(58 days)
Not Found
No
The description focuses on the mechanical function of a motor pump creating negative pressure and a user interface for controlling vacuum pressure. There is no mention of AI, ML, or any data processing that would suggest such technology is incorporated.
No
The primary function of this device is the physical removal of nasal secretions and mucus, not to diagnose, treat, prevent, or mitigate a disease.
No
The device is described as an Electronic Nasal Aspirator, whose intended use is for "intermittent removal of nasal secretions and mucus." This is a therapeutic or relief function, not a diagnostic one.
No
The device description clearly states it consists of a "main unit, and suction working together as one unit" and includes a "motor pump" and "rechargeable battery," indicating it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "intermittent removal of nasal secretions and mucus from children." This is a physical removal process, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device description focuses on the mechanical function of creating negative pressure to remove secretions. It does not mention any analysis of biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device is a medical device, but it falls under a different category than IVD. It's a device for physical intervention (suction) rather than diagnostic testing.
N/A
Intended Use / Indications for Use
The Electronic Nasal Aspirator is intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
Product codes
BTA
Device Description
Electric nasal aspirator consists of main unit, and suction working together as one unit. The Electronic Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter(not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal passages
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)
A series of safety and performance tests were conducted on the subject device.
- Product service life
- Software validation
- Electromagnetic compatibility and electrical safety
- Function test
- Biocompatibility test
All the test results demonstrate Electric nasal aspirator meets the requirements of its predefined acceptance criteria and intended use, and it is substantially equivalent to the predicate devices.
No clinical test data was used to support the decision of substantial equivalence.
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 20, 2022
Shenzhen XinLianFeng Technology Co., LTD % Reanny Wang Manager Shenzhen Reanny Medical Devices Management Consulting Co., Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, Guangdong 518107 China
Re: K222547
Trade/Device Name: Electric nasal aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: August 22, 2022 Received: August 23, 2022
Dear Reanny Wang:
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,
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222547
Device Name Electric nasal aspirator
Indications for Use (Describe)
The Electronic Nasal Aspirator is intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
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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3
Traditional 510(k) Summary
510(k) number: K222547
1. Information of Submitter and Correspondent
Submitter's information:
| Company Name: | Shenzhen XinLianFeng Technology CO.,LTD |
|---|---|
| Street Address: | No.5, Tongxi Road, Pingdong Community, Pingdi Street, Longgang District |
| City: | Shenzhen |
| State/ Province: | Guangdong |
| Country: | China |
| Telephone: | +86-13590244726 |
| Fax: | / |
| Contact Person: | Ma Qiang |
| Contact Title: | General Manager |
| Contact Email: | 156673750@qq.com |
Date Prepared: Aug. 22, 2022
Submission correspondent's information:
Shenzhen Reanny Medical Devices Management Consulting Co., Ltd
Address: Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District, Shenzhen 518107, China
Contact Person: Reanny Wang
E-mail: reanny@reanny.com
Phone: +86(755) 27391220
Device Information 2.
Trade Name: Electric nasal aspirator
4
| Model: | BC026 |
|---|---|
| Common Name: | Powered suction pump |
| Classification Name: | Pump, portable, aspiration (powered) |
| Regulation: | 21 CFR § 878.4780 |
| Device Class: | Class 2 |
| Product Code: | BTA |
Identification of Predicate Device(s) 3.
| Manufacturer | TaiDoc Technology Corporation | AViTA Corporation |
|---|---|---|
| Legally Marketed | ||
| Device | FORA NAS100 Electronic Nasal | |
| Aspirator, NAS100 (Electronic | ||
| Nasal Aspirator, TD-7601) | Avita Nasal Aspirator, | |
| Model NS1 | ||
| 510(K) Number | K180863 | K090379 |
Description of Device 4.
Electric nasal aspirator consists of main unit, and suction working together as one unit. The Electronic Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter(not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.
5. Indications for Use
The Electronic Nasal Aspirator is intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.
6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
6.1 Non-clinical testing
A series of safety and performance tests were conducted on the subject device.
- Product service life
5
- Software validation
- Electromagnetic compatibility and electrical safety
- Function test
- Biocompatibility test
All the test results demonstrate Electric nasal aspirator meets the requirements of its predefined acceptance criteria and intended use, and it is substantially equivalent to the predicate devices.
6.2 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
7. Performance Summary
The devices conform to applicable standards as follow table:
| Test Type | Standard Designation Number | FDA
Recogniti
on Status | Outcome
for Device |
|-----------------------------|----------------------------------------------------------------------------------------------------|-------------------------------|-----------------------|
| Safety | ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Yes | Conforms |
| EMC | IEC 60601-1-2:2014 | Yes | Conforms |
| Home healthcare environment | IEC 60601-1-11:2020 | Yes | Conforms |
| Performance | Enterprise standard | Yes | Conforms |
| Biocompatibility | ISO 10993-1:2018; ISO 10993-10:2010; ISO 10993-5:2009. | Yes | Conforms |
| Software | IEC 62304:2006+A1:2015 | Yes | Conforms |
| Safety of Lithium battery | IEC 62133-2:2017 | Yes | Conforms |
| Safety of lamps | IEC 62471: 2006 | Yes | Conforms |
| Risk management | ISO 14971:2019 | Yes | Conforms |
Discussion of Comparison to Predicate Devices. 8.
6
The Electric nasal aspirator submitted in this 510(k) submission is substantially equivalent in intended use, technological characteristics, materials, and performance to the cleared FORA NAS100 Electronic Nasal Aspirator K180863, and Avita Nasal Aspirator K090379. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness.
| Device | Subject device | Primary Predicate device | Secondary
predicate device | Comparison |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Manufacturer | Shenzhen XinLianFeng
Technology CO.,LTD | TaiDoc Technology
Corporation | AVITA Corporation | / |
| 510(K)
number | K222547 | K180863 | K090379 | / |
| Product name | Electric nasal aspirator,
model: BC026 | FORA NAS100 Electronic
Nasal Aspirator, NAS100
(Electronic Nasal Aspirator, TD-
7601) | Avita Nasal
Aspirator, Model
NS1 | / |
| Classification | Class II Device, BTA (21
CFR § 878.4780) | Class II Device, BTA (21 CFR §
878.4780) | Class II Device, (21
CFR § 878.4780) | SE |
| Classification
Panel | General & Plastic Surgery | General & Plastic Surgery | General & Plastic
Surgery | SE |
| Indication for
Use | The Electronic Nasal
Aspirator is intended for
intermittent removal of
nasal secretions and
mucus from children (age
2-12 years old). This
device is used in a home
environment. | The FORA NAS100 Electronic
Nasal Aspirator (Electronic
Nasal Aspirator, TD-7601),
NAS100 is intended for
intermittent removal of nasal
secretions and mucus from
children (age 2-12 years old).
This device is used in a home
environment. | This device is
designed for using
Intermittent suction
to remove nasal
secretion and
mucus in Children
(age 2-12 years old)
at home
environment. | SE |
| Patient
Population | Age 2-12 years old | Age 2-12 years old | Age 2-12 years old | SE |
| Intended
Environment | Home use | Home use | Home use | SE |
| Device
Description | The BC026 Electronic
Nasal Aspirator is a
portable device which is
intended for suction of
nasal passages in children
2-12 years of age. The
motor pump provides a
negative pressure which
removes nasal secretions. | The FORA NAS100 Electronic
Nasal Aspirator (Electronic
Nasal Aspirator,TD-7601),
NAS100 is a portable device
which is intended for suction of
nasal passages in children 2-12
years of age. The motor pump
provides a negative pressure
which removes nasal
secretions. | AVITA NS1 Nasal
Aspirator is a
portable, DC
powered device
Intended to provide
the suction function
to aspirate
children's nasal
secretion. | SE |
| Vacuum | 52-60Kpa | 52-60Kpa | 52Kpa | SE |
| Device | Subject device | Primary Predicate device | Secondary predicate device | Comparison |
| pressure | | | | |
| Music
function | Yes | Not publicly available | Yes | SE |
| Light function | Yes | Not publicly available | No | Note 1 |
| Noise Level |