IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2

K131901 · 3B Medical, Inc. · BZD · Dec 23, 2013 · Anesthesiology

Device Facts

• Record ID: K131901
• Device Name: IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2
• Applicant: 3B Medical, Inc.
• Product Code: BZD · Anesthesiology
• Decision Date: Dec 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

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: 1. to be used by adult patients (>66lb/30 kg) for whom positive airway pressure has been prescribed. 2. intended for single-patient re-use in the home, hospital, and sub-acute environment.

Device Story

iVolve® Mask Series (Nasal, Full Face, N2) functions as patient interface for positive airway pressure (PAP) devices; channels airflow non-invasively to nose or mouth. Device consists of mask cushion, frame, and adjustable headgear. Connects to standard air delivery hoses via ISO 5356-1-2004 conical connectors. Used in home, hospital, and sub-acute environments by adult patients. Healthcare providers prescribe device; patients use it to receive prescribed pressure therapy. Output is delivery of pressurized air to patient airway; facilitates treatment of sleep-disordered breathing (e.g., OSA). Benefits include non-invasive, comfortable delivery of prescribed therapy.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993), home cleaning validation (200 cycles), and performance bench testing (flow/pressure curves, resistance, dead space) compared to predicates. All results met specifications.

Technological Characteristics

Materials: silicone, molded plastic, stretch nylon. Connectivity: standard 22mm conical connectors (ISO 5356-1-2004). Form factor: nasal and full-face masks with adjustable headgear. Therapy pressure range: 4-30 cmH2O. Non-sterile, single-patient reuse.

Indications for Use

Indicated for adult patients (>30 kg) prescribed positive airway pressure therapy (CPAP or Bi-level) for conditions such as sleep-disordered breathing. Contraindications: None.

Regulatory Classification

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.

Predicate Devices

• Mirage Activa LT Nasal Mask (K030798)
• Mirage Quattro Full Face Mask (K113127)
• Willow Nasal Mask (K112271)

Submission Summary (Full Text)

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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: [phone]

Email: [e-mail]

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® Nasal<br>Mask | Mirage™ Activa LT<br>Nasal Mask<br>(K030798) | Mirage™ Quattro<br>Full Face Mask<br>(K113127) | Willow Nasal<br>Mask<br>(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 –<br>(empty volume of the<br>mask to the end of<br>the swivel) | Nasal Mask<br>S: 123.6ml<br>M: 134ml<br>L: 145 ml<br>Full-Face Mask<br>S: 220ml<br>M: 232ml<br>L: 246ml<br>N2 Mask<br>S:123.6ml<br>M: 129ml<br>L: 134.1ml | S: 123.3ml<br>M: 134.1ml<br>L: 145.2ml | S: 217ml<br>M: 228ml<br>L: 243ml | |
| | The iVolve®<br>channels airflow<br>noninvasively to<br>a patient from a<br>positive airway<br>pressure device<br>such as a<br>continuous<br>positive airway<br>pressure<br>(CPAP) or Bi-<br>level system.<br>The iVolve® is:<br>To be used<br>by adult<br>patients (>30<br>kg) for whom<br>positive<br>airway<br>pressure has<br>been<br>prescribed. Intended for<br>single-patient<br>re-use in the<br>home<br>environment. Intended for<br>prescription<br>use only. | Mirage<br>Activa™ mask<br>is an<br>accessory to a<br>non-<br>continuous<br>ventilator<br>(respirator)<br>intended for<br>single-patient<br>use for adult<br>patients<br>prescribed<br>continuous<br>positive<br>airway<br>pressure<br>(CPAP) and bi-<br>level therapy<br>in hospital,<br>clinic, and<br>home<br>environments. | The Mirage™<br>Quattro Full Face<br>Mask channels<br>airflow<br>noninvasively to a<br>patient from a<br>positive airway<br>pressure device<br>such as a<br>continuous<br>positive airway<br>pressure (CPAP) or<br>bi-level system.<br>The Mirage™<br>Quattro is to be<br>used by adult<br>patients (>66lb/<br>>30kg) for whom<br>positive airway<br>pressure has been<br>prescribed. The<br>Mirage™ Quattro is<br>intended for single<br>patient re-use in<br>the home<br>environment and/or<br>hospital/<br>institutional<br>environment. | The Willow™<br>channels<br>airflow<br>noninvasively<br>to a patient<br>from a<br>positive<br>airway<br>pressure<br>(PAP) device<br>or a bilevel<br>system. The<br>WillowTM is:<br>(1) to be used<br>by adult<br>patients (><br>66lb / 30 kg)<br>for the<br>treatment of<br>sleep<br>disordered<br>breathing,<br>such as<br>obstructive<br>sleep apnea<br>(OSA), for<br>whom<br>positive<br>airway<br>pressure has<br>been<br>prescribed.<br>(2) to be used<br>for single-<br>patient reuse<br>in the home<br>environment. | 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 Forehead<br>Support | Yes | Yes | Yes | | Therapy Pressure | 4-30cmH20 | 4-20 cmH2O | 4-20 cmH2O | 4-20 cmH2O |
| connector | 22mm | 22mm | 22mm | 22mm | | | | | |
| Resistance/Pressure<br>Drop<br>iVolve Nasal Mask | 0.2 cmH2O at<br>50L/min<br>0.7 cmH2O at<br>100L/min | 0.4 cmH2O at<br>50L/min<br>0.9 cmH2O at<br>100L/min | | 1.0 cmH2O at<br>50L/min<br>3.1 cmH2O at<br>100L/min | | | | | |
| iVolve Full Face<br>Mask | 0.1 cm H2O at<br>50L/min<br>0.5 cm H2O at<br>100L/min | 0.4 cm H2O at<br>50ml/min | 0.2 cmH2O at<br>50L/min<br>0.4 cmH2O at<br>100L/min | | | | | | |

### SE Table

3

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:

:

4

:

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| iVolve N2 | 50L/min<br>0.5 cm H2O at<br>100L/min | 0.9 cm H2O at<br>100ml/min | | |
|----------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Operating and Storage Conditions | | | | |
| Operating | +5 to +40°C<br>15% to 93%<br>relative<br>humidity, non-<br>condensing | +5 to +40°C<br>15% to 95%<br>relative<br>humidity, non-<br>condensing | -41 to 104°F(+5 to<br>+40°C)<br>15% to 95% relative<br>humidity, non-<br>condensing | +5°C to +40°C<br>10%-93 %<br>relative<br>humidity non-<br>condensing |
| Storage | -20 to +55°C<br>10% to 93%<br>relative<br>humidity, non-<br>condensing | -20 to +60°C<br>up to 95%<br>relative<br>humidity, non-<br>condensing | -4 to 140°F(-20 to<br>+60°C)<br>15% to 95% relative<br>humidity, non-<br>condensing | -20°C to +<br>55°C<br>10%-93 %<br>relative<br>humidity non-<br>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

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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/Pressure<br>Curve | 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 |
| Pressure<br>Drop/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 Mask<br>A----------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | And And Commend Comments of Children Comments of Children |

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# iVolve® Nasal Mask Series

| Name of Test | Reason for<br>Test | Size<br>Tested | No.<br>Samples<br>Tested | Objective | Result/Conclusion |
|-----------------------------|--------------------------------------------------------------------------------|----------------|--------------------------|-----------------------------------------------------------------------------------------------------------|--------------------|
| Flow/Pressure<br>Curve | to determine<br>the pressure<br>drop/resistance<br>to flow at 50,<br>100L/min. | M* | 3 | a) to meet<br>intended<br>product<br>specifications;<br>b) to compare<br>to range of<br>predicate<br>+15% | within limits/pass |
| Pressure<br>Drop/Resistance | to determine<br>the pressure<br>drop/resistance<br>to flow at 50,<br>100L/min. | M* | 3 | a) to meet<br>intended<br>product<br>specifications;<br>b) to compare<br>to range of<br>predicate<br>+15% | within limits/pass |
| Dead Space | to determine<br>the dead space<br>for each size | s,m,l | 3 | a) to meet<br>intended<br>product<br>specifications;<br>b) to compare<br>to range of<br>predicate<br>+15% | within limits/pass |

| iVolve Full-Face Mask | | | | | |
|------------------------|----------------------------------------------------------------------------------------------------|----------------|--------------------------|-----------------------------------------------------------------------------------------------------------|--------------------|
| Name of Test | Reason for<br>Test | Size<br>Tested | No.<br>Samples<br>Tested | Objective | Result/Conclusion |
| Flow/Pressure<br>Curve | to determine<br>the<br>flow/pressure<br>curve at<br>pressures 4, 8,<br>12, 16, 20, 25,<br>30 cmH20 | M* | 3 | a) to meet<br>intended<br>product<br>specifications;<br>b) to compare<br>to range of<br>predicate<br>±15% | within limits/pass |

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.

| Pressure<br>Drop/Resistance | to determine<br>the pressure<br>drop/resistance<br>to flow at 50,<br>100L/min. | M* | 3 | a) to meet<br>intended<br>product<br>specifications;<br>b) to compare<br>to range of<br>predicate<br>+ I 2 % | within limits/pass |
|-----------------------------|--------------------------------------------------------------------------------|-------|---|--------------------------------------------------------------------------------------------------------------|--------------------|
| Dead Space | to determine<br>the dead space<br>for each size | s,m,l | 3 | a) to meet<br>intended<br>product<br>specifications;<br>b) to compare<br>to range of<br>predicate<br>+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 [phone] or [phone] 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 [phone] or [phone] 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:

- 1. to be used by adult patients (>66lb/30 kg) for whom positive airway pressure has been prescribed.
2. 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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