← Product Code [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF) · K984085 # RITEFLO SPACER (K984085) _Aeromax Technologies, Inc. · CAF · Aug 5, 1999 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K984085 ## Device Facts - **Applicant:** Aeromax Technologies, Inc. - **Product Code:** [CAF](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF.md) - **Decision Date:** Aug 5, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.5630 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology - **Attributes:** Therapeutic, Pediatric ## Indications for Use The Intelliflo Spacer is intended to be used in combination with Metered Dose Inhaler's (MDI) to assist in respiratory steroid drug delivery. The target population includes all patients using MDI's i.e., children, elderly, and adults. ## Device Story Intelliflo Spacer functions as an accessory device for Metered Dose Inhalers (MDI). It acts as a holding chamber to assist in the delivery of respiratory steroid medications. The device is used by patients—including children, adults, and the elderly—to improve the efficiency of drug inhalation from an MDI. By providing a space between the MDI and the patient's mouth, it helps coordinate the timing of actuation and inhalation, potentially reducing oropharyngeal deposition and increasing lung delivery of the medication. It is a non-powered, passive device used in home or clinical settings. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Non-powered, passive respiratory spacer/holding chamber. Designed for use with standard Metered Dose Inhalers (MDI). No electronic components, software, or energy source. ## Regulatory Identification A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device. ## 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}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three wavy lines or abstract human figures. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 5 1898 Allan M. Wachter, M.D. Aeromax Technologies, Inc. 12020 S. Warner-Elliot Loop #124 Phoenix, AZ 85044 Re: K984085 Intelliflo Spacer Requlatory Class: II (two) Product Code: CAF July 6, 1999 Dated: Received: July 6, 1999 Dear Dr. Wachter: 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 leqally 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations 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 requlation (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 In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Reqister. 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 requlations. {1}------------------------------------------------ Page 2 - Allan M. Wachter, M.D. 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/dsma/dsmamain.html". Sincerely yours, Thomas J. Callahan 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}------------------------------------------------ (K984085) Item #1 - Indications for use: The Intelliflo Spacer is intended to be used in combination with Metered Dose Inhaler's (MDI) to assist in respiratory steroid drug delivery. The target population includes all patients using MDI's i.e., children, elderly, and adults. LoA. Westerhausen DTC (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological De 510(k) Number Prescription use √ --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K984085](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAF/K984085) **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