(336 days)
Not Found
No
The description focuses on basic image processing (converting light/color to binary) and standard video drivers (UVC). There is no mention of AI, ML, or any advanced algorithms for image analysis or interpretation.
No
The device is described as an endoscope for visualization purposes only; it does not mention any therapeutic function or treatment.
No
The device is an endoscope used for visualization, which is a tool for observation. While the observation can be part of a diagnostic process, the device itself does not perform analysis or interpretation of the images to render a diagnosis. It simply captures and displays images.
No
The device description clearly states it is a portable video endoscope made up of a grip section and insertion tube, which are physical hardware components. While it utilizes software for image processing and connectivity, it is not solely software.
Based on the provided information, the Patcom Distal Chip Endoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- Patcom Endoscope Function: The Patcom Distal Chip Endoscope is used for direct visualization of internal body cavities (mouth, nasal cavity, upper airway) inside the body. It provides real-time images of the anatomy.
The device's function is purely for visualization and examination of internal structures, not for analyzing biological specimens. Therefore, it falls under the category of a medical device used for diagnostic imaging or examination, but not an IVD.
N/A
Intended Use / Indications for Use
The Patcom Distal Chip Endoscope is indicated when endoscopic visualization in the regions of mouth, nasal cavity, and upper airway is required.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
The PatCom Distal Chip Endoscope is a portable video endoscope for visualization in the regions of the mouth, nasal cavity, and upper airway. It is made up of the grip section and insertion tube. It requires connection via USB to a laptop computer, and gains power from the USB ports which supplies 5V of electricity with a maximum current of 0.5A. This is sufficient to power the endoscope. The endoscope does not need an external CCU for image processing, as the processing is done directly on the device on a small chip. It converts the light and color information received by the image sensor into binary numbers (patterns of zeros and ones). The USB Video Class (UVC) driver is a Microsoft-provided AVStream minidriver that provides driver support for USB Video Class devices. When a device uses UVC, it does not need to support their own driver, but instead works automatically with the system-supplied driver. It is compatible to all Windows and Mac computers, with a simple plug and play feature. The visualization from the distal chip is projected onto the computer monitor, at a resolution of 720px1280p high definition.
The insertion tube portion of the device is used for visualization within the natural orifices of the mouth and the nasal cavities and in the upper airway anatomy. The light emitted by the LED light source at the distal end of the tip is illuminated into the body cavity of the subject, and the image is displayed onto a screen.
The grip section of the device contains a control knob for moving the distal end of the insertion tube bend up or down, up to 130 degrees in either direction.
The proximal end of the grip section contains the USB connector, for plug and play with a computer, for power and to provide visualization of the camera chip found at the distal end of the insertion tube.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth, nasal cavity, and upper airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals who have received adequate training in handling nasopharyngoscopes.
Healthcare facility/hospital
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)
Performance Characteristics: The two devices have been submitted to an external accredited laboratory for extensive comparative imaging testing, such as Field of View (FOV, Depth of Field (DOF), Optimum Working Distance, Noise and Dynamic Range, Geometric Distortion, Image Intensity Uniformity (IIU), Color Performance and Latency Assessment for testing the Quality of the real-time video feed.
The tests conducted were performed in compliance with the following regulations:
ISO 8600-1 (2005-05-1): Optics and photonics-Medical endoscopes and endotherapy devices-Part 1: General Requirements
ISO 8600-3 (2019-8): Determination of field of view and direction of view of endoscopes with optics
ISO 8600-5 (2020-10): Determination of optical resolution of rigid endoscopes with optics
ISO 15739 (2017-05): Photography-Electronic still-picture imaging-Noise measurements
ISO 12233 (2023-02): Photography-Electronic still picture imaging-Resolution and spatial frequency responses
All tests results have been determined to support both devices to be substantially equivalent.
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
§ 874.4760 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.
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 28, 2023
H&A Mui Enterprises Inc. Tammy Mui Operations Manager 145 Traders Blvd. E., Unit #34 Mississauga. Ontario L4Z 3L3 Canada
Re: K222587
Trade/Device Name: PatCom Distal Chip Endoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: June 27, 2023 Received: June 28, 2023
Dear Tammy Mui:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222587
Device Name PatCom Distal Chip Endoscope
Indications for Use (Describe)
The Patcom Distal Chip Endoscope is indicated when endoscopic visualization in the regions of mouth, nasal cavity, and upper airway is required.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Mui Scientific. The logo consists of a circle with a dot in the center and three smaller circles around the perimeter. To the right of the logo is the text "Mui Scientific" in a bold, serif font.
Division of
H&A Mui
Enterprises Inc.
145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 www.muiscientific.com Email: mail@muiscientific.com Website:
July 28, 2023
510(k) Summary
Summary prepared by:
Contact Person: Tammy Mui Title: Operations Manager Manufacturer: H&A Mui Enterprises Inc., o/a Mui Scientific Address: 145 Traders Blvd. East, Unit #33-34, Mississauga, Ontario, Canada L4Z 3L3 Phone: (905) 890-5525 Fax: (905) 890-3523 Email: tammy.mui@muiscientific.com
Trade name: PatCom Distal Chip Endoscope Common name: Nasopharyngoscope Classification name: Nasopharyngoscope (flexible or rigid) (as per CFR 874.4760) Class: 2 Review Panel: Ear Nose & Throat Product Code: EOB
| Predicate Device | 510(k) Number | Manufacturer |
|---|---|---|
| Schoelly CMOS Video | ||
| Nasopharyngoscope | K132009 | Schoelly Fiberoptic GmbH |
An agreement exists between the following companies: Note:
- Zhongshan Wesee Meditech Co., Ltd (the actual manufacturer of the endoscopes) 1.
-
- H&A Mui Enterprises Inc, o/a Mui Scientific (the virtual manufacturer of the endoscopes for Canada, the United States, and the EU)
- PatCom Medical Inc (the exclusive distributor for Canada and the United States only) 3.
Indications for Use:
The Patcom Distal Chip Endoscope is indicated when endoscopic visualization in the regions of mouth, nasal cavity, and upper airway is required.
Intended Use:
The PatCom Distal Chip Endoscope is a video endoscope used for visualization to aid in diagnosis in the regions of mouth, nasal cavity, and upper airway.
4
Image /page/4/Picture/0 description: The image shows a circular diagram with a central dot and five smaller circles evenly spaced around the perimeter of a larger circle. The central dot is solid black, and the smaller circles are outlined in black. The larger circle is also outlined in black, creating a symmetrical and geometric design.
145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 www.muiscientific.com Email: mail@muiscientific.com Website:
It is to be used only by healthcare professionals who have received adequate training in handling nasopharyngoscopes.
As the indicated location of use is not considered a sterile environment: sterility of these medical devices is not required
This device is for transient use (under 24 hrs), and will come in direct contact with the patient's mucosal lining.
Device Description:
The PatCom Distal Chip Endoscope is a portable video endoscope for visualization in the reqions of the mouth, nasal cavity, and upper airway. It is made up of the grip section and insertion tube. It requires connection via USB to a laptop computer, and gains power from the USB ports which supplies 5V of electricity with a maximum current of 0.5A. This is sufficient to power the endoscope. The endoscope does not need an external CCU for image processing, as the processing is done directly on the device on a small chip. It converts the light and color information received by the image sensor into binary numbers (patterns of zeros and ones). The USB Video Class (UVC) driver is a Microsoft-provided AVStream minidriver that provides driver support for USB Video Class devices. When a device uses UVC, it does not need to support their own driver, but instead works automatically with the system-supplied driver. It is compatible to all Windows and Mac computers, with a simple plug and play feature. The visualization from the distal chip is projected onto the computer monitor, at a resolution of 720px1280p high definition.
The insertion tube portion of the device is used for visualization within the natural orifices of the mouth and the nasal cavities and in the upper airway anatomy. The light emitted by the LED light source at the distal end of the tip is illuminated into the body cavity of the subject, and the image is displayed onto a screen.
The grip section of the device contains a control knob for moving the distal end of the insertion tube bend up or down, up to 130 degrees in either direction.
The proximal end of the grip section contains the USB connector, for plug and play with a computer, for power and to provide visualization of the camera chip found at the distal end of the insertion tube.
The PatCom Distal Chip Endoscope is substantially equivalent to the Schoelly CMOS Video Nasopharyngoscope, manufactured by Schoelly Fiberoptic GmbH. The Schoelly Nasopharyngoscope has already been approved for the US market since 2014. Similar to the PatCom Distal Chip Endoscope, their nasopharyngoscope also has a grip section, insertion tube section, and a manual knob for angulation of the tip, and are both used for visualization and diagnosis within the nose, mouth and throat.
The Schoelly Nasopharyngoscope has been selected as an equivalent device based on a detailed comparison of intended use, technological, imaging and biological characteristics. The intended use of PatCom Distal Chip Endoscope was considered the same as the predicate device, but small differences were identified for structure and technological characteristics. Rationales have been provided to ensure that these differences do not raise any additional safety or performance risks of the PatCom Distal Chip Endoscope compared with equivalent
5
Image /page/5/Picture/0 description: The image shows the logo for Mui Scientific. The logo consists of a circular graphic to the left of the text "Mui Scientific". The graphic is a circle with a dot in the center and five smaller circles around the perimeter.
Division of
H&A Mui
Enterprises Inc.
145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com
device. Data generated from performance studies undertaken has also been used for comparison and to substantiate that it is safe to extrapolate data from equivalent devices. The main difference between the submitted device and the predicate device is the power supply. The distal end of the grip section contains the USB connector, for plug and play with a laptop computer, for power and to provide visualization of the distal chip found at the end of the insertion tube. I It requires connection via USB to a laptop computer, and gains power from the USB ports which supplies 5V of electricity with a maximum current of 0.5A. This is sufficient to power the endoscope. The device does not need an external CCU for image processing, as the processing is done directly on the device on a small chip. It converts the light and color information received by the image sensor into binary numbers (patterns of zeros and ones). The USB Video Class (UVC) driver is a Microsoft-provided AVStream minidriver that provides driver support for USB Video Class devices. When a device uses UVC, it does not need to support their own driver, but instead works automatically with the system-supplied driver. It is compatible to all Windows and Mac computers, with a simple plug and play feature. The visualization from the distal chip is projected onto the computer monitor, at a resolution of 720px1280p high definition. The predicate device, however, requires connection to a control unit for power, which in turn, is powered by connection to a 110V outlet.
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Trade name | Schoelly CMOS Video | ||
| Nasopharyngoscope | PatCom Distal Chip Endoscope | ||
| 510K holder | Schoelly Fiberoptic GmbH | Mui Scientific | |
| 510K | |||
| number | K132009 | K222587 | |
| Manufacturer | Schoelly Fiberoptic GmbH | Mui Scientific | |
| Indications | |||
| For Use | The Schoelly CMOS Video | ||
| Nasopharyngoscope System may only | |||
| be used by persons with an appropriate | |||
| medical qualification and who are | |||
| acquainted with the rhino/laryngoscopic | |||
| technique. The endoscope is used for | |||
| endoscopic diagnosis within the nasal | |||
| lumens and airway anatomy, and is | |||
| intended to provide visualization via a | |||
| video monitor. | The Patcom Distal Chip Endoscope is | ||
| indicated when endoscopic | |||
| visualization in the regions of mouth, | |||
| nasal cavity, and upper airway is | |||
| required. | |||
| Environment | |||
| of Use | Healthcare facility/hospital | Healthcare facility/hospital | |
| Discussion | In comparing the Indication for Use of the predicate and the proposed device, we | ||
| found they are general similar, but utilizing different terminology for the same | |||
| physical anatomy structures (lumens/cavity, airway anatomy/upper airway). | |||
| According to the description above, the clinical application of the Distal Chip | |||
| Endoscope and the equivalent device are essentially identical and does not pose | |||
| a significant issue of safety or efficacy. | |||
| Technical Specifications | |||
| Power Supply | Endoscope is powered by a 5V d.c., obtained from the USB connection | ||
| control unit. The control unit | |||
| is powered by standard | |||
| 110V outlet via an IEC cable | with a laptop computer | ||
| Field of View | |||
| angle | 85° | 110° | |
| Direction of | |||
| view | 0° | 0° | |
| Depth of Field | 6 - 60mm | 6-60mm | |
| Insertion Tube | |||
| outer diameter | |||
| (mm) | 3.8mm | 3.2mm | |
| Instrument | |||
| Channel | No channel | No channel | |
| Configuration | Light-Emitting (LED), | ||
| Endoscope UP/DOWN | |||
| angulation control knob, | |||
| Bending section | Light-Emitting (LED), Endoscope UP/DOWN | ||
| angulation control knob, Bending section | |||
| Working length | 300mm | 340mm | |
| Angulation | |||
| range | UP130° Down130° | UP130° Down130° | |
| Source of | |||
| examination | |||
| light | LED | LED | |
| Software | Unknown level of concern | ||
| (possibly low); image | |||
| processing done on external | |||
| control unit; proprietary | |||
| driver required | Low level of concern; image processing done | ||
| on internal chip in endoscope; standard USB | |||
| Video Class (UVC) driver | |||
| Discussion | The biggest difference between the proposed and predicate device exists in | ||
| the aspect of power supply. While the predicate device requires power from a | |||
| control box that is directly connected to a 110V outlet, the submission device | |||
| requires only a small amount of power via USB from a laptop computer. The | |||
| electrical safety of the PatCom Distal Chip Endoscope is further supported | |||
| by the successful completion of the required electrical testing. For software, | |||
| both contain image processing firmware and require a driver to connect | |||
| imaging to a monitor. The difference lies in where the image processing | |||
| chip is located, and what type of driver is required for the display monitor, of | |||
| which the PatCom Distal Chip Endoscope is simpler (with the chip directly | |||
| embedded within the endoscope) and easier to use (with the ability to plug | |||
| and play and use any standard UVC driver. The other minor differences | |||
| noted reflect enhanced features, such as having a wider field of view angle | |||
| for better visualization, a smaller insertion tube outside diameter for safer | |||
| intubation and patient comfort, and longer working length to allow for | |||
| improved maneuverability. Therefore, these minor differences are not | |||
| considered to raise different questions of safety and effectiveness compared | |||
| to the predicate device. | |||
| Performance | |||
| Characteristics | The two devices have been submitted to an external accredited laboratory for | ||
| extensive comparative imaging testing, such as Field of View (FOV, Depth of | |||
| Field (DOF), Optimum Working Distance, Noise and Dynamic Range, | |||
| Geometric Distortion, Image Intensity Uniformity (IIU), Color Performance and | |||
| Latency Assessment for testing the Quality of the real-time video feed. | |||
| The tests conducted were performed in compliance with the following | |||
| regulations: | |||
| ISO 8600-1 (2005-05-1): Optics and photonics-Medical endoscopes | |||
| and endotherapy devices-Part 1: General Requirements | |||
| ISO 8600-3 (2019-8): Determination of field of view and direction of | |||
| view of endoscopes with optics | |||
| ISO 8600-5 (2020-10): Determination of optical resolution of rigid | |||
| endoscopes with optics | |||
| ISO 15739 (2017-05): Photography-Electronic still-picture imaging- | |||
| Noise measurements | |||
| ISO 12233 (2023-02): Photography-Electronic still picture imaging- | |||
| Resolution and spatial frequency responses | |||
| All tests results have been determined to support both devices to be | |||
| substantially equivalent. | |||
| Material Characteristics | |||
| Material: | |||
| Bending section | Stainless steel | Stainless steel | |
| Outer | Insertion | ||
| Tube | Undefined "plastic materials" | TPU | |
| cover | Operation handle | Undefined “plastic materials” | ABS |
| Disposable or | |||
| not | Reuseable (high-level disinfection | ||
| reprocessing) | Reuseable (high-level | ||
| disinfection reprocessing) | |||
| Discussion | From the material characteristics compared above, we can see that most of | ||
| the characteristics are the same, except the exact type of plastics used for the | |||
| predicate device are undefined. The plastic material for the operation handle | |||
| would only make skin contact with the user, but the plastic material covering | |||
| the insertion tube would make direct mucosal membrane contact within the | |||
| patient during the visualization. Concerning the Biocompatibility of the outer | |||
| cover material of insertion tube which contacts the patients, we conducted a | |||
| biocompatibility test, including Skin sensitization, Intracutaneous reactivity | |||
| and in Vitro Cytotoxicity per ISO 10993-1:2018, ISO 10993-5:2009, ISO | |||
| 10993-10:2021. From result of the test, we can arrive at a conclusion that | |||
| outer cover material of insertion tube is safe and biocompatible and does not | |||
| raise different issues of safety or effectiveness. |
Below is a comparison table of the PatCom Distal Chip Endoscope with the predicate device:
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Image /page/6/Picture/0 description: The image shows a black and white diagram of a chemical structure. The structure consists of a central black dot surrounded by four white circles. Each white circle is connected to the central dot by a curved line. The overall arrangement of the circles and lines creates a symmetrical pattern around the central dot.
Division of
H&A Mui Enterprises Inc. 145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com
7
Image /page/7/Picture/0 description: The image shows a black and white diagram. There is a black dot in the center of the image. Surrounding the dot are four circles connected by curved lines.
Division of
H&A Mui
Enterprises Inc.
145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com
8
Image /page/8/Picture/0 description: The image shows a circular diagram with a central dot and four smaller circles arranged around the outer edge. The central dot is solid black, while the outer circles are white with black outlines. A thick black line connects the outer circles, forming a closed loop around the central dot.
Division of H&A Mui Enterprises Inc. 145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com
Below is a summary of the tests performed:
| Evaluation
| Description | Summary |
|---|---|
| Biological | |
| Evaluation | Evaluation of the biocompatibility |
| of the materials contained within | |
| the device | |
| Usability | |
| Evaluation | Evaluation of the usability of the |
| device, it's IFU, and labels. | |
| Lifetime | |
| Validation | Validation of the lifetime claims |
| for the device. | |
| Reprocessing | |
| Evaluation | Evaluation of the reprocessing for |
| the device, and validation of the | |
| cleaning and high-level | |
| disinfection processes. | |
| Electrical | |
| Safety | |
| Evaluation | Evaluation of the electrical safety |
| testing of the device. | |
| Software | |
| Evaluation | Evaluation of the software and its |
| validation. | |
| Design | |
| Verification | |
| and Validation | Evaluation of the design of the |
| device. | |
| Imaging | |
| Evaluation | Evaluation of the imaging of the |
| device, and its comparison to the | |
| predicate device. |
Non-Clinical Bench Performance Testing
Mui Scientific
List of Applicable Standards
| Reference | Description |
|---|---|
| MDR Regulation (EU) 2017/745 | European Medical Device Regulations |
| EN ISO 13485:2016 | Medical devices – Quality management systems – System |
| requirements for regulatory purposes. | |
| EN ISO 14971:2019 including | |
| deviations from EN ISO | |
| 14971:2012 | Medical devices – Application of risk management to |
| medical devices | |
| EN ISO 15223-1:2021 | Medical Devices – Symbols to be used with medical device |
| labels, labelling and information to be supplied – Part | |
| 1:General requirements | |
| EN ISO 20417:2021 | Information supplied by the manufacturer of medical |
| devices | |
| EN/IEC 60601-1-2:2014-(Ed.4.0) | Electromagnetic disturbances requirements and tests |
| (EMC) | |
| EN 60601-1:2015/A1:2013 | Medical electrical equipment — General requirements for |
| basic safety and essential performance | |
| FCC Part 15 Subpart B:2015 | Title 47 of the Code of Federal Regulations that covers |
| EMC and is regulated by the Federal Communications | |
| Commission (FCC). | |
| ICES-003:2020 Issue 7 | Information Technology Equipment |
| CAN/CSA C22.2 No.60601-1:2014 | |
| (R2022) | The Canadian Electrical Code, Part II, |
| ANSI/AAMI/IEC 60601-1- | |
| 2:2014/A1:2021 | an American national standard that is equivalent to IEC |
| 60601-1 | |
| IEC 60601-1-6 Ed. 3.1 b:2013 | General requirements for basic safety and essential |
| performance: Usability | |
| IEC 62304:2006/Amd 1:2015 | Medical device software - software life cycle processes |
| EN ISO 10993-1:2018 | Biological evaluation of medical devices Part 1: Evaluation |
| and testing | |
| EN ISO 10993-5:2009 | Biological evaluation of medical devices Part 5: Tests for in |
| vitro cytotoxicity | |
| EN ISO 10993-10:2021 | Biological evaluation of medical devices Part 10: Tests for |
| irritation and skin sensitization | |
| EN ISO 20695:2020 | Catheters other than intravascular catheters -Test methods |
| for common properties | |
| EN IEC 62366-1:2015 | Part 1: Application of usability engineering to medical |
| devices | |
| MEDDEV 2.12-1 rev 8, December | |
| 2013 | Guidelines on a Medical Device Vigilance System. |
| MEDDEV 2.7/1: rev. 4, June 2016 | Clinical evaluation: A guide for manufacturers and notified |
| bodies. | |
| MEDDEV 2.12/2 rev. 2 January | |
| 2012 | Post market clinical follow-up studies; A guide for |
| manufacturers and notified bodies | |
| MDCG 2020-13 | CER Report Template |
| MDCG 2020-5 | Clinical Evaluation - Equivalence A guide for |
| manufacturers and notified bodies | |
| MDCG 2020-6 | Regulation (EU) 2017/745: Clinical evidence needed for |
| medical devices previously CE marked under Directives | |
| 93/42/EEC or 90/385/EEC | |
| MDCG 2020-7 | Post-market clinical follow-up (PMCF) Plan Template A |
| guide for manufacturers and notified bodies | |
| MDCG 2020-8 | Post-market clinical follow-up (PMCF) Evaluation Report |
| Template A guide for manufacturers and notified bodies | |
| MDCG 2019-9 | Summary of safety and clinical performance A guide for |
| manufacturers and notified bodies | |
| ISO/IEC 17050-1:2007 | Conformity assessment - Supplier's declaration of |
| conformity - Part 1: General requirements | |
| ANSI/AAMI ES60601- | |
| 1:2005/A2:2021 | Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential performance |
9
Image /page/9/Picture/0 description: The image shows the logo for Mui Scientific. The logo consists of a circular graphic to the left of the text "Mui Scientific". The graphic is a circle with a dot in the center and four smaller circles around the perimeter. A line is drawn from each of the smaller circles to the center dot.
Division of
H&A Mui Enterprises Inc. 145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com
10
Image /page/10/Picture/0 description: The image shows a circular diagram with a central black dot and five smaller white circles arranged around the perimeter. A thick black line forms a circle connecting the outer white circles. The overall design is simple and geometric, with a focus on circular shapes and contrasting colors.
Division of H&A Mui Enterprises Inc.
145 Traders Blvd. E., Unit #34, Mississauga, ON, Canada, L4Z 3L3 Tel: (905) 890-5525 Toll Free: 1-800-303-6611 Fax: (905) 890-3523 Website: www.muiscientific.com Email: mail@muiscientific.com
Non-Clinical Non-Performance Evaluations
| Evaluation
| Description | Summary |
|---|---|
| Literature | |
| Review | Supports the safety and |
| effectiveness of the device | |
| through the review of existing | |
| literature. | |
| Risk Analysis | Assesses and reviews all the |
| possible risks of the device, and | |
| any mitigation taken. |
Conclusion:
All the non-clinical tests and evaluations that have been implemented either by the Original Manufacturer (WeSeeMed) or by Mui Scientific met the pre-defined criteria and showed that this device is as safe and effective as the predicate within its intended use.