LungTrainer (MD2 & MD3)

K221058 · Lung Trainers, LLC · BWF · Jul 5, 2023 · Anesthesiology

Device Facts

• Record ID: K221058
• Device Name: LungTrainer (MD2 & MD3)
• Applicant: Lung Trainers, LLC
• Product Code: BWF · Anesthesiology
• Decision Date: Jul 5, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lung Trainer device is intended to be used as (1) an expiratory breathing exerciser for respiratory muscles, and (2) to be used as an expiratory resistance device, providing positive expiratory pressure (PEP) to substitute for pursed lip breathing and to assist in mucus clearance. The LungTrainer device is intended for use in patients ages 12 years and up in a clinical or home use environment.

Device Story

LungTrainer (MD2 & MD3) functions as an expiratory breathing exerciser and PEP device. It provides resistance to expiration to strengthen respiratory muscles and facilitate mucus clearance. Used by patients aged 12+ in clinical or home environments. Device operates mechanically to create positive pressure during exhalation, mimicking pursed-lip breathing techniques. No electronic or software components described.

Indications for Use

Indicated for patients ages 12 and older requiring respiratory muscle exercise or positive expiratory pressure (PEP) therapy for mucus clearance and as a substitute for pursed lip breathing. Used in clinical or home settings under prescription.

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.

Submission Summary (Full Text)

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July 5, 2023

Lung Trainers, LLC % Robert Packard President Medical Device Academy Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738

Re: K221058

Trade/Device Name: LungTrainer (MD2 & MD3) Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: June 1, 2023 Received: June 1, 2023

Dear Robert Packard:

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.

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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) 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

Enclosure

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# Indications for Use

510(k) Number (if known) K221058

Device Name LungTrainer (MD2 & MD3)

#### Indications for Use (Describe)

The Lung Trainer device is intended to be used as (1) an expiratory breathing exerciser for respiratory muscles, and (2) to be used as an expiratory resistance device, providing positive expiratory pressure (PEP) to substitute for pursed lip breathing and to assist in mucus clearance. The LungTrainer device is intended for use in patients ages 12 years and up in a clinical or home use environment.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| | <label><input checked="checked" disabled="disabled" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| | <label><input disabled="disabled" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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