(26 days)
The Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System consists of two accessories intended for use with Microvasive® Biliary Rapid Exchange™ devices:
The Microvasive® Rapid Exchange™ Locking Device is intended to lock the guidewire in place during ERCP procedures.
The Microvasive® Rapid Exchange™ Biopsy Cap is intended to facilitate the use of Rapid Exchange™ devices during ERCP procedures.
The Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System consists of a sterile, single-patient use biopsy cap and a rigid plastic guidewire locking device for use with other Boston Scientific Rapid Exchange catheter devices.
This document is a 510(k) premarket notification for a medical device and therefore describes a device modification and substantial equivalence to a predicate device rather than a study proving the device meets specific acceptance criteria in the manner of an AI/ML or diagnostic study.
Here's an analysis based on the provided text, focusing on what can be inferred about "acceptance criteria" in this context:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics for a diagnostic or AI/ML device.
Instead, the "acceptance criteria" here are framed in terms of substantial equivalence to predicate devices and meeting design specifications through verification testing.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Substantial Equivalence: | Device is substantially equivalent to predicate devices (Microvasive® Extractor Rx (K970052), Microvasive® Ultratome Rx (K970053), Microvasive® Tandem Rx (K970054)). |
| - Similar indications for use | "Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System is best described as a Class II device..." with similar indications to predicates. |
| - Similar descriptive and technological characteristics | "Comparison of descriptive and technological characteristics..." was performed. Specific details not provided in this summary. |
| Design Control Compliance: | Certification of compliance to 21 CFR 820.30 Design Control requirements provided. |
| Risk Analysis: | Description of internal Risk Analysis procedure provided. |
| Design Verification Testing: | "Design Verification testing has been performed to ensure that the Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System meets design specifications." Specific results not provided in this summary. |
| Meeting Minimum Requirements for Intended Use: | "the Microvasive® Rapid Exchange™ Locking Device and Biopsy Cap System has been shown to meet the minimum requirements that are considered acceptable for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the context of diagnostic accuracy or AI/ML performance. The "testing" mentioned is Design Verification testing, which typically involves engineering or bench testing to ensure the device meets its design specifications (e.g., strength, fit, function, sterility), rather than testing on patient data.
- Sample size for test set: Not applicable/Not specified in the context of diagnostic studies. Design verification testing would involve a different type of sampling (e.g., number of devices tested for mechanical properties).
- Data provenance: Not applicable. This is a physical medical device accessory, not a diagnostic or AI/ML system trained on patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. "Ground truth" in the context of patient diagnoses or outcomes is not relevant for this type of device submission. Ground truth for design verification would be the engineering specifications themselves.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the diagnostic sense requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is an accessory (locking device and biopsy cap system) for existing endoscopic procedures, not an AI or diagnostic system that would aid human readers in interpretation.
6. Standalone Performance Study
No, a standalone (algorithm only) performance study was not done. This device is a physical accessory, not a standalone algorithm.
7. Type of Ground Truth Used
Not applicable in the context of diagnostic performance. For design verification, the "ground truth" would be the engineering design specifications and requirements.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device accessory, not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
In Summary:
This document is a 510(k) submission for a non-diagnostic, non-AI/ML medical device accessory. The "acceptance criteria" and "study" mentioned refer to the process of demonstrating substantial equivalence to legally marketed predicate devices and confirming adherence to design controls and specifications through engineering and bench testing (Design Verification), rather than clinical performance studies for diagnostic accuracy. Therefore, most of the requested information (sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this type of device submission.
§ 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.