(62 days)
No
The device description and performance studies focus on basic mechanical and electrical functions (motor pump, battery, buttons, LED display) and standard safety/performance testing. There is no mention of any computational analysis, learning, or adaptive behavior that would indicate AI/ML.
No.
The device's intended use is for intermittent removal of nasal secretions and mucus, which is a physical action rather than a therapeutic treatment for a disease or condition.
No
The device is described as an Electronic Nasal Aspirator, whose intended use is for the "intermittent removal of nasal secretions and mucus." This function is therapeutic/interventional, not diagnostic. A diagnostic device would typically involve identifying, analyzing, or monitoring a condition.
No
The device description explicitly details hardware components such as a main unit, suction portion, motor pump, rechargeable battery, buttons, and LED display. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Electronic Nasal Aspirator is a physical device that uses suction to remove nasal secretions directly from the nasal passages. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the physical removal of mucus, not for diagnostic testing.
Therefore, this device falls under the category of a medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / Indications 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.
Product codes
BTA
Device Description
Electric nasal aspirator consists of main unit, and the suction portion 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
Used in a 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
- Usability
- 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.
Bench tests were conducted to verify that the proposed device met all requirements. The test results demonstrated that the proposed device complies with the following standards:
- ANSI AAMI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012+A2:2021 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)];
- ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)];
- ANSI AAMI HA60601-1-11:2015 [Including AMD1:2021] Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)];
- IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability;
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes;
- IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems;
- ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)
- ISO 10993-10 Fourth edition 2021-11, Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
- ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation.
- Performance tests: Negative pressure measuring, Maximum flow rate, Automatic power-off, and Noise test.
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized design. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.
July 1, 2024
Hetaida Technology Co., Ltd. Tom Chen General Manager Rm 801, 802, 803, 804, 901, 2# Bldg Scientific Research Ctr Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town Dongguan. Guangdong 523423 China
Re: K241202
Trade/Device Name: Electric nasal aspirator (HTD2601US, H2609AU) Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: April 19, 2024 Received: April 30, 2024
Dear Tom Chen:
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" (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).
1
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.
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,
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
2
Indications for Use
Submission Number (if known)
Device Name
Electric nasal aspirator (HTD2601US, H2609AU)
Indications for Use (Describe)
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.
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
510(k) Summary
[As required by 21 CFR 807.92]
| 1. Submission Information
510(k) Number:
Date:
Type of 510(k) Submission:
Basis for 510(k) Submission:
Submitter/Manufacturer:
Contactor: | K241202
April 19th, 2024
Traditional 510(k)
New device
Hetaida Technology Co., Ltd.
Room 801, 802, 803, 804, 901, 2# Building Scientific Research Center,
Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongguan
City, Guangdong Province, P.R.China
Tel: +86-0769-83326886
E-mail: tomchen@hetaida.com.cn
Tom Chen
Hetaida Technology Co., Ltd.
Room 801, 802, 803, 804, 901, 2# Building Scientific Research Center,
Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, Dongguan
City, Guangdong Province, P.R.China
E-mail: tomchen@hetaida.com.cn
Tel: +86-0769-83326886 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Device Description | |
| Proprietary Name: | Electric nasal aspirator |
| Model Name:
Classification Name:
Product Code:
Device Class:
Regulation Number:
Review Panel:
Indications for use: | HTD2601US, H2609AU
Pump, Portable, Aspiration (Manual Or Powered)
BTA
2
21 CFR § 878.4780
General & Plastic Surgery
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. |
| Device Description: | Electric nasal aspirator consists of main unit, and the suction portion
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. |
3. Predicate Device Identification
| 510(k) Number: | K222547 |
|---|---|
| Product Name: | Electric nasal aspirator |
| Submitter: | Shenzhen XinLianFeng Technology CO.,LTD |
4
4. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
4.1 Non-clinical testing
A series of safety and performance tests were conducted on the subject device.
- Product service life
- Software validation
- Electromagnetic compatibility and electrical safety
- Usability
- 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.
4.2 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
5. Substantially Equivalent Comparison
| Parameters | New Device | Predicate Device | Remark | |
|---|---|---|---|---|
| 1. | 510(k) Number: | K241202 | K222547 | -- |
| 2. | Marketing | |||
| clearance date: | No | October 20, 2022 | -- | |
| 3. | Device Name | Electric nasal aspirator | Electric nasal aspirator | -- |
| 4. | Model | HTD2601US, H2609AU | BC026 (Predicate device | |
| Labeling is BC023) | -- | |||
| 5. | 510(k) Owner | Hetaida Technology Co., Ltd. | Shenzhen XinLianFeng | |
| Technology CO.,LTD | -- | |||
| 6. | Classification | Class II Device, BTA (21 CFR § | ||
| 878.4780) | Class II Device, BTA (21 CFR § | |||
| 878.4780) | Same | |||
| 7. | Classification | |||
| Panel | General & Plastic Surgery | General & Plastic Surgery | Same | |
| 8. | Type of use | Over-The-Counter Use | Over-The-Counter Use | Same |
| 9. | Indications | |||
| 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 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. | Same | |||
| 10. | Patient | |||
| Population | Age 2-12 years old | Age 2-12 years old | Same | |
| 11. | Intended | |||
| Environment | Home use | Home use | Same | |
| 12. | Device | |||
| Description | The HTD2601US and H2609AU | |||
| 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 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. | Same | |||
| 13. | Vacuum pressure |