(463 days)
Not Found
No
The device description and the "Mentions AI, DNN, or ML" section explicitly state that AI/ML is not found. The device is a simple battery-powered suction pump with a music feature.
No.
The device is a nasal aspirator intended for removing nasal secretions, which is a supportive care measure rather than a therapeutic intervention aimed at treating a disease or condition. Its function is to clear mucus, not to heal or cure.
No
This device is designed for therapeutic purposes (removing nasal secretions and mucus) rather than diagnosing a condition.
No
The device description explicitly states it is a portable, DC powered device consisting of a pump, batteries, tip, collection cup, and music IC, indicating it is a hardware device with some software components (Music IC).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove nasal secretion and mucus in Children (age 2-12 years old) at home environment." This is a physical action performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device description details a pump, aspiration tip, collection cup, and music IC. These are components for physical aspiration, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), reagents, or any diagnostic purpose.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical removal of nasal secretions.
N/A
Intended Use / Indications for Use
This device is designed for using intermittent suction to remove nasal secretion and mucus in Children (age 2-12 years old) at home environment.
Product codes
JCX
Device Description
AVITA NS1 Nasal Aspirator is a portable, DC powered device intended to provide the suction function to aspirate children's nasal secretion. The device consist of a pump that is driven by Two (2) 1.5V AA size alkaline batteries , soft aspiration tip , collection cup and Music IC with 12 Chord Melody.
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)
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)
bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness.
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.
0
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
| 1. Submitter's Name: | AVITA Corporation |
|---|---|
| Address: | 9F, No. 78, SEC. 1, Kwang-Fu Rd., San-Chung, Taipei |
| County, Taiwan, 241 | |
| Phone: | +886-2-8512-1568 |
| Fax: | +886-2-8512-1347 |
| Contact: | Mr. Nelson Lin / R&D Manager |
| 2. Device Name : | |
| Trade Name: | AVITA Nasal Aspirator, |
| Model no.: NS1 Series | |
| Common Name: | Nasal Aspirator |
| Classification name | apparatus, suction, ward use, portable, ac-powered |
| 3. DEVICE CLASS | The AVITA Nasal Aspirator, (Model no.: NS1 Series) has |
| been classified as | |
| Regulatory Class: II | |
| Panel: General & Plastic Surgery | |
| Product Code: JCX | |
| Regulation Number: 21CFR 878.4780 Class II | |
| 21CFR 874.5550 Class I | |
| 4. Predicate Device: | The predicate device is the |
| • Aardvark Nasal Irrigation and Aspiration System | |
| (K082762) marketed by Aardvark Medical Company. | |
| • DeVilbiss SUCTION UNIT(K982304) marketed by | |
| SUNRISE MEDICAL HHG, ING. | |
| 5. Intended Use: | This device is designed for using intermittent suction to |
| remove nasal secretion and mucus in Children (age 2-12 | |
| years old) at home environment. | |
| 6. Device Description: AVITA NS1 Nasal Aspirator is a portable, DC powered | |
| device intended to provide the suction function to aspirate | |
| children's nasal secretion. The device consist of a pump that is | |
| Product: AVITA NS1 Nasal Aspirator | |
| Page 1 of 2 | Section 4 - 510(k) Summary |
| REV. [C] |
1
driven by Two (2) 1.5V AA size alkaline batteries , soft aspiration tip , collection cup and Music IC with 12 Chord Melody.
In terms of operating specification, Safety & EMC 7. Performance requirements, the device conforms to applicable standards Summary: included IEC 60601-1 and IEC 60601-1-2 requirements.
8. Conclusions:
The AVITA Nasal Aspirator, (Model no.: NS1 Series) has the same intended use and similar technological characteristics as the Aardvark Nasal Irrigation and Aspiration System (K082762) marketed by Aardvark Medical Company. And DeVilbiss SUCTION UNIT(K982304) marketed by SUNRISE MEDICAL HHG, ING. . Moreover, bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Thus, the AViTA Nasal Aspirator, (Model no.: NS1 Series) is substantially equivalent to the predicate devices.
Page 2 of 2
Product: AViTA NS1 Nasal Aspirator Section 4 - 510(k) Summary
REV. [C]
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL = 8 2010
Avita Corporation C/O Ms. Jennifer Reich Senior Consultant Harvest Consulting Corporation 2904 North Boldt Drive Flagstaff, Arizona 86001
Re: K090379
Trade/Device Name: Avita Nasal Aspirator, Model NS1 Regulation Number: 21CFR 878.4780 Regulation Name: Powder Suction Pump Regulatory Class: II Product Code: JCX Dated: May 10, 2010 Received: May 21, 2010
Dear Ms. Reich:
This letter corrects our substantially equivalent letter of May 26, 2010
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 (PMA). 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 (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.
3
Page 2- Ms. Reich
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
ph for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): __K090379
Device Name: AViTA Nasal Aspirator,
Model no.: NS1 Series AVITA Corporation
Indications for Use:
This device is designed for using intermittent suction to remove nasal secretion and mucus in Children (age 2-12 years old) at home environment.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schuster
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
Page 1 of 1
510(k) Number: