(131 days)
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.
The 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.
The provided text describes the 510(k) summary for the Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026). It does not contain information typically found in acceptance criteria or a study design for evaluating an AI/ML powered device. Instead, it focuses on the substantial equivalence of a medical device (a nasal aspirator) to a predicate device.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable or cannot be extracted from this document, as it is related to a conventional medical device rather than an AI/ML-powered one requiring such extensive performance studies as described in your prompt.
Here's an attempt to answer the questions based on the limited relevant information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the context of AI/ML performance metrics (e.g., sensitivity, specificity). Instead, it discusses the equivalence of technological characteristics and performance tests for a physical device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Nasal Aspirator) |
|---|---|
| Vacuum Pressure (similar to predicate) | 52 |
| Power Consumption (compliance with standards) | 5W (Predicate: 2.2W) - Different, but device complies with IEC 60601-1 and IEC 60601-1-2 |
| Power Source (compliance with standards) | DC 3.7 V / 1100mAh (Predicate: 700mAh) - Different, but device complies with IEC 60601-1 and IEC 60601-1-2 |
| Dimensions & Weight (flow rate tests confirm equivalence) | Weight: 272±5g (Predicate: 320±5g) - Differ, but vacuum pressure and flow rate tests indicate substantial equivalence. |
| Product Appearance Test | Conducted, implying satisfactory results. |
| Product Performance Test | Conducted, implying satisfactory results. |
| Human Factors Engineering Verification | Prepared and performed, implying satisfactory results for layperson use. |
| Compliance with Electrical Safety Standards | Complies with IEC 60601-1 and IEC 60601-1-2. |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes tests for a physical medical device (Nasal Aspirator), not an AI/ML algorithm requiring a test set of data. The "tests" mentioned are product appearance tests, performance tests, and human factors engineering verification, which typically involve a limited number of physical units or usability testing, not large datasets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML system that requires expert-established ground truth from a test set of data.
4. Adjudication method for the test set
Not applicable. This device is not an AI/ML system that requires adjudication of a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical nasal aspirator, not an algorithm.
7. The type of ground truth used
Not applicable in the context of AI/ML. For a physical device, "ground truth" would be related to physical measurements and compliance with established engineering and safety standards (e.g., the actual vacuum pressure measured, adherence to IEC standards).
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML algorithm.
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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)
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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 XingfazhongRoad, 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.
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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)
§ 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.