(261 days)
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.
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.
This document outlines the acceptance criteria and the studies conducted to prove that the FORA NAS100 Electronic Nasal Aspirator meets these criteria.
1. Acceptance Criteria and Reported Device Performance
| Standard | Intended Use / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| IEC 60601-1: General requirements for basic safety and essential performance | To evaluate the basic safety and essential performance of medical electrical equipment and medical electrical systems. | All 10 general requirements met (Pass) including general requirements, testing ME equipment, classification, identification/marking, protection against excessive temperatures/other hazards, accuracy/protection against hazardous outputs, construction, protection against strangulation/asphyxiation, additional requirements for electromagnetic emissions, and alarm systems. |
| IEC 60601-1-11: Requirements for medical electrical equipment and systems used in the home healthcare environment | To evaluate the basic safety and essential performance of medical electrical equipment and systems for use in the home healthcare environment. | All 10 general requirements met (Pass) including general requirements, testing ME equipment, classification, identification/marking, protection against excessive temperatures/other hazards, accuracy/protection against hazardous outputs, construction, protection against strangulation/asphyxiation, additional requirements for electromagnetic emissions, and alarm systems. |
| IEC 60601-1-2: EMC Test Report | To maintain the essential performance and basic safety of EMC requirements in the presence of electromagnetic disturbances and emitted disturbances. | All 5 EMC requirements met (Pass): Enclosure port, ESD, RS, RF, PFMF. |
| ISO 14971: Risk Management Report | To ensure all hazards are controlled in an "acceptable region" before/after risk analysis, addressing wrong analytical results and serious impairment to patient health. | Risk distribution showed that all hazards are controlled in the "acceptable region". |
| ISO 10993-1, -5, -10, -12: Biocompatibility Test Report for Thermometer (example component) | To assess if the device poses any direct or indirect tissue-contacting risks, indicated by Cytotoxicity, Skin Sensitization, and Irritation tests. | Cytotoxicity Test: No potential toxicity to L-929 cells (Test article extract did not show potential toxicity to L-929 cells, implying cell viability was not reduced to <70%). Skin Sensitization Test: No significant evidence of causing skin sensitization in guinea pigs (0% positive/negative rate, grades less than 1). Irritation Test: No abnormal clinical symptoms except skin reactions in rabbits (Irritation index of 0), normal weight change. |
| ISO 10993-1, -5, -10, -12: Biocompatibility Test Report for Stainless Steel Cap | (Same as Biocompatibility Test Report for Thermometer) | Cytotoxicity Test: No potential toxicity to L-929 cells. Skin Sensitization Test: No significant evidence of causing skin sensitization in guinea pigs. Irritation Test: No abnormal clinical symptoms except skin reactions in rabbits, normal weight change. |
| ISO 10993-1, -5, -10, -12: Biocompatibility Test Report for Elastic Band | (Same as Biocompatibility Test Report for Thermometer) | Cytotoxicity Test: No potential toxicity to L-929 cells. Skin Sensitization Test: No significant evidence of causing skin sensitization in guinea pigs. Irritation Test: No abnormal clinical symptoms except skin reactions in rabbits, normal weight change. |
| ISO 10993-1, -5, -10, -12: Biocompatibility Test Report for Silicon belt | (Same as Biocompatibility Test Report for Thermometer) | Cytotoxicity Test: No potential toxicity to L-929 cells. Skin Sensitization Test: No significant evidence of causing skin sensitization in guinea pigs. Irritation Test: No abnormal clinical symptoms except skin reactions in rabbits, normal weight change. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each test listed (e.g., number of devices tested for IEC standards, number of animals for biocompatibility tests). The tests are based on established international standards (IEC, ISO), which typically outline the methodologies and sample size considerations for compliance. The document implies that sufficient samples were used to meet the requirements of these standards.
Data provenance (e.g., country of origin, retrospective/prospective) is not specified for the performance studies described in the document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The performance tests described (e.g., IEC electrical safety, EMC, ISO biocompatibility) rely on standardized testing protocols and objective measurements rather than expert consensus on medical image interpretation or clinical outcomes.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. Since the tests described are primarily objective engineering and biological safety evaluations according to international standards, an adjudication method for a test set in this context is not applicable and therefore not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed as this device is an electronic nasal aspirator, not an AI-assisted diagnostic device where human reader performance would be a relevant metric.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable. The device is a physical electronic nasal aspirator, not an algorithm or AI system for which a standalone performance study would be relevant.
7. Type of Ground Truth Used
The "ground truth" for the tests performed is based on adherence to the defined limits and criteria set by international safety, performance, and biocompatibility standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 14971, ISO 10993 series). This includes:
- Objective measurements and observations: For electrical safety (e.g., temperature, current leakage, noise levels, electromagnetic compatibility), physical construction, and operational performance.
- Biological responses: For biocompatibility tests (e.g., cell viability in cytotoxicity, skin reactions in sensitization and irritation tests).
- Risk assessment: Evaluation against defined risk criteria in the risk management report.
8. The Sample Size for the Training Set
This information is not applicable. The FORA NAS100 Electronic Nasal Aspirator is a hardware medical device, and the evaluation described involves traditional engineering and biological safety testing, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
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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.
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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
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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)
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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.
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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 NasalAspirator (Model No: NAS100);Electronic Nasal Aspirator(Model No: TD-7601) | |
| Manufacturer | AVITA Corporation | TaiDoc Technology Corporation | |
| Common/ClassificationName | 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 usingIntermittent suction to remove nasalsecretion and mucus in Children (age 2-12 years old) at home environment. | The FORA NAS100 ElectronicNasal Aspirator (Electronic NasalAspirator, TD- 7601), NAS100 isintended for intermittent removalof nasal secretions and mucus fromchildren (age 2-12 years old). Thisdevice is used in a homeenvironment. | |
| Item | Predicate device | Proposed device | |
| 510K Number | K090379 | K180863 | |
| Population | Age 2-12 years old | Same as the predicate | |
| IntendedEnvironment | Home use | Same as the predicate | |
| Device Description | AVITA NS1 Nasal Aspirator is aportable, DC powered device Intended toprovide the suction function to aspiratechildren's nasal secretion. The deviceconsist of a pump that is driven by Two(2) 1.5V, AA size alkaline batteries, softaspiration tip, collection cup and MusicIC with 12 Chord Melody. | The FORA NAS100 Electronic NasalAspirator (Electronic Nasal Aspirator,TD-7601), NAS100 is a portabledevice which is intended for suctionof nasal passages in children 2-12years of age. The motor pumpprovides a negative pressure whichremoves nasal secretions. Twodifferent shapes of silicone nasal tipsare provided to enable easier andmore effective removal of the nasalmucus. | |
| 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 inconjunction with silicon nasalaspiration tips, which come into thecontact with nasal skin and mucosafor less than 24 hours. Two differentshapes of silicone nasal tips areprovided to enable easier and moreeffective removal of the nasal mucus. | |
| Standard | Unknown | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12 | |
| Contacted Parts | Silicone Tip | Same as predicate | |
| Material | - | KE-941U |
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TaiDoc TechnologyCorp.
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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.
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7. Performance Data
Safety and Effectiveness Characteristics:
| Standard | Title | Intended Use | Acceptance Criteria | Results | |
|---|---|---|---|---|---|
| IEC 60601-1 | Generalrequirements forbasic safety andessentialperformance | This study is to test for thebasic safety and essentialperformance of medicalelectrical equipment andmedical electrical systemswhich are intended by theirmanufacturer for use. | The pass/fail criteria isto evaluate the basicsafety and essentialperformance ofmedical electricalequipment and medicalelectrical systems. | 1. General requirements, Pass.2. General requirements for testingME equipment, Pass.3. Classification of MEequipmentand MEsystems, Pass.4. ME equipment identification,marking and documents, Pass.5. Protection against excessivetemperatures and other hazards,Pass.6. Accuracy if controls andinstruments and protectionagainst hazardous outputs, Pass.7. Construction of MEequipment,Pass.8. Protection against strangulationor asphyxiation, Pass.9. Additional requirements forelectromagnetic emissions of MEequipment and MEsystems,Pass.10. Additional requirements foralarm systems if ME equipmentand MEsystems, Pass. | |
| IEC 60601-1-11 | Generalrequirements forbasic safety andessentialperformance –CollateralStandard: | This study is to evaluate tothe basic safety andessential performance ofmedical electricalequipment and medicalelectrical systems whichare intended by their | The pass/fail criteria isto evaluate the basicsafety and essentialperformance ofmedical electricalequipment and medicalelectrical systems for | 1. General requirements, Pass.2. General requirements for testingME equipment, Pass.3. Classification of MEequipmentand MEsystems, Pass.4. ME equipment identification,marking and documents, Pass.5. Protection against excessivetemperatures and other hazards | |
| Requirementsfor medicalelectricalequipment andmedicalelectricalsystems used inthe homehealthcareenvironment | manufacturer for use in thehome healthcareenvironment, regardless ofwhether the medicalelectrical equipment ormedical electrical system isintended for use by a layoperator or by trainedhealthcare personnel. | use in the homehealthcareenvironment. | Pass.6. Accuracy if controls andinstruments and protectionagainst hazardous outputs, Pass.7. Construction of MEequipment,Pass.8. Protection against strangulationor asphyxiation, Pass.9. Additional requirements forelectromagnetic emissions of MEequipment and MEsystems,Pass.10. Additional requirements foralarm systems if MEequipmentand MEsystems, Pass. | ||
| IEC 60601-1-2 | EMC TestReport | IEC 60601-1-2:2014applies to the basic safetyand essential performanceof Medical Equipment(ME) equipment and MEsystems in the presence ofelectromagneticdisturbances and toelectromagneticdisturbances emitted by meequipment and me systems. | The pass/fail criteria islimited to maintain theEssential Performanceand Basic Safety ofEMC requirements. | 1. Enclosure port, Pass2. ESD, Pass3. RS, Pass4. RF, Pass5. PFMF, Pass | |
| ISO 14971 | RiskManagementReport | The failure of the functionresulting in wronganalytical result which mayhave serious impairment tothe health of a patient mayhappen. Control measureswere taken to reduce the | The risk criteria wereestablished whensetting the context, thelevel of risk wouldagainst this criteria inorder to determinewhether the risk is | The risk distribution is shown thebefore/after risk analysis to be surethat all hazards are controlled on"acceptable region". | |
| risk to as minimum aspossible. Safety andeffectiveness of use aboutthe system was thenverified. | acceptable. | ||||
TaiDoc TechnologyCorp.
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TaiDoc TechnologyCorp.
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Biocompatibility & Clinical Test Report
| Standard | Title | Intended Use | Acceptance Criteria | Results |
|---|---|---|---|---|
| ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12 | BiocompatibilityTest Report forThermometer | When assessing medicaldevice, the sponsorshould specifically stateif the medical devicedoes not result in anyrisk of direct or indirecttissue-contactingcomponents. Thus,performing thebiocompatibility test toindicate the safety ofdevice, which includeswith Cytotoxicity Test,Skin Sensitization Test,and Irritation Test. | Cytotoxicity Test:If cell viability is reduced to <70% of the reagent controlextract, a cytotoxic potentialexists.Skin Sensitization Test:Grades of 1 or greater observedin the test group generallyindicated sensitization,provided that grades of lessthan 1 were observed on thecontrol animals.Irritation Test:For each rabbit, the irritationscore for test area wascalculated by adding togetherthe scores of erythema andedema at each time point anddivide the sum by the totalnumber of observation. | 1. Irritation index for the testresult was calculated to be 0.2. There were not foundabnormal clinicalsymptoms except skinreactions in rabbit.3. There were normal weightchange.4. The positive/negative rateof all sample extract animalis 0%5. The sample extract showedno significant evidence ofcausing skin sensitization inthe guinea pig.6. Under the conditions of theMTT assay, the test articleBreast Pump extract did notshow potential toxicity to L-929 cells. |
| ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12 | BiocompatibilityTest Report forStainless SteelCap | When assessing medicaldevice, the sponsorshould specifically stateif the medical devicedoes not result in anyrisk of direct or indirecttissue-contactingcomponents. Thus,performing thebiocompatibility test toindicate the safety ofdevice, which includeswith Cytotoxicity Test,Skin Sensitization Test,and Irritation Test. | Cytotoxicity Test:If cell viability is reduced to <70% of the reagent controlextract, a cytotoxic potentialexists.Skin Sensitization Test:Grades of 1 or greater observedin the test group generallyindicated sensitization,provided that grades of lessthan 1 were observed on thecontrol animals.Irritation Test:For each rabbit, the irritationscore for test area wascalculated by adding togetherthe scores of erythema andedema at each time point anddivide the sum by the totalnumber of observation. | 1. Irritation index for the testresult was calculated to be 0.2. There were not foundabnormal clinicalsymptoms except skinreactions in rabbit.3. There were normal weightchange.4. The positive/negative rateof all sample extract animalis 0%5. The sample extract showedno significant evidence ofcausing skin sensitization inthe guinea pig.6. Under the conditions of theMTT assay, the test articleBreast Pump extract did notshow potential toxicity to L-929 cells. |
| ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12 | BiocompatibilityTest Report forElastic Band | When assessing medicaldevice, the sponsorshould specifically stateif the medical devicedoes not result in anyrisk of direct or indirecttissue-contactingcomponents. Thus,performing thebiocompatibility test toindicate the safety ofdevice, which includeswith Cytotoxicity Test,Skin Sensitization Test,and Irritation Test. | Cytotoxicity Test:If cell viability is reduced to <70% of the reagent controlextract, a cytotoxic potentialexists.Skin Sensitization Test:Grades of 1 or greater observedin the test group generallyindicated sensitization,provided that grades of lessthan 1 were observed on thecontrol animals.Irritation Test:For each rabbit, the irritationscore for test area wascalculated by adding togetherthe scores of erythema andedema at each time point anddivide the sum by the totalnumber of observation. | 1. Irritation index for the testresult was calculated to be 0.2. There were not foundabnormal clinicalsymptoms except skinreactions in rabbit.3. There were normal weightchange.4. The positive/negative rateof all sample extract animalis 0%5. The sample extract showedno significant evidence ofcausing skin sensitization inthe guinea pig.6. Under the conditions of theMTT assay, the test articleBreast Pump extract did notshow potential toxicity to L-929 cells. |
| ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-12 | BiocompatibilityTest Report forSilicon belt | When assessing medicaldevice, the sponsorshould specifically stateif the medical devicedoes not result in anyrisk of direct or indirecttissue-contactingcomponents. Thus,performing thebiocompatibility test toindicate the safety ofdevice, which includeswith Cytotoxicity Test,Skin Sensitization Test,and Irritation Test. | Cytotoxicity Test:If cell viability is reduced to <70% of the reagent controlextract, a cytotoxic potentialexists.Skin Sensitization Test:Grades of 1 or greater observedin the test group generallyindicated sensitization,provided that grades of lessthan 1 were observed on thecontrol animals.Irritation Test:For each rabbit, the irritationscore for test area wascalculated by adding togetherthe scores of erythema andedema at each time point anddivide the sum by the totalnumber of observation. | 1. Irritation index for the testresult was calculated to be 0.2. There were not foundabnormal clinicalsymptoms except skinreactions in rabbit.3. There were normal weightchange.4. The positive/negative rateof all sample extract animalis 0%5. The sample extract showedno significant evidence ofcausing skin sensitization inthe guinea pig.6. Under the conditions of theMTT assay, the test articleBreast Pump extract did notshow potential toxicity to L-929 cells. |
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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).
§ 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.