(126 days)
Not Found
No
The summary describes a standard bronchoscope and display system for visualization. There is no mention of AI, ML, or advanced image processing beyond basic display and storage. The performance studies focus on safety and basic functionality, not algorithmic performance.
Yes
The device is intended for "endoscopic diagnosis treatment" and its working channel provides access for accessories to "conduct surgical procedures," indicating a therapeutic use beyond just visualization.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MiiS Horus Bronchoscope, when used with its compatible display systems, is intended for "endoscopic diagnosis."
No
The device description clearly outlines hardware components including a flexible bronchoscope with an LED light source and camera, and compatible display systems (Tablet and Video Box) which are also hardware. The performance studies include testing related to electrical safety, electromagnetic compatibility, sterilization, and packaging, all of which are relevant to hardware devices.
Based on the provided information, the MiiS Horus Bronchoscope and its associated display systems are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The MiiS Horus Bronchoscope is used for direct visualization of the airways and tracheobronchial tree within the patient's body. It provides endoscopic images for diagnosis and treatment procedures performed directly on the patient.
- Intended Use: The intended use clearly states "endoscopic visualization of airways and tracheobronchial tree" and "to perform various endoscopic procedures." This is an in-vivo (within the living organism) application, not an in-vitro (in glass/outside the body) application.
- Device Description: The description details a flexible device with a camera and light source for internal viewing, connected to a display system for showing live images from inside the body.
Therefore, the MiiS Horus Bronchoscope and its display systems fall under the category of endoscopic devices used for direct visualization and intervention within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
MiiS Horus Bronchoscope:
The MilS Horus Bronchoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiS Horus Endoscope Display System -Video Box (EVS 700). The device provides endoscopic visualization of airways and tracheobronchial tree, in conjunction with displaying system to perform various endoscopic procedures.
The MilS Horus Bronchoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.
MiiS Horus Endoscope Display System -Tablet:
The MiS Horus Endoscope Display System -Tablet (EDS 500) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.
MiiS Horus Endoscope Display System -Video Box:
The MilS Horus Endoscope Display System -Video Box (EVS 700) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
MiiS Horus Bronchoscope (ECB 100 S/R/L) is a single-use, flexible, sterile Bronchoscope. The device provides visualization for endoscopic procedures within the airways and tracheobronchial tree.
MiiS Horus Bronchoscope (ECB 100 S/R/L) have an LED light source and a camera at the distal end of the applied part. The Bronchoscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System - Video Box (EVS 700) and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.
MiiS Horus Endoscope Display System -Tablet (EDS 500) is a tablet which showing live image or snapshot from ECB 100.
MiiS Horus Endoscope Display System -Video Box (EVS 700) is a standalone imaging transfer system; it can be connected to computer to project live imaging. If needed, the pictures or videos can be storage to Tablet (EDS 500 Tablet) or computer.
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 working channel provide access for accessories to conduct surgical procedures.
MiiS Horus Bronchoscope has been designed to be compatible with the following endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA).
ECB-100S (Slim): Minimum ETT inner diameter: 5.0 mm, Minimum DLT size: 35 Fr, EA minimum working channel width: up to 1.2 mm.
ECB-100R (Regular): Minimum ETT inner diameter: 6.0 mm, Minimum DLT size: 41 Fr, EA minimum working channel width: up to 2.0 mm.
ECB-100L (Large): Minimum ETT inner diameter: 7.0 mm, EA minimum working channel width: up to 2.8 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopic visualization
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
adults
Intended User / Care Setting
hospital environment or medical office 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)
No clinical studies were performed.
Nonclinical Tests:
- Electrical safety per IEC/EN 60601-1:2005/2006+A1:2012/2013+A2:2020/2021.
- Electromagnetic Compatibility per IEC/EN 60601-1-2:2014/2015+A1:2020/2021
- Sterilization Validation per ISO 11135:2014 and ISO 11737-1:2019
- Package Integrity per ISO 11607-1:2019
- EO/ECH Residue per ISO 10993-7:2008
- Transportation test per ASTM D4169-22
- Aging test per ASTM F1980-16
- Light hazards per IEC 62471:2006
- Biocompatibility:
- Cytotoxicity test per ISO 10993-5:2009
- Sensitization and Irritation test per ISO 10993-10:2021
- Material mediated pyrogenicity and systemic toxicity test per ISO 10993-. 11:2017
- Optical and Color performance testing
Bench performance tests support the conclusion of substantial equivalence.
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
§ 874.4680 Bronchoscope (flexible or rigid) and accessories.
(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
May 1, 2024
Medimaging Integrated Solution, Inc. (MiiS) Sandy Chou Regulatory Affairs Industry E. Rd. IV, Hsinchu Science Park, Hsinchu, R.O.C. 3F., No.24-2 Hsinchu. 30077 Taiwan
Re: K234113
Trade/Device Name: MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: December 27, 2023 Received: December 27, 2023
Dear Sandy Chou:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-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.
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,
2
Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K234113
Device Name
Bronchoscope: MiiS Horus Bronchoscope Tablet: MiiS Horus Endoscope Display System -Tablet Video Box: MiiS Horus Endoscope Display System -Video Box
Indications for Use (Describe)
MiiS Horus Bronchoscope:
The MilS Horus Bronchoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiS Horus Endoscope Display System -Video Box (EVS 700). The device provides endoscopic visualization of airways and tracheobronchial tree, in conjunction with displaying system to perform various endoscopic procedures.
The MilS Horus Bronchoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.
MiiS Horus Endoscope Display System -Tablet:
The MiS Horus Endoscope Display System -Tablet (EDS 500) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.
MiiS Horus Endoscope Display System -Video Box:
The MilS Horus Endoscope Display System -Video Box (EVS 700) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.
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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4
Image /page/4/Picture/0 description: The image shows a logo with a circular target-like design at the top and the text "Miis" at the bottom. The target design consists of concentric circles divided into quadrants, with alternating shades of gray and black. The text "Miis" is written in a bold, blue font and is underlined.
Medimaging Integrated Solution Inc.
510(k) Summary
| Prepared: | March 28, 2024 |
|---|---|
| Submitter/Owner's | |
| Name/ Address | Medimaging Integrated Solution Inc. (MiiS) |
| 3F., No. 24-2, Industry E. Rd. IV, Hsinchu Science Park, Hsinchu, 30077, | |
| Taiwan, R.O.C. | |
| Contact Person: | Sandy Chou |
| Telephone: | +886-3-5798860 Ext: 1701 |
| Fax: | +886-3-5798011 |
| Email Address: | ra@miis.com.tw |
5
Image /page/5/Picture/0 description: The image is 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 and white segments. The word "MiiS" is written in a bold, sans-serif font and is underlined with a blue line. The entire logo is set against a white background with a rounded blue border.
ledimaging Integrated Solution Inc.
Device Identification:
Trade/Device Name: Bronchoscope: MiiS Horus Bronchoscope Tablet: MiiS Horus Endoscope Display System -Tablet Video Box: MiiS Horus Endoscope Display System -Video Box Common Name: Bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories. Regulatory Class: Class II Product Code: EOQ
Predicate Device:
K173727 Trade/Device Name: Ambu® aScope™ 4 Broncho Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories. Regulatory Class: Class II Product Code: EOQ
Description of Device:
MiiS Horus Bronchoscope (ECB 100 S/R/L) is a single-use, flexible, sterile Bronchoscope. The device provides visualization for endoscopic procedures within the airways and tracheobronchial tree.
MiiS Horus Bronchoscope (ECB 100 S/R/L) have an LED light source and a camera at the distal end of the applied part. The Bronchoscope needs to connect with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System - Video Box (EVS 700) and the signal captured was then transmitted to the cable-connected display system. Both the Tablet and Video box are reusable devices.
MiiS Horus Endoscope Display System -Tablet (EDS 500) is a tablet which showing live image or snapshot from ECB 100.
MiiS Horus Endoscope Display System -Video Box (EVS 700) is a standalone imaging transfer system; it can be connected to computer to project live imaging. If needed, the pictures or videos can be storage to Tablet (EDS 500 Tablet) or computer.
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 working channel provide access for accessories to conduct surgical procedures.
MiiS Horus Bronchoscope has been designed to be compatible with the following endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA).
Page 2
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Image /page/6/Picture/0 description: The image is a logo with a white background and rounded corners. The logo features a circular target-like design in the upper portion, composed of concentric rings alternating in shades of gray and black. The lower portion of the logo contains the word "MiiS" in bold, blue letters. A blue line is present directly above the word "MiiS".
naging Integrated Solution Inc.
ECB-100S (Slim): Minimum ETT inner diameter: 5.0 mm, Minimum DLT size: 35 Fr, EA minimum working channel width: up to 1.2 mm.
ECB-100R (Regular): Minimum ETT inner diameter: 6.0 mm, Minimum DLT size: 41 Fr, EA minimum working channel width: up to 2.0 mm.
ECB-100L (Large): Minimum ETT inner diameter: 7.0 mm, EA minimum working channel width: up to 2.8 mm.
Indications for Use (IFU):
MiiS Horus Bronchoscope:
The MiiS Horus Bronchoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system MiiS Horus Endoscope Display System -Tablet (EDS 500) or MiiS Horus Endoscope Display System -Video Box (EVS 700). The device provides endoscopic visualization of airways and tracheobronchial tree, in conjunction with displaying system to perform various endoscopic procedures.
The MiiS Horus Bronchoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.
MiiS Horus Endoscope Display System -Tablet:
The MiiS Horus Endoscope Display System -Tablet (EDS 500) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.
MiiS Horus Endoscope Display System -Video Box:
The MiiS Horus Endoscope Display System -Video Box (EVS 700) is intend for use with a MiiS Horus Bronchoscope for endoscopic diagnosis treatment, and video observation.
Substantial Equivalence Summary
Below is a summary table comparing the IFUs and key technological characteristics between the subject and the predicate devices.
| Item | Subject Device
MiiS Horus Bronchoscope | Predicte Device
Ambu® aScope™ 4 Broncho |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Medimaging Integrated Solution Inc. | Ambu Inc. |
| Model name | Bronchoscope:
MiiS Horus Bronchoscope
Tablet: | Ambu® aScope™ 4 Broncho |
| | | |
| | MiiS Horus Endoscope Display System -Tablet
Video Box:
MiiS Horus Endoscope Display System -Video
Box | |
| | -- | K173727 |
| | | |
| K Number | | |
| Product code &
Classification | 21 CFR 874.4680,
EOQ Class II | 21 CFR 874.4680,
EOQ Class II |
| Intended use | MiiS Horus Bronchoscope:
The MiiS Horus Bronchoscope is a sterile,
single-use, and flexible device intended to be
operated with its compatible display system
MiiS Horus Endoscope Display System -Tablet
(EDS 500) or MiiS Horus Endoscope Display
System - Video Box (EVS 700). The device
provides endoscopic visualization of airways
and tracheobronchial tree, in conjunction with
displaying system to perform various
endoscopic procedures.
The MiiS Horus Bronchoscope is intended for
use in a hospital environment or medical office
environment. It is designed for use in adults.
MiiS Horus Endoscope Display System -
Tablet:
The MiiS Horus Endoscope Display System -
Tablet (EDS 500) is intend for use with a MiiS
Horus Bronchoscope for endoscopic diagnosis
treatment, and video observation.
MiiS Horus Endoscope Display System -Video
Box:
The MiiS Horus Endoscope Display System -
Video Box (EVS 700) is intend for use with a
MiiS Horus Bronchoscope for endoscopic
diagnosis treatment, and video observation. | The Ambu® aScope™ 4 Broncho is a sterile,
single-use, flexible endoscope intended for
endoscopic
procedures and examination within the airways
and tracheobronchial tree.
The endoscope is intended to provide
visualization via Ambu displaying unit.
The endoscope is intended for use in a hospital
environment. It is designed for use in adults. |
| Lens Specification | FOV: 120°
DOV: 0°
DOF: 3-50 mm | FOV: 85°
DOV: 0°
DOF: 6-50 mm |
| Mechanical
Specification | Bending angle:
Up: 180°/Down: 180°
Working length:
600 mm
Maximum Diameter of Insertion Section
●
S: 4.2 mm
R: 5.4 mm
L: 6.2 mm
Minimum Working Channel Diameter
●
S: 1.2 mm
R: 2.2 mm
L: 3.0 mm
Minimum ETT Inner Diameter Size
● | Bending angle:
Up: 180°/Down: 180°
Working length:
600 mm
Maximum Diameter of Insertion Section
●
S: 4.3 mm
R: 5.5 mm
L: 6.3 mm
Minimum Working Channel Diameter
●
S: 1.2 mm
R: 2.0 mm
L: 2.6 mm
Minimum ETT Inner Diameter Size
● |
| | R: 6.0 mm | R: 6.0 mm |
| | L: 7.0 mm | L: 7.0 mm |
| | ● Minimum DLT Inner Diameter Size | ● Minimum DLT Inner Diameter Size |
| | S: 35 Fr | S: 35 Fr |
| | R: 41 Fr | R: 41 Fr |
| | L: N/A | L: N/A |
| | EMC | IEC 60601-1-2 |
| Safety | IEC 60601-1
IEC 60601-2-18 | IEC 60601-1
IEC 60601-2-18 |
| Bench test | ISO 8600-1
ISO 8600-3
ISO 8600-4 | ISO 8600-1
ISO 8600-3
ISO 8600-4 |
| Sterilization | EO Sterilization | EO Sterilization |
| LED Light source | At distal tip | At distal tip |
| Appearance | Image: Three endoscopes | Image: Three endoscopes |
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Image /page/7/Picture/0 description: The image shows a logo with the text "MiiS" in blue, underlined, and in a bold font. Above the text is a circular graphic with concentric rings divided into quadrants. The quadrants alternate between white and shades of gray, creating a target-like appearance. The logo is contained within a rounded rectangular border.
Medimaging Integrated Solution Inc.
8
Image /page/8/Picture/0 description: The image shows a logo with a circular target-like design at the top, divided into black and white halves. The target has concentric rings of varying shades of gray. Below the target, the text "MiiS" is written in blue, with the letters underlined. The logo is enclosed in a rounded rectangle with a blue border.
Medimaging Integrated Solution Inc.
Summary of the technological characteristics in comparison to the predicate devices
Similarities:
"MiiS Horus Bronchoscope" and its compatible display system (MiiS Horus Endoscope Display System Tablet (EDS 500) or MiiS Horus Endoscope Display System Video Box (EVS 700)) and the predicate device, Ambu Inc. Ambu® aScope™ 4 Broncho (K173727), have the same intended use and same mechanical specifications such as bending angle, working length, minimum endotracheal tubes (ETT) inner diameter and minimum double lumen tubes (DLT) inner diameter size.
Besides, subject Device has equivalent lens specifications such as field of view, direction of view.
9
Image /page/9/Picture/0 description: The image is a logo with a circular design at the top and the text "MiiS" at the bottom. The circular design consists of concentric circles divided into quadrants, with alternating shades of gray and black. The text "MiiS" is written in blue, with a line underneath it. The logo has a white background and a blue border.
1edimaging Integrated Solution Inc.
Differences:
The difference lies in the mechanical specifications including diameter of insertion section and the minimum working channel diameter. The insertion diameter is smaller 0.1 mm than predictive device. For minimum working channel diameter, the subject device is larger 0.2 ~0.4 mm, which can make the auxiliary device easier to operate. The usability proves that the difference did not raise any clinical difficulties. Thus, it is considered that there is no significance difference occurs between MiiS Horus Bronchoscope with its predicate devices.
Nonclinical Tests
The following tests have been performed in support of the substantial equivalence determination:
- Electrical safety per IEC/EN 60601-1:2005/2006+A1:2012/2013+A2:2020/2021. ।
- Electromagnetic Compatibility per IEC/EN 60601-1-2:2014/2015+A1:2020/2021 ।
- Sterilization Validation per ISO 11135:2014 and ISO 11737-1:2019 -
- Package Integrity per ISO 11607-1:2019 -
- EO/ECH Residue per ISO 10993-7:2008 ।
- Transportation test per ASTM D4169-22 ।
- Aging test per ASTM F1980-16 ।
- Light hazards per IEC 62471:2006 ।
- Biocompatibility: ।
- . Cytotoxicity test per ISO 10993-5:2009
- . Sensitization and Irritation test per ISO 10993-10:2021
- Material mediated pyrogenicity and systemic toxicity test per ISO 10993-. 11:2017
- Optical and Color performance testing -
Clinical Tests
No clinical studies were performed.
Optical Radiation Safety Assessment
The MiiS Horus Bronchoscope was tested according to ISO 62471:2006 to determine acceptable light safety limits for both the illumination. The test results demonstrate the MiiS Horus Bronchoscope meets the requirements of the standard.
Conclusion
Substantial equivalence comparison and bench performance tests support the conclusion
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Image /page/10/Picture/0 description: The image contains the logo for Medimaging Integrated Solution Inc. The logo features a circular icon with alternating black, gray, and white rings, accompanied by the text "MiiS" in blue. To the right of the icon, the full company name, "Medimaging Integrated Solution Inc.," is displayed in a clear, sans-serif font.
of substantial equivalence of MiiS Horus Bronchoscope to the predicate devices Ambu® aScope™ 4 Broncho (K173727).