(58 days)
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.
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.
The provided text describes a 510(k) premarket notification for an Electric nasal aspirator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific performance metrics, and clinical study details (like sample size for test sets, expert qualifications, MRMC studies, effect size, etc.) for AI/ML-driven diagnostic devices is not extensively detailed for this product.
Here's an analysis of the provided information, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that a series of safety and performance tests were conducted and that the "Electric nasal aspirator meets the requirements of its predefined acceptance criteria and intended use." However, it does not provide a specific table of quantitative acceptance criteria alongside corresponding test results for parameters like "Product service life," "Software validation," or "Function test." Instead, it indicates compliance with recognized standards.
| Test Type | Standard Designation Number | FDA Recognition Status | Outcome for Device | Acceptance Criteria (implied) | Reported Performance (implied) |
|---|---|---|---|---|---|
| Safety | ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Yes | Conforms | Compliance with standard | Conforms |
| EMC | IEC 60601-1-2:2014 | Yes | Conforms | Compliance with standard | Conforms |
| Home healthcare environment | IEC 60601-1-11:2020 | Yes | Conforms | Compliance with standard | Conforms |
| Performance | Enterprise standard | Yes | Conforms | Compliance with standard | Conforms |
| Biocompatibility | ISO 10993-1:2018; ISO 10993-10:2010; ISO 10993-5:2009. | Yes | Conforms | Compliance with standard | Conforms |
| Software | IEC 62304:2006+A1:2015 | Yes | Conforms | Compliance with standard | Conforms |
| Safety of Lithium battery | IEC 62133-2:2017 | Yes | Conforms | Compliance with standard | Conforms |
| Safety of lamps | IEC 62471: 2006 | Yes | Conforms | Compliance with standard | Conforms |
| Risk management | ISO 14971:2019 | Yes | Conforms | Compliance with standard | Conforms |
| Vacuum | Not explicitly stated as acceptance criteria, but listed in comparison table | N/A | 52-60Kpa | 52-60Kpa (implied by predicate) | 52-60Kpa |
| Noise Level | Not explicitly stated as acceptance criteria, but listed in comparison table | N/A | <80dBA | Acceptable noise level | <80dBA |
| Expected service life | Not explicitly stated as acceptance criteria, but listed in comparison table | N/A | 2 years | At least 2 years | 2 years |
| Water-resistance | Not explicitly stated as acceptance criteria, but listed in comparison table | N/A | IP22 | IP22 | IP22 |
The study proving the device meets the acceptance criteria is the non-clinical testing described in section 6.1 and 7. These tests confirm the device's adherence to various international and enterprise standards related to safety, electromagnetic compatibility, biocompatibility, software, and performance.
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no test set in the clinical sense, and thus no sample size or data provenance to report for a clinical test set. The testing performed was non-clinical (engineering and lab-based), using the device itself or its components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test data was used and hence no ground truth established by experts for a clinical test set. The "ground truth" for the non-clinical tests would be the requirements defined by the standards themselves, validated through engineering measurement and analysis.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication was used.
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 an Electric Nasal Aspirator, a hardware medical device, not an AI/ML-driven diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a hardware device, not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by the international and enterprise standards that the device conforms to (e.g., IEC 60601-1 for safety, ISO 10993 for biocompatibility). Compliance with these standards is considered sufficient for demonstrating safety and performance in the context of this 510(k) submission.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
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: | +86-13590244726 |
| Fax: | / |
| Contact Person: | Ma Qiang |
| Contact Title: | General Manager |
| Contact Email: | 156673750@qq.com |
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: reanny@reanny.com
Phone: +86(755) 27391220
Device Information 2.
Trade Name: Electric nasal aspirator
{4}------------------------------------------------
| 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 MarketedDevice | FORA NAS100 Electronic NasalAspirator, NAS100 (ElectronicNasal Aspirator, TD-7601) | Avita Nasal Aspirator,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
{5}------------------------------------------------
- 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 | FDARecognition Status | Outcomefor 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.
{6}------------------------------------------------
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 | Secondarypredicate device | Comparison |
|---|---|---|---|---|
| Manufacturer | Shenzhen XinLianFengTechnology CO.,LTD | TaiDoc TechnologyCorporation | AVITA Corporation | / |
| 510(K)number | K222547 | K180863 | K090379 | / |
| Product name | Electric nasal aspirator,model: BC026 | FORA NAS100 ElectronicNasal Aspirator, NAS100(Electronic Nasal Aspirator, TD-7601) | Avita NasalAspirator, ModelNS1 | / |
| Classification | Class II Device, BTA (21CFR § 878.4780) | Class II Device, BTA (21 CFR §878.4780) | Class II Device, (21CFR § 878.4780) | SE |
| ClassificationPanel | General & Plastic Surgery | General & Plastic Surgery | General & PlasticSurgery | SE |
| Indication forUse | The Electronic NasalAspirator is intended forintermittent removal ofnasal secretions andmucus from children (age2-12 years old). Thisdevice is used in a homeenvironment. | The FORA NAS100 ElectronicNasal Aspirator (ElectronicNasal Aspirator, TD-7601),NAS100 is intended forintermittent removal of nasalsecretions and mucus fromchildren (age 2-12 years old).This device is used in a homeenvironment. | This device isdesigned for usingIntermittent suctionto remove nasalsecretion andmucus in Children(age 2-12 years old)at homeenvironment. | SE |
| PatientPopulation | Age 2-12 years old | Age 2-12 years old | Age 2-12 years old | SE |
| IntendedEnvironment | Home use | Home use | Home use | SE |
| DeviceDescription | The BC026 ElectronicNasal Aspirator is aportable device which isintended for suction ofnasal passages in children2-12 years of age. Themotor pump provides anegative pressure whichremoves nasal secretions. | The FORA NAS100 ElectronicNasal Aspirator (ElectronicNasal Aspirator,TD-7601),NAS100 is a portable devicewhich is intended for suction ofnasal passages in children 2-12years of age. The motor pumpprovides a negative pressurewhich removes nasalsecretions. | AVITA NS1 NasalAspirator is aportable, DCpowered deviceIntended to providethe suction functionto aspiratechildren's nasalsecretion. | SE |
| Vacuum | 52-60Kpa | 52-60Kpa | 52Kpa | SE |
| Device | Subject device | Primary Predicate device | Secondary predicate device | Comparison |
| pressure | ||||
| Musicfunction | Yes | Not publicly available | Yes | SE |
| Light function | Yes | Not publicly available | No | Note 1 |
| Noise Level | <80dBA | 45 dBA | 75-80dB/22mm0.25w/1M | SE |
| Powerconsumption | 2.2W | 3W | Not publiclyavailable | |
| Motor Type | 3.7V DC | 3V DC | 3V DC | Different |
| PowerSource | DC 3.7 V / 700mAhRechargeable Li-ionbattery | 2x1.5V AA | 2x1.5V AA | Note 2 |
| DeviceDimension | 160 (H) x 41 (L) x 41(W)mm | 41 (L) x 41 (W) x 200 (H) mm | 93.5(L) x 39.9 (W) x148(H) mm | Different |
| Weight | 320±5g | 175(g) | 250(g) | Note 3 |
| TipsDimension(ψ) | OD4.3/ID2.4 | Type1: 5.5 (OD)/ 3(ID)Type2: 4.5 (OD/ 2.5 (ID) | Type1: 6 (OD)/2(ID)Type2: 4.2 (OD/ 2.6(ID) | SimilarNote 4 |
| MainMaterials | ABS, PC, Silicone | ABS, PC, Silicone | ABS, PC, Silicone | Same |
| Operatingcondition | 5°C(41°F ) to 40°C(104°F );15% to 93% R.H. | 41°F to 104°F ; 15% to 93%R.H. | 60.8°F to 95°F ; upto 85% R.H. | SE |
| Storagecondition | -10°C(-23°F ) to 70°C(158°F ) ; 10% to 95% R.H. | -13°F to 158°F ;10% to 95%R.H. | -13°F to 131°F ; up to85% R.H | SimilarNote 5 |
| Expectedservice life | 2 years | 2 years | Not publiclyavailable | SE |
| Type BFapplied part | Type BF applied part | Type BF applied part | Not publiclyavailable | SE |
| Safety | IEC 60601-1IEC 60601-1-11IEC 62133-2IEC 62471 | IEC 60601-1IEC 60601-1-11 | IEC 60601-1 | SimilarNote 6 |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | SE |
| Water - resistance | IP22 | IP22 | Not publiclyavailable | SE |
| Device | Subject device | Primary Predicate device | Secondarypredicate device | Comparison |
| Biocompatibility | BC026 operates inconjunction with siliconenasal aspiration tips, whichcome into the contact withnasal skin and mucosa forless than 24 hours. | NAS100 (TD-7601) operates inconjunction with silicon nasalaspiration tips, which come intothe contact with nasal skin andmucosa for less than 24 hours. | Not publiclyavailable | SE |
| Standard ofBiocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12 | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12 | Not publiclyavailable | SE |
| ContactedParts | Silicone Tip (funnel nozzle) | Silicone Tip | Silicone Tip | SE |
| Material ofcontactedparts | Silicone | Silicone | Silicone | SE |
{7}------------------------------------------------
{8}------------------------------------------------
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
{9}------------------------------------------------
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.
§ 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.