(210 days)
The single-use BioShield biopsy valve is used to cover the biopsy/suction channel of gastrointestinal endoscopes. It provides 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 BioShield Irrigator - extension tubing is intended to provide irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with the BioShield Irrigator.
The BioShield Irrigating Adaptor is intended to be used with the BioShield Biopsy Valve to provide access for irrigation.
The BioShield biopsy valve is a single-use disposable cap that is used to cover the biopsy/suction channel of endoscopes during endoscopic procedures and other procedures. It provides access to the endoscope's working channel, minimizes leakage of biomaterial and other fluids during insufflation and instrument exchange and allows for irrigation. The device consists of a valve body and a cap. The device is made from thermoplastic elastomer. There are a total of 10 versions of the BioShield biopsy valve. All 10 versions of the BioShield Biopsy valve are subject to the major change of removing the skirt that aided in maintaining insufflation in the predicate device and two of these 10 versions have had an irrigation line added. Seven versions of the biopsy valve that are compatible with Olympus and Fujinon endoscopes and three versions of the valve that are compatible with Pentax endoscopes. Also, of these 10 versions, there are two versions that have an irrigation line to provide another option to the user to irrigate. All valves, with the exception of one version, are supplied non-sterile.
There are two accessories provided with the BioShield biopsy valve. These devices were not previously cleared under the 510(k) process. Their product code is OCX. They are the BioShield Irrigator and the BioShield Irrigator Extension Tubing. The BioShield Irrigator consists of a luer connection attached to a stainless-steel tip. The Bioshield Irrigator is used for intraprocedural gastrointestinal endoscopic irrigation when attached to a luer-lock or slip-tip syringe directly through the BioShield biopsy valve. The BioShield Irrigator Extension Tubing is a 180 cm long piece of irrigation tubing that has connectors on both ends. The tubing can be connected to a BioShield Irrigator biopsy valve on one end and to an irrigation system (irrigation tubing connected to an irrigation source used with an auxiliary water pump) on the other end in order to provide hands-free foot pedal irrigation control. Both of these irrigation accessories are provided non-sterile.
Here's an analysis of the provided text, extracting the acceptance criteria and study details as requested. It's important to note that this document is a 510(k) summary for a medical device and therefore focuses on non-clinical performance testing (bench and simulated use), not clinical studies involving human patients or complex AI algorithms requiring ground truth establishment through expert consensus.
The document discusses devices related to gastrointestinal endoscopes (BioShield Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor). The testing described is primarily focused on the mechanical and fluid dynamic performance of these physical devices, not on diagnostic performance or interpretation of medical images.
Acceptance Criteria and Reported Device Performance
| Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Retention Force Testing (BioShield Biopsy Valves) | The retention force of the BioShield Biopsy valves must be equal to or greater than the predicate device as documented in K070420 (3.2 lbs.). | Pass |
| Leakage Testing (BioShield Biopsy Valves) | The BioShield biopsy valves must not spray or experience geyser type leaks while the endoscope is pressurized. | Pass |
| Device Exchange Testing (BioShield Biopsy Valves) | The BioShield Biopsy valves should allow device passage and should not become detached during instrument usage and exchange. | Pass |
| Backflow testing (through check valve attached to irrigation line) | The BioShield Biopsy Valve Irrigator Olympus/Fuji and Pentax must not leak through the check valve located on the irrigation line while the endoscope is pressurized. | Pass |
| Irrigation Testing (using the BioShield Irrigating Adaptor) | During irrigation, the biopsy valve should not experience spraying geyser type leaks. | Pass |
| Irrigation Testing (Using the Irrigation Extension Tubing - Flow Rate Testing) | The average amount of water displaced when using the BioShield Irrigation Extension tubing must be equal to ± 15% of the average amount of water displaced when the BioShield Irrigation tubing was not used. Also, water flow should not occur when the pinch clamp is closed. | Pass |
Study Details (Based on the provided text)
Given that this is a 510(k) summary for physical medical devices and not an AI/software device, many of the requested categories related to AI performance, human readers, and image interpretation are not applicable (N/A) to this document. The testing described is "Non-clinical performance testing" which "consisted of ... bench and simulated use testing."
1. Sample sized used for the test set and the data provenance:
* Sample Size: Not explicitly stated for each test, but the nature of bench and simulated use testing implies a sample size sufficient to demonstrate consistent performance across different models/versions of the device and against the predicate.
* Data Provenance: The document does not specify country of origin for the test data for these non-clinical tests. The tests are "bench and simulated use testing," implying laboratory-based evaluations rather than patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* N/A. Ground truth in the context of expert review for diagnostic/AI performance is not applicable here. The "ground truth" for these mechanical tests is based on measurable physical properties (e.g., force, flow rate, or visual observation of leakage/spraying) and comparison to a predicate device's established performance.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* N/A. Adjudication methods are typically used in clinical studies or AI performance evaluations involving subjective human assessment. For these mechanical/fluid dynamic tests, results are objective (Pass/Fail based on quantitative and qualitative criteria).
4. 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:
* N/A. This applies to AI-assisted diagnostic tools, not to physical endoscope accessories.
5. Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* N/A. This applies to AI algorithms. The device itself is a physical accessory.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Bench and Simulated Use Data / Objective Measurements / Predicate Device Performance. The ground truth for evaluating these devices is their ability to meet defined physical and functional criteria, often compared directly to a legally marketed predicate device's known performance characteristics (e.g., retention force = 3.2 lbs).
7. The sample size for the training set:
* N/A. No "training set" in the context of machine learning is applicable. Device development would involve iterative design and testing, but not a formally defined AI training set.
8. How the ground truth for the training set was established:
* N/A. As no AI training set is involved, 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.