The ENT Nasopharyngoscope EES 100 is a sterile, single-use, and flexible device intended to be operated with its compatible display (EVS 100) for endoscopic procedures within nasal lumens and upper airway anatomy. The Video Box EVS 100 is intended to provide visualization via the connected tablet. The Nasopharyngoscope is intended for use in a hospital environment. It is designed for adult use.

Device Description

ENT Nasopharyngoscope and Accessories contain nasopharyngoscope (model name: EES 100) and image transfer system (Video Box, model name: EVS 100A). EES 100 is a single-use, flexible, sterile nasopharyngoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected Video Box (EVS 100A). EVS 100A is attached on a tablet. The live imaging or snapshot will present directly on the tablet. The function of Nasopharyngoscope is to provide live imaging of the nasal tissue, including tissue appearance recording, snapshot, vertical flip and horizontal flip. The device does not provide any instruction for diagnosis nor treatment.

AI/ML Overview

This document does not describe the acceptance criteria and a study that proves the device meets those criteria in the way typically seen for AI/ML devices. Instead, it is a 510(k) premarket notification for a medical device called the "ENT Nasopharyngoscope and Accessories" which outlines its substantial equivalence to a predicate device.

Therefore, many of the requested fields related to AI/ML device studies (like sample sizes for test sets, ground truth establishment, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this document, as this device does not appear to be an AI/ML product.

Here's a breakdown of what can be extracted from the provided text, acknowledging the limitations:

1. A table of acceptance criteria and the reported device performance

The document does not present acceptance criteria in a table format with corresponding device performance for specific claims, as would be common for AI/ML device studies. Instead, it focuses on demonstrating substantial equivalence to a predicate device through conformity to various engineering and safety standards, and through similar technical specifications.

The "acceptance criteria" are implied by adherence to these standards and the similarity to the predicate. The "reported device performance" is essentially the statement that the device meets these standards and has comparable specifications.

Category	Acceptance Criteria (Implied by Standards/Predicate)	Reported Device Performance
Electrical Safety	Conformity to IEC 60601-1	Device meets requirements of IEC 60601-1.
Electromagnetic Compatibility	Conformity to IEC 60601-1-2	Device meets requirements of IEC 60601-1-2.
Sterilization Validation	Conformity to ISO 11135	Sterilization validated per ISO 11135.
Package Integrity	Conformity to ISO 11607-1	Package integrity tested per ISO 11607-1.
EO/ECH Residue	Conformity to ISO 10993-7	EO/ECH residue tested per ISO 10993-7.
Transportation Test	Conformity to ASTM D4169-16	Transportation tested per ASTM D4169-16.
Aging Test	Conformity to ASTM F1980-16	Aging tested per ASTM F1980-16.
Sterility Test	Conformity to ISO 11737-1	Sterility tested per ISO 11737-1.
Risk Management	Conformity to ISO 14971, EN ISO 14971, MDR 2017/745	Risk management performed per specified standards.
Light Hazards	Conformity to IEC 62471	Device meets requirements of IEC 62471.
Biocompatibility	Conformity to ISO10993-5 and ISO10993-10	Biocompatibility tested per specified standards.
Optical Specification	Comparable to predicate (FOV 85°, DOV 0°, DOF 6-50 mm)	FOV: 90°, DOV: 0°, DOF: 7-50 mm (differences deemed not significant).
Mechanical Specification	Comparable to predicate (Bending angle 130°, Length 300mm, OD 3.5mm)	Bending angle: 130°, Length: 300mm, OD: 3.6mm (differences deemed not significant).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This device is hardware-focused, and the testing described consists of non-clinical, bench tests against recognized standards rather than a clinical "test set" in the context of an AI/ML algorithm. No data provenance for software performance is discussed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/ML device that requires expert-established ground truth for its performance assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no diagnostic test set requiring adjudication.

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

No. This is not an AI/ML device, so no MRMC study, AI assistance, or effect size is discussed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is an endoscopic instrument and not an algorithm. Its function is to provide live imaging which is interpreted by a human user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of AI/ML. The "ground truth" for this device's performance is its adherence to established engineering and safety standards (e.g., IEC, ISO, ASTM) and its ability to provide clear visualization, confirmed through bench testing and usability testing, as opposed to diagnostic accuracy evaluated against pathology or expert consensus.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, therefore, there is no training set mentioned.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

Summary

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July 1, 2022

Medimaging Integrated Solution Inc. (MiiS) Jung-Yi Yen Regulatory Affairs 3F., No.24-2, Industry E. Rd. IV, Hsinchu Science Park Hsinchu, Taiwan 30077 Taiwan

Re: K214050

Trade/Device Name: ENT Nasopharyngoscope and Accessories Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: Mav 26, 2022 Received: June 3, 2022

Dear Jung-Yi Yen:

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K214050

Device Name ENT Nasopharyngoscope and Accessones

Indications for Use (Describe)

The Nasopharyngoscope is intended for use in a hospital environment. It is designed for adult use.

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)

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Image /page/3/Picture/0 description: The image shows a logo with a circular target-like design at the top and the word "MiiS" in blue at the bottom. The target design consists of concentric circles divided into quadrants, with alternating shades of gray and white. The word "MiiS" is in a bold, sans-serif font and is underlined. The entire logo is enclosed in a rounded rectangular border.

510(k) Summary

July 1st , 2022 Prepared:

Submitter/Owner's	Medimaging Integrated Solution Inc. (MiiS)
Name/ Address	3F., No.24-2, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu, Taiwan30077, R.O.C.
Contact Person:	Yen, Jung-Yi
Telephone: Fax:	+886-3-5798860 Ext: 1706
Email Address:	+886-3-5798011Jungyi.yen@miis.com.tw

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Image /page/4/Picture/0 description: The image is a logo with a circular target-like design at the top and the text "MiiS" in blue at the bottom. The target design consists of concentric circles divided into quadrants, with alternating shades of gray and black. The text "MiiS" is underlined with a blue line. The logo has rounded corners and a white background.

Device Identification:

Trade/Device Name: ENT Nasopharyngoscope and Accessories. Common Name: Nasopharyngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) Regulatory Class: Class II Product Code: EOB

Predicate Device:

K191080

Trade/Device Name: Ambu aScope 4 RhinoLaryngo Slim Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) Regulatory Class: Class II Product Code: EOB

Description of Device:

EVS 100A is attached on a tablet. The live imaging or snapshot will present directly on the tablet.

The function of Nasopharyngoscope is to provide live imaging of the nasal tissue, including tissue appearance recording, snapshot, vertical flip and horizontal flip. The device does not provide any instruction for diagnosis nor treatment. Table 1 below includes a summary of the technical information used in the substantial equivalence comparison.

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Image /page/5/Picture/0 description: The image shows a logo with a circular target-like design at the top and the word "MiiS" in blue at the bottom. The target design consists of concentric circles divided into alternating black, white, and gray segments. The word "MiiS" is underlined with a blue line. The logo is set against a white background with a rounded rectangular border.

Indications for Use (IFU):

The Video Box EVS 100 is intended to provide visualization via the connected tablet. The nasopharyngoscope is intended for use in a hospital environment. It is designed for use in adults.

Substantial Equivalence Summary

Below is a summary table comparing the IFUs and key technological characteristics between the subject and the predicate devices.

Device	K214050	K191080
Model name	Nasopharyngoscope:EES 100Video Box:EVS 100A	Ambu aScope 4RhinoLaryngo Slim
Product code &Classification	21 CFR 874.4760,EOB Class II	21 CFR 874.4760,EOB Class II
Intended use	The ENT NasopharyngoscopeEES 100 is a sterile, flexible,single-use device intended to beused with compatible display.This device is indicated forendoscopic diagnosis procedureswithin the nasal lumen and upperairway anatomy.The Video Box EVS 100 isintended to provide visualizationvia a monitor.The nasopharyngoscope is intendedfor use in a hospital environment. Itis designed for use in adults.	The endoscope is a sterile, single-use, flexible endoscope intendedfor endoscopic proceduresand examination within the nasallumens and upper airwayanatomy. The endoscope isintended to provide visualizationvia Ambu displaying unit.The endoscope is intended for usein a hospital environment. It isdesigned for use in adults.
Lens Specification	FOV: 90°DOV: 0°DOF: 7-50 mm	FOV: 85°DOV: 0°DOF: 6-50 mm

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Image /page/6/Picture/0 description: The image shows a logo with a circular target-like design at the top and the word "MiiS" in blue at the bottom. The target consists of concentric circles alternating in shades of gray and white. The word "MiiS" is underlined with a blue line. The logo has a white background and a blue border.

MechanicalSpecification	Bending angle: 130°(up and down)Working length:300 mmOuter diameter:3.6 mm	Bending angle: 130°(up and down)Working length:300 mmOuter diameter:3.5 mm
EMC	IEC 60601-1-2	IEC 60601-1-2
Safety	IEC 60601-1IEC 60601-2-18	IEC 60601-1IEC 60601-2-18
Bench test	ISO 8600-1ISO 8600-3ISO 8600-4	ISO 8600-1ISO 8600-3ISO 8600-4
Sterilization	EO Sterilization	EO Sterilization
LED Light source	At distal tip	At distal tip
Appearance	Image: endoscopic device	Image: endoscopic device

Substantial Equivalence Discussion

Similarities:

ENT Nasopharyngoscope and Accessories and the predicate device, Ambu aScope 4 RhinoLaryngo Slim (K191080), have the same intended use and similar specifications in field of view, direction of view, depth of field, bending angle, working length, outer diameter, sterilization method, light source location and appearance.

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Image /page/7/Picture/0 description: The image is a logo with a circular target-like design at the top and the text "MiiS" in blue at the bottom. The target design consists of concentric circles divided into alternating black, white, and gray segments. The entire logo is enclosed in a rounded rectangular border with a blue outline.

Differences:

The main differences lie in the optical specification (including field of view and depth of field) and the outer diameter of the insertion tube. For all these features, the differences are not more than 10%, and the image performance and the usability of the device are both validated in usability testing, optical performance and color performance testing. Thus, it is considered that there is no significance difference occurs between ENT Nasopharyngoscope and Accessories with its predicate devices.

Nonclinical Tests

The following tests have been performed in support of the substantial equivalence determination:

IEC/EN 60601-1:2005/2006+A1:2012/2013 for electrical safety. -
IEC/EN 60601-1-2:2014/2015 for electromagnetic compatibility. -
ISO 11135:2014 for sterilization validation ।
ISO 11607-1:2019 for package integrity test. -
ISO 10993-7:2008 for EO/ECH Residue -
ASTM D4169-16 for transportation test. -
ASTM F1980-16 for aging test. -
ISO 11737-1:2019 for sterility test. -
ISO 14971:2019, EN ISO 14971:2019 and MDR 2017/745 for risk management. -
IEC 62471:2006 for light hazards. -
ISO10993-5:2009 and ISO10993-10:2010 standards for biocompatibility. The patient contacting parts is the applied part of the ENT Nasopharyngoscope EES 100.

Clinical Tests

No clinical studies were performed.

Optical Radiation Safety Assessment

The ENT Nasopharyngoscope EES 100 was tested according to ISO 62471:2006 to determine acceptable light safety limits for both the illumination. The test results demonstrate the ENT Nasopharyngoscope EES 100 meets the requirements of the standard.

Conclusion

Substantial equivalence comparison and bench performance tests support the conclusion of substantial equivalence of ENT Nasopharyngoscope and Accessories to the predicate devices Ambu aScope 4 RhinoLaryngo Slim (K191080).

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.