(192 days)
The JAZZ Disposable Valve Kit is comprised of the JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve.
The JAZZ Suction Valve is intended to control the suction (aspiration of air and fluids) of a FUIFILM gastrointestinal endoscope during endoscopy procedures.
The JAZZ Air/Water Valve is intended to control air of a FUJIFILM gastrointestinal endoscope for insufflations and water delivery (for distal lens cleaning) during endoscopy procedures.
The JAZZ Forceps Valve is intended to facilitate passage of an endotherapy device, to prevent a leak or backflow of air and/or fluids, and to enable the suction function of a FUJIFILM gastrointestinal endoscope.
The JAZZ Disposable Valve Kit is comprised of the JAZZ Suction Valve, Air/Water Valve, and Forceps Valve. These devices are intended for single-use and are supplied sterile, eliminating the need for manual cleaning and reprocessing. These valves are designed to the corresponding port of a FUJIFILM G7 gastrointestinal endoscope. The air/water valve can be activated to control air and water flow, while the suction valve can be activated to aspirate excess fluids or other debris. The forceps valve forms a tight seal with the biopsy port to prevent leakage of biomaterial, provide easy passage of endotherapy devices, and support thesuction function.
The provided text describes the JAZZ Disposable Valve Kit, a medical device for use with FUJIFILM gastrointestinal endoscopes. The document is a 510(k) summary submitted to the FDA, asserting substantial equivalence to predicate devices based on performance data.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide explicit "acceptance criteria" in a quantitative format with thresholds for each test. Instead, it states that "The subject devices met performance specifications in the following additional non-clinical tests." and "Bench testing demonstrates that the subject device is as safe and effective as the predicate devices." Implied acceptance is that the device performs functionally and safely, similar to the predicate devices.
| Performance Test (Implied Acceptance Criteria: Met Specifications/Safe and Effective) | Reported Device Performance |
|---|---|
| Biocompatibility | Met consensus standards (ISO 10993-1, 10993-5, 10993-7, 10993-10) and FDA guidance. |
| Sterility | Met consensus standards (ISO 11135, ISO 11607-1). |
| JAZZ Air/Water Valve - Backflow Prevention | Validated for efficiency in preventing backflow to proximal irrigation system as defined by FDA Guidance. |
| Spring Force Testing | Performed; met performance specifications (implied by overall conclusion). |
| Suction Valve - Suction pressure | Met performance specifications. |
| Suction Valve - Tightness | Met performance specifications. |
| Suction Valve - Functional life | Met performance specifications. |
| Suction Valve - Compatibility with endoscope | Met performance specifications. |
| Air/Water Valve - Insufflation pressure | Met performance specifications. |
| Air/Water Valve - Flushing pressure | Met performance specifications. |
| Air/Water Valve - Tightness | Met performance specifications. |
| Air/Water Valve - Functional life | Met performance specifications. |
| Air/Water Valve - Compatibility with endoscope | Met performance specifications. |
| Forceps Valve - Tightness | Met performance specifications. |
| Forceps Valve - Compatibility with endoscope | Met performance specifications. |
| Forceps Valve - Compatibility with endoscopic instruments | Met performance specifications. |
| Forceps Valve - Ease of use | Met performance specifications. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes bench testing and validation studies. It does not specify the sample sizes (e.g., number of valves tested for each parameter) used for these tests. The data provenance is not explicitly stated beyond being "bench testing" and "validation" which implies a controlled laboratory environment. There is no indication of clinical data, animal studies, or human subject data. Therefore, the data can be considered prospective in the sense that the tests were conducted specifically for this submission. The "country of origin of the data" is not stated, but the manufacturer is FUJIFILM medwork GmbH (Germany).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not describe any studies involving human experts to establish "ground truth." The performance evaluations are based on non-clinical tests (bench testing) against established standards and internal specifications to demonstrate functional performance and safety.
4. Adjudication Method for the Test Set:
Not applicable, as no studies involving human interpretation or subjective adjudication are mentioned. The testing involves objective measurements rather than expert consensus on a "ground truth" derived from images or clinical cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not conducted for this device. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The JAZZ Disposable Valve Kit is an accessory for an endoscope, and its evaluation focuses on mechanical and functional performance, sterility, and biocompatibility.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This question is not applicable to the JAZZ Disposable Valve Kit. This device is a mechanical accessory, not an algorithm or AI-driven system. Its performance is inherent in its physical and functional design, not in a standalone algorithm's output.
7. The Type of Ground Truth Used:
The "ground truth" for the performance evaluation can be considered the established consensus standards (ISO standards), FDA guidance documents, and internal performance specifications for medical devices of this type. For example, for sterility, the ground truth is that the device must meet the requirements of ISO 11135 and 11607-1. For backflow prevention, the ground truth is compliance with the FDA guidance. For functional aspects like suction pressure or tightness, the ground truth would be predetermined functional thresholds defined by the manufacturer or industry standards.
8. The Sample Size for the Training Set:
Not applicable. As a physical medical device (valve kit), there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing processes are developed based on engineering principles and regulatory requirements, not through data training.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of 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.