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 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.

AI/ML Overview

The provided document describes the 3B Flex-Lite Nasal Mask, a device intended to channel airflow noninvasively to a patient from a positive airway pressure (PAP) device. The document focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria. Therefore, the information provided does not directly outline "acceptance criteria" as distinct performance thresholds that the device must meet for a specific clinical task. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices through comparable technological characteristics and performance.

Here's an analysis based on the provided text, focusing on how the device meets the implicit acceptance criteria of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria with numerical targets are not stated, this table will frame the "acceptance criteria" as comparability to predicate devices for key performance and safety characteristics.

Acceptance Criteria (Implicit for Substantial Equivalence)	Predicate Device Performance (Nasal-Aire II / Swift FX)	Reported Device Performance (3B Flex-Lite™)	Conformance
Intended Use	Same as proposed device	Channels airflow noninvasively to a patient from a PAP device. Used by adult patients (>66lb / 30 kg); for single-patient reuse in home/multi-patient reuse in hospital/institutional environment; in home, hospital, and sub-acute institutions; for prescription use.	Conforms
Environment of Use	Hospitals, sub-acute institutions, sleep laboratories and home.	Same	Conforms
Patient Population	Adult	Same	Conforms
Contraindications	None	None	Conforms
Single patient, multi-use	Yes	Yes	Conforms
Components	Nasal interface (Nasal-Aire II); Nasal interface with pillows and headgear (Swift FX)	Nasal interface with pillows and headgear	Conforms (similar to Swift FX, evolving from Nasal-Aire II)
Dead Space	Interface - 24-28 ml / Pillows 2-4 ml	Interface 10.5ml / Pillows 3.5 ml	Conforms (similar or improved, within acceptable range for safety)
Fixed leak port	Yes	Yes	Conforms
Deliverable pressure range	3-18 cmH2O (Nasal-Aire II); 4-20 cmH2O (Swift FX)	4-20 cmH2O	Conforms (similar to Swift FX, encompassing broader range)
Nasal Interface Material	Silicone	Silicone (Biocompatibility per ISO 10993-1)	Conforms
Headgear Material	None (Nasal-Aire II); Breath-O-Prene™ (Swift FX)	Breath-O-Prene™	Conforms (similar to Swift FX)
Performance Bench Testing (Flow vs. Leak Pressure)	Performed	Performed	Conforms
Performance Bench Testing (Dead Space)	Performed	Performed	Conforms
Performance Bench Testing (CO2 Rebreathing)	Performed	Performed	Conforms
Safety and Effectiveness Conclusion	Established for predicate devices	Substantially equivalent to predicate devices. Does not raise new questions of safety and effectiveness; at least as safe and effective.	Conforms (as determined by FDA review)

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "Performance bench testing of both the 3B Flex-Lite™ and the Nasal Aire II were conducted" and explicitly mentions a "Piper Medical" test report dated March 23, 2011, annexed at Appendix A. However, the specific sample size for these bench tests (e.g., number of units tested) and the country of origin of the data are not detailed in the provided text. The testing appears to be retrospective in the sense that it evaluates the manufactured device against established performance benchmarks and comparisons to existing devices, rather than a prospective clinical trial with human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for the bench tests would typically be defined by engineering specifications, regulatory standards, and the performance characteristics of the predicate devices. The individuals conducting and reporting the tests (e.g., Piper Medical) would be engineers or technicians with expertise in medical device testing, but their specific qualifications or the number involved are not stated.

4. Adjudication Method for the Test Set

This information is not provided. Given that the tests are bench tests, an adjudication method in the clinical sense (e.g., 2+1 physician consensus) is not directly applicable. The "adjudication" would be based on comparison of test results to predefined criteria or to the predicate device's measured performance.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. The 3B Flex-Lite™ Nasal Mask is a physical medical device (mask interface), not an AI-powered diagnostic or assistive technology for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

A standalone performance study of an algorithm is not applicable to this device, as it is a physical device, not an algorithm or AI system. The performance tests ("Non-clinical Tests") evaluated the physical mask's characteristics.

7. The Type of Ground Truth Used

The ground truth used for evaluating the 3B Flex-Lite™ appears to be based on:

Engineering specifications and regulatory standards for medical devices (implicitly, concerning safety, materials, and performance parameters like dead space, CO2 rebreathing, flow vs. leak pressure).
Performance characteristics of legally marketed predicate devices (InnoMed Nasal-Aire II and Resmed Swift FX) as established through their own testing and marketing. The goal was to demonstrate that the new device is "substantially equivalent" in terms of performance to these predicates.

8. The Sample Size for the Training Set

This is not applicable. The 3B Flex-Lite™ Nasal Mask is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

Summary

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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: (863) 676-5948

Email: alucio@3Bproducts.com

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 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

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-AIRE II (K022465)	PREDICATE SWIFT FX(K090244)	PROPOSED DEVICE 3BFLEX-LITE (K103434)
Indications for Use	A patient interfaceaccessory for use withCPAP and bi-levelsystems used in thetreatment of adultOSA and/or ventilatorsupport.	A patient interfaceaccessory for use withCPAP and bi-levelsystems used in thetreatment of adultOSA and/or ventilatorsupport.	A patient interfaceaccessory for use withCPAP and bi-levelsystems used in thetreatment of adultOSA and/or ventilatorsupport.
Environment of Use	Hospitals, sub-acuteinstitutions, sleeplaboratories andhome.	Same	Same
Patient Population	Adult	Same	Same
Contraindications	None	None	None
Single patient, multi-use	Yes	Yes	Yes
Components	Nasal interface (noheadgear)	Nasal interface withpillows and headgear	Nasal interface withpillows and headgear
Dead Space	Interface - 24-28 ml /Pillows 2-4 ml	Interface - 24-28 ml /Pillows 2-4 ml	Interface 10.5mlPillows 3.5 ml
Fixed leak port	Yes	Yes	Yes

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Deliverable pressurerange	3-18 cmH20	4-20 cmH20	4-20 cmH20
Materials:
Nasal Interface	Silicone	Silicone	Silicone(Biocompatibility perISO 10993-1)
Headgear	None	Breath-O-Prene™	Breath-O-Prene™
Comparative testing for safety and efficacy	Flow vs. Leak PressureDead spaceCO2 rebreathing	Flow vs. Leak PressureDead spaceCO2 rebreathing	Flow vs. Leak PressureDead spaceCO2 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 (800) 638-2041 or (301) 796-7100 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);
1. To be used for single-patient reuse in the home environment or multi-patient reuse in the hospital/institutional environment;
1. 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:

Regulation Number and Section

§ 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).