(59 days)
The InterLock Trocar has applications in abdominal, thoracic, and gynecological minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The InterLock Trocar is comprised of a minimally invasive surgical trocar (outer sheath sleeve, inner trocar and optical obturator) and accessories (lens cleaning syringe and lens cleaning tube). There are two tubes with a luer lock connector attached to the InterLock Trocar. The tube connected to the Outer sheath sleeve is used for abdominal insufflation and the other attached to the Inner trocar is used for the objective lens cleaning function. The outer diameter of the insertion portion of the outer sheath is approximately 18.5 mm and the overall length of the trocar is approximately 180 mm. The trocar provides two instruments (a 3.8 mm laparoscope and a 5 mm standard, currently marketed hand instrument) with access to the abdominal cavity at the same time. The design of the trocar allows the laparoscope to be in direct alignment with and to follow the hand instrument. This feature provides a surgeon with self-visualization control, meaning that the camera is in direct alignment or parallel to the hand instrument. Therefore, the hand instrument is always in the field of view of the laparoscope. The laparoscope does not need to be held by a surgeon. The trocar holds the laparoscope and no additional surgeon or assistant is required to control operation of the laparoscope. The trocar also provides features for insufflating the peritoneal cavity and cleaning the 3.8 mm laparoscope lens without removing it from the trocar. The InterLock Trocar is for exclusive use with a 3.8 mm laparoscope.
This looks like a 510(k) summary for a medical device called "InterLock Trocar." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study that proves the device meets those criteria in the way a clinical trial or algorithm validation typically would.
Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory document, as it's not an AI/algorithm-based device and the approval pathway is based on equivalence to an existing device.
Here's an attempt to extract the information based on your request, with significant clarification regarding what is and isn't present in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria with numerical targets in the same way an algorithm performance study would. Instead, performance is demonstrated through bench testing comparing the investigational device to a predicate device and design verification testing to ensure it meets its own product requirements. The criteria are implicit: the InterLock Trocar must perform comparably to the predicate device and meet its own design specifications.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Performance (Comparison to Predicate) | "substantially equivalent performance" to the Applied Medical Modular Trocar System (K060096) for: - Insertion force |
- Retention force
- Insufflation fill rate
- Insufflation leak rate |
| Cleaning Function Effectiveness (InterLock Specific) | Bench testing established that the lens cleaning technological characteristic is effective. |
| Product Requirements & Design Inputs (InterLock Specific) | Design verification testing demonstrated that the InterLock Trocar predictably met all product requirements and design inputs when tested under nominal conditions. Testing included: - Physical measurements/tests - Obturator performance
- Trocar performance
- Destructive tests |
| Biocompatibility | All patient contacting materials meet applicable biocompatibility standards per ISO 10993-1:2009. |
| Sterilization | Follows ANSI/AAMI/ISO 11137-2:2013 (VDmax25) to achieve a Sterility Assurance Level of 10^-6 for Gamma Irradiation Sterilization. |
| Packaging & Shelf Life | - Packaging design qualified and validated per ISO 11607-1 to meet established performance requirements and specifications. - Shelf life of 6 months substantiated by verifying product and package performance following aging, in accordance with ISO 11607-1. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document refers to "bench testing" and "design verification testing." This typically involves a defined number of units or prototypes tested to perform the specified mechanical, physical, and functional assessments. It is not patient data.
- Data Provenance: Not applicable in the context of patient data. The tests are laboratory-based, performed on manufactured devices.
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. This is a physical medical device, not an AI or diagnostic imaging device that requires expert interpretation for ground truth. Verification is based on engineering and performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a physical medical device, not an AI or diagnostic imaging device that requires human interpretation or adjudication for ground truth.
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 surgical trocar, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical surgical tool and does not have an "algorithm-only" mode.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance would be defined by engineering specifications, international standards (e.g., ISO, ANSI/AAMI), and the performance characteristics of the predicate device. For example, a "ground truth" for insertion force would be a measurable force value, not an expert opinion.
8. The sample size for the training set
- Not Applicable. This device uses traditional engineering design and manufacturing, not machine learning or AI 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.