(269 days)
Not Found
No
The device description and performance studies focus on the mechanical function of an irrigation adapter and do not mention any AI/ML capabilities or data processing.
No.
The device is used to introduce irrigation fluid and does not directly treat a condition or disease.
No
The device is described as an "Accessory Irrigation Adapter" used for introducing irrigation fluid into the gastrointestinal tract. Its intended use and description do not mention any diagnostic function, only operational utility during an endoscopic procedure.
No
The device description explicitly states it is a "non-sterile device" and describes its physical dimensions ("approximately 2 inches long"), indicating it is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction of irrigation fluid into the gastrointestinal tract through the endoscope working channel." This is a procedure performed in vivo (within a living organism), not in vitro (outside of a living organism, typically on samples like blood, urine, or tissue).
- Device Description: The description details a physical adapter used with an endoscope, which is a medical device used for internal examination of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural – facilitating the delivery of fluid during an endoscopic procedure.
N/A
Intended Use / Indications for Use
Used for introduction of irrigation fluid into the gastrointestinal tract through the endoscope working channel.
Product codes
ODC
Device Description
The Accessory Irrigation Adapter is a non-sterile device that is compatible with endoscopes with a maximum working channel of 2.2 mm. The Accessory Irrigation Adapter is approximately 2 inches long. Both the subject device and the predicate device consist of a female luer adapter with a cannula. The subject device is comprised of a stainless steel cannula and a polypropylene luer. The predicate device is comprised of stainless steel. Both the predicate and the subject device can be inserted into a biopsy cap on an endoscope working channel and the user is then able to irrigate through the adapter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
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)
Performance testing consisting of non-clinical bench testing demonstrates that the Accessory Irrigation Adapter met the performance requirements to fulfill the intended use of the device. The testing establishes that functional user requirements (able to insert through biopsy cap, able to irrigate through adapter, able to remove the adapter from working channel) were met after accelerated aging of the subject device. The results of this testing provide reasonable assurance that the Accessory Irrigation Adapter will function as intended over the shelf life of the product. The subject device does not raise new questions of safety or effectiveness as compared to the predicate device.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 27, 2017
Wilson-Cook Medical, Inc. Theresa de Prat Regulatory Affairs Specialist II 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K162142
Trade/Device Name: Accessory Irrigation Adapter Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODC Dated: March 20, 2017 Received: March 21, 2017
Dear Theresa de Prat:
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.
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 (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.
Benjamin R. Fisher -S
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
2
Indications for Use
510(k) Number (if known) K162142
Device Name Accessory Irrigation Adapter
Indications for Use (Describe)
Used for introduction of irrigation fluid into the gastrointestinal tract through the endoscope working channel.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Transaction Use (21 CFR 801 Subpart D) | ☐ Own-Use Consumption (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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3
Summary
| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station Road |
| Winston-Salem, North Carolina 27105 | |
| Phone: | (336) 744-0157 (x6518) |
| Fax: | (336) 201-5994 |
| Contact: | Theresa de Prat, Regulatory Affairs Specialist II |
| Date: | July 29, 2016 |
| Trade Name: | Accessory Irrigation Adapter |
| Common Name: | Accessory Irrigation Adapter |
| Classification Name: | Gastroenterology-Urology Endoscope and accessories (21 CFR §876.1500, |
| Product Code ODC) | |
| Predicate Device: | Scope Introducer, K093329, February 16, 2010 |
| Description of the | |
| Device: | The Accessory Irrigation Adapter is a non-sterile device that is compatible with |
| endoscopes with a maximum working channel of 2.2 mm. The Accessory | |
| Irrigation Adapter is approximately 2 inches long. | |
| Intended Use: | The Accessory Irrigation Adapter is intended for introduction of irrigation fluid |
| into the gastrointestinal tract through the endoscope working channel. | |
| Technological | |
| Characteristics: | Both the subject device and the predicate device consist of a female luer adapter |
| with a cannula. The subject device is comprised of a stainless steel cannula and a | |
| polypropylene luer. The predicate device is comprised of stainless steel. Both the | |
| predicate and the subject device can be inserted into a biopsy cap on an | |
| endoscope working channel and the user is then able to irrigate through the | |
| adapter. | |
| Substantial | |
| Equivalence: | The Accessory Irrigation Adapter (subject device) is substantially equivalent to |
| the Scope Introducer (predicate device) in that it has same intended use (more | |
| limited), method of operation, and fundamental technological characteristics | |
| (same materials for the barrel portion, and the same operational principle) |
4
- Performance Data: Performance testing consisting of non-clinical bench testing demonstrates that the Accessory Irrigation Adapter met the performance requirements to fulfill the intended use of the device. The testing establishes that functional user requirements (able to insert through biopsy cap, able to irrigate through adapter, able to remove the adapter from working channel) were met after accelerated aging of the subject device. The results of this testing provide reasonable assurance that the Accessory Irrigation Adapter will function as intended over the shelf life of the product. The subject device does not raise new questions of safety or effectiveness as compared to the predicate device.
- The Accessory Irrigation Adapter (subject device) is substantially equivalent to Conclusion: the predicate device.