← Product Code [BWF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF) · K972824 # THE BREATHER INSPIRATORY/EXPIRATORY MUSCLE TRAINER (K972824) _Pn Medical · BWF · Apr 3, 1998 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K972824 ## Device Facts - **Applicant:** Pn Medical - **Product Code:** [BWF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF.md) - **Decision Date:** Apr 3, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5690 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic ## Indications for Use The new intended use of this product is to assist the patient in the coordination of breathing during nebulization treatments via hooking the device up with medication delivery systems. i.e., metered dose inhalers, electronic nebulization therapy. It is to be used in addition to and not in place of the delivery device provided by the manufacturer. ## Device Story The Breather is an accessory device designed to assist patients in coordinating breathing during nebulization therapy. It connects to medication delivery systems, such as metered dose inhalers or electronic nebulizers, to facilitate proper inhalation technique. The device is intended for use in conjunction with, not as a replacement for, the manufacturer-provided delivery system. It serves as a respiratory aid to improve the efficacy of medication delivery by ensuring better patient-device synchronization during treatment. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Mechanical respiratory training/coordination device. Connects to standard medication delivery systems (metered dose inhalers, electronic nebulizers). No electronic components, software, or power source. ## Regulatory 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 - The Breather ([K944412](/device/K944412.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble human figures or birds in flight, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR - 3 1000 Ms. Peggy Nicholson PN Medical, Inc. 214 N. Goldenrod Road, Suite 6 Orlando, FL 32807 Re: K972824 The Breather (Inspiratory/Expiratory Muscle Trainer Regulatory Class: II (two) Product Code: 73 BWF Dated: January 9, 1998 Received: January 12, 1998 Dear Ms. Nicholson: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21-CFR-Part 820) and that, through periodic (QS) ========================================================================================================= inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. 、ソファ : {1}------------------------------------------------ ## Page 2 - Ms. Peggy Nicholson This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, sincerely yours, Thomas J. Callahon Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ | 510(k) Number (if known): | Seeking new # - Original # K944412 | |---------------------------|------------------------------------| | Device Name: | The Breather | Indications For Use: The new intended use of this product is to assist the patient in the coordination of breathing during nebulization treatments via hooking the device up with medication delivery systems. i.e., metered dose inhalers, electronic nebulization therapy. It is to be used in addition to and not in place of the delivery device provided by the manufacturer. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |-------------------------------------------------------------------|---------| | Division of Cardiovascular, Respiratory, and Neurological Devices | | | 510(k) Number | K972824 | | Prescription Use (Per 21 CFR 801.109) | | |---------------------------------------|--| |---------------------------------------|--| OR | Over-The-Counter Use | | |----------------------|--| |----------------------|--| (Optional Formal 1-2-96) ﻟﻠﻤﺴﺎ --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K972824](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWF/K972824) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com