(137 days)
The Electric 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.
Electric Nasal Aspirator consists of silicone nozzle which has three models (conical nozzle, flat nozzle, angled nozzle), collection cup, air tube, tweezers, charging cable-USB and aspirator body. The Electric 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. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
The provided text is a 510(k) clearance letter and summary for an Electric Nasal Aspirator. It details the device's characteristics and its comparison to a predicate device, along with the performance data submitted to demonstrate substantial equivalence.
However, the nature of this medical device (a nasal aspirator, essentially a suction pump) means the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on engineering performance parameters (e.g., vacuum pressure, flow rate, safety standards) rather than clinical efficacy studies with human subjects that measure the device's ability to diagnose or treat a condition, which is what is typically discussed in the context of "human-in-the-loop performance," "ground truth," "expert consensus," and "MRMC studies" for AI/software-as-a-medical-device (SaMD).
Therefore, the requested information elements related to AI/SaMD (e.g., training set, test set, expert adjudication, MRMC studies, standalone performance, ground truth for image analysis) are not applicable to this specific device submission. The "study" here is a series of bench tests and electrical/biocompatibility assessments.
Below is a breakdown of the applicable acceptance criteria and the "study" (bench testing) as described in the provided text, while explicitly stating when an element is not applicable.
Acceptance Criteria and Device Performance for Electric Nasal Aspirator (K244033)
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Subject Device) | Compliance/Remark |
|---|---|---|---|
| Intended Use | Intermittent removal of nasal secretions and mucus from children (age 2~12 years old) in a home environment. | Intermittent removal of nasal secretions and mucus from children (age 2~12 years old) in a home environment. | Same, Meets. |
| Patient Population | Age 2-12 years old | Age 2-12 years old | Same, Meets. |
| Vacuum Pressure | 52-60 KPa | 52-60 KPa | Same, Meets. |
| Music Function | Yes | Yes | Same, Meets. |
| Light Function | Yes | Yes | Same, Meets. |
| Motor Type | 3.7V DC | 3.7V DC | Same, Meets. |
| Operating Condition | 5℃(41℉) to 40℃(104℉); 15% to 93% R.H. | 5℃(41℉) to 40℃(104℉); 15% to 93% R.H. | Same, Meets. |
| Storage Condition | -10°C(-23℉) to 70°C (158℉); 10% to 95% R.H. | -10°C(-23℉) to 70°C (158℉); 10% to 95% R.H. | Same, Meets. |
| Expected Service Life | 2 years | 2 years | Same, Meets. |
| Type BF Applied Part | Type BF applied part | Type BF applied part | Same, Meets. |
| Water-Resistance | IP22 | IP22 | Same, Meets. |
| Biocompatibility | Tested to ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Skin Sensitization), ISO 10993-23 (Skin Irritation) for silicone nasal aspiration tips (contact < 24 hrs). | Passed ISO 10993-5, ISO 10993-10, ISO 10993-23 for silicone nasal aspiration tips. | Passed tests, Meets. |
| Electrical Safety | Tested to IEC 60601-1, IEC 60601-1-11. | Passed IEC 60601-1, IEC 60601-1-11. | Passed tests, Meets. |
| Electromagnetic Compatibility (EMC) | Tested to IEC 60601-1-2. | Passed IEC 60601-1-2. | Passed tests, Meets. |
| Battery Safety | Tested to IEC 62133-2. | Passed IEC 62133-2. | Passed tests, Meets. |
| Software Verification & Validation | Consistent with basic documentation level; all software requirements met, hazards mitigated. | System validation testing completed, requirements met, hazards mitigated. | Meets. |
| Appearance (Color, Dimension, Weight) | - (Compared to predicate, but specific criteria not given as numerical range) | Different from predicate, but product performance test met requirements. | Met requirements through performance testing. |
| Flow Rate | 2.5-2.7 L/min (Predicate) | 3.3 - 6.0 L/min (Subject Device) | Higher flow rate in subject device, but same vacuum pressure (52-60 kPa). Performance testing verified requirements. Does not raise issues. |
| Power Consumption | 2W (max) (Predicate) | 5W (Subject Device) | Different, but complies with safety standards (IEC 62133-2, IEC 60601-1, IEC 60601-1-2) so it does not raise safety/effectiveness issues. |
| Power Source | DC 3.7 V / 700mAh Rechargeable Li-ion battery (Predicate) | DC 3.7 V / 2500mAh Rechargeable Li-ion battery (Subject Device) | Different, but complies with safety standards (IEC 62133-2, IEC 60601-1, IEC 60601-1-2) so it does not raise safety/effectiveness issues. |
| Structural Composition | Silicone nozzle, collection cup, charging cable-USB (Predicate) | Silicone nozzle, collection cup, air tube, tweezers, charging cable-USB and aspirator main body. | Different (subject device has air tube and tweezers). Performance tests support safety/effectiveness of air tube. Tweezers are an accessory and do not raise safety/effectiveness concerns. |
| Tubing Bending Resistance | (Implied standard for performance test) | Assured performance (Product Performance Test). | Met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices tested. The studies described are type testing (verification and validation) against engineering standards (e.g., IEC, ISO). This implies a representative sample of manufactured devices were tested to ensure design compliance. For biocompatibility, electrical safety, EMC, battery safety, and software V&V, these are typically conducted on a limited number of devices or components to demonstrate compliance with the standards' requirements for design verification.
- Data Provenance: The device manufacturer, Shenzhen Desida Technology Co., Ltd. (China), performed these tests. The data provenance is internal testing to support the 510(k) submission. These are bench tests, not clinical data.
- Retrospective/Prospective: Not applicable as these are bench tests and not clinical studies involving patient data collected over time.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For this type of medical device (Electric Nasal Aspirator), "ground truth" as typically applied to clinical or diagnostic AI/SaMD studies (e.g., for image interpretation) is not established through expert consensus on a test set. The validation relies on meeting pre-defined engineering and safety standards. The "experts" involved would be accredited test houses and engineers specializing in the relevant standards (e.g., electrical safety, biocompatibility).
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for establishing ground truth in diagnostic accuracy assessments involving human interpretation. This device's validation focuses on engineering performance, not interpretative accuracy.
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/SaMD device, and no MRMC study was conducted. The device is a physical product for suction, not a diagnostic or interpretive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm-based device. Performance testing for this device is "standalone" in the sense that the device itself is tested against its specifications and relevant safety standards, without continuous human operation being part of the assessment of device performance (though a human operates it to perform the tests).
7. The Type of Ground Truth Used
- Engineering and Safety Standards: The "ground truth" for this device's acceptance is adherence to established international and national engineering standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2, ISO 10993 series) and the manufacturer's own verified product requirements derived from these standards and the predicate device's performance. For biocompatibility, this typically involves laboratory assays confirming the absence of cytotoxicity, skin sensitization, and irritation based on ISO 10993 protocols. For physical properties, it involves measurements against specified ranges (e.g., 52-60 KPa vacuum pressure).
- Not clinical outcomes data, pathology, or expert consensus (in the traditional sense for diagnostic/AI devices).
8. The Sample Size for the Training Set
- Not Applicable. This device is a physical product, not an AI/Software device requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no "training set" for this physical device, there is no ground truth established for it in the context of machine learning. The device's design and manufacturing processes are validated against engineering principles and standards.
FDA 510(k) Clearance Letter - Electric Nasal Aspirator
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 16, 2025
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: K244033
Trade/Device Name: Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
Regulation Number: 21 CFR 878.4780
Regulation Name: Powered Suction Pump
Regulatory Class: Class II
Product Code: BTA
Dated: April 18, 2025
Received: April 18, 2025
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.
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K244033 - Youshan Gong
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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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K244033 - Youshan Gong
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assistance/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
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K244033
Device Name
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
Indications for Use (Describe)
The Electric 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)
☒ 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
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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."
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Shenzhen Desida Technology Co., Ltd. 510(k)s –510(k) Summary of K244033
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510(k) Summary of K244033
"510(k) Summary" as required by 21 CFR Part 807.92.
Date Prepared: 2025-5-15
I. Submitter
Shenzhen Desida Technology Co., Ltd.
5th Floor, Building A, Sanmin Industrial Zone, Shilongzai, Shuitian Community, Shiyan Street, Baoan District, Shenzhen Guangdong, CN 518109
Post code: 518109
Tel.: +86-0130-49379025
Yong Gong
General Manager
Tel: +86-13689585641
E-mail: 40888122@qq.com
II. Device
Name of Device: Electric Nasal Aspirator
Model(s): NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610
Regulation Name: Powered Suction Pump
Regulatory Class: II
Product Code: BTA
Regulation Number: 21 CRF 878.4780
III. Predicate Device and Reference Device
Predicate Device
| Manufacturer | Predicate Device | 510(k) Number |
|---|---|---|
| Shenzhen Desida Technology Co., Ltd. | Baby Nasal Aspirator (model: KA1006,KA1001,KA1005,NASA005,NASA006,NASA008,NASA009) | K233901 |
IV. Device Description
Electric Nasal Aspirator consists of silicone nozzle which has three models (conical nozzle, flat nozzle, angled nozzle), collection cup, air tube, tweezers, charging cable-USB and aspirator body. The Electric 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
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Shenzhen Desida Technology Co., Ltd. 510(k)s –510(k) Summary of K244033
Page 2 of 7
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. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.
V. Indications for Use
The Electric 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.
VI. Materials
| Model | Contacted Component Name | Materials |
|---|---|---|
| NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610 | Enclosure | PC, ABS, with seven colour toners |
| Tips (Conical nozzle, Flat nozzle, Angled nozzle) | Silicone |
VII. Comparison of Technological Characteristics With the Predicate Device
The Electric Nasal Aspirator has the same intended use as the predicate device. The technological characteristics such as vacuum pressure, music function, light function and noise level are same as the predicate device. Any minor differences between the subject device and the listed predicate device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the Electric Nasal Aspirator may be found substantially equivalent to its predicate device.
| Comparison Elements | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| 510(k) Number | K244033 | K233901 | / |
| Trade name | Electric Nasal Aspirator | Baby Nasal Aspirator | / |
| Manufacturer | Shenzhen Desida Technology Co., Ltd. | Shenzhen Desida Technology Co., Ltd. | / |
| Regulation number | 21 CFR § 878.4780 | 21 CFR § 878.4780 | Same |
| Product code | BTA | BTA | Same |
| Device classification | Class II | Class II | Same |
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Shenzhen Desida Technology Co., Ltd. 510(k)s –510(k) Summary of K244033
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| Comparison Elements | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Indication for use/Intended use | The Electric 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. | 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. | Same |
| Prescription or OTC | OTC | OTC | Same |
| Model | NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610 | KA1006,KA1001,KA1005,NASA005,NASA006,NASA008,NASA009 | Different Note 1 |
| Patient Population | Age 2-12 years old | Age 2-12 years old | Same |
| Vacuum pressure | 52-60Kpa | 52-60Kpa | Same |
| Music function | Yes | Yes | Same |
| Light function | Yes | Yes | Same |
| Power consumption | 5W | 2W_max | Different Note 2 |
| Motor Type | 3.7V DC | 3.7V DC | Same |
| Power Source | DC 3.7 V / 2500mAh Rechargeable Li-ion battery | DC 3.7 V / 700mAh Rechargeable Li-ion battery | Different Note 2 |
| Device Dimension | W95 x H45mm | L 188×W 40×H 75mm | Different Note 3 |
| Weight | 235g | 155±5g | |
| Flow rate | 3.3 - 6.0 L/min | 2.5-2.7 L/min | Different Note 4 |
| Structural composition | It is component of silicone nozzle, collection cup, air tube, tweezers, charging cable-USB and aspirator main body. | It is component of silicone nozzle, collection cup, charging cable-USB | Different Note 5 |
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Shenzhen Desida Technology Co., Ltd. 510(k)s –510(k) Summary of K244033
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| Comparison Elements | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| and aspirator body. | |||
| Tips Dimension (ψ) | Flat nozzle/Angled nozzle OD 4.0 / ID 2.0 mm Conical nozzle: OD 4.0 / ID 2.0 mm | Flating tip, Bevel tip: OD 4.0 / ID 2.0 mm Calabash tip: OD 5.0 / ID 2.6 mm | Same |
| Main Materials | ABS, PC, Silicone | ABS, PC, Silicone | Same |
| Operating condition | 5℃(41℉) to 40℃(104℉); 15% to 93% R.H. | 5℃(41℉) to 40℃(104℉); 15% to 93% R.H. | Same |
| Storage condition | -10°C(-23℉) to 70°C (158℉) ; 10% to 95% R.H. | -10°C(-23℉) to 70°C (158℉) ; 10% to 95% R.H. | Same |
| Expected service life | 2 years | 2 years | Same |
| Type BF applied part | Type BF applied part | Type BF applied part | Same |
| Water‐resist | IP22 | IP22 | Same |
| Contacted Parts | Silicone Tip | Silicone Tip | Same |
| Material of contacted parts | Silicone | Silicone | Same |
| Biocompatibility | Electric Nasal Aspirator operates in conjunction with silicone nasal aspiration tips, which come into the contact with nasal skin and mucosa for less than 24 hours. • In Vitro Cytotoxicity Test Report • Skin Sensitization Test Report • Skin Irritation Test Report | Baby Nasal Aspirator operates in conjunction with silicone nasal aspiration tips, which come into the contact with nasal skin and mucosa for less than 24 hours. • In Vitro Cytotoxicity Test Report • Skin Sensitization Test Report • Skin Irritation | Same |
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Shenzhen Desida Technology Co., Ltd. 510(k)s –510(k) Summary of K244033
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| Comparison Elements | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Test Report | |||
| Safety | IEC 60601-1 IEC 60601-1-11 IEC 62133-2 IEC 62471 | IEC 60601-1 IEC 60601-1-11 IEC 62133-2 IEC 62471 | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | Same |
Note 1:
Though the model is different from the predicate device, this difference is insignificant and does not raise any safety or effectiveness problems. NASA601, NASA603, NASA605, NASA606, NASA608, NASA610 are completely consistent with the main model NASA602 in terms of circuit design, PCB layout, key components, power supply method, and appearance, only the colors of enclosure are different.
Note 2:
Though the power consumption and power source of subject device is different from the predicate device, the subject device is comply with IEC 62133-2, IEC 60601-1 and IEC 60601-1-2 requirements, so this difference will not raise any safety or effectiveness issue.
Note 3:
Though the device dimension and weight are different from the predicate device, we conducted the Electric Nasal Aspirator Product Performance Test, the product performance can meet the requirement, this difference is insignificant and do not raise any safety or effectiveness problems.
Note 4:
The device flow rate is different from the predicate device, and the subject device is different from the predicate device in terms of product structure. The subject device has the structure of air tube, while the flow rate mainly refers to the volume of secretions inhaled per unit time. The higher the flow rate, the more nasal secretions can be removed per unit time, which can shorten the operation time and may improve cleaning efficiency. Since the subject device has more air tube structure than the predicate device, the performance of the subject device may be reduced at the same flow rate. Although the current flow rate of the subject devices is higher than predicate device, their vacuum pressure range is the same, both 52-60 kPa, which not only ensures effective flow rate but also reduces the risk of mucosal damage. Suction levels and vacuum pressure range have been designed to take into account the vulnerability of children's nasal mucosa to avoid damage due to excessive pressure. Performance testing was completed to verify the product requirements; the differences above do not raise different questions of safety or effectiveness.
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Shenzhen Desida Technology Co., Ltd. 510(k)s –510(k) Summary of K244033
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Note 5:
The structural composition of subject device is different from the predicate device, the subject device has two more components than the predicate device (i.e., air tube and tweezer):
For air tube: The performance tests results support the safety and effectiveness of the device.
For tweezer: Tweezer is an accessory. If necessary, users can use tweezer to remove hard secretions from the nasal cavity. Tweezer is an additional auxiliary tool for users to choose to use. It does not raise any concerns of safety or effectiveness.
VIII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the subject device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA. The following testing was performed to, and passed, including:
- ISO 10993-5, Biological evaluation of medical devices –Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10, Biological evaluation of medical devices –Part 10: Tests for skin sensitization
- ISO 10993-23, Biological evaluation of medical devices –Part 23: Tests for skin irritation
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11 Medical Electrical Equipment –Part 1: General Requirements for Basic Safety and Essential Performance –Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
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Shenzhen Desida Technology Co., Ltd. 510(k)s –510(k) Summary of K244033
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3) Battery Safety
- IEC 62133-2 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
4) Software Verification and Validation
Software documentation consistent with basic documentation level was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
5) Bench testing
Appearance Test: In order to verify and assure the performance of Electric Nasal Aspirator, we have conducted the product appearance test (color, dimension, weight, etc.).
Performance Test: In order to verify and assure the performance of Electric Nasal Aspirator, we have conducted the product performance test (vacuum pressure, noise level, flow rate, tubing bending resistance, etc.).
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Electric Nasal Aspirator is as safe, as effective, and performs as well as the legally marketed predicate device.
§ 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.