(94 days)
The DEFENDO™ Disposable Biopsy Valve is indicated for covering the endoscope biopsy port during an endoscopy procedure. The valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
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Here's an analysis of the provided text regarding the DEFENDO Biopsy Valve, focusing on the requested information:
This document is a 510(k) clearance letter for a medical device (DEFENDO™ Biopsy Valve). It primarily focuses on the regulatory determination of substantial equivalence to a predicate device, rather than a detailed report of a clinical study with specific acceptance criteria and performance metrics for a novel algorithm or AI device.
Therefore, I cannot provide a complete answer to all your questions as the information is not present in the provided text. The document describes a device (biopsy valve), not a diagnostic algorithm or AI. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices. This typically means the manufacturer performed a series of tests to demonstrate that their device functions similarly and is as safe and effective as existing, legally marketed devices. However, the details of these tests, specific acceptance criteria, or a "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm are not described.
Let's address what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The FDA letter is a regulatory clearance, not a detailed technical report of performance metrics. For a device like a biopsy valve, acceptance criteria would likely relate to biocompatibility, fluid sealing, ease of use, durability, and compatibility with specific endoscopes, but these specifics are not listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As this is a physical medical device, "test set" would likely refer to the number of devices tested or the number of simulated procedures performed, but no such details are given.
3. 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)
This information is not provided. This concept of "ground truth" and expert review is typically relevant for diagnostic algorithms or AI that interpret medical images or data. For a biopsy valve, the "ground truth" would be established through engineering specifications and functional testing, not expert consensus on medical findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for studies where multiple readers interpret data, which is not described here.
5. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as described in this document. This type of study is specific to AI or diagnostic imaging interpretation. The device being reviewed is a physical biopsy valve, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not applicable. The DEFENDO™ Biopsy Valve is a physical accessory used during an endoscopy procedure, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated in the document. For a physical device like a biopsy valve, "ground truth" would generally be established through engineering specifications, material safety standards, and functional performance benchmarks (e.g., ability to maintain insufflation, resist leakage, allow instrument passage).
8. The sample size for the training set
This information is not provided. This concept is relevant for machine learning models, which is not what the DEFENDO™ Biopsy Valve is.
9. How the ground truth for the training set was established
This information is not provided. This concept is relevant for machine learning models, which is not what the DEFENDO™ Biopsy Valve is.
In summary:
The provided document is an FDA 510(k) clearance letter for a physical medical device (biopsy valve). It confirms the device's substantial equivalence to existing devices but does not contain the detailed technical or clinical study data typically found in reports for AI or diagnostic algorithms, including specific acceptance criteria, performance metrics, ground truth establishment, or study designs like MRMC or standalone performance evaluations. For such a device, the "study" demonstrating its safety and effectiveness would involve engineering tests (e.g., mechanical durability, fluid integrity), biocompatibility testing, and functional assessments, which are not outlined in this regulatory letter.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird-like figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2009
Ms. Jennifer James Engineer Byrne Medical, Inc. 3150 Pollock Drive CONROE TX 77303
Re: K090851
Trade/Device Name: DEFENDO" Biopsy Valve (Model # 100301 and 100302) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated: June 10, 2009 Received: June 11, 2009
Dear Ms. James:
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.
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K090851
Device Name: DEFENDO™ Biopsy Valve for Olympus® and Fujinon® Endoscopes DEFENDO™ Biopsy Valve for Pentax® Endoscopes
Indications for Use:
The DEFENDO™ Disposable Biopsy Valve is indicated for covering the endoscope biopsy port during an endoscopy procedure. The valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helder Penner
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological 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.