(59 days)
The single use BioShield® biopsy valve EUS is used to cover the opening to the biopsy/suction channel of flexible echoendoscopes. 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® biopsy valve EUS - Linear is an accessory to a linear echoendoscope. The EUS biopsy valve allows the end user to cover the accessory port of a linear echoendoscope. The BioShield® biopsy valve EUS - Linear consists of tether and cap. The biopsy valves' cap can be removed from the accessory port while being held on the echoendoscope via the tether to the cap. The biopsy valve is a single-use, disposable device that is supplied sterile or nonsterile.
Here's a breakdown of the acceptance criteria and study information for the BioShield® biopsy valve EUS - Linear, based on the provided document:
This document is a 510(k) summary for a medical device called the "BioShield® biopsy valve EUS - Linear." It describes the device's technical characteristics, indications for use, and a summary of performance testing conducted to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Retention Force Testing | The retention force of the BioShield EUS biopsy valve - Linear (sterile & non-sterile) must be equal to or greater than the predicate device. | "Testing for the proposed biopsy valves, both sterile and non-sterile showed they were comparable to the predicate devices in maintaining insufflation, allowing for device exchange and minimizing leakage from the biopsy port. The proposed devices met all acceptance criteria of the verification testing." (implies this criterion was met) |
| Leakage Testing | The BioShield biopsy valve EUS - Linear (sterile & non-sterile) must be comparable to or better than the predicate device. The device(s) shall not spray or experience geyser type leaks while pressurized. | "Testing for the proposed biopsy valves, both sterile and non-sterile showed they were comparable to the predicate devices in maintaining insufflation, allowing for device exchange and minimizing leakage from the biopsy port. The proposed devices met all acceptance criteria of the verification testing." (implies this criterion was met) |
| Device Exchange Testing | The BioShield biopsy valve EUS - Linear should allow device passage and should not become detached during instrument usage and exchange. | "Testing for the proposed biopsy valves, both sterile and non-sterile showed they were comparable to the predicate devices in maintaining insufflation, allowing for device exchange and minimizing leakage from the biopsy port. The proposed devices met all acceptance criteria of the verification testing." (implies this criterion was met) |
| Shelf Life Testing | The proposed devices were accelerated aged for a period equal to one year of real-time aging prior to conducting the testing provided in this submission. | Conducted (based on the description). Further details on specific results or whether acceptable aging was achieved are not explicitly stated but are implied by the overall statement that "The proposed devices met all acceptance criteria of the verification testing." |
| Biocompatibility Testing | Tested in accordance with ISO 10993-5:2009 (Cytotoxicity) and ISO 10993-10: 2010 (Irritation and Sensitization). | Tested (based on the description). No specific results are provided, but compliance with standards is indicated. |
| Sterilization | Tested in accordance with AAMI/ANSV/ISO 11135-1:2014. Sterilization Assurance Level (SAL) of 10-6. | Tested (based on the description). An SAL of 10-6 is reported in the comparison table, and method is Ethylene Oxide. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Retention Force Testing:
- 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
- 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).
- Leakage Testing:
- 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
- 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).
- Device Exchange Testing:
- 15 BioShield biopsy valves EUS - Linear (non-sterile) from 3 different lots (5 from each lot).
- 15 BioShield biopsy valves EUS - Linear (sterile) from 3 different lots (5 from each lot).
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the nature of a 510(k) submission for a new device, this testing would typically be prospective bench testing conducted by the manufacturer (Steris Corporation, located in Mentor, OH, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The testing described is bench testing of physical device performance (e.g., retention force, leakage, device passage), not a clinical study involving experts establishing ground truth for diagnostic or interpretative tasks.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above. There wasn't a subjective assessment by experts that required adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. This document describes bench testing of a physical accessory, not a diagnostic or interpretative AI-powered device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical biopsy valve, not an algorithm or software. The "performance" being evaluated is the mechanical functionality of the valve itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on measurable physical properties and functional criteria as defined by the acceptance criteria. For example:
- Retention Force: Measured force in pounds.
- Leakage: Visual observation of spraying or geyser-type leaks.
- Device Exchange: Observation of successful passage and non-detachment during instrument usage.
- Biocompatibility/Sterilization: Adherence to established ISO/AAMI standards.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As mentioned above, there is no training set for this device.
§ 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.