(100 days)
The Single-Use Biopsy 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, and provides access for irrigation.
The Seal Single-Use Biopsy valve is provided non-sterile, and is composed of a cylindrical base and a connected cap. The Single-Use Biopsy Valve provides surgical instruments with sealable access to the working channel port of an endoscope. The valve consists of an attached cap and valve body with a circular opening. The cap is pre-perforated, and ensures instrument access and removal is tight and leak-free.
The valve is designed with a hollow body with a distal end that releasably attaches to the inlet port of the working channel. The valve body provides a flexible diaphragm seal that separates the body into a proximal chamber and distal chamber. The distal chamber secures onto the endoscope, while the proximal chamber secures the cap. Instruments are inserted through the cap and chambers, through the diaphragm seal, and into the endoscope. The diaphragm seal Is configured such that a seal is formed due to deformation of the elastomer around an instrument when it is inserted through the opening, preventing fluids from passing through the biopsy valve.
The cap serves two primary functions. One function of the cap is to provide an additional seal around surgical instruments to prevent leakage. The second function is to allow modification of pressure during insufflation by opening the cap, allowing gasses to flow from the endoscope, and out of the biopsy valve.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Seal Single-Use Biopsy Valve:
The provided text (K133734) is a 510(k) Summary for a Seal Single-Use Biopsy Valve device, which is a modification of a previously cleared device (K111821). The document primarily focuses on demonstrating substantial equivalence to the predicate device, rather than detailed performance studies with clinical outcomes or human-in-the-loop assessments.
Therefore, many of the requested criteria in your prompt are not applicable or cannot be extracted from this type of regulatory submission. This document highlights bench testing and biocompatibility testing to demonstrate that the modified device performs as well as the predicate device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Modified Device) |
|---|---|---|
| Pressure Integrity | 1 minute pressure test at 10 PSI – with device in biopsy valve | Pass |
| Pressure Integrity | 1 minute pressure test at 10 PSI – with device in biopsy valve (re-listed) | Pass |
| Pressure Integrity | 1 minute pressure test at 10 PSI after removing device from biopsy valve | Pass |
| Biocompatibility | Cytotoxicity (in accordance with 21 CFR, Part 58) | No safety or efficacy concerns |
| Biocompatibility | Sensitization (in accordance with 21 CFR, Part 58) | No safety or efficacy concerns |
| Biocompatibility | Intracutaneous injection test (in accordance with 21 CFR, Part 58) | No safety or efficacy concerns |
| Biocompatibility | System injection test (in accordance with 21 CFR, Part 58) | No safety or efficacy concerns |
| Material | Thermoplastic elastomer | Thermoplastic elastomer (Matches predicate) |
| Valve Inner Diameter | Designed to be 7.1 mm (vs. 7 mm predicate) | 7.1 mm |
| Endoscope Compatibility | Olympus series 160, 180, and 190; Fujinon series 530, 590, and 600; EndoChoice Fuse | Compatible with listed endoscopes |
| Slit Accommodation | Accommodates devices up to 3.2 mm (Matches predicate) | Up to 3.2 mm |
| Overall Height | Reduction in overall height for improved fit | Improved fit confirmed (implied by design change) |
Study Details (Based on provided text)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test (e.g., how many biopsy valves were pressure tested). However, "bench testing" was performed.
- Data Provenance: The testing appears to be conducted in a laboratory setting ("bench testing," "laboratory biocompatibility testing"). No country of origin is specified, but given the submission to the FDA, it's likely relevant to US regulatory standards. It is a retrospective analysis in the sense that the results are being presented after the tests were conducted.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document describes performance and biocompatibility testing of a medical device, not a diagnostic or AI-assisted device where expert ground truth is typically established for image or data interpretation. The "ground truth" here is the physical measurement or chemical reaction in the bench and biocompatibility tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 are used for establishing ground truth in clinical studies involving interpretation of data (e.g., radiology reads). This document focuses on physical and biological performance tests.
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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. This is a single-use biopsy valve, not an AI-assisted diagnostic device. Therefore, no MRMC study was conducted or is relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a mechanical component (biopsy valve), not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Established physical and biological testing standards. For pressure tests, the "ground truth" is a pass/fail criterion based on maintaining pressure at 10 PSI for 1 minute. For biocompatibility, the ground truth is determined by established laboratory protocols and thresholds for cytotoxicity, sensitization, etc., as per 21 CFR Part 58.
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The sample size for the training set:
- Not Applicable. This device does not involve a training set as it is not an AI/ML-based device.
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How the ground truth for the training set was established:
- Not Applicable. See point 7.
§ 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.