The Byrne Medical Irrigation Channel Tubing is used with the Byrne Medical Endo Gallerian Channel The Bear The bythe Medical Inigation Chambr Tablish of an and goes down the channel of an Endoscope. The Byrne Connical Irrigation Channel Tubing is provided sterile and is labeled for single use only.

Device Description

100135 – Byrne Medical Irrigation Channel Tubing provides extension tubing to 100135 – Byrne Medical Inigation Onanor Tubing provides with System is utilized the Endodator - Gyor to clean the Endoscope lens area. to provide libio (water) to clouit the Endoospop as a steriie, single patient use The Endo Gallor ™ System labing solo are cold as a strile, In with product label affixed to the clear side of the package.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an "Irrigation Channel Tubing System" (Model 100135) by Byrne Medical, Inc. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria and device performance metrics as would typically be found in an AI/software device submission.

Therefore, many of the requested sections about acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets are not applicable to this type of regulatory submission. This document describes a physical medical device, not a software algorithm.

However, I can extract the relevant information regarding the testing performed:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria	Reported Device Performance
Flow Rate	Not explicitly stated, but implied to be within acceptable range for intended use.	Minimum pump setting: 155 ml/min
		Maximum pump setting: 650 ml/min
		Measurement error: +/- 4%
Pressure	Withstand pressure up to 10 PSI without leaking or any other failure.	Withstood 10 PSI without leaking or failure.
	(Note: Pump manufacturer's stated maximum pressure is 4.4 PSI, so 10 PSI is a safety margin).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical data. The testing described is bench testing of the physical device.

Sample Size: Not explicitly stated how many units were tested for flow and pressure, nor how many "pump cycles" were performed. It generally refers to "the system" being tested.
Data Provenance: N/A (Bench testing, not human data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

N/A. This was bench testing of a physical device, not an AI/software device requiring expert-established ground truth for interpretation.

4. Adjudication Method for the Test Set

N/A. This was bench testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

N/A. This was bench testing of a physical device, not an AI/software device. No human readers or comparison with/without AI assistance was performed.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

N/A. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the bench tests was derived from empirical measurements against engineering specifications and the performance of the known predicate devices.

Flow Rate: Measured volume over time.
Pressure: Observation of leaks/failures.

8. The Sample Size for the Training Set

N/A. This is a physical device, not an algorithm or AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable as there is no training set for a physical device.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The study described is bench testing conducted by Byrne Medical, Inc. on their Irrigation Channel Tubing System, Model 100135.

Testing Method:
- Bench testing utilized Meditron UGI-3000B™ GI Endoscopy Pumps and EndoGator™ Cartridge and tubing sets.
- Flow testing: Measured total volume over time at minimum and maximum pump settings.
- Pressure testing: The system was tested to a pressure of 10 PSI.
Results:
- Flow testing demonstrated flow rates of 155 ml/min at the minimum pump setting and 650 ml/min at the maximum pump setting, with a measurement error of +/- 4%.
- Pressure testing showed the system withstood 10 PSI without leaking or any other failure, exceeding the pump manufacturer's stated maximum pressure of 4.4 PSI.
Conclusion: Based on these bench tests, the manufacturer concluded that the Byrne Medical Endo Gator™ Irrigation Channel Tubing system is equivalent in safety and efficacy to its predicate devices.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human figures in the negative space of the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Byrne Medical, Inc. % N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548

JUL 2 7 2015

Re: K033695

Trade/Device Name: Irrigation Channel Tubing System, Model 100135 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated (Date on orig SE 1tr): December 9, 2003 Received (Date on orig SE ltr): December 11, 2003

Dear Mr. Devine,

This letter corrects our substantially equivalent letter of December 23, 2003.

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. 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

{1}------------------------------------------------

Page 2 -

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number K D'h Noy o

Device Name: Irrigation Channel Tubing System.

Indications for use:

Prescription Device:

Federal Law (US) restricts this device to sale by or on the order of a physician.

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __

Over-The-Counter Use _

Daniel h. bym

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devic 510(k) ! Number

(Optional Format 1-2-96)

{3}------------------------------------------------

DEC 2 3 2003

510(k) Summary

Date: Nov 12, 2003

Assigned 510(k) "K" Number K033695

This summary of 510(k)-safety and effectiveness information is being submitted in This Summary of OTO(in) canny of 21 CFR Part 807.92.

1. Company making the submission:

	Company
Name:	Byrne Medical, Inc.
Address:	2021 Airport Road
	Conroe, TX 77304
Telephone:	800-490-9869
	936-588-0392
Fax:
Contact:	Don Byrne
	President
	Don@byrnemedical.com

1. Device:

Proprietary Name:	Irrigation Channel Tubing System
Common Name:	Endoscope and accessories
Classification Name:	Accessories, Cleaning, for Endoscope

1. Predicate Devices:

Device Name	Manufacturer	"K" #
Endo Gator™ System	Byrne Medical	K031773
Lsi Endoscope ExternalAccessory	Lsi Solutions	K024301

1. Classification and Product Code: 21 CFR § 876.1500, Class II, 78 KOG.
1. Description:

to provide libio (water) to clouit the Endoospop as a steriie, single patient use The Endo Gallor ™ System labing solo are cold as a strile, In with product label affixed to the clear side of the package.

{4}------------------------------------------------

The Endo Gator™ System tubing sets are sold as a sterile, single patient use The Lindo Gally - Oyotent tabling on-style sterile barrier pouch with product label affixed to the clear side of the package.

1. Indications for Use Statement:
  The Byrne Medical Irrigation Channel Tubing is used with the Byrne Medical Endo The Bythe Medical Inngation Channer vour tubing from the pump and goes down the channel of an Endoscope. The Byrne Medical Irrigation Channel Tubing is provided sterile and is labeled for single use only.
1. Summary of Technological Characteristics and Differences:
  The Endo Gator™ Irrigation Channel Tubing system does not allow passage of additional endoscopic instruments, as does the Lsi Solutions device.

The Endo Gator System and the Irrigation Channel Tubing system and all predicate devices provide water to irrigator pumps or cauterizing units.

1. Contraindications:
  The Endo Gator™ System is not designed, sold or intended for use except as indicated.

No other contraindications are known for this device.

1. Comparison:
  The Byrne Medical Irrigation Channel Tubing System has the same device The Dyne Medious Inigation Shanelies. Difference between some systems is craviding tubing sets sterile for single patient use. The Byrne Medical Irrigation Channel Tubing System allows only the passage of water from the pump.
1. Test Data:
  The Byrne Medical Endo Gator™ Irrigation Channel Tubing system has been rne Dymo Moulear Listery, performance, and validations prior to release.

Bench testing was conducted utilizing Meditron UGI-3000B™GI Endoscopy Bench testing was conducted unizing Mounter San Pools and EndoGator™ Cartridge and tubing sets.

Flow testing was completed at the minimum and maximum settings of the pump r low testing was measured as a function of total volume over time. In each test the minimum pump setting produced 155 ml/min and maximum produced 650 ml/min with a measurement error of +/- 4%.

Pressure testing – EndoGator™ Irrigation Channel Tubing system was tested to 10 PSI without leaking or any other failure. The pump manufacturer's stated maximum pressure is 4.4 PSI.

{5}------------------------------------------------

Conclusions:

The conclusion drawn from these tests is that the Byrne Medical Endo Gator™ Tric Concludion drawn lifem in the equivalent in safety and efficacy to its predicate devices.

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.