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 Description

The subject device provides PEP only. The subject device is an oral device that provides positive expiratory airway pressures to enhance expiratory muscle strength while preventing and reversing atelectasis. Furthermore, the device is hands-free.

AI/ML Overview

The provided submission for the Breathe+ device, a Positive Expiratory Pressure (PEP) device, does not contain a typical study that proves the device meets specific acceptance criteria in the manner of a clinical trial or algorithm performance study. Instead, it focuses on bench testing and a comparison to predicate and reference devices to demonstrate substantial equivalence for FDA clearance.

Therefore, the following information will be drawn from the provided text regarding the bench testing that was performed for the device. The document does not describe a clinical study with an AI component or expert ground truth adjudication.

Acceptance Criteria and Reported Device Performance (Bench Testing)

Acceptance Criteria (from predicate/reference or implied)	Reported Device Performance (Breathe+)
Exhalation Resistance (cmH2O) @ 20 lpm	4.4 cmH2O @ 20 lpm
Exhalation Resistance (cmH2O) @ 30 lpm	8.5 cmH2O @ 30 lpm
Exhalation Resistance (cmH2O) @ 40 lpm	9.7 cmH2O @ 40 lpm
Repeatability of PEP values	Tested and found acceptable
Accuracy of PEP values	Tested and found acceptable
Functionality post-aging	Tested and found acceptable
Functionality post-repeated cleaning	Tested and found acceptable

Note: The exact acceptance thresholds for "repeatability and accuracy" are not explicitly stated in the document, but the discussion concludes "The device performance was tested and does not raise any new concerns of safety or effectiveness."

Study Details (Bench Testing)

Sample size used for the test set and the data provenance: Unspecified number of "final, finished samples" of the Breathe+ device. The data provenance is internal testing performed by PEEP Medical, LLC. It is prospective testing on newly manufactured devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was bench testing of a physical device's mechanical performance, not an AI or diagnostic study requiring expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This was mechanical bench testing.
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: Not applicable. No MRMC study was performed as this is a mechanical medical device, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for the bench testing was based on direct physical measurements of the device's performance, such as pressure readings (cmH2O) at various flow rates (lpm) using calibrated equipment.
The sample size for the training set: Not applicable. This refers to bench testing of a physical device.
How the ground truth for the training set was established: Not applicable.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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, LLC9230 Katy Freeway, Suite 600Houston, TX 77055
Official Contact:	Sean Boutros, MDFounder
Submission Correspondent:	Paul DrydenProMedic, LLC
Proprietary or Trade Name:Common/Usual Name:Classification Name:	Breathe+Incentive SpirometerProduct Code – BWF – Spirometer, Therapeutic (Incentive)
Predicate Device:Common/Usual Name:Classification Name:	DHD Diemolding Healthcare Division – Therapep – K962749Incentive SpirometerProduct Code – BWF - Spirometer, Therapeutic (Incentive)
Reference Device:Common/Usual Name:Classification Name:	D R Burton - iPEP System and vPEP – K160636Incentive SpirometerProduct 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; oxygenationdepends on the FiO2 and PEEP, and manipulation of any of these parameters should raise oxygenation inintubated patients. Patients with emphysema instinctively practice pursed lip breathing in order toincrease 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 enhanceexpiratory muscle strength while preventing and reversing atelectasis. Furthermore, the device is hands-free.
Principle of Operation:	Upon inhalation, the "flap" valve opens and one can inhale with limited resistance. During exhalation, the"flap" valve closes and the front plate is pushed open under resistance, ~ 8 cm H2O, that is set by thebands. 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 reverseatelectasis in adult patients needing PEP therapy. Intended for single-patient, multi-use in a hospital orhome care setting.

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Description	Subject Device	Predicate Device	Reference Device	Differences
Sponsor	PEEP Medical	DHD Diemolding HealthcareDivision	D R Burton
510(k) Number	TBD	K962749	K160636
Model Name	Breath+	TheraPEP	iPEP System and vPEP
Classification	Class II DeviceBWF21 CFR 858.5690	Class II DeviceBWF21 CFR 858.5690	Class II DeviceBWF21 CFR 858.5690	Identical
Indications for use	The Breathe+ is intended for use asa Positive Expiratory PressureDevice to help prevent or reverseatelectasis in adult patients needingPEP therapy.Intended for single-patient, multi-use in a hospital or home caresetting.	The DHD TheraPEP is intended foruse as a Positive ExpiratoryPressure Device for patientssuffering from Cystic Fibrosis, lungdiseases with secretory problems,and to prevent or reverse atelectasis.	The D R Burton iPEP TherapySystem is intended for use as aPositive Expiratory Pressure(PEP) by patients capable ofgenerating an exhalation flow of10 lpm for 3-4 seconds and anIncentive Spirometer as aninspiratory, deep breathingpositive exerciser.Intended for single-patient, multiuse.iPEP System for hospital andclinical settings.	The subject device isintended to prevent orreverse 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)	ResistorMouthpiece	ResistorPressure range indicatorPressure adapterMouthpiece	Flap valve, which generates oscillation during exhalationOne-way valveMouthpiece	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 ContactMucosal membraneExternally Communicating TissueDuration of Use - prolonged (>24 hours, <30 days)	Surface ContactMucosal membraneExternally Communicating TissueDuration of Use - prolonged (>24 hours, <30 days)	Surface ContactMucosal membraneExternally Communicating TissueDuration of Use – limited (<24 hours)	Similar
Performance Testing
Exhalation Resistance (cmH2O)	4.4 cmH2O @ 20 lpm8.5 cmH2O @ 30 lpm9.7 cmH2O @ 40 lpm	Unknown	Min - 0 cmH2O @ 5 lpmMin - 2.5 cmH2O @ 25 lpmMax - 5.5 cmH2O @ 5 lpmMax - 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.

Regulation Number and Section

§ 868.5690 Incentive spirometer.

(a)
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.(b)
Classification. Class II (performance standards).