(240 days)
K073638 – Resmed – Swift LT
No
The summary describes a physical medical device (a nasal mask) and its performance characteristics, with no mention of AI or ML technology.
Yes
The device is described as an "interface from a Continuous Positive Airway Pressure (CPAP) or bi-level system" and is used "for the treat of OSA" (Obstructive Sleep Apnea). CPAP and bi-level systems are therapeutic devices for treating sleep apnea, and this mask is an essential component for delivering that therapy.
No
The device is a mask intended to provide an interface for CPAP or bi-level systems for the treatment of OSA, not for diagnosing a condition. Its clinical testing focuses on seal effectiveness, leak rates, and AHI during use, not on diagnosing the underlying sleep apnea.
No
The device description clearly outlines physical components (Nasal Port assembly, Airflow management assembly, foam tape, reusable interface) and performance studies related to hardware characteristics (seal effectiveness, leak rates, mechanical drop test, aging effects). There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide an interface for a CPAP or bi-level system to treat sleep apnea. This is a therapeutic and device-interface function, not a diagnostic one.
- Device Description: The description details a mask and its components for delivering air pressure, not for analyzing biological samples or providing diagnostic information.
- No Mention of Biological Samples: There is no mention of the device interacting with or analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- No Diagnostic Claims: The document does not make any claims about diagnosing a condition or providing information for diagnosis.
- Performance Studies: The performance studies focus on the device's ability to maintain a seal, manage airflow, and its physical properties, not on diagnostic accuracy or performance related to analyzing biological samples.
In summary, the Bleep™ DreamPort nasal adhesive mask is a medical device used in the treatment of sleep apnea by providing an interface for positive airway pressure delivery. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
BZD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal/Nostrils
Indicated Patient Age Range
Adults (>66 lbs. / 30 kg.)
Intended User / Care Setting
single-patient reuse in the home, hospital/institutional environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (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)) were tested per ISO 10993-1 and were found to be non-cytotoxic, non-irritating, non-sensitizing, and with a margin of safety > 1.
- Bench / Performance testing: Comparative performance testing included:
- ISO 17510-2:2015: Medical Devices Sleep apnea breathing therapy Masks and application accessories. These tests included: Exhaust Flow, Pressure Drop, CO2 washout.
- Biocompatibility of Materials
- Cleaning (90 cleaning cycles, differences in performance testing between pre- and post-conditioning was
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized representation of a human figure, while the agency's name is written in blue letters. The words "U.S. FOOD & DRUG" are on the first line, and the word "ADMINISTRATION" is on the second line.
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.
1
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
2
Indications for Use
510(k) Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
SC Publishing Services (301) 443-6740
EF
3
| Date: | 19-Mar-18 |
|---|---|
| Company: | snapCPAP |
| 143 Harrison Pond Dr. | |
| Pittsboro, NC 27312 | |
| Official Contact: | Stuart Heatherington – Founder and CEO |
| 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 |
| Procode - BZD | |
| Non-continuous ventilator (IPPB) | |
| Predicate Device: | |
| Reference Device: | K073638 – Resmed – Swift LT |
| 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
4
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
Resmed Swift LT
K073638 | Bleep™ DreamPort
Proposed Device |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Swift LT channels airflow
noninvasively to a patient from a
positive airway pressure device such
as a continuous positive airway
pressure (CPAP) or bi-level system.
The Swift LT is: * to be used by adult
patients (> 66 lbs. /30 kg.) for whom
positive airway pressure has been
prescribed.
- intended for single-patient re-use in
the home environment and multi-
patient re-use in the 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. |
| Patient Population | Adults > 66 lbs. / > 30 kg. | Adults > 66 lbs. / > 30 kg. |
| Environment of Use | Single-patient reuse in the home
environment
Multi-patient re-use in the
hospital/institutional environment | Single-patient reuse in the home,
hospital/institutional environment |
| Duration of Use | Single patient, multi-use
Multi-patient, re-use | Single patient, multi-use |
| Prescriptive | Yes | Yes |
| Features | | |
| Available sizes | Multiple pillow sizes | One size |
| Components | Nasal pillow
Frame with exhalation port
Hose with swivel adapter
Head gear to assist with holding in
place | Nasal pillow
Frame with exhalation port
Hose with swivel adapter
Adhesive strips to hold in place and
seal |
| Incorporates exhalation port
and connecting tube | Yes | Yes |
| Nasal pillow interface | Silicone pillows | Channels connecting to frame and
Foam tape to create seal and hold in
place
Reference 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 – silicone
Frame – rigid material | Nasal interface – Foam Tape
Frame – Flexible and rigid material |
Table 1 – Comparison to the Predicate
5
| 510(k) Summary | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Attributes | Predicate | |||||||||
| Resmed Swift LT | ||||||||||
| K073638 | Bleep™ DreamPort | |||||||||
| Proposed Device | ||||||||||
| Therapy Pressures and | ||||||||||
| compatibility with CPAP | ||||||||||
| equipment | 4 to 20 cm H2O | |||||||||
| Used with equipment which provide | ||||||||||
| pressures within the defined therapy | ||||||||||
| pressure range. | 4 to 15 cm H2O | |||||||||
| Used with equipment which provide | ||||||||||
| pressures within the defined therapy | ||||||||||
| 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 | ||||||||||
| Tested per ISO 17510-2 | ||||||||||
| Acceptance 1 |
6
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:
7
-
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.