(181 days)
The iVolve® Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The iVolve "Mask is: to be used by adult patients (>66lb/30 kg) for whom positive airway pressure has been prescribed. intended for single-patient re-use in the home, hospital, and sub-acute environment.
The iVolve® N2 and Nasal Masks are respiratory nasal mask interfaces that directs airflow from a positive pressure device to the patient's nose. The iVolve® Full-Face Mask is a mask interface that directs air flow from a positive pressure device to the patient's nose or mouth. The iVolve® Mask Series is held in place with adjustable headgear that straps the mask to the face. The iVolve® is safe when used under the conditions and purposes intended as indicated the labeling provided with the product. The iVolve® is a prescription device supplied non-sterile.
The iVolve® Nasal Mask Series (iVolve® Nasal Mask, iVolve® Full Face Mask, iVolve® N2) is a respiratory mask intended to channel airflow non-invasively to patients from a positive airway pressure device. The device was seeking substantial equivalence to existing predicate devices (Mirage Activa LT Nasal Mask (Resmed, K030798), Mirage Quattro Full Face Mask (Resmed, K113127), and Willow Nasal Mask (BMC, K112271)).
Here's an analysis of the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary acceptance criteria for the iVolve® Mask Series were based on functional performance metrics relative to predicate devices, with the objective for the device to meet intended product specifications and fall within a ±15% range of the predicate devices for key characteristics.
| Test Name | Acceptance Criteria (Objective) | Reported Device Performance (Result/Conclusion) |
|---|---|---|
| Flow/Pressure Curve | a) To meet intended product specifications; b) To compare to range of predicate ±15% | Within limits/pass |
| Pressure Drop/Resistance | a) To meet intended product specifications; b) To compare to range of predicate ±15% | Within limits/pass |
| Dead Space | a) To meet intended product specifications; b) To compare to range of predicate ±15% | Within limits/pass |
Additional Performance Characteristics (Comparison to predicates):
| Characteristic | iVolve® Nasal Mask Performance | Mirage™ Activa LT Nasal Mask (K030798) (Predicate) | Mirage™ Quattro Full Face Mask (K113127) (Predicate) | Willow Nasal Mask (K112271) (Predicate) |
|---|---|---|---|---|
| Dead Space | S: 123.6ml, M: 134ml, L: 145ml (Nasal); S: 220ml, M: 232ml, L: 246ml (Full-Face); S: 123.6ml, M: 129ml, L: 134.1ml (N2) | S: 123.3ml, M: 134.1ml, L: 145.2ml | S: 217ml, M: 228ml, L: 243ml | (N/A – Willow is a nasal pillow mask, direct dead space comparison not provided for all iVolve types) |
| Resistance/Pressure Drop | Nasal Mask: 0.2 cmH2O at 50L/min, 0.7 cmH2O at 100L/min; Full Face Mask: 0.1 cm H2O at 50L/min, 0.5 cm H2O at 100L/min; N2: 0.5 cm H2O at 50L/min, 0.9 cm H2O at 100L/min. | 0.4 cmH2O at 50L/min, 0.9 cmH2O at 100L/min (Nasal); 0.4 cm H2O at 50ml/min (Partial for Full Face equivalence) | 0.2 cmH2O at 50L/min, 0.4 cmH2O at 100L/min (Full Face); 0.9 cm H2O at 100ml/min (Partial for N2 equivalence) | 1.0 cmH2O at 50L/min, 3.1 cmH2O at 100L/min (Willow Nasal) |
| Operating Conditions | +5 to +40°C, 15% to 93% relative humidity, non-condensing | +5 to +40°C, 15% to 95% relative humidity, non-condensing | -41 to 104°F (+5 to +40°C), 15% to 95% relative humidity, non-condensing | +5°C to +40°C, 10%-93 % relative humidity non-condensing |
| Storage Conditions | -20 to +55°C, 10% to 93% relative humidity, non-condensing | -20 to +60°C, up to 95% relative humidity, non-condensing | -4 to 140°F (-20 to +60°C), 15% to 95% relative humidity, non-condensing | -20°C to +55°C, 10%-93 % relative humidity non-condensing |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: For each performance test (Flow/Pressure Curve, Pressure Drop/Resistance, Dead Space), 3 samples of each mask type (iVolve Nasal Mask, iVolve N2 Nasal Mask, iVolve Full-Face Mask) were tested. For Dead Space, all sizes (S, M, L) were tested. For Flow/Pressure Curve and Pressure Drop/Resistance, a medium size (M*) was tested.
- Data Provenance: The document does not specify the country of origin. The data is from non-clinical performance bench testing, implying it's laboratory-generated data rather than patient-derived (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This study relies on bench testing for physical and mechanical performance, not expert-derived ground truth from clinical images or diagnoses.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods are typically associated with human expert review in clinical studies. This study involved direct measurement against established physical/mechanical parameters and comparison to predicate device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This submission focuses on non-clinical performance bench testing for substantial equivalence of a medical device (respiratory mask), not on AI-assisted diagnostic or interpretative tasks that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (a respiratory mask), not an algorithm or AI system. Its performance evaluation is based on its physical characteristics and functionality.
7. The Type of Ground Truth Used:
- The ground truth in this submission is based on intended product specifications and the performance range of legally marketed predicate devices, specifically:
- Biocompatibility Standards: ISO 10993 for materials (cytotoxicity, animal skin irritation, implantation, genotoxicity, Kligman maximization).
- Performance Standards: Internal product specifications for Flow/Pressure, Resistance/Pressure Drop, and Dead Space, and the established ranges of predicate devices (ResMed Mirage Activa LT Nasal Mask (K030798), ResMed Mirage Quattro Full Face Mask (K113127), and BMC Willow Nasal Mask (K112271)).
- Durability: 200 cycles of home cleaning validated the mask's material integrity.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI or machine learning model. There is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device.
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KI31901
DEC 2 3 2013
iVolve® Nasal Mask Series
Section 6: 510(k) Summary
Section 6: 510(k) SUMMARY
[As required by 21 CFR §807.92(c)]
Date Prepared:
Official Contact:
Alex Lucio
·June 12, 2013
Vice President
3B Medical, Inc.
21301 Highway 27N
Lake Wales, FL 33859
Tel: (863) 226-6284
Email: alucio@3Bproducts.com
Device Trade Name:
・
iVolve® Nasal Mask iVolve® Full Face Mask
iVolve® N2
| Device Common Name: | Nasal Mask, Full Face Mask |
|---|---|
| Classification Name: | Vented Nasal Mask |
| Classification: | 21 CFR §868.5905, 73 BZD (CLASS II) |
| Product Code: | BZD |
| Predicate Devices: | Manufacturer: | Resmed |
|---|---|---|
| Trade Name: | Mirage Activa LT Nasal Mask | |
| 510(k) Number: | K030798 |
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| Manufacturer: | Resmed |
|---|---|
| Trade Name: | Mirage Quattro Full Face Mask |
| 510(k) Number: | K113127 |
| Manufacturer: | BMC |
| Trade Name: | Willow Nasal Mask |
| 510(k) Number: | K112271 |
Device Description:
The iVolve® N2 and Nasal Masks are respiratory nasal mask interfaces that directs airflow from a positive pressure device to the patient's nose. The iVolve® Full-Face Mask is a mask interface that directs air flow from a positive pressure device to the patient's nose or mouth. The iVolve® Mask Series is held in place with adjustable headgear that straps the mask to the face.
The iVolve® is safe when used under the conditions and purposes intended as indicated the labeling provided with the product.
The iVolve® is a prescription device supplied non-sterile.
Intended Use:
The iVolve® Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The iVolve "Mask is:
to be used by adult patients (>66lb/30 kg) for whom 1. positive airway pressure has been prescribed.
intended for single-patient re-use in the home, hospital, 2. and sub-acute environment.
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iVolve® Nasal Mask Series
Contraindications: None
Clinical Test: None
Technological Characteristics Comparison:
A comparative table of the iVolve alongside the three identified predicate devices indicates that the iVolve Mask Series is substantially equivalent with the other three with respect to the form, performance, materials, structures and the ventilation characteristics.
The iVolve mask series, including the iVolve Nasal, iVolve Full Face, and iVolve N2, are identical to the identified predicate Willow device in material composition (i.e. silicone, molded plastic, and nylon fabric). Both the proposed devices and the predicate devices connect to a conventional air delivery hose between the mask and the positive airway pressure source via standard conical connectors (ISO 5356-1-2004).
Both the proposed devices (the iVolve Mask Series) and the predicate devices have similar technical performance characteristics, including pressure-flow characteristics and flow impedance.
| Manufacture | BMC | RESmed | RESmed | BMC | With Headgear | Yes | Yes | Yes | Yes |
|---|---|---|---|---|---|---|---|---|---|
| Model | iVolve® NasalMask | Mirage™ Activa LTNasal Mask(K030798) | Mirage™ QuattroFull Face Mask(K113127) | Willow NasalMask(K112271) | With Clips | Yes | Yes | Yes | Yes |
| Picture | Image: iVolve Nasal Mask | Image: Mirage Activa LT Nasal Mask | Image: Mirage Quattro Full Face Mask | Image: Willow Nasal Mask | Multi Size | Yes | Yes | Yes | Yes |
| Intended use | Dead Space –(empty volume of themask to the end ofthe swivel) | Nasal MaskS: 123.6mlM: 134mlL: 145 mlFull-Face MaskS: 220mlM: 232mlL: 246mlN2 MaskS:123.6mlM: 129mlL: 134.1ml | S: 123.3mlM: 134.1mlL: 145.2ml | S: 217mlM: 228mlL: 243ml | |||||
| The iVolve®channels airflownoninvasively toa patient from apositive airwaypressure devicesuch as acontinuouspositive airwaypressure(CPAP) or Bi-level system.The iVolve® is:To be usedby adultpatients (>30kg) for whompositiveairwaypressure hasbeenprescribed. Intended forsingle-patientre-use in thehomeenvironment. Intended forprescriptionuse only. | MirageActiva™ maskis anaccessory to anon-continuousventilator(respirator)intended forsingle-patientuse for adultpatientsprescribedcontinuouspositiveairwaypressure(CPAP) and bi-level therapyin hospital,clinic, andhomeenvironments. | The Mirage™Quattro Full FaceMask channelsairflownoninvasively to apatient from apositive airwaypressure devicesuch as acontinuouspositive airwaypressure (CPAP) orbi-level system.The Mirage™Quattro is to beused by adultpatients (>66lb/>30kg) for whompositive airwaypressure has beenprescribed. TheMirage™ Quattro isintended for singlepatient re-use inthe homeenvironment and/orhospital/institutionalenvironment. | The Willow™channelsairflownoninvasivelyto a patientfrom apositiveairwaypressure(PAP) deviceor a bilevelsystem. TheWillowTM is:(1) to be usedby adultpatients (>66lb / 30 kg)for thetreatment ofsleepdisorderedbreathing,such asobstructivesleep apnea(OSA), forwhompositiveairwaypressure hasbeenprescribed.(2) to be usedfor single-patient reusein the homeenvironment. | Chemical Characteristics | |||||
| Construction | Cushion | Silicone | Silicone | Silicone | Silicone | ||||
| Nasal | Yes | Yes | Yes | Nasal pillows | Headgear | stretch nylon | stretch nylon | stretch nylon | stretch nylon |
| Dual-wall Cushion | Yes | Yes | Yes | Specification | |||||
| Adjustable ForeheadSupport | Yes | Yes | Yes | Therapy Pressure | 4-30cmH20 | 4-20 cmH2O | 4-20 cmH2O | 4-20 cmH2O | |
| connector | 22mm | 22mm | 22mm | 22mm | |||||
| Resistance/PressureDropiVolve Nasal Mask | 0.2 cmH2O at50L/min0.7 cmH2O at100L/min | 0.4 cmH2O at50L/min0.9 cmH2O at100L/min | 1.0 cmH2O at50L/min3.1 cmH2O at100L/min | ||||||
| iVolve Full FaceMask | 0.1 cm H2O at50L/min0.5 cm H2O at100L/min | 0.4 cm H2O at50ml/min | 0.2 cmH2O at50L/min0.4 cmH2O at100L/min |
SE Table
3
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:
:
4
:
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| iVolve N2 | 50L/min0.5 cm H2O at100L/min | 0.9 cm H2O at100ml/min | ||
|---|---|---|---|---|
| Operating and Storage Conditions | ||||
| Operating | +5 to +40°C15% to 93%relativehumidity, non-condensing | +5 to +40°C15% to 95%relativehumidity, non-condensing | -41 to 104°F(+5 to+40°C)15% to 95% relativehumidity, non-condensing | +5°C to +40°C10%-93 %relativehumidity non-condensing |
| Storage | -20 to +55°C10% to 93%relativehumidity, non-condensing | -20 to +60°Cup to 95%relativehumidity, non-condensing | -4 to 140°F(-20 to+60°C)15% to 95% relativehumidity, non-condensing | -20°C to +55°C10%-93 %relativehumidity non-condensing |
Non-Clinical Performance Data:
The materials used in the iVolve series are identical to those used in the predicate Willow mask and have undergone and passed biocompatibility testing in accordance with ISO 10993: cytotoxicity, animal skin irritation, implantation, genotoxicity, and Kligman maximization.
Home Cleaning Validation Testing confirms that the iVolve mask series can withstand 200 cycles of cleaning and assessment for degradation of materials, including simulated use.
Both the proposed devices and the predicate devices have similar performance characteristics as shown in the substantial equivalence table. Performance bench testing of the proposed iVolve Mask Series did not raise any new questions of safety
{6}------------------------------------------------
and efficacy.
The iVolve was performance bench tested against the ResMed Mirage Activa (K030798) and the ResMed Mirage Quattro (K113127). As the tables below show, in terms of performance characteristics (i.e. passive exhalation port flow, resistance to flow, and dead space), the two devices are substantially equivalent.
| iVolve Nasal Mask | |||||
|---|---|---|---|---|---|
| Name of Test | Reason for Test | Size Tested | No. Samples Tested | Objective | Result/Conclusion |
| Flow/PressureCurve | to determine the flow/pressure curve at pressures 4, 8, 12, 16, 20, 25, 30 cmH2O | M* | 3 | a) to meet intended product specifications; b) to compare to range of predicate ±15% | within limits/pass |
| PressureDrop/Resistance | to determine the pressure drop/resistance to flow at 50, 100L/min. | M* | 3 | a) to meet intended product specifications; b) to compare to range of predicate ±15% | within limits/pass |
| Dead Space | to determine the dead space for each size | s,m,l | 3 | a) to meet intended product specifications; b) to compare to range of predicate ±15% | within limits/pass |
| iVolve N2 Nasal MaskA----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|---|
| And And Commend Comments of Children Comments of Children |
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iVolve® Nasal Mask Series
| Name of Test | Reason forTest | SizeTested | No.SamplesTested | Objective | Result/Conclusion |
|---|---|---|---|---|---|
| Flow/PressureCurve | to determinethe pressuredrop/resistanceto flow at 50,100L/min. | M* | 3 | a) to meetintendedproductspecifications;b) to compareto range ofpredicate+15% | within limits/pass |
| PressureDrop/Resistance | to determinethe pressuredrop/resistanceto flow at 50,100L/min. | M* | 3 | a) to meetintendedproductspecifications;b) to compareto range ofpredicate+15% | within limits/pass |
| Dead Space | to determinethe dead spacefor each size | s,m,l | 3 | a) to meetintendedproductspecifications;b) to compareto range ofpredicate+15% | within limits/pass |
| iVolve Full-Face Mask | |||||
|---|---|---|---|---|---|
| Name of Test | Reason forTest | SizeTested | No.SamplesTested | Objective | Result/Conclusion |
| Flow/PressureCurve | to determinetheflow/pressurecurve atpressures 4, 8,12, 16, 20, 25,30 cmH20 | M* | 3 | a) to meetintendedproductspecifications;b) to compareto range ofpredicate±15% | within limits/pass |
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.
| PressureDrop/Resistance | to determinethe pressuredrop/resistanceto flow at 50,100L/min. | M* | 3 | a) to meetintendedproductspecifications;b) to compareto range ofpredicate+ I 2 % | within limits/pass |
|---|---|---|---|---|---|
| Dead Space | to determinethe dead spacefor each size | s,m,l | 3 | a) to meetintendedproductspecifications;b) to compareto range ofpredicate+15% | within limits/pass |
.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2013
3B Medical, Incorporated Mr. Alex Lucio Vice President 21301 Highway 27N Lake Wales, FL 33859
Re: K131901
Trade/Device Name: iVolve Nasal Mask, iVolve Full Face Mask, iVolve N2 Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: November 15, 2013 Received: November 19, 2013
Dear Mr. Lucio:
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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Page 2 - Ms. Lucio
· · · 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
Sincerely yours.
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
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Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K131901
Device Name iVolve Mask Series
Indications for Use (Describe)
The iVolve® Mask channels airflow non-invasively to a partive arway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system.
The iVolve® Mask is:
-
- to be used by adult patients (>66lb/30 kg) for whom positive airway pressure has been prescribed.
- intended for single-patient re-use in the home, hospital, and sub-acute environment
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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§ 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).