The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is ued in a home environment.

Device Description

The Baby 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. It consists of main unit, and suction working together as one unit. The Baby Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The recharged from the external power adapter(not included in this device) through the provided charging line. The user interface consists of buttons and the user can control the vacuum pressure through the button.

AI/ML Overview

The provided text is a 510(k) summary for a Baby Nasal Aspirator. It describes the device, its intended use, and a comparison with a predicate device to establish substantial equivalence. However, it does not include acceptance criteria, performance data in a table format, or details about a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device.

Here's an analysis based on the information provided, highlighting what's present and what's missing in relation to your request about acceptance criteria and a study:

1. A table of acceptance criteria and the reported device performance

Missing. The document states: "In order to verify and assure the performance of the Baby Nasal Aspirator, we have conducted the product appearance test (color, dimension, weight, etc.), product performance test (vacuum pressure, noise level, flow rate, etc.), and verification on lithium battery power indication."
It mentions "vacuum pressure (52 - 60 Kpa) is the same as the predicate device" but does not explicitly state this as an acceptance criterion with a numerical target and then present the measured performance in a table. It also refers to compliance with IEC 60601-1 and IEC 60601-1-2 which are standards for medical electrical equipment, indicating safety and essential performance criteria were met, but details are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Missing. This device is a physical medical device (a nasal aspirator), not an AI/ML or software device that processes data. Therefore, there is no "test set" in the context of data for an algorithm. The "tests" performed were physical product performance tests. The document does not specify the number of units tested for appearance, vacuum pressure, noise level, or flow rate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As this is a physical device and not an AI/ML algorithm requiring expert opinion for ground truth, this information is not relevant or provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is described as this is not a study assessing interpretations of data by multiple experts.

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 device is a standalone nasal aspirator, not an AI-assisted diagnostic or interpretive tool for "human readers." No MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For a physical device like a nasal aspirator, "ground truth" would relate to objective measurements against engineering specifications and safety standards (e.g., measured vacuum pressure against a specified range, noise levels against acceptable limits, compliance with electrical safety standards). These are typically verified through direct measurement and testing rather than expert-derived ground truth as in AI/ML applications.

8. The sample size for the training set

Not applicable. This refers to AI/ML algorithms. There is no concept of a "training set" for a physical device like a nasal aspirator.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary based on the provided document:

The document describes the regulatory clearance for a physical medical device, a Baby Nasal Aspirator. The "study" mentioned for demonstrating substantial equivalence consisted of non-clinical performance tests.

Acceptance Criteria (Implicit/Inferred from the text):
- Vacuum pressure: 52 - 60 Kpa (same as predicate device).
- Compliance with safety standards: IEC 60601-1 and IEC 60601-1-2.
- Product appearance: Conformance to design (color, dimensions, weight).
- Noise level: Within acceptable limits ( implied by "product performance test").
- Flow rate: Conformance (implied by "product performance test").
- Lithium battery power indication: Verification conducted.
Reported Device Performance:
- "The vacuum pressure (52 - 60 Kpa) is the same as the predicate device."
- "The device complies with IEC 60601-1 and IEC 60601-1-2 requirements."
- Other tests (appearance, noise level, flow rate, battery indication) were "conducted to verify and assure the performance" and "demonstrate substantial equivalence," implying they met their respective criteria, although specific numerical results are not detailed.
Study Description:
- Type of Study: Non-clinical bench testing.
- Tests Performed: Product appearance test (color, dimension, weight), product performance test (vacuum pressure, noise level, flow rate), and verification on lithium battery power indication.
- Sample Size: Not specified for any of the individual tests. This is common for bench testing of physical devices where a small representative sample is typically used to confirm design specifications.
- Data Provenance: Not applicable in the sense of patient data. The testing was conducted on manufactured device units.
- Ground Truth: Objective measurements against engineering specifications and recognized safety standards (IEC 60601-1, IEC 60601-1-2).
- No clinical data: The document explicitly states, "Not applicable, there is no clinical data."

In conclusion, the request is largely framed for an AI/ML device or a diagnostic device involving human interpretation, which does not align with the nature of the Baby Nasal Aspirator described in the provided FDA 510(k) summary. The document confirms that the device underwent non-clinical performance testing to demonstrate substantial equivalence to a predicate device, meeting relevant safety and performance standards.

Summary

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March 20, 2024

Shenzhen Desida 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: K233901

Trade/Device Name: Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA006, NASA008, NASA009) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: February 20, 2024 Received: February 20, 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.

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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" (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 QS 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.

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.

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,

Joyce C. Lin -S

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices

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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

Submission Number (if known)

K233901

Device Name

Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)

Indications for Use (Describe)

The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is ued 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) Summary			Prepared on: 2024-03-20
Contact Details			21 CFR 807.92(a)(1)
Applicant Name		Shenzhen Desida Technology Co., Ltd.
Applicant Address	5th Floor, Building A, Sanmin Industrial Zone, Shilongzai, ShuitianCommunity, Shiyan Street, Baoan District Shenzhen Guangdong 518109China
Applicant Contact Telephone	+86-13049379025
Applicant Contact	Mr. Shuangcheng Yuan
Applicant Contact Email	184056776@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 Name21 CFR 807.92(a)(2)
Device Trade Name		Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006,NASA008, NASA009)
Common Name		Powered suction pump
Classification Name		Pump, Portable, Aspiration (Manual Or Powered)
Regulation Number		878.4780
Product Code	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 Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). Thisdevice is used in a home environment.

lt consists of main unit, and suction working together as one unit. The Baby Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The recharged from the external power adapter(not included in this device) through the provided charging line. The user interface consists of buttons and the user can control the vacuum pressure through the button.

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Intended Use/Indications for Use

The Baby Nasal Aspirator is intended for internittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is ued 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 (52 - 60 Kpa) is the same as the predicate device. The power consumption differs from the predicate but the device complies with IEC 60601-1 and IEC 60601-1-2 requirements. The device dimensions and weight are different, but vacuum pressure and flow rate tests were conducted to demonstrate substantial equivalence.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

In order to verify and assure the performance of the Baby Nasal Aspirator, we have conducted the product appearance test (color, dimension , weight, etc.), product performance test (vacuum pressure, noise level, flow rate, etc.), and verification on lithium battery power indication.

Not applicable, there is no clinical data.

The subject device and predicate devices have similar indications for use and technological characteristics. The subject device is substantially equivalence to the predicate device, as supported by comparison to the predicate and performance testing outcomes.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

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.