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.

AI/ML Overview

The provided text describes a 510(k) summary for the AVITA Nasal Aspirator, Model NS1 Series. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on:

Device Identification: Submitter, device name, classification, predicate devices.
Intended Use: For intermittent suction to remove nasal secretions in children aged 2-12 at home.
Device Description: Portable, DC-powered, uses AA batteries, soft aspiration tip, collection cup, and music IC.
Performance Requirements: States conformance to IEC 60601-1 and IEC 60601-1-2 for operating specifications, safety, and EMC. This is a general statement of conformance to standards, not specific acceptance criteria or a study demonstrating achievement.
Conclusion: Declares substantial equivalence to predicate devices based on "same intended use and similar technological characteristics" and "bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
FDA Correspondence: A letter from the FDA confirming substantial equivalence and outlining regulatory requirements.

Therefore, I cannot populate the requested table or provide details about the study as the information is not present in the provided text.

To provide the requested information, the document would need to include:

Specific quantifiable acceptance criteria (e.g., minimum suction pressure, maximum noise level, battery life, mucus removal efficiency).
Details of a performance study conducted to measure these criteria. This would typically include:
- Study design (e.g., bench test, clinical trial).
- Methodology for measuring performance.
- Results of the measurements.
- Comparison of results against the acceptance criteria.

Without this information, I can only state that the document indicates the device conforms to IEC 60601-1 and IEC 60601-1-2 requirements and that "bench testing" was performed to demonstrate substantial equivalence, but it does not elaborate on the specific criteria, the test results, or the study details.

Summary

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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, TaipeiCounty, 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) hasbeen classified as
	Regulatory Class: II
	Panel: General & Plastic Surgery
	Product Code: JCX
	Regulation Number: 21CFR 878.4780 Class II21CFR 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 bySUNRISE MEDICAL HHG, ING.
5. Intended Use:	This device is designed for using intermittent suction toremove nasal secretion and mucus in Children (age 2-12years old) at home environment.
6. Device Description: AVITA NS1 Nasal Aspirator is a portable, DC powereddevice intended to provide the suction function to aspiratechildren's nasal secretion. The device consist of a pump that is
	Product: AVITA NS1 Nasal Aspirator
Page 1 of 2	Section 4 - 510(k) SummaryREV. [C]

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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]

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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.

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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

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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

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510(k) Number:

Regulation Number and Section

§ 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.