(84 days)
These instruments are manually operated surgical devices intended for making incisions into the patient's body to establish pneumoperitoneum and allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.
The Karl Storz MANHES Pneumotrocars are manually operated surgical devices. The body contact portions of the KSEA Plastic Trocars are composed of surgical grade stainless steel which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
This document is a 510(k) premarket notification for the Karl Storz MANHES Pneumotrocar, a manually operated surgical device used to establish pneumoperitoneum and allow insertion of endoscopes and accessories during laparoscopic procedures.
Based on the provided text, the device's acceptance criteria and the study proving it meets them are not explicitly detailed in the format requested. This document is a regulatory submission for substantial equivalence, not a detailed clinical study report with specific performance metrics and acceptance criteria.
However, I can extract the information that is present and indicate where information is not provided.
Here's a breakdown based on the categories you requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Not specified | Not specified | The document states, "The minor differences between the Karl Storz MANHES Pneumotrocars and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This suggests a comparative analysis against predicate devices, but specific performance criteria and results are not provided in this summary. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. This document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with test sets.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described. This type of study is typically for AI-assisted diagnostic devices, which this surgical instrument is not.
6. Standalone Performance Study (Algorithm Only)
- Standalone Performance Study: Not applicable. This device is a manually operated surgical instrument, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not specified. The basis for safety and effectiveness is substantial equivalence to predicate devices, implying that the established safety and efficacy of the predicate devices serve as the "ground truth" for comparison.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is a physical surgical instrument, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. As above, this is not an algorithm requiring a training set.
Summary of Document Focus:
This 510(k) submission primarily focuses on establishing "substantial equivalence" to a predicate device. This means the manufacturer argued that their new device (Karl Storz MANHES Pneumotrocar) is as safe and effective as a device already legally marketed, based on similar features, intended use, and materials. The document doesn't provide details on specific performance acceptance criteria or detailed study results because the regulatory pathway chosen (510(k)) emphasizes comparison to existing devices rather than de novo clinical trials with novel performance measures.
§ 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.