(60 days)
This device is used to collect cells from the bronchi or upper and lower gastrointestinal tracts.
The Bronchi and Gastrointestinal Cytology Brush (subject device) is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel coil spring terminating in a nylon brush at the distal end. The coil spring and brush are secured inside an extruded polytetrafluoroethylene sheath. The brush is advanced from and retracted into the sheath.
The provided text describes a 510(k) premarket notification for a medical device and outlines its comparison to a predicate device and performance data. However, it does not contain the detailed acceptance criteria and the study that proves the device meets those criteria in the format requested.
Here's a breakdown of why the requested information cannot be fully extracted:
- Acceptance Criteria and Reported Device Performance Table: The document states that the device "meets the performance requirements to fulfill the intended use," but it does not list specific numerical acceptance criteria (e.g., minimum brush cell collection efficiency, maximum material degradation over time) or the quantitative results from testing against those criteria.
- Sample Size and Data Provenance (Test Set): No information regarding sample size for a test set, country of origin, or whether data was retrospective or prospective is present. The document mentions "performance testing," but no specifics on the test set are given.
- Number of Experts and Qualifications (Test Set Ground Truth): The document does not describe any study involving experts establishing ground truth for a test set. This type of information would typically be found in a clinical study report.
- Adjudication Method: Since there's no mention of a study involving experts and ground truth establishment, there is no information on an adjudication method.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The device is a physical cytology brush, not an AI or imaging diagnostic tool, so an MRMC study is not applicable to its evaluation.
- Standalone (Algorithm Only) Performance: Similar to the MRMC study, this is not relevant as the device is a physical tool and not an algorithm.
- Type of Ground Truth Used: No information on what type of ground truth was used for performance validation is provided, as specific study details are absent.
- Sample Size for Training Set: The document does not mention any training set, as it refers to a physical device rather than a machine learning model.
- How Ground Truth for Training Set was Established: Again, this is not applicable for the described device.
What the document does provide regarding performance:
The document states:
"Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Bronchi and Gastrointestinal Cytology Brush meets the performance requirements to fulfill the intended use of the device."
This indicates that a range of tests were performed, but the specific details requested are not disclosed in this summary. These details would typically be found in the full technical documentation submitted as part of the 510(k) application, which is not included here.
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July 31, 2017
Wilson-Cook Medical, Inc. / Cook Endoscopy Doris A. Hawks Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
- Re: K171607
Trade/Device Name: Bronchi and Gastrointestinal Cytology Brush Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDX Dated: May 31, 2017 Received: June 1, 2017
Dear Doris A. Hawks:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Joyce M. Whang -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)
Device Name
Bronchi and Gastrointestinal Cytology Brush
Indications for Use (Describe)
This device is used to collect cells from the bronchi or upper and lower gastrointestinal tracts.
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)
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COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. NE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM
009. 510(k) Summary
Bronchi and Gastrointestinal Cytology Brush
Traditional 510(k) Premarket Notification May 31, 2017
Applicant Information
| Applicant: | Wilson-Cook Medical, Inc. /Cook Endoscopy4900 Bethania Station RoadWinston-Salem, North Carolina 27105 |
|---|---|
| Contact: | Doris A. Hawks, Global Regulatory Affairs Specialist |
| Phone: | (336) 744-0157 ext. 396293 |
| Fax: | (336) 201-5994 |
Device Information
| Trade Name: | Bronchi and Gastrointestinal Cytology Brush |
|---|---|
| Common Name: | Endoscopic Cytology Brush |
| Classification Name: | Endoscope and Accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | FDX |
| Device Class: | Class II |
| Review Panel: | Gastroenterology-Urology |
Predicate Device
| Name: | Wilson-Cook Cytology Brush |
|---|---|
| 510(k) Number: | K896318 |
| Date: | Cleared April 9, 1990 |
Device Description
The Bronchi and Gastrointestinal Cytology Brush (subject device) is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel coil spring terminating in a nylon brush at the distal end. The coil spring and brush are secured inside an extruded polytetrafluoroethylene sheath. The brush is advanced from and retracted into the sheath.
Intended Use
This device is used to collect cells from the bronchi and/or upper and lower gastrointestinal tracts.
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Page 2 of 2 cook endoscopy 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. ONE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM
Comparison to Predicate Device
The Bronchi and Gastrointestinal Cytology Brush has the same intended use, principles of operation, fundamental technologies, and materials of construction as the predicate device. The changes to the subject device involve labeling, incorporating the addition of an Instructions for Use with contraindications, and metric dimensional units. These changes do not raise any new questions of safety or effectiveness.
Performance Data
Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Bronchi and Gastrointestinal Cytology Brush meets the performance requirements to fulfill the intended use of the device.
§ 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.