(154 days)
The ASC TriPort and QuadPort Laparoscopic Access Devices are intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
The modified ASC TriPort Laparoscopic Access Device, like the parent TriPort cleared by the FDA under K073719, is still comprised of the following three components:
- an introducer component which creates an abdominal incision (except in the case where the surgeon creates a Hasson cut-down incision) and delivers the Distal Ring of the ASC TriPort into the abdominal cavity
- a retractor component which retracts an abdominal incision to allow the passage of laparoscopic instruments
- a valve component which maintains the pneumoperitoneum established for the surgical procedure
The modified ASC TriPort Laparoscopic Access Device is still intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The modified ASC TriPort Laparoscopic Access Device is identical in function to the parent device, which has been cleared for marketing under K073719.
The modifications made to the parent device labeling to produce the proposed TriPort Laparoscopic Access device informs users and patients that the device does not contain Natural Rubber Latex. Additionally the labelling has been revised to extend the shelf life from three months to three years as notified in the original 510(k) and to make the device safer and easier to use. The changes made to the parent TriPort Laparoscopic Access Device to produce the proposed TriPort are minor and do not represent modifications to the indications for use, operating principles, or mechanism of action for the device.
The TriPort has additionally been modified resulting in the QuadPort device. The modifications to the TriPort comprise the following:
- A fourth valve was added to accommodate an additional laparoscopic instrument.
- The Boot is larger in diameter to accommodate the fourth instrument valve.
- An Introducer and Retaining Clips are not required.
- The Removal Ring is made from a different material (the same material as is used for the TriPort distal ring).
The ASC TriPort and QuadPort Laparoscopic Access Devices are laparoscopic multiinstrument ports which perform the following two functions:
- They retract a small abdominal incision to allow multiple laparoscopic instruments to pass through a small incision to the abdomen at the same time during laparoscopic surgery.
- They ensure that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through them.
The ASC TriPort and QuadPort Laparoscopic Access Devices apply radial force upon the incision creating an aperture though which the laparoscopic instruments pass. The ability to remove the boot, allows the clinician to deliver specimens without removing the entire port, and with the QuadPort, generally without the need to extend the incision.
The physical design and performance of the modified TriPort is unchanged. Materials changes relate to substitution with materials already used for the TriPort. The physical properties of the QuadPort differ from the TriPort in that the diameter of the boot is increased, allowing space for the addition of a fourth port.
The document provided describes the ASC TriPort and QuadPort Laparoscopic Access Devices, which are intended for use as multiple instrument and/or camera ports during minimally invasive abdominal laparoscopic surgery. This submission is a Special 510(k), indicating modifications to an already cleared device (the parent TriPort cleared under K073719).
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (e.g., success rates, leak rates, specific force thresholds) against which the device was evaluated. Instead, the "acceptance criteria" can be inferred from the regulatory context of a 510(k) submission, which relies on demonstrating substantial equivalence to predicate devices and ensuring that modifications do not raise new issues of safety or effectiveness.
The reported device performance is described qualitatively in relation to these overarching goals.
| Acceptance Criteria (Inferred from 510(k) Objectives) | Reported Device Performance |
|---|---|
| For Modified TriPort: | |
| - No new issues of safety or effectiveness: | - Biocompatibility and performance verification testing of the ASC TriPort demonstrates that the modifications do not raise new issues of safety or effectiveness. |
| - Functionality remains identical: | - The modified ASC TriPort Laparoscopic Access Device is identical in function to the parent device (K073719). |
| - Operating principles unchanged: | - The changes made to the parent TriPort Laparoscopic Access Device to produce the proposed TriPort are minor and do not represent modifications to the operating principles. |
| - Mechanism of action unchanged: | - The changes made to the parent TriPort Laparoscopic Access Device to produce the proposed TriPort are minor and do not represent modifications to the mechanism of action for the device. |
| - Extended shelf life validated: | - Labeling was revised to extend the shelf life from three months to three years. (Implies validation of materials over this period, though specific validation data is not detailed here). |
| - Labeling accurately reflects changes: | - Labeling reflects "does not contain Natural Rubber Latex" and revised shelf life. |
| For QuadPort: | |
| - Function as intended: | - Validation testing of the ASC QuadPort in a porcine model demonstrated that the QuadPort functioned as intended. |
| - No new issues of safety or effectiveness: | - Performance did not raise new issues of safety and effectiveness. |
| - User-friendly/no formal training required: | - Formal user training was not required for the QuadPort. (Implies ease of use, alignment with existing surgical practices). |
| - Maintains pneumoperitoneum: | - The devices "ensure that pneumoperitoneum is maintained in the abdomen during the surgical procedure." (This is a core function inherited from the predicate). The testing likely verified this continued functionality for the QuadPort. |
| - Allows multiple instrument passage: | - The devices "retract a small abdominal incision to allow multiple laparoscopic instruments to pass through... at the same time." (This is a core function inherited from the predicate). The testing likely verified this continued functionality for the QuadPort, especially with the addition of a fourth port. |
| - Meets prospectively defined design/performance: | - Based on design verification testing of both the TriPort and QuadPort, along with the validation testing of the QuadPort in the porcine animal model, the modified TriPort and QuadPort fulfill prospectively defined design and performance requirements. (This is a general statement that encompasses the above points; actual "requirements" are not itemized). |
2. Sample size used for the test set and the data provenance:
- Test Set Description:
- Modified TriPort: "Biocompatibility and performance verification testing." The document does not specify the sample size for this testing.
- QuadPort: "Validation testing of the ASC QuadPort in a porcine model." The document does not specify the sample size (number of animals) used in this porcine model study.
- Data Provenance: The document does not explicitly state the country of origin for the testing data. The manufacturer is based in Ireland. The testing was "non-clinical performance testing," indicating it was conducted in a laboratory or animal setting, not on human patients. The study was likely prospective in design, as it describes a planned validation test of a new device modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the QuadPort porcine model study, it "enrolled clinicians with various levels of experience."
- The document does not specify the exact number of clinicians/experts used.
- It does not specify the exact qualifications beyond "various levels of experience" (e.g., number of years, surgical specialty).
- For the TriPort biocompatibility and performance verification testing, no explicit mention of human experts evaluating the "ground truth" is made, as this typically involves standardized technical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document states that the QuadPort study "enrolled clinicians with various levels of experience" who demonstrated that it "functioned as intended."
- It does not describe an adjudication method (like 2+1 or 3+1 consensus) for establishing a "ground truth" based on expert opinion. The assessment appears to be a direct observation of the device's function by the clinicians during the porcine model procedure, rather than an interpretation of complex data requiring consensus.
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:
- No MRMC comparative effectiveness study was done.
- This device is a physical surgical access port, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The device is a physical surgical tool and does not involve an algorithm. Performance assessment inherently involves human interaction (clinicians using the device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the TriPort modifications, the "ground truth" for demonstrating safety and effectiveness relies on standard performance verification testing (e.g., mechanical strength, seal integrity, material biocompatibility) and comparison to the known performance of the predicate device.
- For the QuadPort porcine model study, the "ground truth" was based on the direct observation and assessment by clinicians during a simulated surgical procedure that the device "functioned as intended" and "did not raise new issues of safety and effectiveness."
8. The sample size for the training set:
- This concept is not directly applicable to a physical medical device submission for regulatory clearance. There is no "training set" in the context of machine learning or AI algorithms. The device design and manufacturing processes are refined through engineering and iterative testing, not by training an algorithm on a dataset.
9. How the ground truth for the training set was established:
- Not applicable, as no "training set" in the AI/ML context exists for this 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.