(75 days)
The ICCD Endocam 5502 is designed for video endoscopy and video microscopy. It can be used for both diagnostic and therapeutic interventions. The Electronic CCD Endoscopes are used for viewing the inside of the patient via natural or surgically created passages.
Indication and Field of Application:
For use in various medical disciplines, such as urology, thorax surgery, gastroenterology, by adequately trained and qualified personnel.
The electronic CCD Endoscope is a combination of an endoscope with integrated objective lense: and CCD camera. The CCD endoscope is connected to the camera controller 5502 via a quick connector with camera cable.
The provided 510(k) summary (K983279) describes a medical device, the 1 CCD Endocam (Models 5502, 4934), which is an endoscopic video camera system. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance studies with acceptance criteria in the way a modern AI/ML device submission would.
Here's an analysis of the provided information concerning acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
Based on the document, there are no specific quantitative acceptance criteria or detailed device performance metrics reported for this device in the context of diagnostic accuracy or clinical outcomes. The performance data section refers to compliance with safety standards rather than clinical performance.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety Standards Compliance | IEC601-1, IEC601-1-2, IEC1-1-2, IEC1-2-18, UL2601-1, AAMI safe current limits | Endocam 5502 and 5507 conforms to these standards. |
| Medical Device Directive Compliance | Relevant provisions of Medical Device Directive 93/42/EEC | Camera system 5502 conforms to these provisions. |
| Functional Equivalence | Pose the same type of questions about safety and effectiveness as existing devices; new technological characteristics have not diminished safety or effectiveness. | Determined to be substantially equivalent to existing 510(k) devices (K950502, K942817). |
| Clinical Efficacy | N/A (No specific clinical efficacy criteria documented) | No clinical tests were performed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The submission explicitly states "No clinical tests performed."
- Data Provenance: Not applicable, as no clinical tests were performed to generate a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable, as no clinical tests were performed and therefore no ground truth establishment for a test set was required in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical tests were performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This device is a video camera system, not an AI-powered diagnostic tool, and the submission explicitly states "No clinical tests performed." Therefore, no assessment of human reader improvement with or without AI assistance was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No standalone algorithm performance study was done. This device is an imaging acquisition device, not an algorithm, and no clinical performance studies were conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no clinical tests were performed. The "ground truth" for this submission was primarily related to compliance with electrical and medical device safety standards and demonstration of substantial equivalence to predicate devices based on technological characteristics and intended use.
8. The sample size for the training set
- Not applicable, as this device is a hardware imaging system and does not involve AI/ML requiring a training set.
9. How the ground truth for the training set was established
- Not applicable, as no training set was used 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.