FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Applied GelPort Laparoscopic Hand Access Device is indicated for use in patients undergoing laparoscopic surgical procedures to obtain abdominal access by the surgeon's hand and instrumentation. Additional slits may be made using a trocar at the periphery of the Gel Seal Cap to allow instrument access to the surgical site. The Applied GelPort Laparoscopic Hand Access Device may be used in procedures such as nephrectomy, colectomy and splenectomy in colorectal, urological and general surgery to access the surgical site.. With the use of the Applied GelPort Laparoscopic Hand Access Device, the surgeon regains tactile sense and feedback along with the increased hand-eye and instrumentation manipulation capacity of open surgery. The device allows the surgeon multiple passages of the hand to access the surgical site without losing pneumoperitoneum. Instruments and Trocars may also be placed through the port in the center of the device and at the periphery of the device to allow instrument access to the surgical site, thereby reducing the need for additional incisions to the patient.

The device is designed with a slit for the hand at the center of the Gel Seal Cap. In addition to providing hand access, an instrument or trocar can also be inserted through this port during surgery to access the surgical site. The gel material conforms to the shape of the hand, instrument or trocar inserted through it providing a seal during laparoscopic surgery. Trocars can also be placed at the periphery of the Gel Seal Cap to allow for additional ports for instrument access during Hand Assisted Laparoscopy reducing the number of incisions required during surgery.

The Applied GelPort Laparoscopic Hand Access Device is very simple in design. It is simple to set up, easy to use and has a lower profile to maximize comfort. It consists of a Gel Seal Cap, a Base Ring Assembly, and a Retracting Sheath. The simple design makes installation of the Applied GelPort Laparoscopic Hand Access Device during clinical use very easy. Using a sterile skin marker an incision line is marked at the surgery site. Once the incision is made the retracting sheath is placed in position. The base ring assembly is then attached to the sheath. To complete the set up the Gel Seal Cap is snapped onto the base ring assembly. The sterile lubricant is provided to lube the surgeon's glove and the top of the Gel Seal Cap to make insertion of the hand into the port easy. Instruments may also be placed through the center slit if desired during surgery. If additional ports of entry are required for instrument access to the surgical site, slits can be made at desired locations on the periphery of the Gel Seal Cap using a non-threaded trocar. Instruments can then be inserted through the trocar cannula placed at the peripheral slit.

The Applied GelPort Laparoscopic Hand Access Device is a disposable, single-use device, packaged inside a PETG Tray with a Mylar peel cover, which is standard packaging material for medical products.

AI/ML Overview

I am sorry, but based on the provided text, there is no specific information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, expert involvement, or ground truth establishment.

The document is a 510(k) summary for the Applied GelPort Laparoscopic Hand Access Device, primarily focusing on demonstrating substantial equivalence to predicate devices. This type of submission typically relies on comparing the new device's design, materials, and intended use to already legally marketed devices, rather than presenting extensive performance studies with quantitative acceptance criteria for new functionality.

Here's why the requested information cannot be extracted:

No acceptance criteria or device performance table: The document describes the device's design, function, and intended use, but it does not specify any measurable performance metrics (e.g., seal integrity pressure, hand insertion force, durability cycles) nor does it provide a table comparing these to acceptance criteria.
No mention of a study to prove acceptance criteria: The core of the submission is predicated on substantial equivalence, not on a detailed study demonstrating performance against a novel set of acceptance criteria.
No sample sizes for test sets or data provenance: There is no mention of a "test set" in the context of performance evaluation.
No number of experts or qualifications: No experts are mentioned as being involved in establishing ground truth or evaluating device performance.
No adjudication method: As there's no mention of a test set evaluated by experts, no adjudication method is discussed.
No multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is typically for diagnostic imaging devices evaluating human reader performance with and without AI assistance. This document is for a surgical access device and does not involve such studies.
No standalone algorithm performance: The device is a physical surgical tool; it doesn't involve algorithms in the way AI/software devices do.
No type of ground truth used: Since no performance study is described, there's no mention of ground truth (expert consensus, pathology, outcomes data, etc.).
No sample size for the training set: There is no "training set" as this is a physical medical device, not a machine learning model.
No ground truth for the training set: (Same as above)

In summary, the provided text serves as a regulatory filing for market clearance based on substantial equivalence, and it does not contain the detailed performance study information requested. Such information would typically be found in a separate design validation report or clinical study report, which is usually summarized in a 510(k) but not fully detailed within the summary document itself.

Summary

Regulation Number and Section

§ 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.