(255 days)
The Cellvizio® 100 Series system with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal or respiratory, accessed by an endoscope or endoscopic accessories.
The subject device, "Cellvizio® 100 Series F700-v2 system with Confocal Miniprobes" operates in the same way as the predicate devices in order to provide confocal images of the internal microstructure of tissues in anatomical tracts. The only difference between the devices is the laser used for imaging at 785nm, along with the filters that have been adapted to this wavelength. The Cellvizio® 100 Series F700-v2 system is equipped with a laser emitting at 785nm whereas predicate devices are equipped witha laser emitting at 488nm or 660nm.
Here's a breakdown of the acceptance criteria and study information for the Cellvizio® 100 Series System with Confocal Miniprobes™, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Laser Safety | Conformance with IEC 60825-1:2007 | The laser conforms with requirements of IEC 60825-1:2007. |
| Conformance with 21 CFR Part 1040 | Requirements of 21 CFR Part 1040 are met. | |
| Optical Performance | Spectral Sensitivity evaluation | Spectral sensitivity meets all requirements. |
| Electrical Safety | Conformance with IEC 60601-1-1.2000 | The product conforms to all electrical safety requirements. |
| Conformance with IEC 60601-1-2:2001 | The product conforms to all electrical safety requirements. | |
| Conformance with IEC 60601-1-4 | The product conforms to all electrical safety requirements. | |
| Conformance with IEC 60601-2-18 | The product conforms to all electrical safety requirements. | |
| Software | Software validation | Product software has been satisfactorily validated. |
| Image Quality | Provide similar image performance as predicate device | Mauna Kea Technologies Confocal Miniprobes have been verified to be compatible with the Cellvizio® 100 Series F700-v2 system, and to provide similar image performance as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify sample sizes for test sets in terms of patient data or image data. The performance data primarily relies on engineering and regulatory compliance testing.
The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated beyond stating "Performance Data on which Substantial Equivalence is Based". Given the nature of the tests (laser safety, electrical safety, spectral sensitivity, software validation), these are typically conducted in a laboratory setting by the manufacturer or accredited testing facilities.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. The study described focuses on technical and regulatory compliance rather than clinical accuracy adjudicated by experts.
4. Adjudication Method for the Test Set:
An adjudication method (e.g., 2+1, 3+1) is not applicable or described in this document as the evaluation is based on technical specifications and functional equivalence, not on clinical performance requiring expert consensus on a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done or reported. The submission focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety/performance testing, not on comparative clinical effectiveness with or without AI assistance. The document is for a device that provides images, and the "AI" aspect (if any) is not discussed in terms of improving human reading.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is an imaging system (endoscope and accessories) that produces images for human interpretation. There is no mention of an "algorithm only" or standalone performance study as there isn't an explicit algorithm being independently evaluated separate from the human-in-the-loop use. The primary focus is the performance of the hardware (laser, filters, electrical components, software) to produce images.
7. The Type of Ground Truth Used:
The ground truth used for these tests is based on established engineering standards and regulatory requirements. For example:
- Laser Safety: Ground truth is defined by the limits and specifications in IEC 60825-1:2007 and 21 CFR Part 1040.
- Electrical Safety: Ground truth is defined by the requirements in IEC 60601-1 series.
- Spectral Sensitivity: Ground truth would be the expected or specified spectral response of the system.
- Software Validation: Ground truth is the software design specifications and expected functionality.
- Image Quality: The ground truth for "similar image performance" is qualitative comparison against the predicate device's known image output.
It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set:
The document does not mention a training set. This type of submission (510(k) for a hardware modification) does not typically involve machine learning or AI models that require training sets in the computational sense. The "software validation" mentioned refers to traditional software engineering validation, not AI model training.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set mentioned, this question is not applicable to the provided document.
§ 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.