(22 days)
The C2 CryoBalloon™ EndoGrip is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.
The C2 CryoBalloon™ EndoGrip is an accessory product that is used in conjunction with therapeutic endoscopes and therapeutic catheters (the C2 CryoBalloon™ Catheter of the C2 CryoBalloon™ Ablation System). The C2 CryoBalloon™ EndoGrip consists of a Clip Base, Rubber Grip, and Compression Spring. This is supplied non-sterile. The EndoGrip is used to anchor catheters in place relative to the scope. In a clinical application, once the endoscope is delivered into the gastric anatomy and positioned at its desired location the physician may insert the catheter through the endoscope. When the catheter is located properly in its axial position, the EndoGrip is positioned against the biopsy valve by depressing the clip mechanism and sitting the catheter on the rubber grips. The revised design allows for placing the EndoGrip after the CryoBalloon catheter is in place in the scope and for repositioning without having to completely withdraw and reinsert the catheter. The C2 CryoBalloon™ EndoGrip is designed for one-time, continuous application use (single patient) in conjunction with a therapeutic endoscope (3.7mm accessory channel ID) or a C2 Sidecar (FG -1011), which serves as an external channel for therapeutic devices when a therapeutic endoscope is unavailable for use.
The PENTAX Medical C2 CryoBalloon™ EndoGrip (K193036) is an accessory for endoscopic procedures. The information provided in the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than an AI/ML-driven study. Therefore, sections typically relevant to AI/ML device studies (such as MRMC studies, effect size of AI assistance, sample size for training sets, etc.) are not applicable here.
Here's a breakdown of the available information regarding acceptance criteria and performance testing:
1. A table of acceptance criteria and the reported device performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Characteristics | Verification of dimensions of the device. | All tests passed and met predetermined acceptance criteria. |
| Simulated Use, Performance, & Reliability | - Device can be attached to and detached from an endoscope. |
- Withstands 10 endoscopic delivery cycles.
- Compatible with endoscopic devices.
- Resists dislodgement forces.
- Resists kinking. | All tests passed and met predetermined acceptance criteria. The device performs as intended in the specified use conditions and performs comparably to the legally marketed predicate device. |
| Usability Testing | Validation of user needs. | All tests passed and met predetermined acceptance criteria. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the test set for dimensional verification, simulated use, and usability testing. It refers to these as "evaluations" and "testing" without providing numerical details for the quantity of devices or cycles tested.
3. Number of experts used to establish the ground truth for the test set and their qualifications
This information is not provided. The performance testing appears to be primarily engineering and functional verification, rather than clinical efficacy studies requiring expert ground truth for interpretation of medical images or data.
4. Adjudication method for the test set
Not applicable. The described tests are functional and physical performance evaluations where outcomes are objective (e.g., successful attachment, resistance to dislodgement) rather than subjective assessments requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. The document describes performance testing for an endoscopic accessory, not an AI/ML-driven diagnostic or therapeutic device that would typically involve human-in-the-loop performance evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this is not applicable. The device is a physical accessory (EndoGrip), not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.
7. The type of ground truth used
The "ground truth" for the performance testing cited would be direct physical measurements and engineering specifications, or the successful completion of specified functional tasks. For example:
- Physical characteristic evaluations: Ground truth would be the design specifications and manufacturing tolerances.
- Simulated use, performance, and reliability testing: Ground truth would be the defined functional requirements (e.g., "device can be attached," "withstand 10 cycles," "resist dislodgement").
- Usability testing: Ground truth would be the user needs and successful completion of tasks by users.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as 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.