(14 days)
The YelloPort port access system is indicated for use in laparoscopic procedures to give access to the abdominal cavity while maintaining pneumoperitoneum.
The YelloPort port access system is also indicated for use in laparoscopic procedures to give access to the thoracic cavity.
The device comprises a trocar, available with a range of tips styles, and a base. The base forms the cannula and has a removable 'cap' which retains the valve and/or lip seal. The trocar and cannula elements of the device are fully reusable and can be sterilised in pressurised steam. Valves and seals are essential accessories used in conjunction with the cannula and are available in a range of formats depending on the specific market requirements.
YelloPort is ergonomically designed to be strong and durable yet lightweight and easy to handle. Medical grade polymers ensure the main elements are fully reusable and can be autoclaved in pressurised steam. Cannulae are available with a choice of internal diameters and a range of working lengths.
Trocars are made from the finest surgical steels, hand finished to give reliable and lasting performance. The patented shielded trocar is also fully reusable and can be taken apart for ease of cleaning and maintenance. The precision ground and polished cutting tubes can be replaced economically if they become blunt or damaged.
The combination of reusable cannulae and trocars together with single-use valves / seals makes YelloPort a highly cost effective solution.
The device is manufactured from materials that comply with the requirements of ISO 10993 in terms of biocompatibility.
The YelloPort valves and seals are sterilised using a validated method of gamma irradiation, thereby providing a sterility assurance level of 106.
The YelloPort cannulae bodies and trocars are provided non-sterile. Sterilisation instructions are provided in the instructions for use. The Surgical Innovations steam sterilisation and cleaning validation methods are based on the AAMI TIR No 12-1994, Designing, Testing and Labelling Reusable Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufactures and proves a sterility assurance level of 106. Sterilisation validation of the steam sterilisations is based on three sterilisation cycles at one half the exposure time. The use of Bacillus sterothermophilus spore strips or inoculum is the utilised indicator.
Here's an analysis of the provided text regarding the YelloPort Port Access System's acceptance criteria and study, structured to address your specific points:
Note: The provided document is a 510(k) Summary, which is a premarket notification for devices demonstrating substantial equivalence to a legally marketed predicate device. It primarily focuses on equivalence and safety/performance aspects for regulatory clearance, rather than a full-scale clinical or comparative effectiveness study. Therefore, some of your requested information (especially regarding AI, human readers, and detailed ground truth for training) will not be present as it's not relevant to this type of device or submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance data. Instead, it describes general performance aspects and states that the device was deemed "fit for purpose" based on various bench tests.
| Acceptance Criteria Category | Description of Performance / How it was Assessed |
|---|---|
| Trocar Reliability and Insertion Performance | - Must be sharp. |
- Capable of ease of insertion into abdominal wall.
- Reliable if containing moving parts (for reusable components).
- Assessed through a range of bench tests (TN100097, TN100144, TN100199, TN100200).
- "Performs well." |
| Sealing Performance (Pneumoperitoneum Maintenance) | - Must maintain pneumoperitoneum when instruments are inserted. - Must maintain pneumoperitoneum when no instruments are inserted.
- Tested for both seal and valve performance at ranges from 0mmHg to 24mmHg.
- Assessed through a substantial amount of test work (TN100131, TN100155, TN100156).
- "Performs well." |
| Biocompatibility | - Materials must comply with ISO 10993 requirements. - Stated that materials do comply. |
| Sterility & Sterilization | - Valves and Seals: Sterilised using validated gamma irradiation method, achieving a sterility assurance level (SAL) of 10⁻⁶. - Cannulae Bodies and Trocars (Reusable): Provided non-sterile. Sterilization instructions provided. Steam sterilization and cleaning validated based on AAMI TIR No 12-1994, proving a SAL of 10⁻⁶. Validation based on three sterilization cycles at half exposure time using Bacillus stearothermophilus spore strips/inoculum. |
| Reusability / Durability | - Full reusability of main elements (trocar, base, cannula) with autoclaving in pressurized steam. - Patented shielded trocar fully reusable and can be taken apart for cleaning and maintenance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as numerical counts for "test sets" but refers to "a range of bench tests" and "a substantial amount of test work." The specific number of devices tested for each identified Technical Note (TN) is not provided in this summary.
- Data Provenance: The tests were "bench tests" performed by Surgical Innovations Group plc. The country of origin of the data is implicitly the UK, where the company is based. The data is retrospective in the sense that it's generated as part of design verification and validation prior to market submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document states that "advice from industry experts and clinicians" was used in establishing the "methodical approach" for trocar performance testing.
- The number of experts is not specified.
- The qualifications of those experts are broadly described as "industry experts and clinicians," without further detail on their specific specializations (e.g., surgeon, biomedical engineer) or years of experience.
- No specific "ground truth" was established by experts in the context of clinical outcomes, but rather their advice guided the bench test methodology.
4. Adjudication Method for the Test Set
- Not applicable. This was bench testing, not a study involving human interpretation of data requiring adjudication. Performance was measured objectively against test protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
- This device is a surgical instrument (trocar/cannula system), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- No, a standalone performance study in the context of an algorithm's performance was not done. This device is a manual medical instrument, not an algorithm.
7. Type of Ground Truth Used
- The "ground truth" for this device's performance was established through objective measurements and observations during bench testing against predefined criteria and protocols (e.g., force required for insertion, leakage rate at different pressures, material properties as per ISO standards). It relied on engineering principles and validated sterilization methods.
- It does not involve expert consensus, pathology, or outcomes data in the way AI/diagnostic devices might.
8. Sample Size for the Training Set
- Not applicable. This device does not use an "AI algorithm" that requires a training set. The design and manufacturing process for the device were subject to design controls and risk assessments.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI algorithm, there is no "training set" or "ground truth for the training set" in this context. The manufacturing and design processes followed ISO 9001/ISO 13485, ISO 14971, and 21 CFR § 820.30 standards, with verification and validation activities conducted by Surgical Innovations.
§ 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.