(90 days)
The Applied Access Seal is a sterile single use device, intended for use in conjunction with Applied's currently marketed Trocar products for use as a port of entry for endoscopic or surgical instruments during general, abdominal, gynecological and thoracic minimally invasive procedures.
A standard trocar assembly consists of an obturator, a seal and a cannula system. The Applied Access Seal is designed for use with Applied Medical's Cannulas and Obturators. An Applied Medical Trocar will consist of the Applied Access Seal, a cannula and an obturator.
The Applied Access Seal when used in laparoscopic surgery is designed to maintain pneumoperitoneum or positive pressure at its distal end to prevent loss of surgical gas. The device is designed to seal around surgical instruments, which are typically inserted through the device during surgery, to prevent loss of pneumoperitoneum during use and exchange of such instruments. The Applied Access seal is available with a stop-cock through which carbon dioxide or other gas may be dispensed into the surgical site during laparoscopic surgery.
The Applied Access Seal is made from materials used in currently marketed medical devices and has passed biocompatibility testing required per ISO 10993-1.
The provided text describes a medical device, the Applied Access Seal, and its 510(k) submission. However, it does not include detailed acceptance criteria or a study that specifically "proves" the device meets them in the way modern AI/software device submissions would.
This 510(k) submission is for a physical device (Trocar Seal), not an AI/software device. The regulatory pathway for this type of device in 2001 focused on demonstrating "substantial equivalence" to a predicate device, rather than detailed performance metrics against pre-defined acceptance criteria in the manner requested for an AI/software study.
Therefore, many of the requested points are not applicable or cannot be extracted from the provided text. I will address the points based on the information available and explicitly state when information is missing or not applicable to this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Integrity of Seal (to maintain pneumoperitoneum) | Demonstrated substantial equivalence to predicate device. |
| Leakage through the Seal (to prevent loss of surgical gas) | Demonstrated substantial equivalence to predicate device. |
| Biocompatibility (materials used in currently marketed devices) | Passed biocompatibility testing required per ISO 10993-1. |
Explanation of Implied Criteria:
The document states, "The performance and functional testing of the Applied Access Seal included tests to verify integrity of seal and leakage through the seal." These are implied performance criteria for a trocar seal. The primary method of "meeting" these criteria in a 510(k) is demonstrating "substantial equivalence" to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The testing seems to have been conducted on the physical device itself, not on a dataset of patient images or clinical data as would be the case for an AI/software device.
- Data Provenance: Not applicable in the context of an AI/software device. The testing was functional on the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a physical medical instrument. The "ground truth" would be objective measurements of seal integrity and leakage, not expert interpretation of data.
4. Adjudication method for the test set:
- Not applicable. This is not an AI/software study requiring adjudication of expert interpretations.
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:
- Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The device performs its function independently.
7. The type of ground truth used:
- For the performance tests (seal integrity, leakage), the "ground truth" would be objective physical measurements using scientific instruments and test methods to quantify parameters like pressure maintenance, flow rates, or visual inspection of seal integrity under stress.
- For biocompatibility, the "ground truth" is adherence to ISO 10993-1 standards and successful completion of the required tests.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model was used.
§ 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.