K Number
K181712
Device Name
San Antonio Stopcock
Manufacturer
Date Cleared
2018-07-26

(28 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This device is intended to regulate flow through the working channel of a ureteroscope, cystoscope, or other endoscope.
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.
More Information

Not Found

No
The device description and performance studies focus on mechanical and material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.

No
The device is intended to regulate flow through an endoscope, which is an accessory to a therapeutic procedure, but it does not directly perform a therapeutic function itself.

No
The device is intended to regulate fluid flow through an endoscope, which is a therapeutic rather than a diagnostic function.

No

The device description clearly outlines physical components made of polycarbonate, nylon, and polyethylene, indicating it is a hardware device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "regulate flow through the working channel of a ureteroscope, cystoscope, or other endoscope." This describes a device used during a medical procedure to manage fluid flow within the body, not a device used to test samples outside the body to diagnose a condition.
  • Device Description: The description details a mechanical stopcock with luer lock and barbed fittings. This is consistent with a device used for fluid management in endoscopic procedures. There is no mention of reagents, assays, or analysis of biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring specific substances (analytes)
    • Providing diagnostic information about a patient's health status
    • Using reagents or test kits

The device is clearly intended for use in vivo (within the body) during an endoscopic procedure, which is not the definition of an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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

Product codes

ODC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K173105

Reference Device(s)

Not Found

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.

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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.

1

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,

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

(812) 332-0281

James O. Ebot Enaw

Bloomington, IN 47404

(812) 339-2235 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.

4

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.