(22 days)
No
The device description and performance studies focus on the mechanical and material properties of a physical biopsy brush, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to obtain pathology specimens, which is a diagnostic purpose, not a therapeutic one.
Yes
This device is intended to obtain pathology specimens, which are then used for diagnostic purposes. While the device itself doesn't perform the diagnosis, it is an essential tool in acquiring the samples needed for diagnosis.
No
The device description clearly outlines physical components such as a stainless steel shaft, catheter, nylon brush, and handle, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a biopsy brush. Its purpose is to obtain the specimen (tissue from the ureter, renal pelvis, etc.) from within the body. It is a tool for collecting the sample, not for analyzing it.
- Intended Use: The intended use clearly states "to obtain pathology specimens". This is a sample collection function, not an in vitro diagnostic function.
The specimens collected by this device would then likely be sent to a pathology lab for in vitro analysis, but the brush itself is not performing that analysis.
N/A
Intended Use / 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.
Product codes
FDX
Device Description
The Deflectable Brush Biopsy Set is 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 Deflectable Brush Biopsy Set consists of a stainless steel shaft, radiopaque polytetrafluoroethylene catheter, and a nylon brush at the distal tip. The Deflectable Brush Biopsy Set is 3.2 French with a length of 115 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 6 centimeters from the distal tip of the catheter.
The sets will be supplied sterile and are intended for one-time use. The sets are packaged in a tray with lid in a peel-open pouch with a three-year shelf life.
The Deflectable Brush Biopsy Set subject of this submission have the same intended use, materials, dimensions, sterilization method, and shelf life as the Cook devices subject of reference submission Brush Biopsy Sets and Deflectable Brush Biopsy Set (K182231).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter, renal pelvis, infundibula or calyces
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
The following testing was performed in order to demonstrate that the subject Deflectable Brush Biopsy Set met applicable design and performance requirements:
- Biocompatibility
- Dimensional Verification of the Catheter
- Bristle Integrity
- Corrosion Following Exposure to Artificial Urine
- Tensile Strength
- Catheter Shaft
- Wire Shaft to Distal Tip
- Handle-to-Wire Shaft
- Sterilization
- Packaging/Distribution
- Shelf Life/Stability
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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June 26, 2019
Cook Incorporated Irasema Rivera Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K191485
Trade/Device Name: Deflectable Brush Biopsy Set Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDX Dated: June 3, 2019 Received: June 4, 2019
Dear Irasema Rivera:
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.
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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Glenn B. Bell. Ph.D. Assistant Division Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K191485
Device Name 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 calyces 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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/0 description: The image shows the Cook Medical logo. 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 "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font.
2.0 510(k) Summary
COOK INCORPORA® 750 DANIELS WAY. P
K191485
Page 1 of 3
Deflectable Brush Biopsy Set 21 CFR §876.1500 Date Prepared: June 3, 2019
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Primary Contact: | Irasema Rivera |
| Secondary Contact: | Paul Meyer |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Primary Contact Phone: | (812) 335-3575 x105166 |
| Secondary Contact Phone: | (812) 335-3575 x105299 |
| Contact Fax: | (812) 332-0281 |
Device Information:
| Trade Name: | Deflectable Brush Biopsy Set |
|---|---|
| Common Name: | Endoscopic Cytology Brush |
| Classification Name: | Endoscope and accessories |
| Classification Regulation: | 21 CFR §876.1500, Product Code FDX |
| Device Class/Classification Panel: | Class II, Gastroenterology/Urology |
Predicate Devices:
- . Primary predicate device: Vance Deflectable Biopsy Brush Set (K810372)
- . Secondary predicate device: Urological Biopsy Brush Set (K770913)
Reference Devices:
- Brush Biopsy Sets and Deflectable Brush Biopsy Set (K182231)
Device Description:
The Deflectable Brush Biopsy Set is 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 Deflectable Brush Biopsy Set consists of a stainless steel shaft, radiopaque polytetrafluoroethylene
4
Image /page/4/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 smaller red rectangle. The "COOK" logo has a registered trademark symbol.
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
Page 2 of 3
catheter, and a nylon brush at the distal tip. The Deflectable Brush Biopsy Set is 3.2 French with a length of 115 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 6 centimeters from the distal tip of the catheter.
The sets will be supplied sterile and are intended for one-time use. The sets are packaged in a tray with lid in a peel-open pouch with a three-year shelf life.
The Deflectable Brush Biopsy Set subject of this submission have the same intended use, materials, dimensions, sterilization method, and shelf life as the Cook devices subject of reference submission Brush Biopsy Sets and Deflectable Brush Biopsy Set (K182231).
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 Deflectable Brush Biopsy Set is 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 Brush Biopsy Set (K810372) include:
- . Indications for Use
- Catheter sizes ●
- Packaging, sterilization method, and shelf life .
The differences from the predicate Urological Biopsy Brush Set (K770913) include:
- . Indications for Use
- Catheter material ●
- . Catheter sizes
- Packaging sterilization method and shelf life .
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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 written in white, sans-serif font in the upper portion of the logo. Below "COOK" is the word "MEDICAL" in white, sans-serif font, set against a red banner.
Characteristics of the subject device set that differ from the predicate devise are supported by testing analysis.
Performance Data:
The following testing was performed in order to demonstrate that the subject Deflectable Brush Biopsy Set met applicable design and performance requirements:
- Biocompatibility ●
- . Dimensional Verification of the Catheter
- . Bristle Integrity
- Corrosion Following Exposure to Artificial Urine ●
- Tensile Strength ●
- Catheter Shaft
- . Wire Shaft to Distal Tip
- . Handle-to-Wire Shaft
- Sterilization
- Packaging/Distribution ●
- Shelf Life/Stability ●
Conclusion:
The results of these tests support a conclusion that the Deflectable Brush Biopsy Set will perform as intended. The subject device does 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.