(113 days)
The SILS™ Port device is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures, as well as through the anus to provide access for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.
Three laparoscopic trocars and an insufflation tube bound by a flexible port.
The provided text describes the 510(k) summary for the Covidien SILS™ Port, a surgical trocar. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance in a table format, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document primarily focuses on:
- Device Identification: Name, submitter, contact, date prepared, trade/proprietary name, common name, classification, and predicate devices.
- Device Description: Three laparoscopic trocars and an insufflation tube bound by a flexible port.
- Intended Use/Indications for Use: For multiple instrument or camera access to the abdominal cavity through a single incision for minimally invasive laparoscopic procedures, and through the anus for rectal procedures (TEMS, flap revision, fistula repair).
- Materials and Biological Evaluation: All components evaluated according to ISO 10993-1: 2009.
- Performance Data (General Statement): In-vivo (porcine) and in vitro evaluations were performed to support transanal access. This included in vitro suture pull-out testing and in vivo assessments of insertion force, port security, visualization, removal force, and resultant trauma. The conclusion is that the SILS™ Port is "safe and effective and provides equivalent performance to the predicate device(s)" for transanal access.
- FDA Clearance: A letter from the FDA stating K103253 has been determined substantially equivalent to predicate devices.
Therefore, I cannot fulfill the request to create a table of acceptance criteria and reported device performance or provide detailed information on sample sizes, expert qualifications, adjudication, or specific study types (MRMC, standalone) because this information is not present in the provided text.
The document states that in-vivo and in vitro evaluations were performed and that the device was found to be "safe and effective and provides equivalent performance to the predicate device(s)." This statement implies that certain acceptance criteria were met, but the specific criteria and the numerical results are not disclosed.
Summary of what can be extracted (and what cannot):
- Table of acceptance criteria and reported device performance: Not available. The document states "in vitro suture pull out testing as well as in vivo (porcine) transanal evaluations including insertion force, port security, visualization, removal force, and resultant trauma" were performed and concluded the device is "safe and effective and provides equivalent performance," but does not provide specific criteria or results in a table.
- Sample size used for the test set and data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: In-vivo studies were "porcine" (animal model), and in vitro studies were also conducted. This suggests the data is prospective, but the country of origin of the data is not specified beyond "Covidien" being located in North Haven, CT.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. This device is a surgical instrument, not an AI or diagnostic device that requires expert ground truth for interpretation. The performance evaluation was based on physical and biological testing.
- Adjudication method: Not applicable/Not specified.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No. This is not an AI or diagnostic imaging device.
- Standalone (algorithm only) performance study: No. This is not an AI or algorithm.
- Type of ground truth used: For the in-vivo and in vitro tests, the ground truth would be objectively measured physical properties (e.g., insertion force, pull-out strength) and biological observations (e.g., trauma). It's based on experimental measurements and observations rather than expert consensus or pathology in a diagnostic sense.
- Sample size for the training set: Not applicable/Not specified. As this is not an AI device, there's no concept of a "training set."
- How the ground truth for the training set was established: Not applicable.
§ 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.