(100 days)
Not Found
No
The device description and performance studies focus on mechanical function (vacuum pressure, noise level, flow rate) and battery operation. There is no mention of AI, ML, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration.
No
A therapeutic device is one that treats a disease or condition. This device removes nasal secretions and mucus, which is a supportive function but not a treatment for an underlying condition.
No
The device is intended for the removal of nasal secretions and mucus, which is a therapeutic or clearance function, not a diagnostic one. It does not measure, detect, or analyze any condition or disease.
No
The device description clearly outlines physical components like a main unit, suction, motor, battery, and buttons, indicating it is a hardware device, not software-only.
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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The Baby Nasal Aspirator is a device that physically removes nasal secretions and mucus from the nasal passages. It does not perform any tests on these secretions to diagnose or monitor a condition. It's a physical intervention, not a diagnostic test.
- Intended Use: The intended use is for the "intermittent removal of nasal secretions and mucus," not for analyzing these secretions for diagnostic purposes.
Therefore, the Baby Nasal Aspirator falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BTA
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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.
1
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
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
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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4
| 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, Shuitian | |||
| Community, Shiyan Street, Baoan District Shenzhen Guangdong 518109 | ||||
| China | ||||
| 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 Name | ||||
| 21 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). This | ||||
| device 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.
5
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)