(96 days)
KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.
The KARL STORZ New Generation Trocars provide a port of entry during endoscopic and laparoscopic procedures in pediatric and adult patients. The New Generation Trocars are available in diameters 2.5mm to 13.5mm and consist of a cannula, trocar, and a valve seal. The trocars combine single-use and reusable components since the valve seal is single use while the cannula and trocar are reusable components. The trocars are color coded by size and are available with pyramidal, conical, or conical-blunt tips. Reducers can be used to reduce the size of the trocar to accommodate a smaller instrument without losing pneumoperitoneum.
The KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Seal Leak Test | Adequate sealing to maintain pneumoperitoneum | Bench verification performance testing was performed. |
| Seal Leak Test while Under Torque | Adequate sealing under torque conditions | Bench verification performance testing was performed. |
| Instrument Insertion and Retention Test | Instruments can be inserted smoothly and retained securely | Bench verification performance testing was performed. |
| Penetration Force | Acceptable force required for tissue penetration | Bench verification performance testing was performed. |
| Compression Testing of the Cannula | Cannula withstands compressive forces without failure | Bench verification performance testing was performed. |
| Bending Testing of the Cannula | Cannula withstands bending forces without failure | Bench verification performance testing was performed. |
| Torsional Testing of the Cannula | Cannula withstands torsional forces without failure | Bench verification performance testing was performed. |
| Biocompatibility | ||
| Biocompatibility | Compliant with ISO 10993 standards | Biocompatibility evaluation was performed to ISO 10993. |
| Sterility (Reusable Components) | ||
| Sterility (Reusable Cannula, Trocar, Reducer) | Compliant with ISO 11135 (Steam sterilization) | Sterility of the Reusable Components was validated in accordance with ISO 11135. |
| Sterility (Sterile Single-Use Components) | ||
| Sterility (Sterile Single-Use Valve Seals) | Compliant with ISO 11135 and ISO 10993 | Sterility of the Sterile Single Use Components was validated in accordance with ISO 11135 and ISO 10993. |
| Packaging (Sterile Single-Use Components) | ||
| Packaging (Sterile Single-Use Valve Seals) | Compliant with ISO 11607 and ISO 11737 | Packaging for the Sterile Single Use Components was validated to ISO 11607 and ISO 11737. |
| Clinical Performance | Demonstrate substantial equivalence to predicate device in terms of safety and effectiveness for intended use | Clinical testing was not required; non-clinical bench testing and medical literature review were considered sufficient to assess safety and effectiveness and establish substantial equivalence. |
| Usage in Pediatric Population | Safe and effective for use in pediatric patients | Supported by real-world evidence (medical literature) referencing pediatric minimally invasive surgery effectiveness and safety. |
| Electromagnetic Compatibility (EMC) | Not applicable | The subject device does not require electromagnetic compatibility, electrical safety, or software validation documentation. |
| Electrical Safety | Not applicable | The subject device does not require electromagnetic compatibility, electrical safety, or software validation documentation. |
| Software Validation | Not applicable | The subject device does not require electromagnetic compatibility, electrical safety, or software validation documentation. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each bench test performed. It generally states that "Bench verification performance testing has been performed" for the listed parameters.
- Data Provenance: The studies were bench tests performed by the manufacturer, KARL STORZ Endoscopy-America, Inc. There is no information about the country of origin of the data beyond the manufacturer's location in El Segundo, CA. All testing appears to be retrospective in the sense that it was completed prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for the performance tests was established through direct measurement against pre-defined engineering and regulatory standards (e.g., ISO standards, specific force/leakage thresholds set by the manufacturer for functional performance). There is no mention of human experts establishing ground truth for these objective bench tests.
4. Adjudication Method for the Test Set
Not applicable. For objective bench tests, results are typically determined by measurement against specified criteria, not by human adjudication.
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 device is a mechanical surgical instrument (trocar), not an AI-powered diagnostic or assistive tool that would involve human readers or AI assistance. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a mechanical surgical instrument; it does not involve algorithms or AI.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the bench tests was based on engineering specifications and established regulatory standards (e.g., ISO standards). For example, for biocompatibility, the ground truth was compliance with ISO 10993. For sterility, the ground truth was validation against ISO 11135 and ISO 11737. For mechanical tests, the ground truth would be the defined acceptable ranges for forces, leakage, etc.
For the expansion of indications to include a pediatric population, the "ground truth" was established through medical literature review (real-world evidence) from various peer-reviewed publications covering pediatric minimally invasive surgery.
8. The Sample Size for the Training Set
Not applicable. This device does not use an algorithm that requires a training set. The term "training set" is typically associated with machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no algorithm or AI, there is no training set or ground truth associated with it.
§ 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.