(380 days)
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Not Found
No
The summary does not mention any AI or ML terms, image processing, or data sets typically associated with AI/ML development. The device description focuses on mechanical pressure for secretion removal and saline spray.
No.
The devices are intended for mechanical removal of nasal secretions and mucus, and moisturizing nasal cavities, which are physical actions rather than therapeutic interventions that treat or cure a disease or condition.
No
The device is described as an electronic medical device that uses pressure to remove nasal secretions and mucus, and to moisturize nasal cavities. Its intended use is for cleaning and moisturizing, not for diagnosing a condition or disease.
No
The device description explicitly states "electronic medical devices" and describes physical actions like applying pressure and using saline solution, indicating a hardware component is involved.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Geonic Nasal Aspirator and Nasal Cleaner are described as devices that physically remove nasal secretions and mucus or moisturize the nasal cavities. They are used directly on the body and do not involve testing samples taken from the body.
Therefore, the function and intended use of these devices do not align with the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Geonic Nasal Aspirator (Model Name: AH2, S1) and Geonic Nasal Cleaner (Model Name: H2) are hand-held, noninvasive, electronic medical devices that pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geonic Nasal Cleaner (Model Name: H2) additionally provide positive pressure to moisturize the nasal cavities by using saline solution in the form of spray for adults and pediatrics (3 years old). The nasal aspirator and nasal cleaner are intended for over-the-counter (OTC) use at home environment.
Product codes
BTA. KMA
Device Description
Geonic Nasal Aspirator (Model Name: AH2, S1) and Geonic Nasal Cleaner (Model Name: H2) are hand-held, noninvasive, electronic medical devices that pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geonic Nasal Cleaner (Model Name: H2) additionally provide positive pressure to moisturize the nasal cavities by using saline solution in the form of spray for adults and pediatrics (3 years old).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
nasal cavities
Indicated Patient Age Range
children (age 2-12 years old), adults and pediatrics (3 years old).
Intended User / Care Setting
over-the-counter (OTC) use at home environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 2, 2023
Geon Corporation % Wan-Chi Chang CEO AlfaBeta Clinical Research Co., Ltd. Rm. R103, 1F., No. 8, Sec. 2, Shengyi Rd., Chupei City, Hsinchu County, 30261 Taiwan
Re: K220126
Trade/Device Name: Geonic Nasal Aspirator, Geonic Nasal Cleaner Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA. KMA Dated: January 2, 2023 Received: January 4, 2023
Dear Wan-Chi Chang:
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.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220126
Device Name Geonic Nasal Aspirator Geonic Nasal Cleaner
Indications for Use (Describe)
Geonic Nasal Aspirator (Model Name: AH2, S1) and Geonic Nasal Cleaner (Model Name: H2) are hand-held, noninvasive, electronic medical devices that pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geonic Nasal Cleaner (Model Name: H2) additionally provide positive pressure to moisturize the nasal cavities by using saline solution in the form of spray for adults and pediatrics (3 years old). The nasal aspirator and nasal cleaner are intended for over-the-counter (OTC) use at home environment.
Type of Use (Select one or both, as applicable)
| ☐ Exported solely for use in FDA-regulated Products | ☑ Exported for use in Non-FDA-regulated Products |
|---|---|
| ----------------------------------------------------- | -------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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