The submitted document, K107409, describes the Byrne Medical DEFENDO™ Disposable Air/Water Valve and compares it to a predicate device, the Olympus® MH-438 Air/Water Valve (K001241). The primary goal of the submission appears to be to demonstrate substantial equivalence to the predicate device, rather than to prove the device meets specific acceptance criteria through a clinical study. The performance data presented focuses on comparative bench testing.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense for a clinical study. Instead, it aims to demonstrate substantial equivalence to a predicate device, which implies that its performance should be comparable to the predicate. The performance reported is from comparative testing against the predicate device for water flow.

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Byrne Medical DEFENDO™)
Water Flow Rate (Overall)	Comparable to Olympus® MH-438 Air/Water Valve	Correlation Coefficient r = 0.989 with Olympus (n=188)
Water Flow Rate (0-7 seconds)	Comparable to Olympus® MH-438 Air/Water Valve	Correlation Coefficient r = 0.96 with Olympus (n=36)

Study Proving Acceptance Criteria:

The study proving the implied acceptance criteria is a comparative performance (bench) test.

Study Type: Comparative Bench Testing (Water Flow Test)
Objective: To compare the water flow rates of the Byrne Medical DEFENDO™ Disposable Air/Water Valve with the Olympus® MH-438 Air/Water Valve.

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

Sample Size (Test Set):
- Overall Water Flow Test: 10 Byrne Medical 100304 Air/Water valves and 10 Olympus MH-438 Air/Water valves. Measurements were taken over a time period of 0 to 40 seconds, yielding an 'n' of 188 for correlation analysis.
- 0-7 Second Interval Water Flow Test: Although the same number of valves were likely used, the analysis focused on a shorter time period, resulting in an 'n' of 36 for correlation analysis.
Data Provenance: The data is generated from bench testing (in-vitro performance testing) and not from human subjects. Therefore, concerns like country of origin for patient data or retrospective/prospective status are not applicable.

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

Not Applicable. This study is a bench test comparing physical device performance (water flow) under controlled conditions. It does not involve human interpretation or subjective assessment that would require expert consensus for a "ground truth" as typically defined in diagnostic studies. The "ground truth" here is the measured performance of the predicate device.

4. Adjudication Method for the Test Set

Not Applicable. As this is a bench test measuring physical parameters, there is no need for an adjudication method by experts. The measurements are objective and quantitative.

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

No. An MRMC study was not conducted. This is a bench test of physical device performance, not a study involving human readers interpreting clinical cases.

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

No. This device is a physical medical instrument (an air/water valve), not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

Bench Test Measurement/Predicate Performance: The "ground truth" in this context is the measured performance of the legally marketed predicate device (Olympus® MH-438 Air/Water Valve). The Byrne Medical device's performance is compared directly against these objective measurements.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not a machine learning algorithm. Hence, there is no "training set."

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

Not Applicable. As there is no training set for a machine learning algorithm, this question is not relevant.

Summary

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K107409.
Pg 1 of 3

Summary of Safety and Effectiveness Data

NOV - 4 2010

The Byrne Medical DEFENDO™ Disposable Air/Water Valve is intended to be used The Bythe Medical DEFEND - Disposable Mining a GI endoscopic procedure.

The Byrne Medical DEFENDO™ Disposable Air/Water Valve is substantialiy The Dyme McGlour DEF ENDO - Sports Water Valve. The following table is a comparison between the two:

Table 14-1: Comparison of features and principles of operation between the DEFENDO™ Disposable Air/Water Valve and Predicate Device (Olympus®MH-438 Air/Water Valve, K001241)

Characteristic	Byrne Medical	Olympus®	Same?
Part number	100304	MH-438	N/A
Trade Name	100304: DEFENDO™Disposable Air/Water Valve	Olympus® EVIS EXERAColovideoscopes	N/A
510(k) DocumentNumber	This submission	K001241	N/A
Product Code	KOG	FDF	No
RegulationNumber	876.1500	876.1500	Yes
Class	II	II	Yes
Review AdvisoryCommittee	Gastroenterology/Urology	Gastroenterology/Urology	Yes
Indications for use	The DEFENDO™Disposable Air/WaterValve is intended to beused to control theair/water function on anendoscope during a GIendoscopic procedure.	The Olympus® Air/Watervalve is intended to beused to control theair/water function on anOlympus ®endoscopeduring a GI endoscopicprocedure.	Yes
Sterile	Yes	No, user must sterilize	No
Single Use	Yes	No, re-sterilize, re-use	No
CompatibleEndoscope(s)	Olympus®140/160/180/240/260series endoscopes	Olympus®140/160/180/240/260series endoscopes	Yes
Patient Population	Male/Female, Pediatric toAdult	Male/Female Pediatric toAdult	Yes
Reusable ordisposable	Disposable	Reuseable	No

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K 102 409
pg r g3

Summary of Safety and Effectiveness Data

Performance Testing

Comparitive Testing

Water Flow Test

Ten BMI 100304 Air/Water valves and ten Olympus MH-438 Air/Water valves Ten DMF 100004 Mirrolet Varros varros side-by-side comparison of flow rates were compared to ouon other in a same as a surements were made over a time through the endoscope, whereby 100 most of flow of water through the scope. penod of 07.4 8000nds measures and intervals for comparison and statistical analysis yielded the following:

Image /page/1/Figure/7 description: The image is a graph comparing the flow rate of the Olympus and Byrne air water valves. The x-axis represents time in seconds, ranging from 0 to 40, while the y-axis represents flow rate in ml/min, ranging from -20 to 100. Both valves show a rapid increase in flow rate initially, reaching a plateau around 80-90 ml/min before sharply decreasing around 25 seconds.

n = 188 Correlation Coefficient r = 0.989

Image /page/1/Figure/9 description: The image is a black and white photograph that appears to be a scan of a document or a piece of paper. The majority of the image is white, with a scattering of small black specks or dots across the surface, giving it a slightly textured or aged appearance. A dark, horizontal line is present near the bottom of the image, stretching across the majority of the width.

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K 102409 pg 3 of 3

Additionally, measurements from 0 – 7 seconds were analyzed for comparison, the 0-7 second period is significant as this is the typical amount of oompanoon, the o i so i so r sens cleaning. The following is a graphical depiction of the results:

n = 36 Correlation coefficient r = 0.96

Image /page/2/Figure/4 description: This image is a line graph comparing two different data sets, labeled as 'Olympus' and 'Byrne'. The x-axis ranges from 0 to 8, while the y-axis ranges from -10 to 90. Both lines show an increasing trend, with 'Byrne' starting at a slightly higher value and generally remaining above 'Olympus'. The 'Olympus' line has a more pronounced dip around x=2 before continuing its upward trajectory.

Olympus vs. Byrne

Based on the above Comparative Testing results and the Bench Testing results (see Bench Testing results, Section 20 of this submission)from the comparison between the Olympus® and the Byrne Medical Air/Water Valves, we have concluded that the Byrne Medical DEFENDO™Disposable Air/Water Valve is substantially equivalent to the Olympus® MH-438 Air/Water Valve.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

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

Mr. John Willis Director of Regulatory Affairs Byrne Medical Inc. 3150 Pollok Dr. CONROE TX 77303

4 2010 NOV

Re: K102409

Trade/Device Name: DEFENDO™ Disposable Air/Water Valve for GI Endoscopes Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscopes and accessories Regulatory Class: II Product Code: ODC, FDF Dated: August 23, 2010 Received: August 24, 2010

Dear Mr. Willis:

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------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 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 of medical device-related

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Page 2

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hukut Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name: DEFENDO™ Disposable Air/Water Valve for GI Endoscopes

2102409

Indications for Use:

The DEFENDO™ Disposable Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ohlut hum

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102409

Page 1 of 1

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.