The Bleep™ DreamPort nasal adhesive mask is intended to provide an interface from a Continuous Positive Airway Pressure (CPAP) or bi-level system. The mask to be used by adult patients (>66 lbs. / 30 kg, for whom positive airway pressure has been prescribed. The mask is for single-patient reuse in the home, hospital/institutional environment.

Device Description

The Bleep™ DreamPort nasal adhesive mask is similar to standard nasal pillow CPAP mask for use with patients using CPAP and bi-level equipment for the treat of OSA. The Bleep™ DreamPort nasal adhesive mask is comprised of 2 sub-assemblies: Nasal Port assembly and Airflow management assembly. The device uses single use foam tape to create the seal at the nostrils. This allows the interface to be used without head gear. There is a reusable interface which connects the nasal adhesive to the circuit of the CPAP equipment. It includes integrated exhalation ports.

AI/ML Overview

The provided text describes the Bleep™ DreamPort nasal adhesive mask and its acceptance criteria for FDA clearance, comparing it to a predicate device (Resmed Swift LT). The study primarily focuses on non-clinical performance testing and a limited user study to demonstrate substantial equivalence, rather than a typical multi-reader multi-case (MRMC) or standalone AI performance study. Therefore, some of the requested information, particularly regarding AI-specific criteria, human reader improvement, and extensive expert ground truth establishment, is not applicable to this device's clearance process as described.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate device (Resmed Swift LT, K073638) and compliance with international standards like ISO 17510-2:2015 and ISO 10993-1.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance (Bleep™ DreamPort)	Assessment
Indications for Use	Intended to provide an interface from a Continuous Positive Airway Pressure (CPAP) or bi-level system for adult patients (≥66 lbs. / 30 kg) for whom positive airway pressure has been prescribed. For single-patient reuse in home, hospital/institutional environment.	The Bleep™ DreamPort nasal adhesive mask is intended to provide an interface from a Continuous Positive Airway Pressure (CPAP) or bi-level system. The mask to be used by adult patients (>66 lbs. / 30 kg.) for whom positive airway pressure has been prescribed. The mask is for single-patient reuse in the home, hospital/institutional environment.	Met: Identical Indications for Use to predicate.
Patient Population	Adults > 66 lbs. / > 30 kg.	Adults > 66 lbs. / > 30 kg.	Met: Identical Patient Population to predicate.
Environment of Use	Single-patient reuse in the home, hospital/institutional environment.	Single-patient reuse in the home, hospital/institutional environment.	Met: Identical Environment of Use to predicate.
Therapy Pressures & Compatibility	Used with equipment providing therapy pressures within a defined range.	4 to 15 cm H2O. Used with equipment which provide pressures within the defined therapy pressure range.	Met: Compatible within a defined range. While the predicate is 4-20 cm H2O, the Bleep still operates within a common CPAP range.
CO2 Washout Profile (ISO 17510-2)	< 20% increase from baseline (compared to the predicate, though the predicate's data wasn't explicitly tested here).	Pressure ETCO2% at mask: 4 cm H2O 5.3 (2%), 5 cm H2O 5.3 (1%), 10 cm H2O 5.15 (-2%).	Met: Values within acceptable range (minimal increase/decrease).
Exhaust Flow (ISO 17510-2)	Performance comparable to predicate at various pressure settings.	4 - 20.4 Lpm, 8 – 29.2 Lpm, 12 - 35.7 Lpm, 16 - 41.3 Lpm, 20 - 46.0 Lpm.	Met: Values are comparable to (and slightly higher than, implying efficient exhaust) the predicate.
Pressure Drop (ISO 17510-2)	Performance comparable to predicate at various flow rates.	50 Lpm - 0.9 cmH2O, 100 Lpm – 4.4 cmH2O.	Met: Values are lower than the predicate, indicating better flow efficiency.
Dead Space	Comparable to predicate.	16 mL (Predicate: 22 mL).	Met: Smaller dead space than the predicate, which is a positive attribute.
Drop Test	No visual damage.	No visual damage.	Met.
Cleaning of Reusable Components	Performance differences between pre- and post-conditioning < 10% after 90 cycles.	Differences in performance testing between pre- and post-conditioning was < 10%.	Met: Sustained performance after cleaning cycles.
Effects of Aging	Performance differences between pre- and post-conditioning < 10%.	Differences in performance testing between pre- and post-conditioning was < 10%.	Met: Sustained performance after aging simulation.
Shelf-life	Not explicitly stated as a comparative criterion for predicate, but tested for the device.	6 months.	Met: Shelf-life defined.
Biocompatibility (ISO 10993-1, -5, -10)	Non-cytotoxic, non-sensitizing, non-irritating, with Margin of Safety (MOS) > 1 for leachable/extractable components for permanent contact with intact skin.	Non-cytotoxic, non-irritating, non-sensitizing. MOS > 1 for leachable/extractable. Risk-based assessment.	Met: Passed all required biocompatibility tests.
User Study (Clinical Testing)	Demonstrate effectiveness of seal under different CPAP pressure settings and compare leak rates and mean AHI (Apnea-Hypopnea Index).	Found to be substantially equivalent in performance (seal effectiveness, leak rates, mean AHI) over 2 nights.	Met: "Substantially equivalent in performance" is the stated finding.

Study Information:

Sample size used for the test set and the data provenance:
- User study (Clinical Testing): The document states a "user study was performed," but does not explicitly mention the sample size (number of participants/patients).
- Non-clinical performance testing (Bench Tests): This refers to the physical device being tested against standards (e.g., CO2 washout, exhaust flow). No "test set" in the sense of patient data is applicable here; tests are performed on the device itself.
- Data Provenance: Not explicitly stated for the user study (e.g., country of origin, specific clinics). The user study was conducted over "2 nights" for each participant. It's implicitly prospective as it's a "user study" where performance was compared.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- User Study (Clinical Testing): The document does not specify the number or qualifications of experts involved in establishing ground truth (e.g., reading sleep study data). It mentions "mean AHI during use" was compared, implying that existing clinical methods for AHI calculation would be the "ground truth." This is not an AI-specific ground truth establishment (like image annotation by multiple radiologists).
- Non-clinical performance testing: Ground truth here are the engineering standards and measurements, not expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- User Study (Clinical Testing): The document does not specify any adjudication method for the clinical/user study results (e.g., for AHI measurements or leak rates). The comparison was seemingly direct or averaged.
- Non-clinical performance testing: Not applicable.
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, an MRMC comparative effectiveness study was not done. This device is a medical accessory (mask) and not an AI-powered diagnostic tool, so such a study is not relevant to its clearance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not applicable. This is a physical medical device, not an algorithm. Bench testing is the "standalone" performance for the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- User Study: The "ground truth" for the user study appears to be clinical measurements such as leak rates and AHI, which are standard metrics in sleep apnea therapy. This would typically be derived from objective CPAP machine data and sleep study results, often interpreted by sleep physicians. It is not described as involving extensive expert consensus or pathology data.
- Non-clinical performance testing: The ground truth is engineering measurements against established ISO standards.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that sense. It's a manufactured product whose performance is demonstrated through physical and limited user testing.
How the ground truth for the training set was established:
- Not applicable. See point 7.

Summary

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March 30, 2018

snapCPAP % Paul Dryden snapCPAP c/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K172335

Trade/Device Name: Bleep DreamPort Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: March 1, 2018 Received: April 1, 2017

Dear Paul 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 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tina
Kiang-S

Tina Kiang, Ph.D. 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)

K172335

Device Name

Bleep™ DreamPort

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) XX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (7/17)

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Date:	19-Mar-18
Company:	snapCPAP143 Harrison Pond Dr.Pittsboro, NC 27312
Official Contact:	Stuart Heatherington – Founder and CEOTel - 919-619-7170
Proprietary or Trade Name:	Bleep™ DreamPort
Common/Usual Name:	CPAP Nasal adhesive mask
Classification Name:	21 CFR 868.5905, Class IIProcode - BZDNon-continuous ventilator (IPPB)
Predicate Device:Reference Device:	K073638 – Resmed – Swift LTK112404 – Ventus Medical – ProVent

Device Description:

The Bleep™ DreamPort nasal adhesive mask is similar to standard nasal pillow CPAP mask for use with patients using CPAP and bi-level equipment for the treat of OSA.

The Bleep™ DreamPort nasal adhesive mask is comprised of 2 sub-assemblies:

Nasal Port assembly
Airflow management assembly ●

The device uses single use foam tape to create the seal at the nostrils. This allows the interface to be used without head gear. There is a reusable interface which connects the nasal adhesive to the circuit of the CPAP equipment. It includes integrated exhalation ports.

We included the following reference device K102502Ventus Medical – ProVent as it utilizes foam tape to seal at the nostrils. The ProVent has the same intended use as the subject device but deploys a different technology of creating positive pressure and both devices require an effective seal created by flexible adhesive tape at the nostrils to function.

Indications for Use:

The Bleep™ DreamPort nasal adhesive mask is intended to provide an interface from a Continuous Positive Airway Pressure (CPAP) or bi-level system. The mask to be used by adult patients (>66 lbs. / 30 kg.) for whom positive airway pressure has been prescribed. The mask is for single-patient reuse in the home, hospital/institutional environment.

Patient Population:

For adults (>66 lbs. / >30 kg.).

Environment of Use:

Home, hospital/institutional environment

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Contraindications:

The contraindications are the same as the predicate and include the standard cautions and warnings typical of CPAP and bi-level positive pressure device patient interfaces and are included in the labeling.

Attributes	PredicateResmed Swift LTK073638	Bleep™ DreamPortProposed Device
Indications for Use	The Swift LT channels airflownoninvasively to a patient from apositive airway pressure device suchas a continuous positive airwaypressure (CPAP) or bi-level system.The Swift LT is: * to be used by adultpatients (> 66 lbs. /30 kg.) for whompositive airway pressure has beenprescribed.* intended for single-patient re-use inthe home environment and multi-patient re-use in the hospital /institutional environment.	The Bleep™ DreamPort nasaladhesive mask is intended to providean interface from a ContinuousPositive Airway Pressure (CPAP) orbi-level system. The mask to be usedby adult patients (>66 lbs. / 30 kg.) forwhom positive airway pressure hasbeen prescribed. The mask is forsingle-patient reuse in the home,hospital/institutional environment.
Patient Population	Adults > 66 lbs. / > 30 kg.	Adults > 66 lbs. / > 30 kg.
Environment of Use	Single-patient reuse in the homeenvironmentMulti-patient re-use in thehospital/institutional environment	Single-patient reuse in the home,hospital/institutional environment
Duration of Use	Single patient, multi-useMulti-patient, re-use	Single patient, multi-use
Prescriptive	Yes	Yes
Features
Available sizes	Multiple pillow sizes	One size
Components	Nasal pillowFrame with exhalation portHose with swivel adapterHead gear to assist with holding inplace	Nasal pillowFrame with exhalation portHose with swivel adapterAdhesive strips to hold in place andseal
Incorporates exhalation portand connecting tube	Yes	Yes
Nasal pillow interface	Silicone pillows	Channels connecting to frame andFoam tape to create seal and hold inplaceReference K102404 Ventus Medical -ProVent
Frame with exhalation port	Yes	Yes
Head gear	Yes	No
Cleaning method	Soap and water	Soap and water
Materials	Nasal pillow – siliconeFrame – rigid material	Nasal interface – Foam TapeFrame – Flexible and rigid material

Table 1 – Comparison to the Predicate

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	510(k) Summary
Attributes	PredicateResmed Swift LTK073638	Bleep™ DreamPortProposed Device
Therapy Pressures andcompatibility with CPAPequipment	4 to 20 cm H2OUsed with equipment which providepressures within the defined therapypressure range.	4 to 15 cm H2OUsed with equipment which providepressures within the defined therapypressure range.
Operating Temperature	+5 to 40°C (+41 to 104°F)	+10 to 40°C (+50 to 104°F)
Storage Temperature	-20 to + 60°C (-4 to 140°F)	-20 to +60°C (-4 to 140°F)
Non-clinical Performance Testing
ISO 17510-2 - CPAP Mask testing
CO2 washout profileTested per ISO 17510-2Acceptance < 20% increasefrom baseline	Not tested	Pressure ETCO2% at mask(% increase) 4 cm H2O 5.3 (2%) 5 cm H2O 5.3 (1%) 10 cm H2O 5.15 (-2%)
Exhaust flowAverage(Lpm) at various pressuresettings in cmH2O)	4 - 19.58 – 25.512 - 32.116 - 37.820 - 42.8	4 - 20.48 – 29.212 - 35.716 - 41.320 - 46.0
Pressure Drop(cmH2O) at various flow rates	50 Lpm - 2.0 cmH2O100 Lpm - 8.4 cmH2O	50 Lpm - 0.9 cmH2O100 Lpm – 4.4 cmH2O
Dead space (interface only notincluding the hose)	22 mL	16 mL
Drop test	N/A	No visual damage
Cleaning of reusable tubing andexhalation valve portion		90 cleaning cyclesDifferences in performance testingbetween pre- and post-conditioningwas < 10%
Effects of Aging	N/A	Differences in performance testingbetween pre- and post-conditioningwas < 10%
Shelf-life	Not stated	6 months
Biocompatibility -ISO 10993-1	Externally communicating	Externally communicating
Patient profile	TissueAndSurface Contact (pillow)SkinPermanent duration	TissueAndSurface Contact (foam tape)Intact SkinPermanent duration
Testing	N/A	CytotoxicitySensitizationIrritationLeachable / ExtractableRisk Based Assessment with MOS >1

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Substantial Equivalence Discussion

The Bleep™ DreamPort nasal adhesive mask is viewed as substantially equivalent to the predicate device because:

Indications -

The Bleep™ DreamPort nasal adhesive mask is intended to provide a patient interface for ● application of positive pressure therapy. The mask is to be used as an accessory for use with CPAP or Bi-level positive pressure systems intended for application of CPAP or bi-level therapy.
. Similar to the predicate Resmed Swift LT - K073638

Patient Population -

The masks are for patients > 66 Ibs. /> 30 kg. for whom positive airway pressure therapy has ● been prescribed.
Similar to the predicate Resmed Swift LT K073638. ●

Environment of Use -

The masks are intended for use in the home, hospital/institutional environment
. Similar to the predicate Resmed Swift LT - K073638.

Technology -

The design of subject device is similar in that they both have a soft nasal interface with a rigid ● frame and exhalation port with extension hose to connect to the CPAP equipment and its own circuit.
The subject device utilizes an already cleared exhalation valve and hose. The nasal patient interface is a flexible set of nostril inserts that are then held in place with adhesive foam tape.
The Bleep™ DreamPort does not require head gear to hold it in place as it uses foam tape ● whereas the predicate is held in place with head gear.
Testing has demonstrated that the subject device performed equivalent to the predicate when ● tested according to ISO 17510:2015: Medical Devices -- Sleep apnoea breathing therapy --Masks and application accessories.

Discussion -

The difference in the subject device is that the attachment to the user to hold the device in place is flexible foam tape vs. soft, silicone pillows which are "pressurized" to be held in place with a head strap. Bench and clinical testing demonstrated the subject device as substantially equivalent to the predicate.

Clinical testing

A user study was performed where comparison of performance between the predicate and the subject was performed over 2 nights. The objectives were to evaluate the effectiveness of the subject device seal under different CPAP pressure settings when used with a humidifier and compare leak rates and mean AHI during use. The subject device was found to be substantially equivalent in performance.

Non-clinical performance testing

Biocompatibility / Materials -

The materials in patient contact have been tested thev are characterized as:

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External Communicating (Indirect gas pathway), Tissue / Bone / Dentin communicating, Duration of Use - permanent (> 30 days)
And
Surface Contact, Skin, Duration of Use - permanent (> 30 days)
The materials in patient contact were tested per ISO 10993-1 were found to be non-cytotoxic, . non-irritating, non-sensitizing, and with a margin of safety > 1.

The following tests and the results were acceptable.

Cytotoxicity ISO 10993-5:2009 ●
Sensitization - ISO 10993-10:2010
Irritation (for surface contact materials) ISO 10993-10:2010 ●
. Leachable and Extractables - polar and non-polar
. Risk based assessment

Bench / Performance testing -

Comparative performance testing the tests included:

ISO 17510-2:2015: Medical Devices Sleep apnea breathing therapy Masks and application ● accessories. These tests included:
- O Exhaust Flow
- o Pressure Drop
- 0 CO2 washout
. Biocompatibility of Materials
Cleaning
Mechanical Drop test ●
Effects of Aging on Performance ●
. Environmental Testing / Shelf-life

The results demonstrated that the device performance was met after conditioning and was substantially equivalent to the predicate.

Substantial Equivalence Conclusion

The performance testing demonstrates that the subject device is substantially equivalent to the predicate device.

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).