(262 days)
K941305/A
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
This device is used for endoscopic injection into gastrointestinal mucosa (delivery of a substance), which is not considered a therapeutic effect in itself, and the provided information does not mention any therapeutic claims or effects of the device itself.
No
The device is used for endoscopic injection, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components like needles, catheters, sheaths, and handles, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for endoscopic injection into gastrointestinal mucosa." This describes a procedure performed within the body (in vivo) to deliver a substance.
- Device Description: The description details a physical device used for injection, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or other bodily fluids) outside the body (in vitro) to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device's function is to deliver a substance directly into tissue during an endoscopic procedure.
N/A
Intended Use / Indications for Use
This device is used for endoscopic injection into gastrointestinal mucosa. The intended population is adult use only.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
The Gastrointestinal Injection Needles (subject devices) are sterile, single use devices that consist of a needle on an inner catheter fitted inside an outer catheter sheath featuring a luer slip/adjustment wheel handle with either a plastic or metal hub used as an injection port at the proximal end of the device. The devices are compatible with endoscopes with a minimum accessory channel of 2.0 mm or 2.8 mm. The Gastrointestinal Injection Needles have catheters which ranges in length from 195 to 315 cm, outer diameters of 5.4 FR and 6.9 FR, and needle gauges of 21, 23 and 25. Some configurations of the Gastrointestinal Injection Needles include ink marks at the distal end of the device to aid endoscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal mucosa
Indicated Patient Age Range
adult use only
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)
Performance testing consisting of non-clinical bench testing demonstrates that the Gastrointestinal Injection Needles meet the performance requirements to fulfill the intended use of the device. Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness.
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended:
- Functional Testing
- Tensile Strength Testing
- Needle Verification and Validation Testing
- Shelf Life Testing
- Packaging Validation
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part I: Evaluation and testing within a risk management process" and per ISO 10993-1:2009, Biological evaluation of medical devices-Evaluation and testing within risk management process.
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.
Wilson-Cook Variable Length GI Injection Needle, K941305/A
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
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December 19, 2019
Wilson-Cook Medical, Inc. /Cook Endoscopy Tiffanny Thomas Global Regulatory Affairs Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
K190829 Re:
Trade/Device Name: Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: November 4, 2019 Received: November 5, 2019
Dear Tiffanny Thomas:
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. 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
1
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-regulatory-information/postmarketing-safety-reportingcombination-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
Shani P. Haugen, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant 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
Indications for Use
510(k) Number (if known) K190829
Device Name
Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)
Indications for Use (Describe)
This device is used for endoscopic injection into gastrointestinal mucosa. The intended population is adult use only.
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) |
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3
510 (k) Summary
| Submission Information | |
|---|---|
| Type: | Traditional 510(k) Premarket Notification |
| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
| Address: | 4900 Bethania Station Road |
| Winston-Salem, North Carolina 27105 | |
| Phone: | (336) 744-0157 |
| Fax: | (336) 201-5994 |
| Contact: | Tiffanny A. Thomas, Global Regulatory Affairs Specialist |
| Therese de Prat, Regulatory Affairs Specialist II | |
| Date: | December 11, 2019 |
| Trade or Proprietary Name: | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) |
| Common/Usual Name: | Endoscopic Injection Needle, Gastroenterology-Urology |
| Classification Name: | Endoscope and accessories |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 876.1500 |
| Review Panel: | Gastroenterology-Urology |
| Procode: | FBK |
| Predicate Device: | Wilson-Cook Variable Length GI Injection Needle, K941305/A, cleared |
| June 2, 1994 |
Intended Use:
This device is used for endoscopic injection into gastrointestinal mucosa. The intended population is adult use only.
Device Description:
The Gastrointestinal Injection Needles (subject devices) are sterile, single use devices that consist of a needle on an inner catheter fitted inside an outer catheter sheath featuring a luer slip/adjustment wheel handle with either a plastic or metal hub used as an injection port at the proximal end of the device. The devices are compatible with endoscopes with a minimum accessory channel of 2.0 mm or 2.8 mm. The Gastrointestinal Injection Needles have catheters which ranges in length from 195 to 315 cm, outer diameters of 5.4 FR and 6.9 FR, and needle gauges of 21, 23 and 25. Some configurations of the Gastrointestinal Injection Needles include ink marks at the distal end of the device to aid endoscopic visualization.
Substantial Equivalence:
The Gastrointestinal Injection Needles (subject device) is substantially equivalent to the predicate device with respect to the intended use, operating principle and the technological characteristics. Minor changes were made from predicate Wilson-Cook Variable Length GI Injection Needle cleared to market via K941305/A. These changes include catheter dimensions, material changes and needle configurations. The modifications do not result in a change of intended us or indications.
4
K190829 Page 2 of 2
Performance Data:
Performance testing consisting of non-clinical bench testing demonstrates that the Gastrointestinal Injection Needles meet the performance requirements to fulfill the intended use of the device. Results from design validation and/or verification testing provide reasonable assurance that the modifications to the device do not raise any new questions of safety or effectiveness.
Summary of non-clinical testing:
The following non-clinical testing was conducted to demonstrate the performance of the subject device and confirmed that the subject device performs as intended.
- Functional Testing
- Tensile Strength Testing
- Needle Verification and Validation Testing
- Shelf Life Testing
- Packaging Validation
Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices-Part I: Evaluation and testing within a risk management process" and per ISO 10993-1:2009, Biological evaluation of medical devices-Evaluation and testing within risk management process.
Conclusion:
We believe that the subject devices are substantially equivalent to the predicate device in terms of intended use, key operating principles, materials and technological characteristics. We consider the risks associated with the modifications to the subject device to have been adequately addressed through our Design Control Processes and do not affect safety or effectiveness of the device.