(269 days)
Used for introduction of irrigation fluid into the gastrointestinal tract through the endoscope working channel.
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.
This document is a 510(k) premarket notification for an "Accessory Irrigation Adapter." It describes the device and claims substantial equivalence to a predicate device. This type of regulatory submission historically focuses on bench testing to demonstrate performance, rather than clinical studies to evaluate diagnostic or therapeutic effectiveness.
Therefore, the input doesn't provide information about an AI/ML powered device, and the specifics requested in your prompt regarding acceptance criteria, study details, expert involvement, and ground truth are typically not part of a 510(k) submission for a non-diagnostic, non-therapeutic accessory like an irrigation adapter.
Based on the provided document, here's what can be extracted and what cannot:
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Functional user requirements met after accelerated aging. Such as: - Able to insert through biopsy cap - Able to irrigate through adapter - Able to remove the adapter from working channel Met. Non-clinical bench testing demonstrated that the Accessory Irrigation Adapter met the performance requirements to fulfill the intended use of the device after accelerated aging. -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. The document refers to "performance testing consisting of non-clinical bench testing," but doesn't quantify the number of devices or tests performed.
- Data Provenance: Not specified. This was non-clinical bench testing, not human data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth as typically defined for AI/ML diagnostic devices (e.g., expert consensus on images, clinical outcomes) is not relevant for this type of device's performance testing. The "ground truth" here is whether the device physically performs its function.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used for expert review of cases in diagnostic studies. For bench testing, success/failure is determined by whether the device meets pre-defined engineering and functional specifications.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This device is an irrigation adapter, not an AI-powered diagnostic or therapeutic tool for which an MRMC study would be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical accessory and does not involve algorithms or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of diagnostic/AI ground truth. For this device, the "ground truth" is its functional performance determined by engineering specifications and bench tests (e.g., the ability to insert, irrigate, and remove).
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
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How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device, so there is no training set or its associated ground truth establishment.
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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.
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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.
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
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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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Summary
| Name: | Wilson-Cook Medical, Inc. /Cook Endoscopy |
|---|---|
| Address: | 4900 Bethania Station RoadWinston-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 theDevice: | The Accessory Irrigation Adapter is a non-sterile device that is compatible withendoscopes with a maximum working channel of 2.2 mm. The AccessoryIrrigation Adapter is approximately 2 inches long. |
| Intended Use: | The Accessory Irrigation Adapter is intended for introduction of irrigation fluidinto the gastrointestinal tract through the endoscope working channel. |
| TechnologicalCharacteristics: | Both the subject device and the predicate device consist of a female luer adapterwith a cannula. The subject device is comprised of a stainless steel cannula and apolypropylene luer. The predicate device is comprised of stainless steel. Both thepredicate and the subject device can be inserted into a biopsy cap on anendoscope working channel and the user is then able to irrigate through theadapter. |
| SubstantialEquivalence: | The Accessory Irrigation Adapter (subject device) is substantially equivalent tothe Scope Introducer (predicate device) in that it has same intended use (morelimited), method of operation, and fundamental technological characteristics(same materials for the barrel portion, and the same operational principle) |
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- 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.
§ 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.