(50 days)
Not Found
No
The summary describes a mechanical device for tissue sampling and does not mention any computational or analytical functions that would involve AI/ML.
No.
The device is used for sampling lesions, which is a diagnostic purpose, not a therapeutic one.
No
The device is used for sampling lesions, which is a step in the diagnostic process, but it is not performing the diagnosis itself. It is a tool for specimen collection, not analysis or interpretation.
No
The device description explicitly details physical components like a cytology brush, handle, nitinol shaft, and shrink tube, indicating it is a hardware device.
No, the EchoBrush™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment. They perform tests on samples like blood, urine, tissue, etc.
- The EchoBrush™ is a tool used to collect a specimen (a cytology sample) from the human body. It is a sampling device, not a device that performs a diagnostic test on the collected sample.
The collected sample from the EchoBrush™ would then likely be sent to a laboratory for in vitro diagnostic testing, but the EchoBrush™ itself is the instrument for obtaining the sample.
N/A
Intended Use / Indications for Use
The EchoBrush™ is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
Product codes
FDX
Device Description
The EchoBrush™ consists of a cytology brush for sampling submucosal gastrointestinal lesions. There is a handle attached to the proximal end of the device. The handle can be attached and locked onto the ECHO-19 Ultrasound needle. A white piece of shrink tube can be seen for a length of 9mm from the handle along the nitinol shaft. This will indicate to the user that the brush is about exit the tip of the needle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
submucosal gastrointestinal lesions
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
Non-Clinical testing was performed on characteristics and operational functions of the EchoBrushTM deemed necessary to verify safety and performance.
Summary of Performance Studies
Non-Clinical testing was performed on characteristics and operational functions of the EchoBrushTM deemed necessary to verify safety and performance. Genotoxicity (Ames Test): The results of this test indicated that under the experimental conditions, the extracts of this test article were not mutagenic for any tester strain, with or without any S9 activation.
Key Metrics
Not Found
Predicate Device(s)
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.
0
OCT 1 1 2005
Cook Ireland Ltd.
O'Halloran Road, National Technology Park, Limerick, IRELAND Phone: +353 61 334440 Fax: +353 61 334441 www.cookgroup.com
Image /page/0/Picture/4 description: The image shows handwritten text on a white background. The text at the top reads "Ko 52279", with the "Ko" possibly indicating a document or reference number. Below this, the text "Page 1 of 3" is written, suggesting that this is the first page of a three-page document. The handwriting appears somewhat cursive and slightly faded, giving the impression of an older or copied document.
510(k) Summary
SPONSOR:
Cook Ireland Ltd. O'Halloran Road, National Technology Park, Limerick, Ireland
Contact Submitter:
Emmett Devereux QA/RA Manager Cook Ireland Limited O'Halloran Road National Technology Park Limerick, Ireland Phone: +353-61-334440 Fax: +353-61-334441 Email: edevereux@cook.ie
August 19, 2005 Date of Submission: EchoBrush™ Device: Cook Ireland EchoBrush TM Trade Name: Endoscopic Ultrasound Cytology Brush Common/Usual Name: Brush Cytology, For Endoscope 21 CFR§ Class: 876.1500, FDX Predicate Device: Wilson-Cook GI Aspiration Needle, K934356 Wilson-Cook Biliary Cytology Brush, K040324 The EchoBrush™ is used to sample targeted Intended Use: submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
Page 1 of 2
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UUIN
K5227"
Page 2003
Device Description:
The EchoBrush™ consists of a cytology brush for sampling submucosal gastrointestinal lesions. There is a handle attached to the proximal end of the device. The handle can be attached and locked onto the ECHO-19 Ultrasound needle. A white piece of shrink tube can be seen for a length of 9mm from the handle along the nitinol shaft. This will indicate to the user that the brush is about exit the tip of the needle.
Comparison of Characteristics:
The subject device is similar with respect to intended use and/or design features to the predicate devices in terms of section 510(k) substantial equivalence.
Test Data:
Non-Clinical testing was performed on characteristics and operational functions of the EchoBrushTM deemed necessary to verify safety and performance.
2
K052279
Kaye Stokes
Genotoxicity (Ames Test): The results of this test indicated that under the experimental conditions, the extracts of this test article were not mutagenic for any tester strain, with or without any S9 activation.
Mentor also performed chemical testing to support a 36 month shelf life for the SCHG.
3
Image /page/3/Picture/2 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle.
OCT 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Emmett Devereux OA/RA Manager Cook Ireland Limited O'Halloran Road National Technology Park Limerick IRELAND
Re: K052279
Trade/Device Name: Cook Ireland EchoBrush"" Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDX Dated: August 19, 2005 Received: August 22, 2005
Dear Mr. Devereux:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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. 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); 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.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter with and in your e organ finding of substantial equivalence of your device to a legally prematics notification: "Pressults in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dearle spearle da nee of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 807.77). " Ou may ooualif ourers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| 510(k) Number (if known): | K 052279 |
|---|---|
| --------------------------- | ---------- |
Device Name: EchoBrush™
Indications for Use:
The EchoBrush™ is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only (Per 21 CFR § 801.109)
Or
Over-the-Counter______________________________________________________________________________________________________________________________________________________________
Daniel A. Symon
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number .