(187 days)
Not Found
No
The device description and performance studies focus on mechanical functions (suction, spray), safety, and software validation for basic device operation, with no mention of AI or ML.
Yes
The device is designed to remove nasal secretions and mucus and moisten/loosen them, which are actions intended to alleviate or prevent a condition (nasal congestion), thus qualifying it as a therapeutic device.
No
The device is designed for removing nasal secretions and moistening/loosening them, which are therapeutic actions, not diagnostic ones. It does not identify, assess, or monitor a medical condition.
No
The device description explicitly lists hardware components such as a pump, silicone tip, collecting nasal mucus, sprayer head module, buttons, and batteries. The software verification and validation testing mentioned is for software contained in the medical device, not the device being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed for the physical removal of nasal secretions and mucus, and for moistening the nasal cavity. It does not involve testing or analyzing biological samples (like blood, urine, or tissue) to diagnose a disease or condition.
- Device Description: The description focuses on the mechanical functions of suction and spraying. There is no mention of reagents, test strips, or any components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies described relate to the physical and electrical safety, biocompatibility, and cleaning/disinfection of the device. They do not involve evaluating the accuracy or reliability of a diagnostic test.
In summary, this device is a medical device used for physical intervention (suction and irrigation) within the body, not for in vitro diagnostic testing of samples taken from the body.
N/A
Intended Use / Indications for Use
The device is designed for using suction to remove nasal secretion and mucus in Children (age 2~12 years old) at home environment.
The additional spray/irrigation function helps moisten and loosen/soften nasal secretions in Children (over 3 years old), making them easier to aspirate.
Product codes
BTA, KMA
Device Description
This AViTA nasal aspirator (Model NS13) consists of a pump that can generate negative pressure suction, a silicone tip for contacting the nostrils, a collecting nasal mucus, a sprayer head module for moistening the nasal cavity, and two buttons that activate suction and sprayer functions. This nasal aspirator is powered by two AAA batteries. The accessories are the batteries, silicone tips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal
Indicated Patient Age Range
Children (age 2~12 years old), Children (over 3 years old)
Intended User / Care Setting
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)
Performance testing has been carried out to demonstrate that this device meets the performance specifications for its intended use. The following tests were performed on the device. The results of those testing show that the required limits for mean difference and standard deviation are fulfilled by the subject device.
Biocompatibility testing:
The biocompatibility evaluation and testing of the Product name was conducted in accordance with the following standards and guidance, as recognized by the FDA:
- FDA Draft Guidance Use of International Standard ISO- 10993, "Biological Evaluation of - Medical Devices, Part 1: Evaluation and Testing".
- -ISO 10993-5, Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
- ISO 10993-11. Biological evaluation of medical devices- Part 11: Tests for systemic toxicity. -
- -ISO 10993-23, Biological evaluation of medical devices- Part 23: Test for irritation.
Cleaning and Disinfecting Test:
The Nasal Aspirator is a medical device that does not supply sterilized. This product has passed the cleaning verification of 1000 times with mild mom-abrasive soap and 70℃ water and soft dry cloth wiping, confirming that the product can be used continuously without any functional abnormalities.
Safety Test:
- -IEC 60601-1:2005+A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- -IEC 60601-1-11:2010, Medical electrical equipment-Part 1-11: General Requirement for basic safety and essential performance- Collateral Standard: Requirements for medical electrical systems used in the home healthcare environment
Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Basic documentation" level of concern, since a failure or latent flaw in the software could not directly result in serious injury or death to the patient or operator.
Clinical Studies: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 31, 2024
AViTA Corporation Maggie Chao Adm. Manager 9F, No.78, Sec.1, Kwang Fu Road, Sanchong Dist. New Taipei City, 24158 Taiwan
Re: K241852
Trade/Device Name: Nasal Aspirator (NS13) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA, KMA Dated: December 2, 2024 Received: December 2, 2024
Dear Maggie Chao:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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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
3
Indications for Use
Submission Number (if known)
Device Name
Nasal Aspirator (NS13)
Indications for Use (Describe)
The device is designed for using suction to remove nasal secretion and mucus in Children (age 2~12 years old) at home environment.
The additional spray/irrigation function helps moisten and loosen/soften nasal secretions in Children (over 3 years old), making them easier to aspirate.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/1 description: The image shows the logo for AViTA. The logo consists of the word "AViTA" in blue, with a stylized heart shape to the right. The heart is colored in three sections: the top is yellow, the bottom is red, and the right side is green. There is a registered trademark symbol to the bottom right of the heart.
AVITA CORPORATION
510(k) Submission for AViTA Nasal Aspirator
510(K) Summary
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Image /page/5/Picture/0 description: The image shows the logo for AViTA. The logo features the word "AViTA" in blue, with the "i" dotted with a yellow semi-circle. The word is set to the left of a heart shape, which is formed by a red curve at the bottom and a green curve at the top and right. A registered trademark symbol is located at the bottom right of the heart.
| Applicant: | AVITA Corporation |
|---|---|
| Address: | 9F, No.78, Sec.1, Kwang-Fu Rd., San-Chung District, New Taipei |
| City 24158, Taiwan | |
| Applicant Establishment Number: | 9617543 |
| Applicant Contact: | Maggie Chao |
| Email: | Maggie_chao@avita.com.tw |
| Phone Number: | +886-2-8512-1568 |
| Fax Number: | +886-2-8512-1347 |
| Date of Submission: | November 28, 2024 |
DEVICE
| Trade/Proprietary Name: | AViTA Nasal Aspirator |
|---|---|
| Common Name: | Nasal Aspirator |
| Model: | NS13 |
| Review Panel: | General & Plastic Surgery |
| Classification Product Code: | BTA KMA |
| Regulation Number: | 870.4780- Powered suction pump |
| Device Class: | II |
DEVICE DESCRIPTION
This AViTA nasal aspirator (Model NS13) consists of a pump that can generate negative pressure suction, a silicone tip for contacting the nostrils, a collecting nasal mucus, a sprayer head module for moistening the nasal cavity, and two buttons that activate suction and sprayer functions. This nasal aspirator is powered by two AAA batteries. The accessories are the batteries, silicone tips.
6
Image /page/6/Picture/0 description: The image shows the logo for AViTA. The logo consists of the word "AViTA" in blue, with a heart shape to the right. The heart shape is made up of three different colors: yellow at the top, red at the bottom, and green on the right side. There is also a registered trademark symbol to the bottom right of the heart.
INDICATIONS FOR USE
The device is designed for using suction to remove nasal secretion and mucus in children (age 2~12 years old) at home environment.
The additional spray function helps moisturize and soften nasal secretions in children (over 3 years old), making them easier to aspirate.
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Image /page/7/Picture/0 description: The image shows the logo for AVITA. The logo has the word "AVITA" in blue font on the left side of the image. To the right of the word is a heart shape that is made up of three different colors: yellow, red, and green.
COMPARISON WITH PREDICATE DEVICE
| Item | Subject
(AVITA Nasal Aspirator NS13) | Predicate
(AVITA Nasal Aspirator NS1 Series) | Predicate
(Geonic Nasal Cleaner) |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K number | - | K090379 | NA |
| Classification | 21CFR 878.4780 | 21CFR 878.4780 | 21 CFR 874.5550 |
| Product code | BTA | BTA | KMA |
| FDA class | II | II | I |
| Intended use | The device is designed for using suction to remove nasal
secretion and mucus in Children (age 212 years old) at home0.5 ml/10sec
environment. The additional spray/irrigation function helps
moisten and loosen/soften nasal secretions in Children (over 3
years old), making them easier to aspirate. | The device is designed for using intermittent suction to remove
nasal secretion and mucus in Children (age 2-12 years old) at
home environment. | 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 cleaner is intended for
over-the-counter (OTC) use at home
environment. |
| Effective
Vacuum Pressure | Vacuum Pressure: 100-120 mmHg | Max.120mmHg | N/A |
| Optional Levels | N/A | N/A | N/A |
| Sound
Pressure Level | ≤60dB | 65±3dB | N/A |
| Spray Capacity | 0.4
(2.4~3 ml/min) | N/A | 5 ml/min |
| Operating
Temperature Range | 16°C ~ 35°C
(60.8°F ~ 95°F)
15%~85% RH | 15°C ~ 40°C