(106 days)
The device is intended to provide access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
The Seal Reusable biopsy valve is composed of a cylindrical base and a connected cap. The device is designed to mount easily and seal securely on the biopsy port of endoscopes. It allows passage of instruments or devices of up to 3.2 mm in diameter. providing a seal both during use and following removal of the device. The Seal reusable biopsy valve is compatible with Olympus series 160, 180, and 190. Fujinon series 530. 590, and 600, and Fuse gastrointestinal endoscopes.
To use the device, the operator positions the device onto the instrument channel, pushing down on the cap and pressing the valve on the port until it fits snugly. Instruments of up to 3.2 mm in diameter may then be passed through the slit in the diaphragm of the valve. The deformation of the material provides a seal around the introduced device. After the procedure, the instrument is withdrawn prior to removal of the biopsy seal from the port. Users are instructed to remove the cap from the seal prior to pre-cleaning.
By maintaining a seal at the biopsy port, the device allows irrigation access while allowing insufflation to be maintained, and it minimizes leakage of biomaterial from the biopsy port during the endoscopic procedure.
The Seal reusable biopsy valve is provided non-sterile. It does not bear single-use labeling, and includes steps for cleaning and disinfection in the instructions for use (see section 13, proposed labeling).
Here's an analysis of the provided text regarding the Seal Biopsy Valve - reusable, focusing on the acceptance criteria and the study proving it:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state specific pass/fail acceptance criteria (e.g., minimum seal pressure, maximum leakage rate). Instead, it relies on a general statement of equivalency to a predicate device and positive outcomes from a suite of tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance: | Benchtop functional performance testing: "All test results passed, demonstrating that the device is safe and effective in comparison with predicate devices." (Implied: device effectively provides access for instruments, maintains insufflation, and minimizes biomaterial leakage as intended). |
| Cleaning Effectiveness: | Laboratory validation testing of the cleaning instructions: "All test results passed..." (Implied: cleaning instructions are effective in preparing the device for reuse). |
| Disinfection Effectiveness: | Laboratory validation testing of the high-level disinfection instructions: "All test results passed..." (Implied: high-level disinfection instructions are effective in preparing the device for reuse). |
| Biocompatibility: | Biocompatibility testing in conformance with ISO 10993-1: "All test results passed..." (Implied: the device materials are not harmful to biological systems). |
| Substantial Equivalence: | Intended use, design, materials, and labeling are all substantially equivalent to the predicate (Seal Single Use biopsy valve K111821). The principle of operation is the same. Materials (Thermoplastic elastomer for predicate, silicone for new device) are considered equivalent in elastic properties. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for any of the non-clinical tests (benchtop functional performance, cleaning validation, HLD validation, biocompatibility testing). It only states that the tests were performed.
The data provenance is retrospective in the sense that the studies were performed specifically for this 510(k) submission, but the source of the data (e.g., patient data, specific lab environment) is not detailed beyond being "benchtop" and "laboratory validation." No geographical data provenance is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. The tests described are laboratory and benchtop evaluations of the device's physical and biological properties.
4. Adjudication Method for the Test Set
No adjudication method is described, as the tests performed are primarily objective measurements against predefined (but not explicitly stated in the document) criteria, not subjective assessments requiring expert consensus.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically used for AI-powered diagnostic tools or systems where human performance is enhanced by the AI. The Seal Biopsy Valve is a mechanical accessory, not an AI device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
A standalone performance evaluation (algorithm only) was not performed because this device is a mechanical accessory and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would have been established by:
- Engineering Specifications/Performance Standards: For benchtop functional performance, the "ground truth" would be the device meeting predefined engineering specifications related to sealing, instrument passage, and maintaining insufflation.
- Industry Standards (e.g., ISO 10993-1): For biocompatibility, the ground truth is conformance to the requirements outlined in ISO 10993-1.
- Validated Cleaning/Disinfection Protocols: For cleaning and high-level disinfection, the "ground truth" would be the successful reduction of microbial load and removal of organic soil based on established and validated laboratory protocols.
No pathology, expert consensus (in the clinical sense), or outcomes data was used for establishing ground truth for this device's non-clinical testing.
8. The Sample Size for the Training Set
There is no training set mentioned or applicable, as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 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.