(22 days)
The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues. The Clamp is indicated for use in bariatric procedures such as sleeve gastrectomy as a guide, to clamp and manipulate flat tissue and organs, such as the stomach.
The Standard Clamp, Disposable is a disposable non-energized, hand held surgical instrument designed for use in laparoscopic procedures to clamp long planes of soft tissue such as the stomach. The Standard Clamp, Disposable is provided sterile (gamma). There are no accessories provided with the device. The instrument is comprised of three main sections: handle, shaft, and end effector. The handle is a pistol grip with a trigger and release button which are manually activated in order to open and close the end effector. The shaft is sized to fit a standard 12 mm trocar. The clamp is comprised of an upper and lower jaw that close to grasp and hold tissue. The environment of use is in a hospital during laparoscopic surgical procedures. The current Standard Clamp, Disposable has a jaw length of 25 cm. This Special 510(k) is being filed to add a new shorter jaw length (22 cm) to accommodate patients with smaller abdomens.
The Standard Clamp, Disposable is intended to be used by a surgeon on a single patient during a single laparoscopic surgery under normal operating conditions. The Standard Clamp, Disposable is intended to be inserted into the peritoneal cavity through a 12mm trocar and used in up to six cycles of opening and closure to grasp, clamp and manipulate long, 1.2 to 4.5mm thick, planes of soft tissues such as the stomach. The Standard Clamp, Disposable is not intended for direct contact with the cardiovascular system, lymphatic system or cerebrospinal fluid. The Standard Clamp, Disposable can be used while a surgeon uses devices such as a stapler adjacent to tissue that is clamped with the Standard Clamp, Disposable, e.g., to help guide endoscopic staplers during resection of tissue such as in sleeve gastrectomy.
The provided text is a 510(k) summary for the Standard Clamp, Disposable surgical instrument. The document discusses the addition of a new, shorter jaw length (22 cm) to an existing device (Standard Clamp, Disposable 25 cm), and it asserts substantial equivalence to the predicate device.
However, the document does not contain the detailed type of study information requested in your prompt. Specifically, it does not include:
- A table of acceptance criteria and reported device performance (beyond a general statement that it "meets the same specifications").
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts or adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm-only) performance data.
- Specific ground truth types for testing or training sets.
- Sample size for a training set.
- How ground truth for the training set was established.
Instead, the document states:
"Standard Clamp, Disposable performance bench testing was provided in K170379. Testing for the Standard Clamp, Disposable 22 cm is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Standard Clamp, Disposable 25 cm previously provided in K 170379. The data demonstrates that the Standard Clamp, Disposable 22 cm meets the same specifications for clamping and slip force as the Standard Clamp, Disposable 25 cm."
This indicates that bench testing was performed to compare the new device to the predicate device based on previously established specifications for "clamping and slip force." The specifics of these specifications, the acceptance criteria, and the detailed results are not present in this 510(k) summary but are referenced as being in another section (Section 018) and a previous submission (K170379).
Therefore, I cannot populate the table or answer the specific questions about clinical study details, expert involvement, or AI performance, as this information is not provided in the given text.
The document primarily focuses on demonstrating substantial equivalence based on:
- Identical Indications for Use.
- Similar Technological Characteristics (with the only difference being the jaw length).
- Bench Testing to ensure the new jaw length performs to the "same specifications for clamping and slip force" as the predicate.
- Validation of a packaging change.
This type of 510(k) submission, especially a "Special 510(k)" as mentioned for the jaw length change, often relies heavily on engineering bench tests rather than extensive clinical studies or expert-driven evaluations, particularly when the change is considered minor and does not significantly alter the device's fundamental technology or safety profile. The absence of details about clinical studies, expert reviews, or AI integration further supports the conclusion that this is not the type of device or submission that would typically include such data.
§ 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.