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.

AI/ML Overview

The provided text is a 510(k) summary for an Electric Nasal Aspirator. This document describes its substantial equivalence to a predicate device based on non-clinical testing. It explicitly states that "No clinical test data was used to support the decision of substantial equivalence."

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a clinical study to prove the device meets acceptance criteria cannot be extracted from this document, as no such clinical study was conducted or presented.

The document focuses on demonstrating substantial equivalence through non-clinical testing, which includes various safety and performance benchmarks.

However, based on the non-clinical tests mentioned, we can infer the acceptance criteria and reported performance for those specific tests:

1. Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Tests)

Acceptance Criteria (Implied)	Reported Device Performance
Product service life meets predefined requirement.	Meets requirements; 5 years (longer than predicate)
Software functions as validated.	Validation performed (implies success)
Electromagnetic compatibility (EMC) meets standards.	Complies with ANSI AAMI IEC 60601-1-2:2014 & AMD 1:2021
Electrical safety meets standards.	Complies with ANSI AAMI ES60601-1:2005 & AMD2:2021
Usability meets standards.	Complies with IEC 60601-1-6 Ed 3.2 2020-07
Function tests (Negative pressure, Max flow, Auto power-off, Noise) meet requirements.	Negative pressure <68kPa; Max flow ≥1.6L/min; Noise <60dB (all tests successful)
Biocompatibility meets standards (ISO 10993 series).	Complies with ISO 10993-5, ISO 10993-10, ISO 10993-23
Water resistance meets standard.	IP22

Points 2 through 9 are not applicable as no clinical study was performed or reported in this document.

2. Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set discussed. Non-clinical tests would use a sample of devices for testing, but no specific numbers are given, nor is "data provenance" in the sense of patient data relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth established.

4. Adjudication method for the test set: Not applicable.

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 is not an AI device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" is defined by the technical specifications and international standards the device must meet (e.g., a certain decibel level for noise, a certain pressure for suction).

8. The sample size for the training set: Not applicable. No AI model or training set discussed.

9. How the ground truth for the training set was established: Not applicable.

Summary

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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).

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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

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Indications for Use

Submission Number (if known)

K241202

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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510(k) Summary

[As required by 21 CFR 807.92]

1. Submission Information510(k) Number:Date:Type of 510(k) Submission:Basis for 510(k) Submission:Submitter/Manufacturer:Contactor:	K241202April 19th, 2024Traditional 510(k)New deviceHetaida Technology Co., Ltd.Room 801, 802, 803, 804, 901, 2# Building Scientific Research Center,Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, DongguanCity, Guangdong Province, P.R.ChinaTel: +86-0769-83326886E-mail: tomchen@hetaida.com.cnTom ChenHetaida Technology Co., Ltd.Room 801, 802, 803, 804, 901, 2# Building Scientific Research Center,Songhu Intelligent Valley, No.6 Minfu Road, Liaobu Town, DongguanCity, Guangdong Province, P.R.ChinaE-mail: tomchen@hetaida.com.cnTel: +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, H2609AUPump, Portable, Aspiration (Manual Or Powered)BTA221 CFR § 878.4780General & Plastic SurgeryThe Electronic Nasal Aspirator is intended for intermittent removal ofnasal secretions and mucus from children (age 2-12 years old). This deviceis used in a home environment.
Device Description:	Electric nasal aspirator consists of main unit, and the suction portionworking together as one unit. The Electronic Nasal Aspirator is a portabledevice which is intended for suction of nasal passages in children 2-12years of age. The motor pump provides a negative pressure which removesnasal secretions. The motor pump operates on a rechargeable battery. Therechargeable battery can be charged from the external power adapter (notincluded in this device) through the provided charging line. The userinterface consists of buttons and LED display, and the user can control thevacuum pressure through the button.

3. Predicate Device Identification

510(k) Number:	K222547
Product Name:	Electric nasal aspirator
Submitter:	Shenzhen XinLianFeng Technology CO.,LTD

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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.	Marketingclearance date:	No	October 20, 2022	--
3.	Device Name	Electric nasal aspirator	Electric nasal aspirator	--
4.	Model	HTD2601US, H2609AU	BC026 (Predicate deviceLabeling is BC023)	--
5.	510(k) Owner	Hetaida Technology Co., Ltd.	Shenzhen XinLianFengTechnology CO.,LTD	--
6.	Classification	Class II Device, BTA (21 CFR §878.4780)	Class II Device, BTA (21 CFR §878.4780)	Same
7.	ClassificationPanel	General & Plastic Surgery	General & Plastic Surgery	Same
8.	Type of use	Over-The-Counter Use	Over-The-Counter Use	Same
9.	IndicationsforUse	The Electronic Nasal Aspirator isintended for intermittent removalof nasal secretions and mucusfrom children (age 2-12 yearsold). This device is used in ahome environment.	The Electronic Nasal Aspirator isintended for intermittent removalof nasal secretions and mucusfrom children (age 2-12 yearsold). This device is used in ahome environment.	Same
10.	PatientPopulation	Age 2-12 years old	Age 2-12 years old	Same
11.	IntendedEnvironment	Home use	Home use	Same
12.	DeviceDescription	The HTD2601US and H2609AUElectronic Nasal Aspirator is aportable device which is intendedfor suction of nasal passages inchildren 2-12 years of age. Themotor pump provides a negativepressure which removes nasalsecretions.	The BC026 Electronic NasalAspirator is a portable devicewhich is intended for suction ofnasal passages in children 2-12years of age. The motor pumpprovides a negative pressurewhich removes nasal secretions.	Same

13.	Vacuum pressure	<68kPa	52-60Kpa	DifferentNote 1
14.	Maximum flowvalue	≥1.6L/min	No
15.	Noise Level	<60dB	<80dBA	Similar
16.	Powerconsumption	1.5W	2.2W
17.	Motor Type	3.7V DC	3.7V DC	DifferentNote 2
18.	Power Source	DC 3.7 V / 500mAhRechargeable Li-ion battery	DC 3.7 V / 700mAhRechargeable Li-ion battery
19.	DeviceDimension	HTD2601US: 185 mm x 42 mmx 42 mm (Lx WxH)H2609AU: 191 mm x 42 mm x42 mm (Lx WxH)	160 (H) x 41 (L) x 41 (W)mm	DifferentNote 3
20.	Weight	Approx.167g	320±5g
21.	Tips Dimension(ψ)	Type1: OD4.1mm/ID2.3mmType2: OD7.9mm/ID3.0mm	OD4.3/ID2.4	DifferentNote 4
22.	Main Materials	ABS, PCTG, Silicone	ABS, PC, Silicone	DifferentNote 5
23.	Operatingcondition	5°C~~40°C(41°F~~104°F);<85% R.H.;	5°C(41°F) to 40°C(104°F);15% to 93% R.H.	Similar
24.	Storage condition	-20°C~~55°C(-4°F~~131°F);<93% R.H.;	-10°C(-23°F) to 70°C(158°F) ; 10% to 95% R.H.	DifferentNote 6
25.	Expected servicelife	5 years	2 years	DifferentNote 7
26.	Type BF appliedpart	Type BF applied part	Type BF applied part	Same
27.	Safety	ANSI AAMI ES60601-1ANSI AAMI HA60601-1-11IEC 60601-1-6IEC 62133-2	IEC 60601-1IEC 60601-1-11IEC 62133-2IEC 62471	Note 8
28.	EMC	ANSI AAMI IEC 60601-1-2	IEC 60601-1-2
29.	Water-resistance	IP22	IP22	Same
30.	Biocompatibility	HTD2601US and H2609AUoperates in conjunction withsilicone nasal aspiration tips,which come into the contact withnasal skin and mucosa for lessthan 24 hours.	BC026 operates in conjunctionwith silicone nasal aspiration tips,which come into the contact withnasal skin and mucosa for lessthan 24 hours.	Note 9
31.	Standard ofBiocompatibility	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-23	ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12	Note 9
32.	Contacted Parts	Silicone Tip (funnel nozzle)	Silicone Tip (funnel nozzle)	Same
33.	Material ofcontacted parts	Silicone	Silicone	Same

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

Note 1: Although the pressures of the proposed device and the predicate device are slightly different, and the proposed device adds the flow rate to performance, both can evaluate that the nasal aspirator provides sufficient suction to clean the nasal cavity. Moreover, the performance test results have shown that the

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proposed device meets the necessary requirements in terms of suction level properties and daily application. Therefore, the differences do not affect the safety and effectiveness.

Note 2: Although the Power consumption and Power Source between the proposed device and the predicate device are different, the battery of the proposed device is widely available on the market and has been tested to the IEC 62133-2. In addition, the proposed device has been tested to AAMI/ANSI ES60601-1 and IEC 60601-1-2. Therefore, the difference does not raise any new safety and effectiveness issues.

Note 3: Although the Device Dimension and the Weight between the proposed device and the predicate device are different, they are all complied with IEC 60601-1-2, so the differences do not affect the safety and effectiveness.

Note 4: Although the Tips Dimension of proposed device is different from that of predicate device, the Tip's OD Dimension (Type 2) of proposed device is larger than that of predicate device, but the Tip's OD Dimension (Type 1) of proposed device is slightly smaller than that of predicate device, in general, the OD size is with the similar range of the predicate device;

The Tip's ID Dimension (Type 2) of the proposed device is slightly larger than that of predicate device, but the Tip's ID Dimension (Type 1) of proposed device is slightly smaller than that of predicate device, in general, the ID size is with the similar range of predicate device. Besides, both the predicate device and proposed device are complied with the ANSI AAMI ES60601-1 and ANSI AAMI HA60601-1-11, so the differences do not affect the safety and effectiveness.

Note 5: Although the materials of the proposed device and the predicate device are slightly different, the PCTG is BPA-free and safer than PC. Moreover, the biocompatibility test results have shown that the proposed device and the predicate device meet the necessary requirements in terms of biocompatibility.

Note 6: The Storage environment of proposed 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 any new safety and effectiveness issues.

Note 7: Although the Expected service life of the proposed device and the predicate device are slightly different, the service life of the proposed device is longer than that of predicate device. Moreover, the life test results have shown that the service life of proposed device meets the requirements in terms of 5 years. Therefore, the difference does not raise any new safety and effectiveness issues.

Note 8: Although the Safety and EMC standards of the proposed device and the predicate device are slightly different, the proposed device does not have the Music and Light function, so there is no need to meet the IEC 62471, and complied with the IEC 60601-1-6 for usability is also important. Therefore, the difference does not raise any new safety and effectiveness issues.

Note 9: Although the Biocompatibility standards of the proposed device and the predicate device are slightly different, the standard ISO 10993-10 has undergone a new revision that has resulted in the addition of standard ISO 10993-23, so should also comply with the new revision and the new standard for biocompatibility.

The proposed device has the same indication for use as the predicate device as well as comparable technical and biocompatibility properties and characteristics, and the minor differences don't raise any additional questions for safety and effectiveness. Therefore, the proposed device is substantially equivalent to the predicate device.

6. Non-clinical Testing Summary

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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.

7. Conclusion

The conclusion drawn from the non-clinical testing, comparison, and analysis demonstrates that the subject device in 510(k) submission, the subject device is substantially equivalent to the legally marketed predicate device K222547.

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.