Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device for positive expiratory pressure therapy and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The device is described as a Positive Expiratory Pressure Device intended to help prevent or reverse atelectasis in adult patients needing PEP therapy, which is a therapeutic function.

Diagnostic

No
The device is described as a Positive Expiratory Pressure Device intended to prevent or reverse atelectasis, providing PEP therapy to enhance expiratory muscle strength. It is a therapeutic device, not one that identifies or diagnoses a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "oral device" and provides "positive expiratory airway pressures," indicating a physical hardware component is involved in delivering the therapy.

IVD (In Vitro Diagnostic)

Based on the provided information, the Breathe+ device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's a "Positive Expiratory Pressure Device to help prevent or reverse atelectasis in adult patients needing PEP therapy." This describes a therapeutic device used to treat a condition, not a device used to diagnose a condition by examining samples from the human body.
Device Description: The description focuses on providing positive expiratory airway pressures, which is a physical therapy technique, not a diagnostic test.
Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Breathe+ device does not fit this description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

BWF

Device Description

The subject device provides PEP only. The applications of PEEP (PEP) in patients with lung disease is a well-known entity; oxygenation depends on the FiO2 and PEEP, and manipulation of any of these parameters should raise oxygenation in intubated patients. Patients with emphysema instinctively practice pursed lip breathing in order to 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 expiratory muscle strength while preventing and reversing atelectasis. Furthermore, the device is hands-free.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult patients

Intended User / Care Setting

single-patient, multi-use in a hospital or home care setting.

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)

Bench testing was performed, including 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. The device performance was tested and does not raise any new concerns of safety or effectiveness.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Exhalation Resistance (cmH2O): 4.4 cmH2O @ 20 lpm, 8.5 cmH2O @ 30 lpm, 9.7 cmH2O @ 40 lpm.

Predicate Device(s)

K962749

Reference Device(s)

K160636

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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)

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
9230 Katy Freeway, Suite 600
Houston, TX 77055
Official Contact:	Sean Boutros, MD
Founder
Submission Correspondent:	Paul Dryden
ProMedic, LLC
Proprietary or Trade Name:
Common/Usual Name:
Classification Name:	Breathe+
Incentive Spirometer
Product Code – BWF – Spirometer, Therapeutic (Incentive)
Predicate Device:
Common/Usual Name:
Classification Name:	DHD Diemolding Healthcare Division – Therapep – K962749
Incentive Spirometer
Product Code – BWF - Spirometer, Therapeutic (Incentive)
Reference Device:
Common/Usual Name:
Classification Name:	D R Burton - iPEP System and vPEP – K160636
Incentive Spirometer
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
depends on the FiO2 and PEEP, and manipulation of any of these parameters should raise oxygenation in
intubated patients. Patients with emphysema instinctively practice pursed lip breathing in order to
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
expiratory 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 the
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
atelectasis in adult patients needing PEP therapy. Intended for single-patient, multi-use in a hospital or
home care setting.

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Description	Subject Device	Predicate Device	Reference Device
Sponsor	PEEP Medical	DHD Diemolding Healthcare
Division	D R Burton
510(k) Number	TBD	K962749	K160636
Model Name	Breath+	TheraPEP	iPEP System and vPEP
Classification	Class II Device
BWF
21 CFR 858.5690	Class II Device
BWF
21 CFR 858.5690	Class II Device
BWF
21 CFR 858.5690	Identical
Indications for 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. | The DHD TheraPEP is intended for
use as a Positive Expiratory
Pressure Device for patients
suffering from Cystic Fibrosis, lung
diseases with secretory problems,
and to prevent or reverse atelectasis. | The D R Burton iPEP Therapy
System is intended for use as a
Positive Expiratory Pressure
(PEP) by patients capable of
generating an exhalation flow of
10 lpm for 3-4 seconds and an
Incentive Spirometer as an
inspiratory, deep breathing
positive exerciser.

Intended for single-patient, multi
use.