The Glo-Tip® Spray Catheter (subject device) is a sterile, single use device compatible with the accessory channel of an endoscope. The device consists of a long, thin polytetrafluoroethylene (PTFE) tube (catheter) with a stylet (metal wire) that together are introduced into the ductal area or elsewhere in the GI tract. Fluid (e.g., water or saline) can be injected through the catheter to spray the tissue that needs cleaning. The Glo-Tip® Spray Catheter can also be used in chromoendoscopy (to apply a dye to the mucosa of the gastrointestinal tract through an endoscope to aid in disease detection).

AI/ML Overview

The provided text describes the Glo-Tip® Spray Catheter and its performance data, but it does not detail a study involving AI or human readers. The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, many of the requested categories related to AI performance, human reader studies, and ground truth establishment in that context are not applicable.

Here's the information that can be extracted and a note on the unavailable information:

Table of acceptance criteria and the reported device performance:

Requirement	Acceptance Criteria (summary)	Reported Device Performance
Packaging shall maintain functional integrity of the device following EO sterilization and shipping.	Meet user requirements and have acceptable visual appearance following two sterilization cycles and simulated shipping conditions.	Packages met acceptance criteria.
Product must perform intended use over labeled shelf life.	Same requirements as above, except following two sterilization cycles and aging.	Product performed as intended over labeled shelf life.
Sterile product must be adequately packaged to maintain sterile barrier during expected shipping conditions.	Non-opened sterile packaging shall not show any signs of functional damage, such as holes in the pouch and/or voids in the seal area after simulated shipping conditions.	No signs of functional damage.
Package maintains sterile barrier over labeled shelf life.	Same requirements as above previous, except following aging.	Package has acceptable sterile barrier.
Device must be a Glo-tip device.	Distal tip of device must be fluoroscopically visible.	Tip is fluoroscopically visible.
The product label shall contain accurate dimensional/compatibility information (Catheter outer diameter and length).	Catheter outer diameter: 6.9 Fr with acceptable tolerance. Working length: 235 with acceptable tolerance.	Device dimensions are in accordance with labeling.
In accordance with ISO 8600-1:2013, Clause 4.3: The maximum insertion portion width shall not be larger than that stated in the instruction manual.	Maximum insertion portion width < 2.6 mm when measured in accordance with ISO 8600-4:2014, using a measuring instrument with a minimum accuracy of 0.05 mm.	Device dimensions are in accordance with labeling (implied by previous result).
Biocompatibility Testing:
ISO 1X MEM Elution Method	(Implied: Non-cytotoxic)	Test article considered not cytotoxic.
ISO Intracutaneous Irritation Study in Rabbits: two extracts	(Implied: Non-irritant)	Test article considered a non-irritant.
ISO Guinea Pig Maximization: two extracts	(Implied: Not a sensitizer)	Test article considered not a sensitizer.
Sterilization:	Sterility assurance level of 10⁻⁶ with acceptable sterilization residuals.	Sterilization validation demonstrates device meets this.

Sample size used for the test set and the data provenance:
The document refers to "Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing." It does not specify sample sizes for these tests, nor the exact provenance of any data used (e.g., country of origin, retrospective/prospective). These are typically internal lab tests conducted by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The performance testing described is for a physical medical device (catheter), not an AI/diagnostic device that would require expert-established ground truth.
Adjudication method for the test set:
Not applicable, as this is for a physical medical device and not an AI/diagnostic device involving expert review.
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:
Not applicable. This is not an AI/diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a physical device like this, "ground truth" would correspond to objective physical, chemical, and biological measurements or observations made during bench, sterilization, biocompatibility, and shelf-life testing, conforming to established standards (e.g., ISO for biocompatibility). There is no "expert consensus" or "pathology" in the diagnostic sense.
The sample size for the training set:
Not applicable. This is not an AI/diagnostic device requiring a training set.
How the ground truth for the training set was established:
Not applicable. This is not an AI/diagnostic device requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

February 1, 2019

Wilson-Cook Medical, Inc. % Daniel Dillon Senior Regulatory Scientist MED Institute 1330 Win Hentschel Boulevard West Lafayette, Indiana 47906

Re: K182319/S001 Trade/Device Name: Glo-Tip® Spray Catheter Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCX Dated: January 24, 2019 Received: January 24, 2019

Dear Daniel Dillon:

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

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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel G. Walter Jr -S

for

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

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Indications for Use

510(k) Number (if known)

K182319

Device Name Glo-Tip® Spray Catheter

Indications for Use (Describe)

The Glo-Tip® Spray Catheter is used in conjunction with an endoscope to spray the gastrointestinal mucosa.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a red background. The red background is shaped like a rectangle with a diagonal cut on the bottom left corner.

510(k) Summary 001.

Glo-Tip® Spray Catheter

Traditional 510(k) Premarket Notification October 1, 2018

Applicant Information

Applicant:	Wilson-Cook Medical, Inc. /Cook Endoscopy4900 Bethania Station RoadWinston-Salem, North Carolina 27105
Contact:	Paula Joyce, Vice President, Regulatory Affairs\CorporateCompliance Officer
Phone:	(336) 744-0157 ext. 396245
Fax:	(336) 201-5994

Device Information

Trade Name:	Glo-Tip® Spray Catheter
Common Names:	Spray catheter
Classification Name:	Endoscope and accessories
Regulation Number:	21 CFR 876.1500
Product Code:	OCX
Device Class:	Class II
Review Panel:	Gastroenterology-Urology

Predicate Device

Name:	Hobbs Mistifier Medical Endoscopic Spray Catheter
510(k) Number:	K030765
Date:	Cleared June 9, 2003

Device Description

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font at the top, and the word "MEDICAL" is in smaller, white, sans-serif font at the bottom.

Spray Catheter can also be used in chromoendoscopy (to apply a dye to the mucosa of the gastrointestinal tract through an endoscope to aid in disease detection).

Indications for Use

The Glo-Tip® Spray Catheter is used in conjunction with an endoscope to spray the gastrointestinal mucosa.

Comparison to Predicate Device

The subject device and predicate device have the same intended use and different technological characteristics, as follows:

Characteristic	Hobbs Mistifier MedicalEndoscopic Spray Catheter(K030765)	Glo-Tip® Spray Catheter(Subject of This 510(k))
Intended Use	Used as a flexible endoscopicaccessory to apply legally marketedsolutions for washing or stainingmucosal tissue.	Used in conjunction with anendoscope to spray thegastrointestinal mucosa.
Design
Catheter working length	165 cm or 260 cm	235 cm
Catheter diameter	2.6 mm	6.9 Fr (2.3 mm)
Compatible scope channel	Unknown	2.8 mm
Spray tip	Forward-facing, 360°	Same
Materials
Catheter	PTFE	PTFE
Proximal-fitting	Unknown	Polycarbonate
Radiopaque crimping band	Unknown	Tantalum
Spray tip	"Metal"	303 Stainless Steel and Brass
Packaging	Unknown	Tyvek/Mylar Pouch
Other
Injection Port?	Yes	Same
Sterile?	Yes	Same
Single Use?	Yes	Same

None of the differences in technological characteristics raise different questions of safety and effectiveness. Furthermore, performance data from acceptable scientific methods provide evidence that the subject device is substantially equivalent to the predicate device.

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K182319 page 3 of 4

Image /page/5/Picture/1 description: The image is a logo for Cook Medical. The logo consists of the word "COOK" in white, bold, sans-serif font, with the registered trademark symbol next to it. Below the word "COOK" is the word "MEDICAL" in white, bold, sans-serif font. The background is a solid red color.

COOK ENDOSCOPY 0 BETHANIA STAT ON-SALEM, NC 27 TOLL FREE: 800 WWW.COOKMEDICAL

Performance Data

Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrates that the Glo-Tip® Spray Catheter meets the performance requirements to fulfill the intended use of the device.

Sterilization validation demonstrates that the device has a sterility assurance level of 10° with acceptable sterilization residuals. Biocompatibility testing is summarized as follows:

Test method	Results
ISO 1X MEM Elution Method	Test article considerednot cytotoxic.
ISO Intracutaneous Irritation Study in Rabbits: two extracts	Test article considereda non-irritant.
ISO Guinea Pig Maximization: two extracts	Test article considerednot a sensitizer.

Requirement	Acceptance Criteria (summary)	Results
Packaging shall maintainfunctional integrity of the devicefollowing EO sterilization andshipping.	Meet user requirements and haveacceptable visual appearancefollowing two sterilization cyclesand simulated shipping conditions.	Packages met acceptancecriteria.
Product must perform intendeduse over labeled shelf life.	Same requirements as above,except following two sterilizationcycles and aging.	Product performed as intendedover labeled shelf life
Sterile product must beadequately packaged to maintainsterile barrier during expectedshipping conditions.	Non-opened sterile packagingshall not show any signs offunctional damage, such as holesin the pouch and/or voids in theseal area after simulated shippingconditions.	No signs of functionaldamage.
Package maintains sterile barrierover labeled shelf life.	Same requirements as aboveprevious, except following aging.	Package has acceptable sterilebarrier.
Device must be a Glo-tip device.	Distal tip of device must befluoroscopically visible.	Tip is fluoroscopically visible.

Shelf-life and non-clinical bench testing is summarized as follows:

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Image /page/6/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and below it, the word "MEDICAL" is in a smaller, white, sans-serif font.

cook endoscopy 4900 bethania station road WINSTON-SALEM, NC 27105 U.S.A. PHONE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM

Requirement	Acceptance Criteria (summary)	Results
The product label shall containaccurate dimensional/compatibility information	Catheter outer diameter: 6.9 Frwith acceptable tolerance.	Device dimensions are inaccordance with labeling.
	Working length: 235 withacceptable tolerance.
In accordance with ISO8600-1:2013, Clause 4.3: Themaximum insertion portionwidth shall not be larger thanthat stated in the instructionmanual	Maximum insertion portion width<2.6 mm when measured inaccordance with ISO 8600-4:2014, using a measuringinstrument with a minimumaccuracy of 0.05 mm

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.