(14 days)
For use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by instrumentation. Trocars may be placed through the Gel Seal Cap to allow instrument access to the surgical site. The device may be used in procedures such as nephrectomy, colectomy and splenectomy in colorectal, wological and general surgery to access.the surgical site.
The subject device is a modified version of the predicate . device. It has a simpler design, specific indications for use and allows a surgeon to choose an alternate method of accessing body cavities. It also improves patient safety by reducing the size of an abdominal incision. The subject device is designed for surgeons who prefer to perform laparascopic surgery without a hand in the peritoneum. There is no slit, thus simplifying the role of the Gel-Cap to a means of accommodating trocars only. The trocars are clustered near the center of the Gel-Cap which allows the abdominal incision to be smaller. The indications for use changes from "hand access plus trocars" to "trocars only". APPLIED refers to the resulting device as a Single Incision Access System. The new system will be available in diameters of 40-120mm for use in incisions ranging from 15-90mm. The predicate and subject device consists of a Gel-Cap and wound retractor. The Gel-Cap is constructed of a semirigid polycarbonate ring and a flexible gel-like material. An attachment lever locks the cap onto the wound retractor. The wound retractor consists of a thin-film flexible cylinder that has semi-rigid polyurethane rings at each end. The inner ring - which is placed in the patient's abdominal cavity - has a tether that aids removal of the wound retractor at the end of the procedure. The Gel-Cap attaches to the outer ring of the wound retractor via the attachment lever. APPLIED plans to market the subject device individually and also in a convenience kit. The kit will include trocars from APPLIED's extensive trocar model family. Those trocars will have a flange at the distal end of the cannula to prevent the cannulas from migrating during instrument exchanges.
The provided 510(k) summary for the GelPort Single Incision Access System (K090275) describes nonclinical performance testing rather than a clinical study involving human readers or ground truth established by experts. Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC study, ground truth type for training set) are not applicable or cannot be extracted from this document as it focuses on device functionality and safety in a laboratory setting.
Here's an analysis based on the available information:
K090275 - GelPort Single Incision Access System
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for the tests. Instead, it frames the tests as demonstrating "safety and efficacy of the subject device relative to the predicate device" and concludes with "substantially equivalent to the predicate device... and introduces no new safety and effectiveness issues." This implies that the acceptance criterion was generally "performance comparable to or better than the predicate device," without specific numerical thresholds being listed in this summary.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Minimum Incision Size: Ability to install inner ring of wound retractor with minimal incision. | Testing determined the minimum incision required to install the inner ring of the wound retractor. (Specific sizes/comparison not detailed in this summary, but presumably met or exceeded predicate performance). |
| Leak Testing: Ability to maintain pneumoperitoneum before and after multiple trocar insertions. | Testing demonstrated the ability of the system to maintain pneumoperitoneum. (Details on exact pressure maintained, number of insertions, or comparison to predicate not provided in this summary, but implicitly acceptable). |
| Particulate Testing: Ability to resist gel particulation from trocar insertions. | Testing demonstrated the ability of the system to resist gel particulation caused by inserting trocars through the Gel-Cap. (No quantitative results or comparison to predicate provided in this summary, but implicitly acceptable). |
| Leak Testing after Vigorous Manipulation of Trocars: Ability to maintain pneumoperitoneum despite active use. | Testing performed to assess leak resistance after vigorous manipulation of trocars. (No quantitative results or comparison to predicate provided in this summary, but implicitly acceptable). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. As this was nonclinical testing of a physical device, the "sample size" would refer to the number of devices or components tested. This information is not detailed in the summary.
- Data Provenance: Not applicable in the context of clinical data. This was nonclinical, laboratory-based performance testing conducted by Applied Medical Resources Corporation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This was nonclinical performance testing of a physical device, not a study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication Method
- Not applicable. This was nonclinical performance testing, not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This 510(k) summary describes nonclinical device performance testing.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical medical instrument (a single incision access system), not an algorithm or AI software, so standalone algorithm performance is not relevant.
7. Type of Ground Truth Used
- Not applicable. As this was nonclinical performance testing, the "ground truth" was based on objective physical measurements and observations of the device's functional integrity (e.g., whether it leaked, whether it allowed particulation, whether it fit a certain incision size).
8. Sample Size for the Training Set
- Not applicable. This was nonclinical performance testing of a physical device. There is no "training set" in the context of device performance in the way there would be for an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the reasons stated above.
In summary, this 510(k) pertains to a physical medical device and its nonclinical performance testing. The requested information regarding clinical studies, AI algorithms, human readers, and expert-established ground truth is not relevant to this type of submission. The manufacturer conducted laboratory-based tests to demonstrate that the new device performs comparably to its predicate device in terms of safety and basic functionality.
§ 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.