(148 days)
No
The device description and intended use focus on a physical introducer made of plastic tubing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is an introducer designed to facilitate the placement of other medical devices (catheters and tubes) by providing a guide channel, rather than directly treating a condition or disease itself. Its function is to make insertion easier and minimize aggravation, which is supportive rather than therapeutic.
No
The device is described as an introducer designed to guide catheters and tubes during esophageal intubation, not to diagnose a medical condition. Its function is to facilitate the placement of other devices, not to acquire information about the patient's health status.
No
The device description clearly indicates it is a physical, single-use introducer made of medical-grade plastic tubing and a polycarbonate cone. It is a hardware device used to guide catheters and tubes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Single-Use Introducer is a physical tool used to facilitate the placement of catheters and tubes into the esophagus via the nasal or oral cavity. It acts as a guide and channel.
- Lack of Specimen Analysis: The device itself does not analyze any biological specimens. Its function is purely mechanical and procedural.
- Intended Use: The intended use clearly describes a procedural aid for intubation and catheter placement, not a diagnostic test performed on a sample.
Therefore, the Single-Use Introducer falls under the category of a medical device used in a clinical procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FED
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 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal, nasal or oral cavity, nasopharyngeal or oropharyngeal wall, pharyngeal wall, upper gastrointestinal tract, small intestine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified healthcare professional, hospital or clinical setting
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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
1
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
2
Indications for Use
510(k) Number (if known) K192691
Device Name PatCom Single-Use Introducer
Indications for Use (Describe)
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.
| 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 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
4
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.
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.
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 Mui |
| Scientific |
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-Use | ||
| Introducer | Enteroscopy Overtube | Motility Catheters | |
| 510K holder | Submitter: H&A Mui | ||
| Enterprises, o/a Mui | |||
| Scientific | United States Endoscopy | ||
| Group | 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 |
5
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 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. | Overtube is indicated for
use to aid the insertion,
advancement and
removal of appropriately
sized endoscopes and
endoscopic devices
during diagnostic and
therapeutic endoscopic
procedures in the upper
gastrointestinal tract,
including the small
intestine. | nasal passage, orally, or
anorectally, to measure
the muscle contractions
along the
gastrointestinal system. |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Device OD | 5mm-6mm | Not found in the predicate
510(k) Summary | Various (2.5mm-6.2mm) |
| Device ID | 4mm-5mm | Not found in the predicate
510(k) Summary | Various (0.4mm-3.3mm) |
| Material | PVC, PC | Not found in the predicate
510(k) Summary | PVC, PC, stainless steel |
| Length | 30cm | Not found in the predicate
510(k) Summary | Various (100cm
standard) |
| 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.