The Brush Biopsy Sets are intended to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula or calyces under direct vision.

Device Description

The Brush Biopsy Set and Deflectable Brush Biopsy Set are designed to be used through rigid or flexible endoscopes in order to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula, or calyces under direct vision. The Brush Biopsy Set consists of a stainless steel shaft, a catheter, and a nylon brush at the distal tip. The Brush Biopsy Set is available in two sizes: 3.2 French with a length of 115 centimeters, or 5 French with a length of 67 centimeters. The 3.2 French version has a stainless steel wire shaft, a catheter constructed of radiopaque polytetrafluoroethylene, and a connector cap and pin vise located at the proximal end. The 5 French version has a stainless steel coil shaft, a catheter constructed of vinyl radiopaque tubing, and a side-arm adapter attached to the proximal end.

The Deflectable Brush Biopsy Set consists of a stainless steel shaft, a radiopaque vinyl catheter, and a nylon brush at the distal tip. The Deflectable Brush Biopsy Set is 5 French with a length of 67 centimeters. The Deflectable Brush Biopsy Set has a 3-ring handle at the proximal end that allows for deflection of the brush tip to within 15° from the shaft.

The stainless steel shaft of the brush assembly is straight for the length of the catheter, and protrudes 7 centimeters from the distal tip of the catheter on the 5 French Deflectable Brush Biopsy Set to allow for deflection.

The sets will be supplied sterile and are intended for one-time use. The sets are packaged in a peel-open pouch with a three-year shelf life.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Brush Biopsy Set and Deflectable Brush Biopsy Set, as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes performance testing rather than specific, quantified acceptance criteria with corresponding numerical results. Instead, it lists the types of tests performed to demonstrate that the device "met applicable design and performance requirements." It concludes that the device "will perform as intended" based on these tests.

Therefore, I cannot create a table with specific numerical acceptance criteria and reported device performance. The document only lists the categories of tests conducted.

Acceptance Criteria (Category)	Reported Device Performance (Summary)
Biocompatibility	Met applicable design and performance requirements
Dimensional Verification of the Catheter	Met applicable design and performance requirements
Simulated Use and Bristle Integrity	Met applicable design and performance requirements
Corrosion Following Exposure to Artificial Urine	Met applicable design and performance requirements
Tensile Strength (Catheter Shaft, Wire Shaft to Distal Tip, Proximal Wire Shaft)	Met applicable design and performance requirements
Sterilization	Met applicable design and performance requirements
Packaging/Distribution	Met applicable design and performance requirements
Shelf Life/Stability	Met applicable design and performance requirements
Acute Performance in a Porcine Urinary Model	Performed as intended

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

The document does not specify the sample sizes used for any of the tests (e.g., number of devices tested for tensile strength, number of porcine models used, etc.). It also does not explicitly state the provenance of the data (country of origin, whether retrospective or prospective). The testing appears to be conducted by the manufacturer, Cook Incorporated.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to the type of device and testing described. The Brush Biopsy Set and Deflectable Brush Biopsy Set are physical medical devices used for specimen collection. The "ground truth" in this context would relate to the physical properties and functionality of the device itself (e.g., did it break, did it corrode, did it successfully collect a specimen in a model). Expert interpretation of images or clinical data (which is where expert ground truth and adjudication are typically relevant) is not mentioned as part of the performance data.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3. Adjudication methods like 2+1 or 3+1 are used for establishing a consensus ground truth among multiple experts, particularly in image interpretation or clinical diagnosis studies. The performance data here pertains to engineering and material testing of a physical device.

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

No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human readers' performance in tasks like diagnostics. The device described is a physical tool for biopsy, not an AI-powered diagnostic system.

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

No, a standalone algorithm performance study was not done. The device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context would be based on:

Engineering specifications and standards: For dimensional verification, tensile strength, and corrosion.
Direct observation and measurement: For simulated use, bristle integrity, and acute performance in the porcine model (e.g., successful specimen collection, device integrity during use).
Laboratory analysis: For biocompatibility and sterilization efficacy.
Environmental testing: For packaging/distribution and shelf life/stability.

There is no mention of expert consensus, pathology (beyond the specimens collected by the device), or outcomes data used to establish the "ground truth" for the device's technical performance.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument; it does not involve a training set as would be used for machine learning or AI models.

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

This information is not applicable for the reasons stated in point 8.

Summary

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May 1, 2019

Cook Incorporated Chelsea Woods Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47402

Re: K182231

Trade/Device Name: Brush Biopsy Set and Deflectable Brush Biopsy Set Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDX Dated: March 25, 2019 Received: March 26, 2019

Dear Chelsea Woods:

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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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)

K182231

Device Name

Brush Biopsy Set and Deflectable Brush Biopsy Set

Indications for Use (Describe)

The Brush Biopsy Sets are intended to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula or calvces under direct vision.

Type of Use (Select one or both, as applicable)

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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See PRA Statement below.

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Image /page/3/Picture/0 description: The image shows the Cook Medical logo and the text "510(k) Summary". The Cook Medical logo is a red square with the word "COOK" in white letters on the top half. The bottom half of the logo has the word "MEDICAL" in white letters. The text "510(k) Summary" is below the logo in black letters.

COOK INCORPORATED 750 DANIELS WAY, P.O. BOX BLOOMINGTON, IN 47402-0489 U.S 12.339.2235 TOLLEREE: 800.457.4500 WWW.COOKMEDICAL.COM

K182231 Page 1 of 3

Brush Biopsy Set and Deflectable Brush Biopsy Set 21 CFR §876.1500 Date Prepared: April 25, 2019

Submitted By:

Submission: Applicant: Primary Contact: Secondary Contact: Applicant Address:

Primary Contact Phone: Secondary Contact Phone: Contact Fax:

Device Information:

Trade Name:

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

Traditional 510(k) Premarket Notification Cook Incorporated Chelsea Woods Andrew Breidenbach Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 339-2235 x104707 (812) 339-2235 x105147 (812) 332-0281

Brush Biopsv Set and Deflectable Brush Biopsy Set Endoscopic Cytology Brush Endoscope and accessories 21 CFR §876.1500, Product Code FDX Class II, Gastroenterology/Urology

Predicate Devices:

Primary predicate device: Vance Deflectable Biopsy Brush Set (K810372)
Secondary predicate device: Urological Biopsy Brush Set (K770913)

Device Description:

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Image /page/4/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, sans-serif font in the upper portion of the logo. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font.

750 DANIELS WAY, P.O. LOOMINGTON, IN 47402-04 12 339 2235 TOULESEE, 800 4 WWW.COOKMEDIC

shaft, a catheter constructed of radiopaque polytetrafluoroethylene, and a connector cap and pin vise located at the proximal end. The 5 French version has a stainless steel coil shaft, a catheter constructed of vinyl radiopaque tubing, and a side-arm adapter attached to the proximal end.

The sets will be supplied sterile and are intended for one-time use. The sets are packaged in a peel-open pouch with a three-year shelf life.

Indications for Use:

The Brush Biopsy Sets are intended to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula or calyces under direct vision.

Comparison to Predicate Devices:

The Brush Biopsy Set and Deflectable Brush Biopsy Set are substantially equivalent to the predicate devices, Vance Deflectable Biopsy Brush Set (K810372), and Urological Biopsy Brush Set (K770913) in that the devices have the same intended uses and fundamental technological characteristics and are similar in design, dimensions, and materials of construction.

The differences from the predicate Vance Deflectable Biopsy Brush Set (K810372) include:

. Indications for Use
. Catheter sizes
Packaging, sterilization method, and shelf life (not stated in predicate 510(k)s) .

The differences from the predicate Urological Biopsy Brush Set (K770913) include:

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Image /page/5/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font, and is placed at the top of the logo. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font, set against a black trapezoid.

COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

K182231 Page 3 of 3

Indications for Use ●
Catheter material ●
. Catheter sizes
Proximal fitting on 5 Fr Brush Biopsy Set ●
Packaging, sterilization method, and shelf life (not stated in predicate 510(k)s) ●

Characteristics of the subject device sets that differ from the predicate devices are supported by testing and analysis.

Performance Data:

The following testing was performed in order to demonstrate that the subject Brush Biopsy Set and Deflectable Brush Biopsy Set met applicable design and performance requirements:

Biocompatibility .
. Dimensional Verification of the Catheter
Simulated Use and Bristle Integrity
Corrosion Following Exposure to Artificial Urine ●
Tensile Strength ●
- . Catheter Shaft
- Wire Shaft to Distal Tip .
- . Proximal Wire Shaft
. Sterilization
Packaging/Distribution ●
Shelf Life/Stability ●
Acute Performance in a Porcine Urinary Model

Conclusion:

The results of these tests support a conclusion that the Brush Biopsy Set and Deflectable Brush Biopsy Set will perform as intended. The subject devices do not raise new questions of safety or effectiveness as compared to the predicate devices. Therefore, the data provided in this submission support a determination of substantial equivalence.

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.