(140 days)
The US Endoscopy Endoscopic Retrieval Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for "The US Endoscopy Endoscopic Retrieval Device." This letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This type of FDA clearance does not typically involve the rigorous multi-reader multi-case (MRMC) comparative effectiveness studies, standalone algorithm performance studies, or detailed statistical evaluations of acceptance criteria that would be conducted for novel AI/ML medical devices.
Instead, substantial equivalence is determined by demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this type of regulatory document.
Here's why and what can be inferred:
Reasons for Absence of Requested Information:
- Device Type: This is for an "Endoscopic Retrieval Device," which is a physical instrument (likely a forceps or snare) used to grasp and retrieve objects during endoscopy. It is not an AI/ML diagnostic or prognostic device.
- Regulatory Pathway (510(k)): The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device. This typically involves bench testing, biocompatibility testing, and sometimes limited clinical testing, but not the extensive multi-reader performance studies or detailed statistical analyses of acceptance criteria for diagnostic accuracy characteristic of AI/ML devices.
- Focus of the Document: The provided text is an FDA clearance letter and an "Indications for Use" statement. These documents confirm clearance and define intended use, but do not contain detailed study reports.
Information that CAN be inferred or stated based on the document:
- Acceptance Criteria and Reported Device Performance: This information is not provided in a quantified manner. The letter establishes "substantial equivalence" as the primary acceptance criterion, meaning the device performs similarly to existing predicate devices.
- Sample Size for Test Set and Data Provenance: Not applicable for this type of device and regulatory submission as detailed in the document. Performance would typically be assessed through bench testing (e.g., strength, durability, material compatibility) rather than a clinical "test set" in the context of diagnostic accuracy.
- Number of Experts and Qualifications for Ground Truth: Not applicable. For physical medical devices, "ground truth" might relate to physical properties or performance in a simulated environment, not expert consensus on diagnostic images.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is typically for evaluating the impact of AI on human diagnostic performance, which is not relevant for a physical endoscopic retrieval device.
- Standalone (algorithm-only) Performance: No. This is not an algorithm.
- Type of Ground Truth Used: Not applicable in the context of diagnostic accuracy. "Ground truth" for this device would relate to its mechanical function and safety (e.g., ability to grasp, material integrity, biocompatibility).
- Sample Size for Training Set: Not applicable. This device is not an AI/ML model that undergoes "training."
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document is for a physical medical device cleared via the 510(k) pathway based on substantial equivalence. It does not contain the information requested, which is typically associated with the evaluation and clearance of AI/ML diagnostic or prognostic devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Eric J. Maynard Sr. Regulatory Specialist United States Endoscopy Group, Inc. 5976 Heisley Road MENTOR OH 44060
MAY 3 0 2012
Re: K120084
Trade/Device Name: The US Endoscopy Endoscopic Retrieval Device Regulation Number: 21 CFR8 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCZ Dated: May 16, 2012 Received: May 17, 2012
Dear Mr. Maynard:
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 (reporting of medical
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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 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.
Sincerely yours,
Benjamin R. Evans
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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CONFIDENTIAL United States Endoscopy Group, Inc. 510(k) Premarket Notification: Traditional The US Endoscopy Endoscopic Retrieval Device
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INDICATIONS FOR USE
K120084 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: The US Endoscopy Endoscopic Retrieval Device
Indications for Use:
The US Endoscopy Endoscopic Retrieval Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
ivision Sign-Off) sion of Reproductive, Gastro-Renal, and ological Devices 510(k) Number
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§ 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.