(105 days)
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No
The summary describes a simple nasal inhaler for essential oils and contains no mention of AI or ML technology.
No
The device is described as "a medium for aroma inhalation of essential oils," indicating it's for general well-being rather than treating a specific medical condition. Therapeutic devices are typically intended to treat, diagnose, cure, or prevent disease.
No
Explanation: The device is intended for aroma inhalation of essential oils by the general public, not for diagnosing any medical condition.
No
The device description explicitly states "Aromapatch™ nasal inhaler," which is a physical hardware device used for aroma inhalation. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aroma inhalation of essential oils." This is a general wellness or therapeutic use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of disease or to determine the state of health.
- Device Description: The device is a "nasal inhaler," which is consistent with delivering substances for inhalation, not for analyzing biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Target User: The intended user is the "general public," which is typical for a consumer product, not necessarily a medical device used for diagnosis.
Therefore, the Aromapatch™ nasal inhaler, as described, falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
77 LRD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
general public
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines that resemble a person.
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
1
| 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