Who is the manufacturer of FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator?

Taidoc Technology Corporation filed the 510(k) submission for FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator (K180863).

What is the FDA product code for FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator?

BTA. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator?

510(k) clearance (submission type: Traditional).

What are the predicate devices for FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator?

Avita Nasal Aspirator, Model NS1 (K090379).

Who can help prepare an FDA 510(k) submission like FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator

K180863 · Taidoc Technology Corporation · BTA · Dec 19, 2018 · General, Plastic Surgery

Device Facts

Record ID	K180863
Device Name	FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator
Applicant	Taidoc Technology Corporation
Product Code	BTA · General, Plastic Surgery
Decision Date	Dec 19, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 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 Story

Portable, battery-operated (2x1.5V AA) suction device; utilizes motor pump to generate negative pressure (52-60 Kpa); nasal secretions collected in device container via silicone tips. Used in home environment by parents/caregivers for children aged 2-12. Device provides non-invasive removal of mucus; lower noise level (45 dBA) compared to predicate; smaller form factor. Healthcare providers do not interact with output; device is for symptom relief/hygiene.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via electrical safety (IEC 60601-1), home healthcare environment safety (IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-1, -5, -10, -12).

Technological Characteristics

Materials: ABS, PC, Silicone (KE-941U). Principle: Motor-driven negative pressure suction. Power: 3V DC (2x1.5V AA batteries). Dimensions: 41x41x200 mm. Weight: 175g. Connectivity: None. Ingress protection: IP22. Applied part: Type BF. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993.

Indications for Use

Indicated for intermittent removal of nasal secretions and mucus in 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

Avita Nasal Aspirator, Model NS1 (K090379)

Related Devices

K233901 — Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) · Shenzhen Desida Technology Co., Ltd. · Mar 20, 2024
K242028 — Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) · Dongguanshi Yiyingmei Technology Co., Ltd. · Nov 19, 2024
K090379 — AVITA NASAL ASPIRATOR, MODEL, NS1 SERIES · Avita Corporation · May 26, 2010
K260147 — Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) · Shenzhen Kingboom Technology Co., Ltd. · Mar 13, 2026
K243138 — Geon (S2) Nasal Aspirator · Geon Corporation · Feb 4, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. December 19, 2018 TaiDoc Technology Corporation Sylvia Liu Regulatory Affairs Specialist 6F, No.127, Wugong 2nd Rd., Wugu District New Taipei City, 24888 TW Re: K180863 Trade/Device Name: FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: BTA Dated: March 31, 2018 Received: April 2, 2018 Dear Sylvia Liu: 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. 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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Srinivas Nandkumar -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K180863 #### Device Name FORA NAS100 Electronic Nasal Aspirator (Model No: NAS100), Electronic Nasal Aspirator (Model No: TD-7601) Indications for Use (Describe) The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 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) #### 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}------------------------------------------------ # 510(k) Summary This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92. | The Assigned 510(k) number is: K180863 | | | | | |----------------------------------------|--|--|--|--| |----------------------------------------|--|--|--|--| | 1. Submitter Information | | | |--------------------------|------------------------------------------------------------|--| | Company Name: | TaiDoc Technology Corporation | | | Contact Person: | Sylvia Liu | | | Title: | Regulatory Affairs Specialist | | | Address: | B1-7F., No. 127, Wugong 2nd Rd., Wugu District, New Taipei | | | | City 24888, TAIWAN | | | Phone: | +886-2-6625-8188 #6134 | | | Fax: | +886-2-6625-0288 | | | E-mail: | Sylvia.liu@taidoc.com.tw | | | Prepared Date: | December 10th, 2018 | | ## 2. Device Name | Proprietary Name: | FORA NAS100 Electronic Nasal Aspirator, NAS100 (Electronic Nasal Aspirator, TD-7601) | |-------------------|-----------------------------------------------------------------------------------------| | Common Name: | Powered Suction Pump | | Product Code: | BTA | | Review Panel: | General & Plastic Surgery | | Device Class: | Class II | 21 CFR § 878.4780 #### Regulation Number: 3. Predicate Device | Proprietary Name: | Avita Nasal Aspirator, Model NS1 | |-------------------|----------------------------------| | Manufacturer | AVITA Corporation | | 510(K) no. | K090379 | #### 4. Device Descrip tion #### The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 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. Two different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus. #### Principle of Oneration #### The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100, utilizes a motor pump to generate negative pressure in the suction system, which allows nasal secretions to flow into the device container. {4}------------------------------------------------ # 5. Indications for Use #### The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 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. ### 6. Technological Characteristics Table of Specification Comnarison | Item | Predicate device | Proposed device | | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510K Number | K090379 | K180863 | | | | General Information | | | | Appearance | Image: Avita Nasal Aspirator | Image: FORA NAS100 Electronic Nasal Aspirator | | | Device Trade Name / Proprietary name | Avita Nasal Aspirator, Model NS1 | FORA NAS100 Electronic Nasal Aspirator (Model No: NAS100); Electronic Nasal Aspirator (Model No: TD-7601) | | | Manufacturer | AVITA Corporation | TaiDoc Technology Corporation | | | Common /Classification Name | Powered Suction Pump | Same as the predicate | | | Device Class | II | Same as the predicate | | | Product Code | BTA | Same as the predicate | | | Classification Panel | General & Plastic Surgery | Same as the predicate | | | Regulation Number | 21 CFR § 878.4780 | Same as the predicate | | | Indication for Use | This device is designed for using Intermittent suction to remove nasal secretion and mucus in Children (age 2- 12 years old) at home environment. | | The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD- 7601), NAS100 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. | | Item | Predicate device | Proposed device | | | 510K Number | K090379 | K180863 | | | Population | Age 2-12 years old | Same as the predicate | | | Intended Environment | Home use | Same as the predicate | | | Device Description | AVITA NS1 Nasal Aspirator is a portable, DC powered device Intended to provide the suction function to aspirate children's nasal secretion. The device consist of a pump that is driven by Two (2) 1.5V, AA size alkaline batteries, soft aspiration tip, collection cup and Music IC with 12 Chord Melody. | The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator, TD-7601), NAS100 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. Two different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus. | | | General Functions | | | | | Vacuum pressure | 52Kpa | 52-60 Kpa | | | Noise Level | 75-80dB/22mm 0.25w/1M | 45 dBA | | | Power consumption | - | 3W | | | Device Dimension | 93.5(L) x 39.9 (W) x 148(H) mm | 41 (L) x 41 (W) x 200 (H) mm | | | Tips Dimension (ψ) | Type1: 6 (OD)/ 2(ID) Type2: 4.2 (OD)/2.6 (ID) | Type1: 5.5 (OD)/ 3(ID) Type2: 4.5 (OD)/2.5 (ID) | | | Weight | 250(g) | 175(g) | | | Motor Type | 3V DC | Same as the predicate | | | Power Source | 2x1.5V AA | Same as the predicate | | | Material | ABS, PC, Silicone | Same as the predicate | | | Operating condition | 60.8°F to 95°F; up to 85% R.H. (non condensing) | 41°F to 104°F; 15% to 93% R.H. (non condensing) | | | Storage condition | -13°F to 131°F; up to 85% R.H | -13°F to 158°F;10% to 95% R.H. | | | Expected service life | - | 2 years | | | Type BF applied part | - | Type BF Applied part | | | Safety | - | IEC 60601-1 | | | EMC | | IEC 60601-1-2 | | | Water-resistance | | IP22 | | | Biocompatibility Information | | | | | Item | Predicate device | Proposed device | | | 510K Number | K090379 | K180863 | | | Description | Unknown | NAS100 (TD-7601) operates in conjunction with silicon nasal aspiration tips, which come into the contact with nasal skin and mucosa for less than 24 hours. Two different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus. | | | Standard | Unknown | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-12 | | | Contacted Parts | Silicone Tip | Same as predicate | | | Material | - | KE-941U | | {5}------------------------------------------------ TaiDoc TechnologyCorp. {6}------------------------------------------------ The conceptual design of the proposed device (K180863) is similar to the predicate device (K090379). Both have the same principle of operation, general function, and indications for use. The proposed device (K180863) has been designed to have smaller dimensions, which makes it more convenient to operate. Another advantage of the proposed device (K180863) is a lower noise level, which decreases hearing discomfort during device use. Additionally, the silicone nasal tips of the proposed device have undergone biocompatibility evaluation. The device complies with general requirements for basic safety and essential performance, and electromagnetic compatibility according to IEC 60601-1-2, IEC60601-11, and IEC 60601-1. {7}------------------------------------------------ # 7. Performance Data ## Safety and Effectiveness Characteristics: | Standard | Title | Intended Use | Acceptance Criteria | Results | | |----------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | IEC 60601-1 | General requirements for basic safety and essential performance | This study is to test for the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their manufacturer for use. | The pass/fail criteria is to evaluate the basic safety and essential performance of medical electrical equipment and medical electrical systems. | 1. General requirements, Pass. 2. General requirements for testing ME equipment, Pass. 3. Classification of MEequipment and MEsystems, Pass. 4. ME equipment identification, marking and documents, Pass. 5. Protection against excessive temperatures and other hazards, Pass. 6. Accuracy if controls and instruments and protection against hazardous outputs, Pass. 7. Construction of MEequipment, Pass. 8. Protection against strangulation or asphyxiation, Pass. 9. Additional requirements for electromagnetic emissions of ME equipment and MEsystems, Pass. 10. Additional requirements for alarm systems if ME equipment and MEsystems, Pass. | | | IEC 60601-1-11 | General requirements for basic safety and essential performance – Collateral Standard: | This study is to evaluate to the basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended by their | The pass/fail criteria is to evaluate the basic safety and essential performance of medical electrical equipment and medical electrical systems for | 1. General requirements, Pass. 2. General requirements for testing ME equipment, Pass. 3. Classification of MEequipment and MEsystems, Pass. 4. ME equipment identification, marking and documents, Pass. 5. Protection against excessive temperatures and other hazards | | | | Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | manufacturer for use in the home healthcare environment, regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel. | use in the home healthcare environment. | Pass. 6. Accuracy if controls and instruments and protection against hazardous outputs, Pass. 7. Construction of MEequipment, Pass. 8. Protection against strangulation or asphyxiation, Pass. 9. Additional requirements for electromagnetic emissions of ME equipment and MEsystems, Pass. 10. Additional requirements for alarm systems if MEequipment and MEsystems, Pass. | | | IEC 60601-1-2 | EMC Test Report | IEC 60601-1-2:2014 applies to the basic safety and essential performance of Medical Equipment (ME) equipment and ME systems in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by me equipment and me systems. | The pass/fail criteria is limited to maintain the Essential Performance and Basic Safety of EMC requirements. | 1. Enclosure port, Pass 2. ESD, Pass 3. RS, Pass 4. RF, Pass 5. PFMF, Pass | | | ISO 14971 | Risk Management Report | The failure of the function resulting in wrong analytical result which may have serious impairment to the health of a patient may happen. Control measures were taken to reduce the | The risk criteria were established when setting the context, the level of risk would against this criteria in order to determine whether the risk is | The risk distribution is shown the before/after risk analysis to be sure that all hazards are controlled on "acceptable region". | | | | | risk to as minimum as possible. Safety and effectiveness of use about the system was then verified. | acceptable. | | | | | | | | | | TaiDoc TechnologyCorp. {8}------------------------------------------------ TaiDoc TechnologyCorp. {9}------------------------------------------------ Biocompatibility & Clinical Test Report | Standard | Title | Intended Use | Acceptance Criteria | Results | |------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-12 | Biocompatibility Test Report for Thermometer | When assessing medical device, the sponsor should specifically state if the medical device does not result in any risk of direct or indirect tissue-contacting components. Thus, performing the biocompatibility test to indicate the safety of device, which includes with Cytotoxicity Test, Skin Sensitization Test, and Irritation Test. | Cytotoxicity Test: If cell viability is reduced to < 70% of the reagent control extract, a cytotoxic potential exists. Skin Sensitization Test: Grades of 1 or greater observed in the test group generally indicated sensitization, provided that grades of less than 1 were observed on the control animals. Irritation Test: For each rabbit, the irritation score for test area was calculated by adding together the scores of erythema and edema at each time point and divide the sum by the total number of observation. | 1. Irritation index for the test result was calculated to be 0. 2. There were not found abnormal clinical symptoms except skin reactions in rabbit. 3. There were normal weight change. 4. The positive/negative rate of all sample extract animal is 0% 5. The sample extract showed no significant evidence of causing skin sensitization in the guinea pig. 6. Under the conditions of the MTT assay, the test article Breast Pump extract did not show potential toxicity to L- 929 cells. | | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-12 | Biocompatibility Test Report for Stainless Steel Cap | When assessing medical device, the sponsor should specifically state if the medical device does not result in any risk of direct or indirect tissue-contacting components. Thus, performing the biocompatibility test to indicate the safety of device, which includes with Cytotoxicity Test, Skin Sensitization Test, and Irritation Test. | Cytotoxicity Test: If cell viability is reduced to < 70% of the reagent control extract, a cytotoxic potential exists. Skin Sensitization Test: Grades of 1 or greater observed in the test group generally indicated sensitization, provided that grades of less than 1 were observed on the control animals. Irritation Test: For each rabbit, the irritation score for test area was calculated by adding together the scores of erythema and edema at each time point and divide the sum by the total number of observation. | 1. Irritation index for the test result was calculated to be 0. 2. There were not found abnormal clinical symptoms except skin reactions in rabbit. 3. There were normal weight change. 4. The positive/negative rate of all sample extract animal is 0% 5. The sample extract showed no significant evidence of causing skin sensitization in the guinea pig. 6. Under the conditions of the MTT assay, the test article Breast Pump extract did not show potential toxicity to L- 929 cells. | | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-12 | Biocompatibility Test Report for Elastic Band | When assessing medical device, the sponsor should specifically state if the medical device does not result in any risk of direct or indirect tissue-contacting components. Thus, performing the biocompatibility test to indicate the safety of device, which includes with Cytotoxicity Test, Skin Sensitization Test, and Irritation Test. | Cytotoxicity Test: If cell viability is reduced to < 70% of the reagent control extract, a cytotoxic potential exists. Skin Sensitization Test: Grades of 1 or greater observed in the test group generally indicated sensitization, provided that grades of less than 1 were observed on the control animals. Irritation Test: For each rabbit, the irritation score for test area was calculated by adding together the scores of erythema and edema at each time point and divide the sum by the total number of observation. | 1. Irritation index for the test result was calculated to be 0. 2. There were not found abnormal clinical symptoms except skin reactions in rabbit. 3. There were normal weight change. 4. The positive/negative rate of all sample extract animal is 0% 5. The sample extract showed no significant evidence of causing skin sensitization in the guinea pig. 6. Under the conditions of the MTT assay, the test article Breast Pump extract did not show potential toxicity to L- 929 cells. | | ISO 10993-1 ISO 10993-5 ISO 10993-10 ISO 10993-12 | Biocompatibility Test Report for Silicon belt | When assessing medical device, the sponsor should specifically state if the medical device does not result in any risk of direct or indirect tissue-contacting components. Thus, performing the biocompatibility test to indicate the safety of device, which includes with Cytotoxicity Test, Skin Sensitization Test, and Irritation Test. | Cytotoxicity Test: If cell viability is reduced to < 70% of the reagent control extract, a cytotoxic potential exists. Skin Sensitization Test: Grades of 1 or greater observed in the test group generally indicated sensitization, provided that grades of less than 1 were observed on the control animals. Irritation Test: For each rabbit, the irritation score for test area was calculated by adding together the scores of erythema and edema at each time point and divide the sum by the total number of observation. | 1. Irritation index for the test result was calculated to be 0. 2. There were not found abnormal clinical symptoms except skin reactions in rabbit. 3. There were normal weight change. 4. The positive/negative rate of all sample extract animal is 0% 5. The sample extract showed no significant evidence of causing skin sensitization in the guinea pig. 6. Under the conditions of the MTT assay, the test article Breast Pump extract did not show potential toxicity to L- 929 cells. | {10}------------------------------------------------ ## 8. Conclusions #### The FORA NAS100 Electronic Nasal Aspirator (Electronic Nasal Aspirator), NAS100 (TD-7601) is designed to help users remove the nasal mucus in their children (age 2-12 years old) in a home environment. The proposed device (K180863) has been designed to have smaller dimensions, which makes it more convenient to operate. Another advantage of the proposed device (K180863) is a lower noise level, which decreases hearing discomfort during the device use. Also, the NAS100 (TD-7601) has been evaluated according to IEC 60601-1-2, IEC60601-11, IEC 60601-1, and ISO 10993. The performance testing demonstrated that the NAS100 (TD-7601) is substantially equivalent to the legally marketed predicate device (K090379).