Bleep DreamPort

K172335 · Snapcpap · BZD · Mar 30, 2018 · Anesthesiology

Device Facts

• Record ID: K172335
• Device Name: Bleep DreamPort
• Applicant: Snapcpap
• Product Code: BZD · Anesthesiology
• Decision Date: Mar 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Bleep DreamPort is a nasal adhesive mask interface for CPAP/bi-level therapy; replaces traditional headgear with single-use adhesive foam tape to seal at nostrils. Device consists of nasal port assembly and airflow management assembly with integrated exhalation port. Used in home or hospital/institutional settings by adult patients. Patient connects device to CPAP circuit; adhesive tape secures interface to nostrils, eliminating need for head straps. Provides stable seal for positive pressure delivery; benefits include improved comfort and elimination of headgear-related issues. Healthcare provider monitors therapy effectiveness via CPAP system data; device output is the delivery of prescribed pressure to the airway.

Clinical Evidence

Two-night user study comparing Bleep DreamPort to predicate. Evaluated seal effectiveness across various CPAP pressure settings with humidifier, comparing leak rates and mean AHI. Results demonstrated performance substantial equivalence to predicate.

Technological Characteristics

Nasal interface uses single-use adhesive foam tape for nostril seal; reusable frame includes integrated exhalation port and hose connection. Materials tested per ISO 10993-1 (cytotoxicity, sensitization, irritation, leachable/extractables). Performance tested per ISO 17510-2:2015. Operating temperature +10 to 40°C. Shelf-life 6 months. No electronic components or software.

Indications for Use

Indicated for adult patients (>66 lbs. / 30 kg) prescribed positive airway pressure therapy via CPAP or bi-level systems. No specific contraindications listed beyond standard CPAP/bi-level interface cautions.

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

• Resmed Swift LT (K073638)

Reference Devices

• Ventus Medical ProVent (K112404)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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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| Date: | 19-Mar-18 |
|----------------------------------------|--------------------------------------------------------------------------------|
| Company: | snapCPAP<br>143 Harrison Pond Dr.<br>Pittsboro, NC 27312 |
| Official Contact: | Stuart Heatherington – Founder and CEO<br>Tel - 919-619-7170 |
| Proprietary or Trade Name: | Bleep™ DreamPort |
| Common/Usual Name: | CPAP Nasal adhesive mask |
| Classification Name: | 21 CFR 868.5905, Class II<br>Procode - BZD<br>Non-continuous ventilator (IPPB) |
| Predicate Device:<br>Reference Device: | K073638 – Resmed – Swift LT<br>K112404 – 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 | Predicate<br>Resmed Swift LT<br>K073638 | Bleep™ DreamPort<br>Proposed Device |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Swift LT channels airflow<br>noninvasively to a patient from a<br>positive airway pressure device such<br>as a continuous positive airway<br>pressure (CPAP) or bi-level system.<br>The Swift LT is: * to be used by adult<br>patients (> 66 lbs. /30 kg.) for whom<br>positive airway pressure has been<br>prescribed.<br>* intended for single-patient re-use in<br>the home environment and multi-<br>patient re-use in the hospital /<br>institutional environment. | The Bleep™ DreamPort nasal<br>adhesive mask is intended to provide<br>an interface from a Continuous<br>Positive Airway Pressure (CPAP) or<br>bi-level system. The mask to be used<br>by adult patients (>66 lbs. / 30 kg.) for<br>whom positive airway pressure has<br>been prescribed. The mask is for<br>single-patient reuse in the home,<br>hospital/institutional environment. |
| Patient Population | Adults > 66 lbs. / > 30 kg. | Adults > 66 lbs. / > 30 kg. |
| Environment of Use | Single-patient reuse in the home<br>environment<br>Multi-patient re-use in the<br>hospital/institutional environment | Single-patient reuse in the home,<br>hospital/institutional environment |
| Duration of Use | Single patient, multi-use<br>Multi-patient, re-use | Single patient, multi-use |
| Prescriptive | Yes | Yes |
| Features | | |
| Available sizes | Multiple pillow sizes | One size |
| Components | Nasal pillow<br>Frame with exhalation port<br>Hose with swivel adapter<br>Head gear to assist with holding in<br>place | Nasal pillow<br>Frame with exhalation port<br>Hose with swivel adapter<br>Adhesive strips to hold in place and<br>seal |
| Incorporates exhalation port<br>and connecting tube | Yes | Yes |
| Nasal pillow interface | Silicone pillows | Channels connecting to frame and<br>Foam tape to create seal and hold in<br>place<br>Reference K102404 Ventus Medical -<br>ProVent |
| Frame with exhalation port | Yes | Yes |
| Head gear | Yes | No |
| Cleaning method | Soap and water | Soap and water |
| Materials | Nasal pillow – silicone<br>Frame – rigid material | Nasal interface – Foam Tape<br>Frame – Flexible and rigid material |

Table 1 – Comparison to the Predicate

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| | 510(k) Summary | | | | | | | | | |
|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|
| Attributes | Predicate<br>Resmed Swift LT<br>K073638 | Bleep™ DreamPort<br>Proposed Device | | | | | | | | |
| Therapy Pressures and<br>compatibility with CPAP<br>equipment | 4 to 20 cm H2O<br>Used with equipment which provide<br>pressures within the defined therapy<br>pressure range. | 4 to 15 cm H2O<br>Used with equipment which provide<br>pressures within the defined therapy<br>pressure 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 profile<br>Tested per ISO 17510-2<br>Acceptance < 20% increase<br>from baseline | Not tested | Pressure ETCO2% at mask<br>(% increase) 4 cm H2O 5.3 (2%) 5 cm H2O 5.3 (1%) 10 cm H2O 5.15 (-2%) | | | | | | | | |
| Exhaust flow<br>Average<br>(Lpm) at various pressure<br>settings in cmH2O) | 4 - 19.5<br>8 – 25.5<br>12 - 32.1<br>16 - 37.8<br>20 - 42.8 | 4 - 20.4<br>8 – 29.2<br>12 - 35.7<br>16 - 41.3<br>20 - 46.0 | | | | | | | | |
| Pressure Drop<br>(cmH2O) at various flow rates | 50 Lpm - 2.0 cmH2O<br>100 Lpm - 8.4 cmH2O | 50 Lpm - 0.9 cmH2O<br>100 Lpm – 4.4 cmH2O | | | | | | | | |
| Dead space (interface only not<br>including the hose) | 22 mL | 16 mL | | | | | | | | |
| Drop test | N/A | No visual damage | | | | | | | | |
| Cleaning of reusable tubing and<br>exhalation valve portion | | 90 cleaning cycles<br>Differences in performance testing<br>between pre- and post-conditioning<br>was < 10% | | | | | | | | |
| Effects of Aging | N/A | Differences in performance testing<br>between pre- and post-conditioning<br>was < 10% | | | | | | | | |
| Shelf-life | Not stated | 6 months | | | | | | | | |
| Biocompatibility -ISO 10993-1 | Externally communicating | Externally communicating | | | | | | | | |
| Patient profile | Tissue<br>And<br>Surface Contact (pillow)<br>Skin<br>Permanent duration | Tissue<br>And<br>Surface Contact (foam tape)<br>Intact Skin<br>Permanent duration | | | | | | | | |
| Testing | N/A | Cytotoxicity<br>Sensitization<br>Irritation<br>Leachable / Extractable<br>Risk 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.