(336 days)
The Patcom Distal Chip Endoscope is indicated when endoscopic visualization in the regions of mouth, nasal cavity, and upper airway is required.
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 provided text is a 510(k) summary for the "PatCom Distal Chip Endoscope," detailing its substantial equivalence to a predicate device. It primarily focuses on comparing the new device's technical specifications, materials, and performance characteristics to those of the predicate device, rather than presenting a study proving the device meets specific acceptance criteria for a new AI/algorithm system.
The document discusses performance characteristics from an engineering perspective (e.g., field of view, depth of field, noise, latency) and states that "extensive comparative imaging testing" was done against the predicate device to show substantial equivalence. However, it does not describe an AI/algorithm-based study with acceptance criteria related to clinical performance metrics like sensitivity, specificity, reader improvement, or expert adjudication. Therefore, most of the requested information regarding AI/algorithm study specifics (MRMC, standalone performance, ground truth establishment, sample sizes for training/test sets, expert qualifications, and adjudication methods) cannot be extracted from this document.
Here's what can be extracted and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists various performance testing categories and applicable standards, implying that the device was tested against criteria outlined in these standards and found to meet them, thereby supporting substantial equivalence to the predicate. However, it does not provide a specific table of acceptance criteria as clinical performance targets (e.g., minimum sensitivity or specificity) for an AI/algorithm, nor exact numerical results for each reported aspect explicitly stated as "device performance." Instead, it generally states that tests "support both devices to be substantially equivalent."
| Evaluation Description/Characteristic | Acceptance Criteria (Implied by Standards/Equivalence) | Reported Device Performance |
|---|---|---|
| Imaging Performance | - Field of View (FOV): Comparison to predicate and suitability for indicated use (ISO 8600-1, ISO 8600-3) | Subject Device: 110° FOV (Predicate: 85°) - "wider field of view angle for better visualization" |
| - Depth of Field (DOF): Comparison to predicate (ISO 8600-1) | Subject Device: 6-60mm (Predicate: 6-60mm) | |
| - Optimum Working Distance (OWD): Comparison to predicate (ISO 8600-1) | Not explicitly detailed, but part of "extensive comparative imaging testing" | |
| - Noise and Dynamic Range: Comparison to predicate (ISO 15739) | Not explicitly detailed, but part of "extensive comparative imaging testing" | |
| - Geometric Distortion: Comparison to predicate (ISO 8600-1, ISO 12233) | Not explicitly detailed, but part of "extensive comparative imaging testing" | |
| - Image Intensity Uniformity (IIU): Comparison to predicate (ISO 8600-1) | Not explicitly detailed, but part of "extensive comparative imaging testing" | |
| - Color Performance: Comparison to predicate (ISO 8600-1) | Not explicitly detailed, but part of "extensive comparative imaging testing" | |
| - Latency Assessment (Quality of real-time video feed): Comparison to predicate (ISO 8600-1) | Not explicitly detailed, but part of "extensive comparative imaging testing" | |
| Biocompatibility | Safety and biocompatibility per ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021 | "Outer cover material of insertion tube is safe and biocompatible and does not raise different issues of safety or effectiveness." |
| Electrical Safety | Compliance with EN/IEC 60601-1-2:2014, EN 60601-1:2015, CAN/CSA C22.2 No.60601-1:2014, ANSI/AAMI/IEC 60601-1-2:2014 | "Successful completion of the required electrical testing." |
| Software | Compliance with IEC 62304:2006/Amd 1:2015 (Medical device software life cycle processes) | "Low level of concern; image processing done on internal chip; standard USB Video Class (UVC) driver." Software validation was successful. |
| Usability | Evaluation of device, IFU, and labels per IEC 60601-1-6 Ed. 3.1 b:2013, EN IEC 62366-1:2015 | Evaluation completed, implies meeting usability requirements. |
| Lifetime Validation | Validation of lifetime claims for the device. | Validation completed. |
| Reprocessing Evaluation | Evaluation and validation of cleaning and high-level disinfection processes. | Evaluation completed. |
| Design Verification and Validation | Evaluation of the device design. | Evaluation completed. |
| Risk Analysis | Assessment of all possible risks and mitigation measures. | Assessment completed, implies risks are adequately controlled. |
2. Sample sized used for the test set and the data provenance
The document describes "extensive comparative imaging testing" against a predicate device. This is bench testing, not a clinical study on patient data. Therefore, there is no "test set" in the context of patient data, nor data provenance (country of origin, retrospective/prospective). The "sample size" would refer to the number of devices or test conditions, which is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was not a study involving human interpretation of images to establish ground truth for clinical cases. The performance evaluation was technical bench testing of the endoscope's imaging capabilities.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no human readers or clinical ground truth adjudication were involved in the described tests.
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. The document explicitly describes bench testing to demonstrate substantial equivalence of a medical imagery device (endoscope), not an AI algorithm. Therefore, no MRMC study or AI assistance effect size is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This document is about an endoscope, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the imaging performance, the "ground truth" would be the known physical properties and measurements from the test targets and laboratory setups used for the imaging evaluations (e.g., resolution charts, color targets). For biocompatibility, it's the results from the specific ISO 10993 tests themselves. For electrical safety, it's compliance with standard electrical safety measurements. These are not clinical ground truths (e.g., pathology, outcomes).
8. The sample size for the training set
Not applicable. There is no AI/algorithm training set mentioned.
9. How the ground truth for the training set was established
Not applicable. There is no AI/algorithm training set mentioned.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & 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
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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
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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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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 VideoNasopharyngoscope | 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.
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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
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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 VideoNasopharyngoscope | PatCom Distal Chip Endoscope | |
| 510K holder | Schoelly Fiberoptic GmbH | Mui Scientific | |
| 510Knumber | K132009 | K222587 | |
| Manufacturer | Schoelly Fiberoptic GmbH | Mui Scientific | |
| IndicationsFor Use | The Schoelly CMOS VideoNasopharyngoscope System may onlybe used by persons with an appropriatemedical qualification and who areacquainted with the rhino/laryngoscopictechnique. The endoscope is used forendoscopic diagnosis within the nasallumens and airway anatomy, and isintended to provide visualization via avideo monitor. | The Patcom Distal Chip Endoscope isindicated when endoscopicvisualization in the regions of mouth,nasal cavity, and upper airway isrequired. | |
| Environmentof Use | Healthcare facility/hospital | Healthcare facility/hospital | |
| Discussion | In comparing the Indication for Use of the predicate and the proposed device, wefound they are general similar, but utilizing different terminology for the samephysical anatomy structures (lumens/cavity, airway anatomy/upper airway).According to the description above, the clinical application of the Distal ChipEndoscope and the equivalent device are essentially identical and does not posea 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 unitis powered by standard110V outlet via an IEC cable | with a laptop computer | ||
| Field of Viewangle | 85° | 110° | |
| Direction ofview | 0° | 0° | |
| Depth of Field | 6 - 60mm | 6-60mm | |
| Insertion Tubeouter diameter(mm) | 3.8mm | 3.2mm | |
| InstrumentChannel | No channel | No channel | |
| Configuration | Light-Emitting (LED),Endoscope UP/DOWNangulation control knob,Bending section | Light-Emitting (LED), Endoscope UP/DOWNangulation control knob, Bending section | |
| Working length | 300mm | 340mm | |
| Angulationrange | UP130° Down130° | UP130° Down130° | |
| Source ofexaminationlight | LED | LED | |
| Software | Unknown level of concern(possibly low); imageprocessing done on externalcontrol unit; proprietarydriver required | Low level of concern; image processing doneon internal chip in endoscope; standard USBVideo Class (UVC) driver | |
| Discussion | The biggest difference between the proposed and predicate device exists inthe aspect of power supply. While the predicate device requires power from acontrol box that is directly connected to a 110V outlet, the submission devicerequires only a small amount of power via USB from a laptop computer. Theelectrical safety of the PatCom Distal Chip Endoscope is further supportedby the successful completion of the required electrical testing. For software,both contain image processing firmware and require a driver to connectimaging to a monitor. The difference lies in where the image processingchip is located, and what type of driver is required for the display monitor, ofwhich the PatCom Distal Chip Endoscope is simpler (with the chip directlyembedded within the endoscope) and easier to use (with the ability to plugand play and use any standard UVC driver. The other minor differencesnoted reflect enhanced features, such as having a wider field of view anglefor better visualization, a smaller insertion tube outside diameter for saferintubation and patient comfort, and longer working length to allow forimproved maneuverability. Therefore, these minor differences are notconsidered to raise different questions of safety and effectiveness comparedto the predicate device. | ||
| PerformanceCharacteristics | The two devices have been submitted to an external accredited laboratory forextensive comparative imaging testing, such as Field of View (FOV, Depth ofField (DOF), Optimum Working Distance, Noise and Dynamic Range,Geometric Distortion, Image Intensity Uniformity (IIU), Color Performance andLatency Assessment for testing the Quality of the real-time video feed. | ||
| The tests conducted were performed in compliance with the followingregulations: | |||
| ISO 8600-1 (2005-05-1): Optics and photonics-Medical endoscopesand endotherapy devices-Part 1: General Requirements | |||
| ISO 8600-3 (2019-8): Determination of field of view and direction ofview of endoscopes with optics | |||
| ISO 8600-5 (2020-10): Determination of optical resolution of rigidendoscopes 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 besubstantially equivalent. | |||
| Material Characteristics | |||
| Material: | |||
| Bending section | Stainless steel | Stainless steel | |
| Outer | InsertionTube | Undefined "plastic materials" | TPU |
| cover | Operation handle | Undefined “plastic materials” | ABS |
| Disposable ornot | Reuseable (high-level disinfectionreprocessing) | Reuseable (high-leveldisinfection reprocessing) | |
| Discussion | From the material characteristics compared above, we can see that most ofthe characteristics are the same, except the exact type of plastics used for thepredicate device are undefined. The plastic material for the operation handlewould only make skin contact with the user, but the plastic material coveringthe insertion tube would make direct mucosal membrane contact within thepatient during the visualization. Concerning the Biocompatibility of the outercover material of insertion tube which contacts the patients, we conducted abiocompatibility test, including Skin sensitization, Intracutaneous reactivityand in Vitro Cytotoxicity per ISO 10993-1:2018, ISO 10993-5:2009, ISO10993-10:2021. From result of the test, we can arrive at a conclusion thatouter cover material of insertion tube is safe and biocompatible and does notraise 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
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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
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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:
| EvaluationDescription | Summary |
|---|---|
| BiologicalEvaluation | Evaluation of the biocompatibilityof the materials contained withinthe device |
| UsabilityEvaluation | Evaluation of the usability of thedevice, it's IFU, and labels. |
| LifetimeValidation | Validation of the lifetime claimsfor the device. |
| ReprocessingEvaluation | Evaluation of the reprocessing forthe device, and validation of thecleaning and high-leveldisinfection processes. |
| ElectricalSafetyEvaluation | Evaluation of the electrical safetytesting of the device. |
| SoftwareEvaluation | Evaluation of the software and itsvalidation. |
| DesignVerificationand Validation | Evaluation of the design of thedevice. |
| ImagingEvaluation | Evaluation of the imaging of thedevice, and its comparison to thepredicate 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 – Systemrequirements for regulatory purposes. |
| EN ISO 14971:2019 includingdeviations from EN ISO14971:2012 | Medical devices – Application of risk management tomedical devices |
| EN ISO 15223-1:2021 | Medical Devices – Symbols to be used with medical devicelabels, labelling and information to be supplied – Part1:General requirements |
| EN ISO 20417:2021 | Information supplied by the manufacturer of medicaldevices |
| 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 forbasic safety and essential performance |
| FCC Part 15 Subpart B:2015 | Title 47 of the Code of Federal Regulations that coversEMC and is regulated by the Federal CommunicationsCommission (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 IEC60601-1 |
| IEC 60601-1-6 Ed. 3.1 b:2013 | General requirements for basic safety and essentialperformance: 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: Evaluationand testing |
| EN ISO 10993-5:2009 | Biological evaluation of medical devices Part 5: Tests for invitro cytotoxicity |
| EN ISO 10993-10:2021 | Biological evaluation of medical devices Part 10: Tests forirritation and skin sensitization |
| EN ISO 20695:2020 | Catheters other than intravascular catheters -Test methodsfor common properties |
| EN IEC 62366-1:2015 | Part 1: Application of usability engineering to medicaldevices |
| MEDDEV 2.12-1 rev 8, December2013 | Guidelines on a Medical Device Vigilance System. |
| MEDDEV 2.7/1: rev. 4, June 2016 | Clinical evaluation: A guide for manufacturers and notifiedbodies. |
| MEDDEV 2.12/2 rev. 2 January2012 | Post market clinical follow-up studies; A guide formanufacturers and notified bodies |
| MDCG 2020-13 | CER Report Template |
| MDCG 2020-5 | Clinical Evaluation - Equivalence A guide formanufacturers and notified bodies |
| MDCG 2020-6 | Regulation (EU) 2017/745: Clinical evidence needed formedical devices previously CE marked under Directives93/42/EEC or 90/385/EEC |
| MDCG 2020-7 | Post-market clinical follow-up (PMCF) Plan Template Aguide for manufacturers and notified bodies |
| MDCG 2020-8 | Post-market clinical follow-up (PMCF) Evaluation ReportTemplate A guide for manufacturers and notified bodies |
| MDCG 2019-9 | Summary of safety and clinical performance A guide formanufacturers and notified bodies |
| ISO/IEC 17050-1:2007 | Conformity assessment - Supplier's declaration ofconformity - Part 1: General requirements |
| ANSI/AAMI ES60601-1:2005/A2:2021 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance |
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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
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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
| EvaluationDescription | Summary |
|---|---|
| LiteratureReview | Supports the safety andeffectiveness of the devicethrough the review of existingliterature. |
| Risk Analysis | Assesses and reviews all thepossible risks of the device, andany 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.
§ 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.