(53 days)
The YelloPort Elite port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.
The YelloPort Elite port access system is also indicated for use in thoracoscopic procedures to give access to the thoracic cavity.
The YelloPort Elite Port Access System comprises a trocar, available with a range of tip styles, cannula. Universal Seal and Hasson (fascia) adaptor. The trocar, cannula and Hasson (fascia) adaptor elements of the device are fully reusable and can be sterilised in pressurised steam. The Universal seal is single use only.
In order to obtain access to the surgical site during laparoscopic surgery, the YelloPort Elite Trocar is introduced into the YelloPort Elite Cannula to accomplish cannula penetration of the abdominal wall. The cannula is connected to the YelloPort Elite Universal Seal at its proximal end and once the abdominal/thoracic wall is punctured, the trocar is removed. The cannula acts as a channel for the introduction of the endoscopes and instruments. Generically, trocars and cannulas are available in a range of lengths and diameters.
This document is a 510(k) premarket notification for the YelloPort Elite Port Access System. It demonstrates substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a study in the same way a new, innovative device might.
Therefore, the requested information elements related to performance studies, ground truth, expert adjudication, MRMC studies, and sample sizes for test and training sets are not applicable in this context. The provided text details non-clinical (bench) testing to show equivalence, not clinical performance against acceptance criteria for a novel functionality.
Here's a breakdown of the applicable and non-applicable information based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense of a clinical performance study with acceptance criteria for a novel claim.
- The document's purpose is to demonstrate substantial equivalence to existing predicate devices based on technological characteristics and non-clinical testing. The "acceptance criteria" here are implicitly related to meeting the performance characteristics of the predicate devices for safety and effectiveness through bench testing.
The document lists various non-clinical tests performed:
| Test | Purpose (Implied Acceptance Criteria) | Reported Performance |
|---|---|---|
| Sealing Performance | Ensure gas retention (pneumoperitoneum) | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Instrument Insertion Force (Universal Seal) | Ensure instruments can be inserted with appropriate force | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Seal Contamination Testing | Ensure seal does not contaminate the surgical field or instruments | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Instrument Compatibility Testing (Universal Seal) | Ensure compatibility with a range of instruments | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Port Insertion Force Testing | Ensure appropriate force for port insertion | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Insufflation Testing | Verify ability to maintain insufflation | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Seal Inversion Testing | Evaluate seal integrity under stress | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Trocar Knob Pull Testing | Assess trocar retention/security | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Stopcock Torque Lever Test | Evaluate function of the stopcock mechanism | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Universal Seal Attachment and Removal Test | Verify ease and security of seal handling | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Cannula Mechanical Testing | Assess structural integrity of the cannula | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Pressure Retention of Universal Seal (With Use of Locking Shielded Trocar) | Ensure seal maintains pressure during use with specific trocar type | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Trocar Peritoneum Insertion Simulation Test (Locking Shielded) | Simulate insertion to ensure safety and effectiveness | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Torque Force Test (Locking Shielded) | Evaluate torque limits of the locking shielded trocar | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Tensile Test (Locking Shielded) | Evaluate tensile strength of the locking shielded trocar | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Biocompatibility Testing in accordance with ISO 10993-1 | Ensure materials are safe for patient contact | Compliance with ISO 10993-1, implying successful completion of biocompatibility evaluations. |
| Shelf life and lifecycle studies | Determine product stability and usability over time and repeated use | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Transit studies | Ensure device integrity during shipping/transport | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
| Cleaning and sterilisation validation | Validate methods for proper cleaning and sterilization of reusable components | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance and that reusable components "can be sterilised in pressurised steam." |
| Clinical (Design) validations which include a simulated surgical evaluation by a consultant surgeon | Evaluate design in a simulated surgical environment by an expert | "Simulated surgical evaluation by a consultant surgeon" was performed. Conclusion states "shows no adverse indications or results" and "is safe, effective". |
| Usability assessments | Ensure ease of use for the intended user | Not explicitly detailed, but stated that "The YelloPort Elite Port Access System shows no adverse indications or results" and "is safe, effective and performs within its design specifications" implying successful performance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission is for a 510(k) premarket notification relying on substantial equivalence demonstrated through non-clinical (bench) testing, not a clinical study with test sets in the context of AI/diagnostic device performance. No sample sizes for "test sets" or data provenance (country, retrospective/prospective) are mentioned as no clinical data in that format was required or provided.
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 information relates to clinical studies, particularly for diagnostic devices. For this 510(k), evidence of safety and effectiveness was established through non-clinical bench testing and comparison to predicate devices. A "consultant surgeon" conducted a "simulated surgical evaluation" as part of the "Clinical (Design) validations," but this is not establishing ground truth for a diagnostic test set. No number or specific qualifications beyond "consultant surgeon" are given, nor is "ground truth" established in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for clinical studies, particularly for diagnostic devices where disagreement among readers needs resolution for ground truth. This 510(k) focused on non-clinical engineering and performance testing.
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. An MRMC study is relevant for evaluating the impact of AI or new diagnostic methods on human reader performance. This device is a surgical access system, not a diagnostic AI system, and no clinical MRMC studies were conducted. The document explicitly states: "No clinical studies were conducted as part of submission to prove substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to the performance of an AI algorithm. The YelloPort Elite Port Access System is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth, in the context of clinical studies for diagnostic accuracy, is not relevant here. The "ground truth" for this device's performance is established by successfully meeting the engineering and performance specifications during the non-clinical bench tests and demonstrating equivalence to existing predicate devices.
8. The sample size for the training set
- Not Applicable. This refers to training data for AI algorithms. This device is a physical medical device, not an AI algorithm.
9. How the ground truth for the training set was established
- Not Applicable. This refers to the establishment of ground truth for training data for AI algorithms. This device is a physical medical 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.