(40 days)
The ADAPt™ Universal Balloon Open Access Port is indicated for use in thoracic, abdominal, and gynecologic minimally invasive surgical procedures to provide a pathway for the introduction of endoscopic surgical devices.
ADAPt™ Universal Balloon Open Access Port is used to establish a port of entry into the abdominal cavity, facilitating the access of various diameter devices, while maintaining insufflation at the surgical site. The port is positioned into the peritoneum during minimally invasive surgical procedures, in order to provide a pathway for the insertion and removal of various sized surgical devices. ADAPTM Universal Balloon Open Access Port is intended to be used by trained physicians.
The ADAPT™ Universal Balloon Open Access Port (K112456) is a surgical trocar device. The submission is a Special 510(k), indicating a modification to an already cleared device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not include a specific table of quantitative acceptance criteria or detailed reported device performance in terms of numerical metrics for the ADAPT™ Universal Balloon Open Access Port. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through comparative bench testing.
The acceptance criterion, by its nature as a Special 510(k), is that the modified device (ADAPt™ Universal Balloon Open Access Port) is substantially equivalent in performance, safety, and effectiveness to its predicate devices (ADAPT™ Balloon Open Access Port Model 41244, K023261, and ADAPt™ Universal Laparoscopic Port, K082156).
The reported device performance, therefore, is a statement of this equivalency based on bench testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Overall Performance Equivalency: The ADAPt™ Universal Balloon Open Access Port is substantially equivalent in performance to the predicate devices and performs as intended. | "The results of this comparison demonstrate that the ADAPI™ Universal Balloon Open Access Port is equivalent to the marketed predicate devices in performance characteristics." |
"Based upon the comparative test results, the proposed ADAPT™ Universal Balloon Open Access Port is substantially equivalent in performance to the predicate devices cleared to market via 510(k) K023261 and K082156." |
| Safety and Effectiveness: The modifications do not introduce any new issues of safety and effectiveness. | "No new Indications for Use, patient contacting materials, manufacturing processes, or risks have been introduced with these proposed modifications."
"The modifications made to the proposed ADAPT™ Universal Balloon Open Access Port do not introduce any new issues of safety and effectiveness." |
| Biocompatibility: Patient contacting materials comply with ISO 10993-1. | "All patient contacting materials are in compliance with ISO 10993-1." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "bench testing has been performed." However, it does not specify the sample size used for this bench testing.
The data provenance is from internal bench testing, conducted by Teleflex Medical, Inc. The data is retrospective in the sense that it relies on comparisons to previously cleared predicate devices and their known performance characteristics. No details are provided regarding the country of origin of the specific test data, but it would presumably be from the manufacturer's own R&D or testing facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The study involves bench testing of a medical device (a surgical trocar) for physical and functional equivalence to predicate devices, not for diagnostic accuracy or human interpretation. Therefore, there is no "ground truth" in the traditional sense established by experts for a test set of data points (e.g., medical images).
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As the study is based on bench testing for substantial equivalence, there is no need for expert adjudication of test results in the way there would be for a diagnostic AI study. The comparison is against established performance characteristics of predicate devices.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, typically in imaging or clinical decision support. The ADAPT™ Universal Balloon Open Access Port is a physical surgical device, and its evaluation focuses on its mechanical and functional equivalence, not on human interpretive performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
A standalone performance study, as typically understood for an algorithm or AI without human intervention, was not done. The "standalone" performance here relates to the device's physical function. The bench testing performed can be considered an evaluation of the device's standalone performance in a controlled environment, demonstrating that "the ADAPIt™ Universal Balloon Open Access Port will perform as intended."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for diagnostic or AI studies is not directly applicable here. For this device, the "ground truth" for comparison is the established performance characteristics and safety profile of the predicate devices. The new device's performance is measured against these known attributes through engineering and functional bench tests to determine if it meets the same standards.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As there is no AI algorithm or training set, the concept of establishing ground truth for a training set does not apply.
§ 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.