(261 days)
Not Found
No
The device description and performance studies focus on the mechanical function of suction and electrical safety standards, with no mention of AI or ML.
No
The device is strictly for the removal of nasal secretions and mucus and does not imply any therapeutic action or treatment of a condition.
No
The device is an electronic nasal aspirator intended for the physical removal of nasal secretions, not for diagnosis.
No
The device description clearly states it is a "portable device" with a "motor pump" and "silicone nasal tips," indicating it is a physical hardware device, not software only.
Based on the provided information, the FORA NAS100 Electronic Nasal Aspirator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "intermittent removal of nasal secretions and mucus from children." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device description focuses on the mechanical function of suctioning nasal passages.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on safety, electrical standards, risk management, and biocompatibility, which are typical for medical devices that interact with the body, not IVDs.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The FORA NAS100 does not perform this function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BTA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal passages
Indicated Patient Age Range
2-12 years old
Intended User / Care Setting
Home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was evaluated for:
- IEC 60601-1: General requirements for basic safety and essential performance. Results: All general requirements, requirements for testing, classification, identification, marking and documents, protection against excessive temperatures and other hazards, accuracy, construction, protection against strangulation or asphyxiation, additional requirements for electromagnetic emissions, and additional requirements for alarm systems passed.
- IEC 60601-1-11: 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. Results: All general requirements, requirements for testing, classification, identification, marking and documents, protection against excessive temperatures and other hazards, accuracy, construction, protection against strangulation or asphyxiation, additional requirements for electromagnetic emissions, and additional requirements for alarm systems passed.
- IEC 60601-1-2: EMC Test Report. Results: Enclosure port, ESD, RS, RF, and PFMF passed.
- ISO 14971: Risk Management Report. Results: The risk distribution is shown in the before/after risk analysis to be sure that all hazards are controlled on "acceptable region".
- Biocompatibility Test Reports (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12) for Thermometer, Stainless Steel Cap, Elastic Band, and Silicon belt. Results:
- Irritation index for the test result was calculated to be 0.
- No abnormal clinical symptoms except skin reactions in rabbit were found.
- Normal weight change was observed.
- The positive/negative rate of all sample extract animal is 0%.
- The sample extract showed no significant evidence of causing skin sensitization in the guinea pig.
- Under the conditions of the MTT assay, the test article Breast Pump extract did not show potential toxicity to L-929 cells.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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)
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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. |
- General requirements for testing
ME equipment, Pass. - Classification of MEequipment
and MEsystems, Pass. - ME equipment identification,
marking and documents, Pass. - Protection against excessive
temperatures and other hazards,
Pass. - Accuracy if controls and
instruments and protection
against hazardous outputs, Pass. - Construction of MEequipment,
Pass. - Protection against strangulation
or asphyxiation, Pass. - Additional requirements for
electromagnetic emissions of ME
equipment and MEsystems,
Pass. - 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. - General requirements for testing
ME equipment, Pass. - Classification of MEequipment
and MEsystems, Pass. - ME equipment identification,
marking and documents, Pass. - 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. - Accuracy if controls and
instruments and protection
against hazardous outputs, Pass. - Construction of MEequipment,
Pass. - Protection against strangulation
or asphyxiation, Pass. - Additional requirements for
electromagnetic emissions of ME
equipment and MEsystems,
Pass. - 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 - ESD, Pass
- RS, Pass
- RF, Pass
- 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.
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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 |