(49 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of the injection system and gel, with no mention of AI or ML components or functionalities.
No
The device aids in the excision of gastrointestinal lesions by creating a submucosal lift, but it does not directly treat the disease or condition. The therapeutic effect (excision) is performed by a separate device.
No
The device is designed for submucosal lift of polyps or lesions to facilitate excision, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly outlines physical components like a handle, needle cannula, pressure gauge, and syringe, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "submucosal lift of polyps or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device." This describes a procedure performed directly on the patient's tissue in vivo (within the living body) to facilitate a surgical removal.
- Device Description: The device is a kit for injecting a substance into the tissue. This is a therapeutic or procedural device, not a device used to examine specimens in vitro (outside the living body) to obtain diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue biopsies) or providing diagnostic information about a patient's health condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to physically manipulate tissue during an endoscopic procedure.
N/A
Intended Use / Indications for Use
This device is indicated for submucosal lift of polyps or other gastrointestinal mucosal lessons, prior to excision with a snare or endoscopic device.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
The proposed Cook Device is assembled by the end user from three component pieces: a handle with a threaded piston and directional arrow, a sterile needle cannula with an attached pressure gauge to track pressure in the event of needle kinks/bends in the tortuous GI anatomy and a sterile 10 cc syringe filled with a mixture of sterile water and sodium CMC. Blue colorant may or may not be added to enhance endoscopic visibility. After creation of a starter bleb below affected tissue, the gel is then injected into the starter bleb. The bleb will then stay elevated from the muscle layer to allow for endoscopic dissection or resection with a separately supplied endoscopic electrosurgical device. After excision and retrieval of affected tissue, the bleb will dissolve and pass out of the body naturally.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal mucosal
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)
Pre-clinical testing verified the biological safety of the injection media and validated the performance capabilities of the GI Endoscopic Injection Gel Kit to meet its design criteria through a series of bench and animal testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
(111495
JUL 1 9 2011
ATTACHMENT F: 510(k) Summary
SPONSOR:
CONTACT/SUBMITTER:
DATE OF SUBMISSION:
DEVICE:
Trade Name: Common Name: Classification:
PREDICATE DEVICES:
.TENDED USE:
DEVICE DESCRIPTION:
Wilson-Cook Medical, Inc. /Cook Endoscopy 4900 Bethania Station Road Winston-Salem, NC 27105
Marge Walls-Walker Senior Regulatory Specialist: Engineering [336] 744-0157 Ex. 6290
May 26, 2011
Gastroenterology Injection Needle
Cook GI Endoscopic Injection Gel Kit GI Endoscopic Injection Needle GI/GU Injection Needle, Class II FBK 21 CFR § 876.1500
US Endoscopy Dual Lumen Injector Needle Snare (K040961) Cook Endoscopic Ultra Ultrasound Needle (K083330)
This device is indicated for sub mucosal lift of polyps or other gastrointestinal mucosal lesions. prior to excision with a snare or endoscopic device
The proposed Cook Device is assembled by the end user from three component pieces: a handle with a threaded piston and directional arrow, a sterile needle cannula with an attached pressure gauge to track pressure in the event of needle kinks/bends in the tortuous GI anatomy and a sterile 10 cc syringe filled with a mixture of sterile water and sodium CMC. Blue colorant may or may . not be added to enhance endoscopic visibility. After creation of a starter bleb below affected tissue, the gel is then injected into the starter bleb. The bleb will then stay elevated from the muscle layer to allow for endoscopic dissection or resection with a separately supplied endoscopic electrosurgical device. After excision and retrieval of affected tissue, the bleb will dissolve and pass out of the body naturally.
1
COMPARISON OF CHARACTERISITICS:
equivalent to the named predicates in terms of Intended Use, Indications for Use, performance characteristics tested, needle gauge, principle of operation and biocompatibility. No electrosurgical instrument is provided with the subject device to allow for the excision, but the removal of the bleb can be accomplished using one of the many existing technologies available,
Pre-clinical testing verified the biological safety of
the injection media and validated the performance
We believe the proposed device to be substantially
PERFORMANCE DATA:
capabilities of the GI Endoscopic Injection Gel Kit to meet its design criteria through a series of bench and animal testing. The IFU suggests a preliminary injection of saline to begin the bleb to reduce the inherent risk of all iniection needles for perforation/iniection into the muscularis. The subject device is meant to complement existing technologies for excision of GI tract tissue by creation of a visible bleb using a viscous injectate that is easily available, and effective. The viscosity of the subject gel overcomes the limitation of injection of saline and other low viscosity materials with respect to time the bleb remains elevated from the muscularis and other mechanical mucosal separation techniques that may result in muscle layer involvement.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Marge Walls-Walker Senior Regulatory Affairs Specialist Wilson Cook Medical, Inc. / Cook Endoscopy 4900 Bethania Station Rd WINSTON-SALEM NC 27105
JUL 19 2011
Re: K111495
Trade/Device Name: Cook GI Endoscopic Injection Gel Kit Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: May 26, 2011 Received: May 31, 2011
Dear Ms. Walker:
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. 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
3
Page 2
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm428674.htm
Sincerely yours,
Dukart Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
Indications for Use
510(k) Number (if known):
Device Name: Cook GI Endoscopic Injection Gel Kit
Indications for Use:
This device is indicated for submucosal lift of polyps or other gastrointestinal mucosal lessons, prior to excision with a snare or endoscopic device.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Logu m Why
(Division Sign-Off)
Page 1 of 1
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __ K 111495