(120 days)
The CardioOptics Coronary Sinus Access (CSA™) System is intended to provide subclavian access to the right heart for accessing the coronary sinus and placing a quide sheath suitable for pacemaker lead implantation into the coronary sinus. The system includes visualization means to image anatomical structures to augment navigation.
The Coronary Sinus Access (CSA™) System provides a catheter and sheath system for providing percutaneous access to the coronary sinus. In addition, the catheter provides visualization to augment the user's ability to locate the coronary sinus for placement of a guide sheath. The system includes a sterile, single use Coronary Sinus Access Kit, which includes a deflecting tip catheter with visualization capability (FLAIR™ CS Catheter), a Guide Sheath Set including a dilator and sheath slitters, and a Sterile Sleeve to drape over the camera pod. The system also includes an Imaging Acquisition System to collect and display video images present in front of the catheter tip.
The CardioOptics Coronary Sinus Access (CSA™) System underwent performance testing, including mechanical, functional, and animal studies, to establish substantial equivalence to predicate devices. Biocompatibility testing was also conducted.
Here is a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it states that various tests were performed to support "substantial equivalence" to predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Testing | Performed to support substantial equivalence. |
| Functional Testing | Performed to support substantial equivalence. |
| Animal Testing | Performed to support substantial equivalence. |
| Biocompatibility | All specified biocompatibility requirements (consistent with ISO 10993) were met for blood and tissue contacting materials. |
| Sterilization | Components will be sterilized using validated Ethylene Oxide (EtO) sterilization processes. |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: The document does not specify the sample sizes used for the mechanical, functional, or animal testing.
- Data Provenance: The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated. Animal testing implies prospective data collection in a controlled environment.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. The device's performance is described in terms of "substantial equivalence" to predicate devices and meeting general testing requirements, rather than an evaluation against human expert-defined ground truth in a clinical setting.
4. Adjudication Method for Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document focuses on demonstrating substantial equivalence through device testing.
6. Standalone Performance Study
A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not explicitly described or conducted, as the device is a system with visualization to augment human navigation rather than an autonomous algorithm. The visualization aspect of the FLAIR™ CS Catheter was shown to be substantially equivalent to angioscopes and associated video display systems.
7. Type of Ground Truth Used
The ground truth used for assessing the device's performance appears to be established through:
- Engineering and pre-clinical testing standards: Mechanical and functional performance would be measured against predefined specifications or engineering benchmarks.
- Biocompatibility standards: ISO 10993 serves as the ground truth framework for biocompatibility.
- Comparison to predicate devices: The concept of "substantial equivalence" implies that the device's performance or characteristics are compared to those of already legally marketed predicate devices, which serve as a de facto "ground truth" for regulatory clearance.
- Animal models: Animal testing provides a physiological environment to assess aspects like access and visualization, where observations by skilled operators in the animal model would serve as the ground truth.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI, as the device is not described as an AI/ML product. The testing performed relates to the physical and functional aspects of the medical device.
9. How Ground Truth for the Training Set was Established
As there is no mention of a training set for an AI/ML component, this information 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.