(90 days)
The SCB Computer Motion Interface Controller is indicated for use with the Storz Communication Bus (SCB) manufactured by Karl Storz to connect HERMES-Ready™ devices to the SCB.
The SCB Computer Motion Interface Controller (SCIC) connects devices that are controlled by Computer Motion's voice-control system to the Storz Communication Bus (SCB) manufactured by Karl Storz.
The provided document is a 510(k) summary for a medical device called the "SCB Computer Motion Interface Controller" (SCIC). It focuses on establishing substantial equivalence to a predicate device and demonstrating adherence to various electrical and safety standards.
There is no information in the provided document about:
- Acceptance criteria for clinical performance or diagnostic accuracy. The document exclusively discusses electrical safety and functional equivalence.
- A clinical study involving human patients or data to prove device performance in terms of diagnostic or clinical outcomes.
- Sample sizes for test sets or training sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth (pathology, outcomes data).
The "Device Testing" section only mentions "Hazard analyses and hardware/software validations procedures were provided in this submission." This indicates that the testing focused on engineering and functional validation, not clinical performance.
Based on the provided text, the only "acceptance criteria" and "device performance" described are related to compliance with electrical and medical device safety standards.
Here's a summary of what is available regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test / Standard | Title | Device Performance (Implied) |
|---|---|---|
| IEC 601-1 | International Standard for Medical Electrical Equipment | Compliant (Implied by submission for 510(k)) |
| IEC 601-1-1 | International Standard for Medical Electrical Equipment | Compliant (Implied by submission for 510(k)) |
| IEC 601-2-18 | International Standard for Medical Electrical Equipment | Compliant (Implied by submission for 510(k)) |
| UL 2601-1 | Underwriters Laboratory (Standard for Medical Electrical Equipment) | Compliant (Implied by submission for 510(k)) |
| EN55011/A1 CISPR 11 | Conducted Emission | Compliant (Implied by submission for 510(k)) |
| EN55011/A1 CISPR11 | Radiated Emission | Compliant (Implied by submission for 510(k)) |
| EN61000-4-2 | Electrostatic Discharge | Compliant (Implied by submission for 510(k)) |
| EN61000-4-3 and EN50140 | RF Immunity | Compliant (Implied by submission for 510(k)) |
| EN61000-4-4 | EFT/Bursts Immunity | Compliant (Implied by submission for 510(k)) |
| EN61000-4-5 | Surge Immunity | Compliant (Implied by submission for 510(k)) |
| EN61000-4-6 | Conducted Immunity | Compliant (Implied by submission for 510(k)) |
| EN60601-1 | International Standard for Medical Electrical Equipment | Compliant (Implied by submission for 510(k)) |
| EN60601-1-1 | General Requirements for Safety - Collateral Standard | Compliant (Implied by submission for 510(k)) |
| EN 60601-1-2 | Emissions and Immunity Test Measurements | Compliant (Implied by submission for 510(k)) |
| CAN/CSA-C22.2 No. 601.1 | Medical Electrical Equipment Part 1, General Requirements for Safety, General Instructions Part 1 | Compliant (Implied by submission for 510(k)) |
| VA-19795 | CMI Environmental Testing | Compliant (Implied by submission for 510(k)) |
| Substantial Equivalence to HERMES® Port Expander | Functional equivalence in extending connectivity from a central control system for medical devices. | Achieved (FDA determined substantially equivalent) |
| Hazard analyses and hardware/software validations | Safety and effectiveness of the device when connecting HERMES-Ready™ devices to the Storz Communication Bus. | Demonstrated safety and effectiveness |
Study Demonstrating Acceptance Criteria:
The "study" or rather, the evidence provided to demonstrate that the device meets its acceptance criteria, consists of the following:
- Compliance with various international and national electrical and medical device safety standards (IEC, UL, EN, CISPR, CSA). The document explicitly lists these tests that the SCIC was subjected to.
- Hazard analyses and hardware/software validation procedures. These were submitted as part of the 510(k) application.
- Establishment of substantial equivalence to the predicate device (HERMES® Port Expander) in terms of intended use and technological characteristics (providing additional device connection ports). The FDA's letter confirms this determination.
2. Sample size used for the test set and the data provenance
- Not Applicable. This device is an interface controller, not a diagnostic or clinical AI device that processes data from a test set of patient cases. The testing described relates to electrical safety and functional validation of the hardware and software components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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
- Not Applicable. This is not an AI device involved in diagnostic interpretation or human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device. It's a hardware interface controller.
7. The type of ground truth used
- Not Applicable. The "ground truth" for this device's validation is adherence to engineering specifications, electrical safety standards, and functional performance as an interface. There is no biological or diagnostic "ground truth" in the context of this submission.
8. The sample size for the training set
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.