Breathe+

K222018 · Peep Medical, LLC Dba Go2 Devices · BWF · Jun 2, 2023 · Anesthesiology

Device Facts

• Record ID: K222018
• Device Name: Breathe+
• Applicant: Peep Medical, LLC Dba Go2 Devices
• Product Code: BWF · Anesthesiology
• Decision Date: Jun 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Breathe+ is intended for use as a Positive Expiratory Pressure Device to help prevent or reverse atelectasis in adult patients needing PEP therapy. Intended for single-patient, multi-use in a hospital or home care setting.

Device Story

Breathe+ is an oral Positive Expiratory Pressure (PEP) device; used in hospital or home settings. Input: patient exhalation. Operation: inhalation opens a flap valve with limited resistance; exhalation closes the flap, forcing air through a resistance mechanism (set by bands) to generate ~8 cm H2O pressure. Output: positive expiratory airway pressure. Benefits: enhances expiratory muscle strength; prevents/reverses atelectasis. Hands-free operation. Healthcare providers use the device to manage lung pressure and improve oxygenation in patients with lung disease.

Clinical Evidence

Bench testing only. Testing included resistance to flow, PEP value repeatability, and accuracy. Performance was evaluated on finished samples pre- and post-aging and post-repeated cleaning. No clinical data provided.

Technological Characteristics

Oral PEP device; resistor-based pressure generation; hands-free design. Materials: surface-contact, mucosal, externally communicating tissue (prolonged duration >24h, <30 days). Connectivity: none. Sterilization: not specified (single-patient, multi-use, cleanable with soapy water).

Indications for Use

Indicated for adult patients requiring PEP therapy to prevent or reverse atelectasis.

Regulatory Classification

Identification

An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.

Predicate Devices

• DHD Diemolding Healthcare Division – Therapep (K962749)

Reference Devices

• D R Burton - iPEP System and vPEP (K160636)

Submission Summary (Full Text)

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June 2, 2023

PEEP Medical, LLC % Paul Dryden Consultant 131 Bay Point Drive St. Petersburg, Florida 33704

Re: K222018

Trade/Device Name: Breathe+ Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: April 16, 2023 Received: April 17, 2023

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known) K222018

Device Name Breathe+

Indications for Use (Describe)

The Breathe+ is intended for use as a Positive Expiratory Pressure Device to help prevent or reverse atelectasis in adult patients needing PEP therapy. Intended for single-patient, multi-use in a hospital or home care setting.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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| Date Prepared: | 02-Jun-2023 |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | PEEP Medical, LLC<br>9230 Katy Freeway, Suite 600<br>Houston, TX 77055 |
| Official Contact: | Sean Boutros, MD<br>Founder |
| Submission Correspondent: | Paul Dryden<br>ProMedic, LLC |
| Proprietary or Trade Name:<br>Common/Usual Name:<br>Classification Name: | Breathe+<br>Incentive Spirometer<br>Product Code – BWF – Spirometer, Therapeutic (Incentive) |
| Predicate Device:<br>Common/Usual Name:<br>Classification Name: | DHD Diemolding Healthcare Division – Therapep – K962749<br>Incentive Spirometer<br>Product Code – BWF - Spirometer, Therapeutic (Incentive) |
| Reference Device:<br>Common/Usual Name:<br>Classification Name: | D R Burton - iPEP System and vPEP – K160636<br>Incentive Spirometer<br>Product Code – BWF – Spirometer, Therapeutic (Incentive) |
| Device Description: | The subject device provides PEP only. |
| | The applications of PEEP (PEP) in patients with lung disease is a well-known entity; oxygenation<br>depends on the FiO2 and PEEP, and manipulation of any of these parameters should raise oxygenation in<br>intubated patients. Patients with emphysema instinctively practice pursed lip breathing in order to<br>increase the lung pressure, decrease alveolar collapse and dead space, and improve oxygenation. |
| | The subject device is an oral device that provides positive expiratory airway pressures to enhance<br>expiratory muscle strength while preventing and reversing atelectasis. Furthermore, the device is hands-<br>free. |
| Principle of Operation: | Upon inhalation, the "flap" valve opens and one can inhale with limited resistance. During exhalation, the<br>"flap" valve closes and the front plate is pushed open under resistance, ~ 8 cm H2O, that is set by the<br>bands. The exhaled breath exits through the sides. |
| Indications for Use: | The Breathe+ is intended for use as a Positive Expiratory Pressure Device to help prevent or reverse<br>atelectasis in adult patients needing PEP therapy. Intended for single-patient, multi-use in a hospital or<br>home care setting. |

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| Description | Subject Device | Predicate Device | Reference Device | Differences |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Sponsor | PEEP Medical | DHD Diemolding Healthcare<br>Division | D R Burton | |
| 510(k) Number | TBD | K962749 | K160636 | |
| Model Name | Breath+ | TheraPEP | iPEP System and vPEP | |
| Classification | Class II Device<br>BWF<br>21 CFR 858.5690 | Class II Device<br>BWF<br>21 CFR 858.5690 | Class II Device<br>BWF<br>21 CFR 858.5690 | Identical |
| Indications for use | The Breathe+ is intended for use as<br>a Positive Expiratory Pressure<br>Device to help prevent or reverse<br>atelectasis in adult patients needing<br>PEP therapy.<br><br>Intended for single-patient, multi-<br>use in a hospital or home care<br>setting. | The DHD TheraPEP is intended for<br>use as a Positive Expiratory<br>Pressure Device for patients<br>suffering from Cystic Fibrosis, lung<br>diseases with secretory problems,<br>and to prevent or reverse atelectasis. | The D R Burton iPEP Therapy<br>System is intended for use as a<br>Positive Expiratory Pressure<br>(PEP) by patients capable of<br>generating an exhalation flow of<br>10 lpm for 3-4 seconds and an<br>Incentive Spirometer as an<br>inspiratory, deep breathing<br>positive exerciser.<br><br>Intended for single-patient, multi<br>use.<br><br>iPEP System for hospital and<br>clinical settings. | The subject device is<br>intended to prevent or<br>reverse atelectasis. |
| | | | vPEP for hospital, clinical, and home care setting. | |
| Environment of Use | Hospital and home under HCP direction | Clinical settings | Hospital, clinical, and home settings | Similar |
| Patient Population | Patients requiring inspiratory exercise and / or PEP therapy | Patients requiring inspiratory exercise and / or PEP therapy | Patients requiring inspiratory exercise and / or PEP therapy and capable of generating an exhalation flow of 10 lpm for 3-4 seconds | Similar |
| Principle of Operation (PEP) | Resistor<br>Mouthpiece | Resistor<br>Pressure range indicator<br>Pressure adapter<br>Mouthpiece | Flap valve, which generates oscillation during exhalation<br>One-way valve<br>Mouthpiece | Similar |
| Use with a nebulizer | No | Yes | No | Use without a nebulizer does not raise new concerns of safety or effectiveness. |
| Duration of Use | Prolonged < 30 days | Prolonged < 30 days | Prolonged < 30 days | Similar |
| Biocompatibility ISO 10993-1 | Surface Contact<br>Mucosal membrane<br><br>Externally Communicating Tissue<br><br>Duration of Use - prolonged (>24 hours, <30 days) | Surface Contact<br>Mucosal membrane<br><br>Externally Communicating Tissue<br><br>Duration of Use - prolonged (>24 hours, <30 days) | Surface Contact<br>Mucosal membrane<br><br>Externally Communicating Tissue<br><br>Duration of Use – limited (<24 hours) | Similar |
| Performance Testing | | | | |
| Exhalation Resistance (cmH2O) | 4.4 cmH2O @ 20 lpm<br>8.5 cmH2O @ 30 lpm<br>9.7 cmH2O @ 40 lpm | Unknown | Min - 0 cmH2O @ 5 lpm<br>Min - 2.5 cmH2O @ 25 lpm<br>Max - 5.5 cmH2O @ 5 lpm<br>Max - 25.1 cmH2O @ 25 lpm | The exhalation resistance does not raise new concerns of safety or effectiveness. |
| Single patient, multi-use | Yes | Yes | Yes | Similar |
| Clean with soapy water | Yes | N/A | N/A | Cleaning the device does not raise concerns of safety or effectiveness. Test results did not show a degradation |

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#### Indications for Use -

The indications for use are similar for the proposed device when compared to the predicate -Discussion - Each device is indicated to provide PEP during patient exhalation, though the subject device makes no claims regarding Cystic Fibrosis.

#### Technology and construction -

The technology of using a resistor to create PEP during exhalation is common to both devices. Discussion - There are no technological differences which would raise different questions of safety or effectiveness between the proposed device and the predicate.

#### Environment of Use -

The environments of use are similar - home and clinical settings. Discussion - The environments of use are similar. Home use is supported by the reference device.

#### Patient Population -

The patient population of the proposed device and predicate are the same. Discussion - The patient population is equivalent to the predicate.

# Non-Clinical Testing Summary -

#### Bench testing -

We performed the following tests: Resistance to flow, and PEP values for repeatability and accuracy. These tests were performed on final, finished samples both pre- and post-aging as well as post-repeated cleaning. Discussion - The device performance was tested and does not raise any new concerns of safety or effectiveness.

# Biocompatibility -

Contact Type and Duration: Surface Contact, Mucosa, Externally Communicating, Tissue; prolonged (>24 hours, <30 days)

Discussion - The proposed device materials, contact type, and duration are identical to the device materials that were cleared under K062104. A Material Certification was used to support the Biocompatibility.

# Discussion of Differences –

The design, performance and function of the device does not raise any significant differences that would raise concerns of safety or effectiveness.

# Substantial Equivalence Conclusion

The sponsor has demonstrated through performance testing, design and non-clinical testing that the subject device and predicate have been found to be substantially equivalent.