San Antonio Stopcock

K181712 · Cook Incorporated · ODC · Jul 26, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K181712
• Device Name: San Antonio Stopcock
• Applicant: Cook Incorporated
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Jul 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

This device is intended to regulate flow through the working channel of a ureteroscope, cystoscope, or other endoscope.

Device Story

San Antonio Stopcock is a one-way stopcock device used to regulate liquid flow through endoscope working channels. Device consists of a polycarbonate body, nylon barbed adapter, and polyethylene valve stem. Operation involves connecting the male luer end to an endoscope and the barbed end to an irrigation set or tubing. Used in clinical settings by healthcare providers during endoscopic procedures to control irrigation or fluid delivery. Device is single-use and provided sterile. Output is the controlled flow of liquids into the endoscope channel, facilitating irrigation or fluid management during procedures.

Clinical Evidence

Bench testing only. Compatibility and leakage testing confirmed performance under gravity flow conditions. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, sensitization, and intracutaneous reactivity, met all acceptance criteria.

Technological Characteristics

Materials: Polycarbonate body, nylon barbed adapter, polyethylene valve stem. Design: One-way stopcock with male luer lock adapter and barbed fitting. Connectivity: Mechanical luer connection. Sterilization: Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for regulating fluid flow through the working channel of ureteroscopes, cystoscopes, or other endoscopes in patients requiring endoscopic procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Endoscopic Cap, Check-Flo® Adapter, Side-Arm Adapter, Tuohy-Borst Adapter (K173105)

Submission Summary (Full Text)

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July 26, 2018

Cook Incorporated James O. Ebot Enaw, M.D., MS Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47402

Re: K181712

> Trade/Device Name: San Antonio Stopcock Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODC Dated: June 27, 2018 Received: June 28, 2018

Dear James O. Ebot Enaw:

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 mav, 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 avare 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.

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Glenn B. Bell -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) K181712

Device Name San Antonio Stopcock

Indications for Use (Describe)

This device is intended to regulate flow through the working channel of a ureteroscope, or other endoscope.

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 Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font. The word "MEDICAL" is set against a darker red background.

510(k) Summary

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA NE. 812.339.2235 TOLL FREE. 800.457.4500 WWW.COOKMEDICAL.COM

San Antonio Stopcock As required by 21 CFR §807.92 Date Prepared: July 09, 2018

Cook Incorporated

Cook Incorporated 750 Daniels Way

[phone]

James O. Ebot Enaw

Bloomington, IN 47404

[phone] x105648

## Submitted By:

Submission: Applicant: Contact: Applicant Address:

Contact Phone: Contact Fax:

#### Device Information:

Trade Name: Common Name: Classification Name: Classification Regulation: Device Class/Classification Panel:

San Antonio Stopcock Endoscope Channel Accessory Endoscope and Accessories 21 CFR §876.1500, Product Code ODC Class II, Gastroenterology/Urology

Traditional 510(k) Premarket Notification

## Predicate Device:

The predicate device is the Endoscopic Cap, Check-Flo® Adapter, Side-Arm Adapter, Tuohy-Borst Adapter cleared on March 22, 2018, under 510(k) K173105.

#### Device Description:

The San Antonio Stopcock is a one-way stopcock with a male luer lock adapter (MLLA) and a barbed fitting. The device is comprised of a polycarbonate body, a nylon barbed adapter, and a polyethylene valve stem. The polycarbonate stopcock body has a MLLA and a female luer adapter (FMLA). The nylon barbed fitting has a MLLA that is attached to the FMLA of the stopcock body. The polyethylene valve stem assembly is seated within the polycarbonate stopcock body and controls the flow of liquids. The San Antonio Stopcock is operated by fitting the male luer end to the female connection of the endoscope and the barbed end to an irrigation set or other tubing. The device is sold sterile and is intended for one-time use.

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Image /page/4/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, sans-serif font, stacked on top of the word "MEDICAL" in white, sans-serif font. The words are set against a red background. The word "COOK" is larger than the word "MEDICAL".

COOK INCORPORATED WWW.COOKMEDIC

# Indications for Use:

This device is intended to regulate flow through the working channel of a ureteroscope, cystoscope, or other endoscope.

# Comparison to Predicate Device:

The proposed device has similar indications for use, methods of operation, and fundamental technological characteristics to the One-Way Stopcock component of the Check-Flo® Adapter included in the predicate device. Differences between the proposed device and the predicate device include minor differences in indications for use, design, and material. Characteristics of the subject device that differ from the One-Way Stopcock component of the Check-Flo® Adapter included in the predicate device are supported by testing and analysis.

# Technological Characteristics:

Performance and biocompatibility testing was conducted in accordance with applicable standards to confirm the reliable performance of device characteristics. The following tests have been conducted on the San Antonio Stopcock, subject of this submission, to ensure reliable design and performance under the specified design requirements:

- . Compatibility and Leakage Testing – Testing demonstrated that the San Antonio Stopcock met the compatibility requirements with supporting devices and that the device does not leak under a gravity flow test setup.
- Biocompatibility Testing Per ISO 10993-1 and FDA guidance, testing for Cytotoxicity, . Sensitization, and Intracutaneous Reactivity demonstrated that the devices are biocompatible.

For these tests, all pre-determined acceptance criteria were met.

## Conclusion:

The results of these tests provide reasonable assurance that the San Antonio Stopcock will function as intended. The available evidence demonstrates that the subject devices are substantially equivalent to the predicate device, the Endoscopic Cap, Check-Flo® Adapter, Side-Arm Adapter, Tuohy-Borst Adapter cleared on March 22, 2018 (K173105). The minor differences between the subject and predicate devices also do not raise new questions of safety and/or effectiveness. The data provided support a determination of substantial equivalence to the predicate device.