSleepNetIQ® Ventilation Nasal mask | |
|---|---|---|---|---|---|---|
| 5 Merrill Industrial Drive | Tel - 603-758-6625 | Accessory to ventilators that have adequate alarms and safety systems for ventilator failure and which are intended to administer positive pressure ventilation for treatment of respiratory failure or respiratory insufficiency. | Intended to be used with positive airway pressure devices such as CPAP operating at or above 3 cmH2O for the treatment of adult OSA | Intended to be used with positive airway pressure devices such as CPAP or bi-level systems | Intended to be used with positive airway pressure devices such as CPAP or bi-level systems | |
| Hampton, NH 03842 | Fax - 603-758-6699 | Patient population | Adults >30 kg | Adults >30 kg | Adults >30 kg | Adults >30 kg |
| Official Contact: | Jennifer Kennedy - Director of Quality | Environment of use | HospitalInstitutionalHome | HospitalInstitutionalHome | HospitalInstitutionalHome | HospitalInstitutionalHome |
| Proprietary or Trade Name: | IQ® Ventilation Nasal Mask | Single Patient, multi-use | Yes | Yes | Yes (Deluxe model) | Yes |
| Common/Usual Name: | Patient interface | Multi-patient, reusable | Yes | No | Yes | Yes |
| Classification Code/Name: | BZD - accessory to non-continuous ventilator (respirator)CFR 868.5895 | Vent ports | No | Yes | No | No |
| Device: | IQ® Ventilation Nasal Mask | Equipment to which attached | Positive pressure ventilators with exhalation valves | CPAP | CPAP/bi-level Positive pressure systems with exhalation valves in circuit or system | CPAP/bi-level Positive pressure systems with exhalation valves in circuit or system |
| Predicate Devices: | K021534 – SleepNet IQ® Nasal maskK063806 - SleepNet MoJo Full Face maskK991648 - Respironics - Contour nasal mask (Deluxe) |
Device Description:
The SleepNet IQ® Ventilation Nasal mask is a standard type nasal mask but with no vent ports in the swivel elbow which allows this mask to be used with CPAP and bi-level positive pressure systems.
The IQ® Ventilation Nasal mask requires that the mask and circuit be connected to a positive pressure (CPAP / bi-level) system with its own exhalation valve having adequate alarms and safety systems for positive pressure delivery failure.
The IQ® Ventilation Nasal mask also utilizes standard headgear, swivel elbow (without vent holes) and a delivery tube.
Indications for Use:
The IQ® Ventilation Nasal Mask is to be used as an accessory to CPAP / bi-level positive pressure systems that have adequate alarms and safety systems for positive pressure delivery failure. Use of this product is indicated for use with CPAP / BI-LEVEL POSITIVE PRESSURE SYSTEMS CONTAINING EXHALATION VALVES.
Adult patients (>30 kg) Patient Population:
Environment of Use: Home or hospital / institutional environments.
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510(k) Summary
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510(k) Summary
| PredicateSleepNet MoJo Non-vented Full face maskK063806 | PredicateSleepNetIQ® Nasal maskK021534 | PredicateRespironics – Contournasal mask (Deluxe) –K991648 | ProposedSleepNetIQ® Ventilation Nasalmask | |
|---|---|---|---|---|
| Comparative Performance Testing | ||||
| Unintentional leak | $5 cm H_2O - 5.8 lpm$$15 cm H_2O - 9.5 lpm$$30 cm H_2O - 14.2 lpm$ | N/A | $3 cm H_2O - 2.3 lpm$$10 cm H_2O - 5.4 lpm$$20 cm H_2O - 9.6 lpm$$30 cm H_2O - 15.9 lpm$$40 cm H_2O - 25.9 lpm$ | $3 cm H_2O - 1.8 lpm$$10 cm H_2O - 4.3 lpm$$20 cm H_2O - 7.9 lpm$$30 cm H_2O - 13.7 lpm$$40 cm H_2O - 22.9 lpm$ |
| Intentional leak | N/A | This model has vent holes | $3 cm H_2O - 1.5 lpm$$10 cm H_2O - 3.6 lpm$$20 cm H_2O - 5.8 lpm$$30 cm H_2O - 7.5 lpm$$40 cm H_2O - 9.1 lpm$ | $3 cm H_2O - 1.5 lpm$$10 cm H_2O - 3.9 lpm$$20 cm H_2O - 6.4 lpm$$30 cm H_2O - 8.5 lpm$$40 cm H_2O - 10.2 lpm$ |
| Internal volume /Dead space(measured) | N/A | N/A | 120 ml | 120 ml |
| Pressure Drop | This mask covers the full face vs. nasal$0.08 cm H_2O @ 30 lpm$$0.15 cm H_2O @ 60 lpm$ | N/A | $0.25 cm H_2O @ 30 lpm$Tested with extension tube$1.02 cm H_2O @ 60 lpm$ | $0.31 cm H_2O @ 30 lpm$$1.28 cm H_2O @ 60 lpm$ |
| Components | HeadgearShell / CushionSwivel elbow | HeadgearShell / CushionSwivel elbow | HeadgearShell / CushionSwivel elbow | HeadgearShell / CushionSwivel elbow |
| Materials | Tested to ISO 10993 | Tested to ISO 10993 | Tested to ISO 10993 |
Page 14
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510(k) Summary Page 4 of 4 11-May-11
The IQ® Ventilation Nasal Mask is viewed as substantially equivalent to the predicate devices because:
Indications -
- Similar to Respironics Contour nasal mask (Deluxe) K991648 .
Patient Population -
Technology -
- Identical technology to SleepNet IQ® Nasal mask K021534 .
Materials -
- The materials in patient contact are identical to predicate device or have been tested per . ISO 10993
Environment of Use -
- . Identical to predicates - SleepNet MoJo - K063806 and Respironics - Contour nasal mask (Deluxe) - K991648
Differences -
There are no differences between the predicates and the proposed device.
Comparative Performance
We have performed comparative performance testing including - Pressure Drop, Unintentional leak, Internal volume / dead space, CO2 rebreathing, and ISO 10993 biocompatibility testing,
The results demonstrated that the device is substantially equivalent to legally marketed predicates.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a semi-circle around the left side of the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sleepnet Corporation C/O Mr. Paul E. Dryden President Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
MAY 17 2011
Re: K102317
Trade/Device Name: IQ® Ventilation Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 11, 2011 Received: May 12, 2011
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K102317
Device Name: IQ® Ventilation Nasal Mask
Indications for Use:
The IQ® Ventilation Nasal Mask is to be used as an accessory to CPAP / bi-level positive pressure systems that have adequate alarms and safety systems for positive pressure delivery failure. Use of this product is indicated for use with CPAP / BI-LEVEL POSITIVE PRESSURE SYSTEMS CONTAINING EXHALATION VALVES.
The IQ® Ventilation Nasal mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/institutional environment.
Patient Population: Adult patients (>30 kg)
Environment of Use:
Home or hospital / institutional environments.
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L Achuttn
(Division Sign-Off) livision of Anesthesiology, General Hospital rection Control, Dental Devices
10(k) Number: K102317
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).