3B FLEX-LITE

K103434 · 3B Products, LLC · BZD · Oct 13, 2011 · Anesthesiology

Device Facts

• Record ID: K103434
• Device Name: 3B FLEX-LITE
• Applicant: 3B Products, LLC
• Product Code: BZD · Anesthesiology
• Decision Date: Oct 13, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 3B Flex-Lite™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or a bilevel system. The 3B Flex-Lite™ is: - to be used by adult patients (>66lb / 30 kg); (1) - to be used for single-patient reuse in the home environment and multipatient (2) reuse in the hospital/institutional environment. (3) to be used in the following environments: home, hospital, and sub-acute institutions. intended for prescription use. (4)

Device Story

3B Flex-Lite is a nasal pillow mask interface; directs airflow from CPAP or bi-level PAP device to patient nose. Device consists of nasal interface with pillows and Breath-O-Prene fabric headgear. Used in home, hospital, and sub-acute institutional settings; operated by patient or clinician. Mask incorporates four vent holes for continuous air leak to flush CO2. Device connects to PAP tubing; provides noninvasive airway pressure delivery. Healthcare providers use device to treat adult OSA or provide ventilator support. Benefits include noninvasive pressure delivery for respiratory therapy.

Clinical Evidence

Bench testing only. Performance testing conducted by Piper Medical compared 3B Flex-Lite to Nasal-Aire II. Metrics included passive exhalation port flow, resistance to flow, CO2 rebreathing percentage, and dead space measurement. Results demonstrated substantial equivalence in performance.

Technological Characteristics

Nasal pillow interface; silicone construction (ISO 10993-1 biocompatibility). Headgear made of Breath-O-Prene (laminated knit textile). Features four vent holes for CO2 flushing. Fixed leak port design. Compatible with CPAP/bi-level systems (4-20 cmH2O pressure range).

Indications for Use

Indicated for adult patients (>30kg) requiring CPAP or bi-level positive airway pressure therapy for treatment of obstructive sleep apnea (OSA) or ventilator support. 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

• Nasal-Aire II (K022465)
• Swift FX (K090244)

Reference Devices

• GoLife Nasal Mask (K110008)
• Opus Nasal Mask (K063036)
• Ultra Mirage Nasal Mask (K050359)

Submission Summary (Full Text)

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3B™

# 3B Flex-Lite Nasal Mask

OCT 1 3 2011

### Section 5:

### 510(k) SUMMARY

[As required by 21 CFR §807.92(c)]

DATE PREPARED:

March 28, 2011

Revised September 8, 2011

OFFICIAL CONTACT:

Albert A. Lucio

Managing Partner

3B Products, LLC

1142 N. Scenic Highway

Lake Wales, FL 33853

Tel: [phone]

Email: [e-mail]

DEVICE TRADE NAME: 3B FLEX-LITE™

DEVICE COMMON NAME/

CLASSIFICATION NAME: Vented Nasal Mask:

Accessory to Noncontinuous Ventilator (IPPB)

CLASSIFICATION:

21 CFR 868.5905, 73 BZD (CLASS II)

Manufacturer:

PREDICATE DEVICES:

InnoMed Technologies, Inc.

Trade Name: Nasal-Aire II

510(k) Number: K022465

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3B Flex-Lite Nasal Mask (K 103434)

000008

Resmed, Ltd. Manufacturer: Swift FX Trade Name: 510(k) Number: K090244

### DEVICE DESCRIPTION

The 3B Flex-Lite™ is a mask interface, of the nasal pillow variety, that directs airflow from a positive pressure device to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face.

The 3B Flex-Lite™ is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product.

The 3B Flex-Lite™ is a prescription device supplied non-sterile.

### INTENDED USE

The 3B Flex-Lite™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or a bilevel system. The 3B Flex-Lite™ is:

- to be used by adult patients (>66lb / 30 kg); (1)
- to be used for single-patient reuse in the home environment and multipatient (2) reuse in the hospital/institutional environment.
- (3) to be used in the following environments: home, hospital, and sub-acute institutions.
- intended for prescription use. (4)

CONTRAINDICATIONS: None

### TECHNOLOGICAL CHARACTERISTICS COMPARISON

The 3B Flex-Lite™ is differentiated from the predicate devices based primarily on differences in form, fit and comfort. The headgear is constructed out of Breath-O-Prene™ fabric, a laminated knit textile which serves as the loop for a Velcro fastener. Breath-O-Prene™ is a popular fabric for the CPAP headgear market used in the predicate devise Swift FX, and is also currently being used in similar applications by several other manufacturers, including Phillips Respironics GoLife Nasal Mask K110008) , Fisher & Paykel (Opus Nasal Mask K063036) and Resmed (Ultra Mirage Nasal Mask K050359).

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## 3B"

The nasal mask itself incorporates four vent holes to provide continuous air, leak to flush out The nask Room moorporates a rebreathed by the patient. The design of the mask and infinitize the anount of these vent-holes does not interfere with the intended performance of the mask.

The 3B Flex-Lite™ nasal mask is very similar to the predicate InnoMed Nasal Aire-II mask. Both rre cannula style mask systems with similar performance characteristics. Performance bench are connula style mash by virus™ and the Nasal Aire II were conducted. These tests demonstrate testing of both the BB Tion of the proposed device with the predicate device. Copies of test reports are included in Appendix A.

The 3B Flex-Lite™ is similar to the predicate Resmed Swift FX inasmuch as they have similar air The DD Fex alle - b and pillow design) and utilize the same headgear fabric (i.e. Breath-O-9car 3f3cms (inst hase phonomisons of the proposed device and the predicate devises is shown below in tabular form:

### COMPARATIVE TABLE:

| FEATURES | PREDICATE NASAL-<br>AIRE II (K022465) | PREDICATE SWIFT FX<br>(K090244) | PROPOSED DEVICE 3B<br>FLEX-LITE (K103434) |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | A patient interface<br>accessory for use with<br>CPAP and bi-level<br>systems used in the<br>treatment of adult<br>OSA and/or ventilator<br>support. | A patient interface<br>accessory for use with<br>CPAP and bi-level<br>systems used in the<br>treatment of adult<br>OSA and/or ventilator<br>support. | A patient interface<br>accessory for use with<br>CPAP and bi-level<br>systems used in the<br>treatment of adult<br>OSA and/or ventilator<br>support. |
| Environment of Use | Hospitals, sub-acute<br>institutions, sleep<br>laboratories and<br>home. | Same | Same |
| Patient Population | Adult | Same | Same |
| Contraindications | None | None | None |
| Single patient, multi-<br>use | Yes | Yes | Yes |
| Components | Nasal interface (no<br>headgear) | Nasal interface with<br>pillows and headgear | Nasal interface with<br>pillows and headgear |
| Dead Space | Interface - 24-28 ml /<br>Pillows 2-4 ml | Interface - 24-28 ml /<br>Pillows 2-4 ml | Interface 10.5ml<br>Pillows 3.5 ml |
| Fixed leak port | Yes | Yes | Yes |

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| Deliverable pressure<br>range | 3-18 cmH20 | 4-20 cmH20 | 4-20 cmH20 |
|---------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------|
| Materials: | | | |
| Nasal Interface | Silicone | Silicone | Silicone<br>(Biocompatibility per<br>ISO 10993-1) |
| Headgear | None | Breath-O-Prene™ | Breath-O-Prene™ |
| Comparative testing for safety and efficacy | Flow vs. Leak Pressure<br>Dead space<br>CO2 rebreathing | Flow vs. Leak Pressure<br>Dead space<br>CO2 rebreathing | Flow vs. Leak Pressure<br>Dead space<br>CO2 rebreathing |

### Non-clinical Tests

Testing of the 3B Flex-Lite™ was compared to the predicate innoMed Nasal Aire II for performance and safety. Performance testing of both the proposed device, the 3B Flex-Lite™, and the Nasal-Aire II predicate device was performed by Piper Medical. A copy of the test report dated March 23, 2011 is annexed at Appendix A.

In terms of design, both the Nasal-Aire If and the proposed device are cannula style nasal interfaces, with the air flow supplied to the interface from lateral sides. The performance bench testing consisted of three sets of testing: passive exhalation port flow (App. A at p. 6), resistance to flow (App. A at p. 8), CO2 re-breathing percentage (App. at p. 9), and measurement of dead space (App. A at p. 9). Based on the results of these tests, the report finds that the 3B Flex-Lite™ is "substantially equivalent to the Nasal-Aire II in terms of performance".

### Substantial Equivalence Conclusion:

3B Flex-Lite™ is substantially equivalent to the predicate devices. It has the same intended use. It has similar technological characteristics to both predicates. It does not raise new questions of safety and effectiveness. And, it is at least as safe and effective as the predicate devices Nasal-Aire II and Swift FX.

000010

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 1 3 2011

Mr. Albert A. Lucio Managing Partner 3B Products. LLC 1142 N. Scenic Highway Lake Wales, Florida 33853

Re: K103434

Trade/Device Name: Flex-Lite™ CPAP Nasal Pillows Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: September 15, 2011 Received: September 20. 2011

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 - Mr. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices /ucm115809.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/MedicallDevices/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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

ાંડ

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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### 4.0 Indications for Use Form

510(k) Number (if known): K103434

Device Name: Flex-Lite™ CPAP Nasal Pillows Mask

Indications for Use:

- 1. To be used by adult patients (>66lb /30kg);
- 2. To be used for single-patient reuse in the home environment or multi-patient reuse in the hospital/institutional environment;
- 3. To be used in the following environments: Home, Hospital, and sub-acute institutions

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over –The-Counter Use

000006

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Office of Device Evaluation

Evaluation and Safety

510(k) K103434

L. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: