Electric nasal aspirator

K222547 · Shenzhen Xinlianfeng Technology Co.,Ltd · BTA · Oct 20, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222547
• Device Name: Electric nasal aspirator
• Applicant: Shenzhen Xinlianfeng Technology Co.,Ltd
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Oct 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Electronic Nasal Aspirator is intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

Device Story

Portable electric nasal aspirator (model BC026) for home use; intended for pediatric nasal secretion removal. Device consists of main unit with motor pump, rechargeable Li-ion battery, and silicone suction tips. User operates device via buttons and LED interface to control vacuum pressure (52-60Kpa). Motor generates negative pressure to aspirate mucus through tip into device. Includes integrated music and light functions. Healthcare provider/parent uses device to clear nasal passages, potentially improving patient comfort and breathing. Safety verified via electrical, EMC, and biocompatibility testing.

Clinical Evidence

No clinical data was used to support the decision of substantial equivalence. Bench testing only.

Technological Characteristics

Portable powered suction pump; 3.7V DC rechargeable Li-ion battery (700mAh). Materials: ABS, PC, Silicone. Dimensions: 160x41x41mm. Vacuum: 52-60Kpa. Applied part: Type BF. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2 (battery), IEC 62471 (lamp), ISO 10993-1/5/10/12 (biocompatibility). IP22 water resistance. Software validated per IEC 62304.

Indications for Use

Indicated for intermittent removal of nasal secretions and mucus from children aged 2-12 years in a home environment.

Regulatory Classification

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.

Predicate Devices

• FORA NAS100 Electronic Nasal Aspirator, NAS100 (Electronic Nasal Aspirator, TD-7601) (K180863)
• Avita Nasal Aspirator, Model NS1 (K090379)

Submission Summary (Full Text)

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October 20, 2022

Shenzhen XinLianFeng Technology Co., LTD % Reanny Wang Manager Shenzhen Reanny Medical Devices Management Consulting Co., Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, Guangdong 518107 China

Re: K222547

Trade/Device Name: Electric nasal aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: August 22, 2022 Received: August 23, 2022

Dear Reanny Wang:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K222547

Device Name Electric nasal aspirator

Indications for Use (Describe)

The Electronic Nasal Aspirator is 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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# Traditional 510(k) Summary

510(k) number: K222547

#### 1. Information of Submitter and Correspondent

# Submitter's information:

| Company Name: | Shenzhen XinLianFeng Technology CO.,LTD |
|------------------|-------------------------------------------------------------------------|
| Street Address: | No.5, Tongxi Road, Pingdong Community, Pingdi Street, Longgang District |
| City: | Shenzhen |
| State/ Province: | Guangdong |
| Country: | China |
| Telephone: | [phone] |
| Fax: | / |
| Contact Person: | Ma Qiang |
| Contact Title: | General Manager |
| Contact Email: | [e-mail] |

# Date Prepared: Aug. 22, 2022

### Submission correspondent's information:

Shenzhen Reanny Medical Devices Management Consulting Co., Ltd

Address: Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District, Shenzhen 518107, China

Contact Person: Reanny Wang

E-mail: [e-mail]

Phone: [phone]

#### Device Information 2.

Trade Name: Electric nasal aspirator

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| Model: | BC026 |
|----------------------|--------------------------------------|
| Common Name: | Powered suction pump |
| Classification Name: | Pump, portable, aspiration (powered) |
| Regulation: | 21 CFR § 878.4780 |
| Device Class: | Class 2 |
| Product Code: | BTA |

#### Identification of Predicate Device(s) 3.

| Manufacturer | TaiDoc Technology Corporation | AViTA Corporation |
|----------------------------|--------------------------------------------------------------------------------------------|-------------------------------------|
| Legally Marketed<br>Device | FORA NAS100 Electronic Nasal<br>Aspirator, NAS100 (Electronic<br>Nasal Aspirator, TD-7601) | Avita Nasal Aspirator,<br>Model NS1 |
| 510(K) Number | K180863 | K090379 |

#### Description of Device 4.

Electric nasal aspirator consists of main unit, and suction 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.

# 5. Indications for Use

The Electronic Nasal Aspirator is intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

# 6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

# 6.1 Non-clinical testing

A series of safety and performance tests were conducted on the subject device.

- Product service life

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- Software validation
- Electromagnetic compatibility and electrical safety
- 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.

# 6.2 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

# 7. Performance Summary

The devices conform to applicable standards as follow table:

| Test Type | Standard Designation Number | FDA<br>Recogniti<br>on Status | Outcome<br>for Device |
|-----------------------------|----------------------------------------------------------------------------------------------------|-------------------------------|-----------------------|
| Safety | ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Yes | Conforms |
| EMC | IEC 60601-1-2:2014 | Yes | Conforms |
| Home healthcare environment | IEC 60601-1-11:2020 | Yes | Conforms |
| Performance | Enterprise standard | Yes | Conforms |
| Biocompatibility | ISO 10993-1:2018; ISO 10993-10:2010; ISO 10993-5:2009. | Yes | Conforms |
| Software | IEC 62304:2006+A1:2015 | Yes | Conforms |
| Safety of Lithium battery | IEC 62133-2:2017 | Yes | Conforms |
| Safety of lamps | IEC 62471: 2006 | Yes | Conforms |
| Risk management | ISO 14971:2019 | Yes | Conforms |

#### Discussion of Comparison to Predicate Devices. 8.

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The Electric nasal aspirator submitted in this 510(k) submission is substantially equivalent in intended use, technological characteristics, materials, and performance to the cleared FORA NAS100 Electronic Nasal Aspirator K180863, and Avita Nasal Aspirator K090379. Differences between the subject and predicate devices do not raise new questions of safety and effectiveness.

| Device | Subject device | Primary Predicate device | Secondary<br>predicate device | Comparison |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Manufacturer | Shenzhen XinLianFeng<br>Technology CO.,LTD | TaiDoc Technology<br>Corporation | AVITA Corporation | / |
| 510(K)<br>number | K222547 | K180863 | K090379 | / |
| Product name | Electric nasal aspirator,<br>model: BC026 | FORA NAS100 Electronic<br>Nasal Aspirator, NAS100<br>(Electronic Nasal Aspirator, TD-<br>7601) | Avita Nasal<br>Aspirator, Model<br>NS1 | / |
| Classification | Class II Device, BTA (21<br>CFR § 878.4780) | Class II Device, BTA (21 CFR §<br>878.4780) | Class II Device, (21<br>CFR § 878.4780) | SE |
| Classification<br>Panel | General & Plastic Surgery | General & Plastic Surgery | General & Plastic<br>Surgery | SE |
| Indication for<br>Use | The Electronic Nasal<br>Aspirator is intended for<br>intermittent removal of<br>nasal secretions and<br>mucus from children (age<br>2-12 years old). This<br>device is used in a home<br>environment. | The FORA NAS100 Electronic<br>Nasal Aspirator (Electronic<br>Nasal Aspirator, TD-7601),<br>NAS100 is intended for<br>intermittent removal of nasal<br>secretions and mucus from<br>children (age 2-12 years old).<br>This device is used in a home<br>environment. | This device is<br>designed for using<br>Intermittent suction<br>to remove nasal<br>secretion and<br>mucus in Children<br>(age 2-12 years old)<br>at home<br>environment. | SE |
| Patient<br>Population | Age 2-12 years old | Age 2-12 years old | Age 2-12 years old | SE |
| Intended<br>Environment | Home use | Home use | Home use | SE |
| Device<br>Description | The BC026 Electronic<br>Nasal Aspirator is a<br>portable device which is<br>intended for suction of<br>nasal passages in children<br>2-12 years of age. The<br>motor pump provides a<br>negative pressure which<br>removes nasal secretions. | The FORA NAS100 Electronic<br>Nasal Aspirator (Electronic<br>Nasal Aspirator,TD-7601),<br>NAS100 is a portable device<br>which is intended for suction of<br>nasal passages in children 2-12<br>years of age. The motor pump<br>provides a negative pressure<br>which removes nasal<br>secretions. | AVITA NS1 Nasal<br>Aspirator is a<br>portable, DC<br>powered device<br>Intended to provide<br>the suction function<br>to aspirate<br>children's nasal<br>secretion. | SE |
| Vacuum | 52-60Kpa | 52-60Kpa | 52Kpa | SE |
| Device | Subject device | Primary Predicate device | Secondary predicate device | Comparison |
| pressure | | | | |
| Music<br>function | Yes | Not publicly available | Yes | SE |
| Light function | Yes | Not publicly available | No | Note 1 |
| Noise Level | <80dBA | 45 dBA | 75-80dB/22mm<br>0.25w/1M | SE |
| Power<br>consumption | 2.2W | 3W | Not publicly<br>available | |
| Motor Type | 3.7V DC | 3V DC | 3V DC | Different |
| Power<br>Source | DC 3.7 V / 700mAh<br>Rechargeable Li-ion<br>battery | 2x1.5V AA | 2x1.5V AA | Note 2 |
| Device<br>Dimension | 160 (H) x 41 (L) x 41<br>(W)mm | 41 (L) x 41 (W) x 200 (H) mm | 93.5(L) x 39.9 (W) x<br>148(H) mm | Different |
| Weight | 320±5g | 175(g) | 250(g) | Note 3 |
| Tips<br>Dimension<br>(ψ) | OD4.3/ID2.4 | Type1: 5.5 (OD)/ 3(ID)<br>Type2: 4.5 (OD/ 2.5 (ID) | Type1: 6 (OD)/<br>2(ID)<br>Type2: 4.2 (OD/ 2.6<br>(ID) | Similar<br>Note 4 |
| Main<br>Materials | ABS, PC, Silicone | ABS, PC, Silicone | ABS, PC, Silicone | Same |
| Operating<br>condition | 5°C(41°F ) to 40°C(104°F );<br>15% to 93% R.H. | 41°F to 104°F ; 15% to 93%<br>R.H. | 60.8°F to 95°F ; up<br>to 85% R.H. | SE |
| Storage<br>condition | -10°C(-23°F ) to 70°C<br>(158°F ) ; 10% to 95% R.H. | -13°F to 158°F ;10% to 95%<br>R.H. | -13°F to 131°F ; up to<br>85% R.H | Similar<br>Note 5 |
| Expected<br>service life | 2 years | 2 years | Not publicly<br>available | SE |
| Type BF<br>applied part | Type BF applied part | Type BF applied part | Not publicly<br>available | SE |
| Safety | IEC 60601-1<br>IEC 60601-1-11<br>IEC 62133-2<br>IEC 62471 | IEC 60601-1<br>IEC 60601-1-11 | IEC 60601-1 | Similar<br>Note 6 |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | SE |
| Water - resist<br>ance | IP22 | IP22 | Not publicly<br>available | SE |
| Device | Subject device | Primary Predicate device | Secondary<br>predicate device | Comparison |
| Biocompatibili<br>ty | BC026 operates in<br>conjunction with silicone<br>nasal aspiration tips, which<br>come into the contact with<br>nasal skin and mucosa for<br>less than 24 hours. | NAS100 (TD-7601) operates in<br>conjunction with silicon nasal<br>aspiration tips, which come into<br>the contact with nasal skin and<br>mucosa for less than 24 hours. | Not publicly<br>available | SE |
| Standard of<br>Biocompatibili<br>ty | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-12 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-12 | Not publicly<br>available | SE |
| Contacted<br>Parts | Silicone Tip (funnel nozzle) | Silicone Tip | Silicone Tip | SE |
| Material of<br>contacted<br>parts | Silicone | Silicone | Silicone | SE |

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The discussion of differences exist between the subject and predicate devices is listed as follows:

# Note 1

The subject device has light function for users to choose. The light of lamp had been verified to comply with IEC 62471, beside, both the predicate devices and subject device are complied with the IEC 60601-1, IEC 60601-1-11 and IEC 60601-1-2, so the differences do not affect the safety and effectiveness.

### Note 2

Although the "Power consumption" , "Motor Type" and "Power the predicate devices and subject device are different, the battery of subject device complied with IEC 62133-2, and both the subject device and predicate devices are all complied with IEC 60601-1. So the difference will not raise safety or effectiveness issue.

### Note 3

Although the "Device Dimension" and "Weight" between the predicate devices and subject device are different, they are all complied with IEC 60601-1 and IEC 60601-1-2, so the differences do not affect the safety and effectiveness.

### Note 4

Although the "Tips Dimension" of the subject device is different from that of predicate devices, the Tip's OD Dimension of subject device is slightly larger than that of (Type 2) secondary predicate device but smaller than that of (Type 2 and type 1) primary predicate device, in general, the OD size is within the range of the predicate devices;

The Tip's ID Dimension of subject device is larger than that of (Type 1) secondary predicate device but smaller than that of (Type 2 and type 1) primary predicate device, in general, the ID size is within the range of the predicate devices. Beside, both the predicate devices and subject device are complied with the IEC 60601-1and IEC 60601-1-11, so the differences do not affect the safety and effectiveness.

### Note 5

The Storage environment of subject device is different from that of predicate devices, but they all complied with the IEC 60601-1-11 and IEC 60601-1, so the difference will not raise safety or effectiveness

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issue.

# Note 6

Because the Subject device is powered by a lithium battery, the lithium battery needs to meet the requirements of IEC 62133-2, and the subject device has a light function, so its lamp needs to meet the requirements of IEC 62471. In addition, both subject devices meet the requirements of IEC 60601-1 and/or IEC 60601-1-11, therefore, the difference will not raise safety or effectiveness issue.

#### 9. Conclusions

Based on performance testing, comparison and analysis, the subject device Electric nasal aspirator, model BC026 is substantially equivalent to the predicate devices.