The Single-Use Introducer is used for patient esophageal intubation to guide the catheters and tubes via the nasal or oral cavity. It is to be used in conjunction with endoscopes to allow visualization of the placement process. The Single-Use Introducer is to be used in a hospital or clinical setting and under the supervision of a qualified healthcare professional who has received professional training in using the equipment.

The Single-Use Introducer is provided non-sterile, and is intended to be non-reusable.

The Single-Use Introducer is for transient use (under 24 hrs), and will come in direct contact with the patient's mucosal lining.

Device Description

The PatCom Single-Use Introducers are made from single lumen, medical grade polyvinyl chloride plastics. The tubing length is 30cm, with an open tip at one end, and a polycarbonate cone made of 2 halves at the other end.

This device is designed to work in conjunction with endoscopes to make the placement of certain catheters and tubes more pleasant for the patient and easier for the end user. The endoscope is placed inside the introducer and both devices together are guided through the nasal or oral passage into the pharynx, via the visual aid provided by the endoscope. The purpose of the visual aid is to prevent unnecessary aggravation of the nasopharyngeal or oropharyngeal wall. Once the introducer is in its desired position, the endoscope is extracted.

The introducer then functions as an open channel from the mouth or the tip of the nose through to the distal opening end of the introducer, as a guide for the placement of catheters and tubes, especially ones that do not contain their own open lumen for use of guidewires that are standard in the gastrointestinal industry. By feeding the catheters or tubes through the introducer, it again minimizes any possible aggravation of the pharyngeal wall as the catheters and tubes would follow the tunnel created by the introducer.

After the catheter is inserted through the introducer and placed into its proper positioning, the introducer is then extracted out of the nasal or oral cavity along the length of the catheter. Once the entire introducer is exposed, the user grips the 2 halves of the cone and pulls apart the introducer to remove and discard.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically an "PatCom Single-Use Introducer." It focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data as would be found for a novel AI/software medical device.

Therefore, much of the requested information regarding AI-specific studies, ground truth establishment, expert adjudication, and comparative effectiveness (MRMC) cannot be found in this type of document.

The document primarily describes nonclinical bench testing to demonstrate the device's performance, safety, and effectiveness.

Here's an attempt to answer your questions based on the provided text, indicating where information is not applicable or not present:

1. Table of acceptance criteria and the reported device performance

The document mentions that "Individual verification testing was conducted to verify the performance requirements and specifications of the introducer..." and lists the types of tests. However, it does not provide specific numerical acceptance criteria or detailed reported performance values for these tests. It only states that "All testing and results were successfully completed."

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Dimensional verification meets specifications	Successfully completed
Visual inspection meets quality standards	Successfully completed
Kink resistance within acceptable limits	Successfully completed
Tensile strength within acceptable limits	Successfully completed
Device is as safe and effective as predicate	Demonstrated through testing

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

Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for nonclinical bench testing.
Data Provenance: The testing was conducted by H&A Mui Enterprises Inc., o/a Mui Scientific, which is based in Mississauga, Ontario, Canada (manufacturer's address). This is a prospective set of nonclinical bench tests.

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

This device is not an AI/software device that relies on human expert interpretation for "ground truth" in the way clinical diagnostic AI products do. Therefore, information about experts for establishing ground truth is not applicable/not provided. The "ground truth" for nonclinical bench testing is typically defined by engineering specifications and objective measurements against those specifications.

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

Not applicable. As the "test set" refers to nonclinical bench testing, there is no human adjudication process involved as there would be for subjective clinical assessments. The results are objective measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI device, and therefore, an MRMC study comparing human readers with and without AI assistance was not performed and is not applicable.

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

No. This is a physical medical device, not an algorithm. Standalone algorithm performance is not applicable.

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

For the nonclinical bench testing, the "ground truth" is based on engineering specifications and objective physical measurements (e.g., dimensions, force required for kinking, tensile strength). There is no "expert consensus" or "pathology" in this context.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no training set in the context of data used to train an algorithm.

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

Not applicable. As there is no AI/machine learning training set, this question is not relevant to the PatCom Single-Use Introducer.

Summary

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February 21, 2020

H&A Mui Enterprises Inc. Tammy Mui Operations Manager 145 Traders Blvd. E., Unit #34 L4Z 3L3 Mississauga, Ontario CANADA

Re: K192691

Trade/Device Name: PatCom Single-Use Introducer Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: December 13, 2019 Received: December 18, 2019

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

Sincerely,

for

Shani P. Haugen, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K192691

Device Name PatCom Single-Use Introducer

Indications for Use (Describe)

The Single-Use Introducer is provided non-sterile, and is intended to be non-reusable.

The Single-Use Introducer is for transient use (under 24 hrs), and will come in direct contact with the patient's mucosal lining.

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/1 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 circle is the text "Mui Scientific" in a 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

February 10, 2020

510(k) Summary

RE: PatCom Single-Use Introducer

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 Single-Use Introducer Common name: Introducer Classification name: Endoscopes and accessories (as per CFR 876.1500)

This 510(k) Summary is for the PatCom Single-Use Introducer

Indications for Use:

The Single-Use Introducer is to be used in a hospital or clinical setting and under the supervision of a qualified healthcare professional who has received professional training in using the equipment.

The Single-Use Introducer is provided non-sterile, and is intended to be non-reusable.

The Single-Use Introducer is for transient use (under 24 hrs), and will come in direct contact with the patient's mucosal lining.

Device Description:

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Image /page/4/Picture/1 description: The image shows the logo for Mui Scientific. The logo consists of a circular atom-like symbol on the left, followed by the text "Mui Scientific" on the right. There are two horizontal lines above and below the text.

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

nasal or oral passage into the pharynx, via the visual aid provided by the endoscope. The purpose of the visual aid is to prevent unnecessary aggravation of the nasopharyngeal or oropharvngeal wall. Once the introducer is in its desired position, the endoscope is extracted.

The introducer then functions as an open channel from the mouth or the tip of the nose through to the distal opening end of the introducer, as a quide for the placement of catheters and tubes, especially ones that do not contain their own open lumen for use of guidewires that are standard in the gastrointestinal industry. By feeding the catheters or tubes through the introducer, it again minimizes any possible aggravation of the pharyngeal wall as the catheters and tubes would follow the tunnel created by the introducer.

We are claiming equivalence to the following predicate device:

Product Name	510(k) Number	Manufacturer
Enteroscopy Overtube	K100081	United States Endoscopy Group

The PatCom Single-Use Introducers are similar to the overtubes manufactured by United States Endoscopy Group in that they have the same intended purpose, where both devices require the use of a scope, are slid over top of the endoscopic device, and are used to aid in the guidance of medical devices to be inserted into the upper gastrointestinal tract.

We would also like to acknowledge a reference device, listed below:

Product Name	510(k) Number	Manufacturer
Motility Catheters	K823701	H&A Mui Enterprises Inc., o/a MuiScientific

The PatCom Single-Use Introducers are similar to the motility catheters manufactured by Mui Scientific in that they are also made of the same polyvinyl chloride (PVC) and polycarbonate (PC) material as the motility catheters, and are assembled following similar manufacturing procedures. They are both also intubated into a patient via the same nasal or oral cavity pathway.

Below, please find a comparison table of the PatCom Single-Use Introducer with the predicate device and reference device:

	Submission Device	Predicate Device	Reference Device
Trade name	PatCom Single-UseIntroducer	Enteroscopy Overtube	Motility Catheters
510K holder	Submitter: H&A MuiEnterprises, o/a MuiScientific	United States EndoscopyGroup	H&A Mui Enterprises,o/a Mui Scientific
510K number	K192691	K100081	K823701
Indication for	The Single-Use Introducer is used for	The Enteroscopy	To be inserted via the

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Image /page/5/Picture/1 description: The image shows the logo for Mui Scientific. The logo consists of a circular symbol to the left of the text "Mui Scientific". The word "Scientific" is underlined.

Division of 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:

use	patient esophageal intubation toguide the catheters and tubes via thenasal or oral cavity. It is to be used inconjunction with endoscopes to allowvisualization of the placementprocess. The Single-Use Introducer isto be used in a hospital or clinicalsetting and under the supervision of aqualified healthcare professional whohas received professional training inusing the equipment. The Single-UseIntroducer is provided non-sterile, andis intended to be non-reusable. TheSingle-Use Introducer is for transientuse (under 24 hrs), and will come indirect contact with the patient'smucosal lining.	Overtube is indicated foruse to aid the insertion,advancement andremoval of appropriatelysized endoscopes andendoscopic devicesduring diagnostic andtherapeutic endoscopicprocedures in the uppergastrointestinal tract,including the smallintestine.	nasal passage, orally, oranorectally, to measurethe muscle contractionsalong thegastrointestinal system.
Device OD	5mm-6mm	Not found in the predicate510(k) Summary	Various (2.5mm-6.2mm)
Device ID	4mm-5mm	Not found in the predicate510(k) Summary	Various (0.4mm-3.3mm)
Material	PVC, PC	Not found in the predicate510(k) Summary	PVC, PC, stainless steel
Length	30cm	Not found in the predicate510(k) Summary	Various (100cmstandard)
Number of uses	Single-use	Single-use	Single-use or reusable
Sterility status	Non-sterile	Non-sterile	Non-sterile

Nonclinical bench testing was carried out on the PatCom Single-Use Introducer to verify and validate its performance and intended use. Individual verification testing was conducted to verify the performance requirements and specifications of the introducer, such as dimensional verification, visual inspection, kink resistance testing, and tensile strength testing. Validation testing was then conducted on the user's needs and intended use. All testing and results were successfully completed, thereby demonstrating that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.