(105 days)
Aromapatch™ nasal inhaler shall be single use only and are to be used by the general public as a medium for aroma inhalation of essential oils, such as eucalyptus oil.
Aromapatch™ nasal inhaler
The provided documents are a Food and Drug Administration (FDA) 510(k) clearance letter and an "Indications for Use Statement" for the Aromapatch™ Nasal Inhaler.
These documents do not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The FDA letter (K984345) confirms that the Aromapatch™ Nasal Inhaler has been found substantially equivalent to a legally marketed predicate device. This type of clearance (510(k)) generally focuses on demonstrating substantial equivalence to a device already on the market, rather than requiring detailed efficacy studies with acceptance criteria as might be seen for novel high-risk devices or those undergoing Premarket Approval (PMA).
The "Indications for Use Statement" simply describes the intended use of the device: "Aromapatch™ nasal inhaler shall be single use only and are to be used by the general public as a medium for aroma inhalation of essential oils, such as eucalyptus oil."
Therefore, I cannot fulfill your request for the specific information about testing and acceptance criteria. The information requested is not present in these documents.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 1999
Steve Woody Submission Correspondent Integrated Quality Systems 25 Heritage Drive Asheville, NC 28806
Re:
Aromapatch™ Nasal Inhaler Dated: January 27, 1999 Received: February 1, 1999 Regulatory class: I 21 CFR 874.5220/Procode: 77 LRD
Dear Mr. Woody:
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 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). 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 to 895. A substantially equivalent determination assumes compliance 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 regulatory 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.
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) 594-4613. 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Envis, Inc. | |
|---|---|
| Appendix B | |
| Indication for Use Statement | |
| 510(k) Number (if known): | Pending 510(k) Request |
| Device Name: | Aromapatch™ |
| Indications for Use: | |
| Aromapatch™ nasal inhaler shall be single use only and are to be used by the general public as a medium for aroma inhalation of essential oils, such as eucalyptus oil. |
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 Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K984345 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The Counter Use ✓ |
|---|---|---|
| ------------------------------------------ | ---- | ------------------------------------------------------------------------- |
510(k) Facilitated By: Integrated Quality Systems
§ 874.5220 Ear, nose, and throat drug administration device.
(a)
Identification. An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.