(131 days)
Not Found
No
The device description focuses on mechanical components (motor pump, silicone tips, tube, mucus collector) and basic electronic controls (buttons, indicator/display). There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies described are basic product and human factors tests, not studies related to AI/ML model performance.
Yes
The document states its intended use is for "intermittent removal of nasal secretions and mucus from children," which is a direct treatment of a physical condition, aligning with the definition of a therapeutic device.
No
The device is intended for the removal of nasal secretions and mucus, which is a therapeutic or relief function, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components such as silicone tips, host, tube, mucus collector, motor pump, and battery, indicating it is a hardware device with potentially embedded software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The Nasal Aspirator is a mechanical device that physically removes nasal secretions and mucus from the nasal passages. It does not analyze or test any biological specimens to provide diagnostic information.
- Intended Use: The intended use is for the intermittent removal of nasal secretions and mucus, not for diagnosing any condition.
Therefore, the Nasal Aspirator falls under the category of a physical medical device used for therapeutic or symptomatic relief, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 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.
Product codes
BTA
Device Description
The 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.
Nasal Aspirator consists of silicone tips which has three models (A, B, C), host, tube, mucus collector. The accessory are charging cable-USB, clean brush, clip, sponge. The 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 exter (not included in this device) through the provided charging line. The user interface consists of buttons and indicator/ display, and the vacuum pressure through the button. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
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
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)
ln order to verify and assure the performance of the Nasal Aspirator, we have conducted the product appearance test and product performance test.
Meanwhile, in order to ensure the laypersons can use the Nasal Aspirator, the human factors engineering verfication have been prepared and performed.
No clinical test data was performed 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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
November 19, 2024
Dongguanshi Yiyingmei Technology Co., Ltd. % Youshan Gong RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K242028
Trade/Device Name: Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: October 21, 2024 Received: October 21, 2024
Dear Youshan Gong:
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"
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(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-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.
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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).
Sincerely,
Shuchen Peng -S
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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Nasal Aspirator (BC-021, BC-022, BC-022, BC-024, BC-025, BC-026)
Indications for Use (Describe)
The 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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| 510(k) #: | K242028 | 510(k) Summary | Prepared on: 2024-11-19 |
|---|---|---|---|
| ----------- | --------- | ---------------- | ------------------------- |
21 CFR 807.92(a)(1)
| Contact Details | |
|---|---|
| Applicant Name | Dongguanshi Yiyingmei Technology Co., Ltd. |
| Applicant Address | 301 Room, Building No.1, No. 3 West Second Street, Wusha Xingfazhong |
| Road, Chang 'an Town Dongguan Guangdong 523000 China | |
| Applicant Contact Telephone | +18-13612905723 |
| Applicant Contact | Mr. Junbing Chen |
| Applicant Contact Email | 1533193128@qq.com |
| Correspondent Name | Feiying Drug & Medical Consulting Technical Service Group |
| Correspondent Address | Rm 2401 Zhenye International Business Center, No. 3101-90, |
| Qianhai Road Shenzhen Guangdong 518052 China | |
| Correspondent Contact Telephone | +86-13418040887 |
| Correspondent Contact | Ms. Youshan Gong |
| Correspondent Contact Email | youshangong@qq.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) |
|---|---|
| Common Name | Powered suction pump |
| Classification Name | Pump, Portable, Aspiration (Manual Or Powered) |
| Regulation Number | 878.4780 |
| Product Code(s) | BTA |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K222547 | Electric nasal aspirator | BTA |
Device Description Summary
21 CFR 807.92(a)(4)The 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.
Nasal Aspirator consists of silicone tips which has three models (A, B, C), host, tube, mucus collector. The accessory are charging cable-USB, clean brush, clip, sponge. The 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 exter (not included in this device) through the provided charging line. The user interface consists of buttons and indicator/ display, and the vacuum pressure through the button. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
5
Intended Use/Indications for Use
The 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.
Indications for Use Comparison
The subject device and predicate devices have the same indications for use.
Technological Comparison
The vacuum pressure (5260 ±5 Kpa versus 5260 Kpa) is similar to the predicate device. The device dimensions (including tip dimensions) and weight (272±5g versus 320±5g) differ from the predicate, but vacuum pressure and flow rate tests were conducted to demonstrate substantial equivalence. The power consumption (5W versus 2.2W), power source (DC 3.7 V / 1100mAh versus 700mAh) differs from the predicate but the device complies with IEC 60601-1 and IEC 60601-1-2 requirements.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
ln order to verify and assure the performance of the Nasal Aspirator, we have conducted the product appearance test and product performance test.
Meanwhile, in order to ensure the laypersons can use the Nasal Aspirator, the human factors engineering verfication have been prepared and performed.
No clinical test data was performed to support the decision of substantial equivalence.
The subject device and predicate devices have indications for use, technological characteristics. The subject device is as safe, as effective and performs as well as the predicate devices.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)