(162 days)
The Standard Clamp, Disposable is indicated for use in laparoscopic procedures to grasp, clamp, and manipulate soft tissues.
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 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 end effector of 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 Standard Clamp, Disposable is a laparoscopic surgical instrument designed to grasp, clamp, and manipulate soft tissues. The following information details the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Reliability Testing | 95% reliability at 90% confidence for performing 6 use cycles (opening and closure) and meeting requirements for trocar insertion, visual inspection, and functional performance for each cycle. | Testing completed without deviations. All samples met requirements for trocar insertion, visual inspection, and functional performance for each cycle. Zero failures were observed in simulated use cycles, demonstrating the ability to perform for its intended use, similar to the predicate device. |
| Tissue Compression | Clamping forces of the Standard Clamp, Disposable should be less than or equal to that of the reusable Standard Clamp (predicate device) when tested with excised porcine stomach. | Testing completed without deviations. Thirty (30) test runs demonstrated the Standard Clamp, Disposable compressed tissue with forces less than or equal to that of the Standard Clamp, Reusable. |
| Tissue Slippage | Tissue will not slip from the jaws when a working load (maximum load typically applied in surgical procedures) is applied, with 95% probability and 90% confidence, using excised porcine stomach. | Testing completed without deviations. Thirty (30) test runs demonstrated that tissue did not slip from the Standard Clamp, Disposable jaws when a working load was applied to the tissue, achieving 95% probability with 90% confidence. This demonstrates functionality substantially equivalent to the predicate device, reusable Standard Clamp. |
| Closure Strength | Closure mechanism must have a safety margin greater than or equivalent to 1.5, ensuring the worst-case stress on the closure system will not exceed the strength of the device closure system (jaws remain closed when placed in the closed position). | Testing completed without deviations. Ten (10) test runs demonstrated that the closure mechanism had a safety margin of 11.6, exceeding the required safety margin. This demonstrates that the closure system is functional for device use and substantially equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Reliability Testing: The exact sample size for reliability testing is not explicitly stated, but the text mentions "All samples" and "zero failures" in "simulated use cycles."
- Tissue Compression: 30 test runs.
- Tissue Slippage: 30 test runs.
- Closure Strength: 10 test runs.
The data provenance is retrospective bench testing conducted by Standard Bariatrics. The type of data appears to be primarily laboratory measurements and observations from simulated use conditions. The country of origin of the data is not specified, but the submission is from Standard Bariatrics in Cincinnati, Ohio, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided text does not mention the use of experts to establish ground truth for the bench tests. These tests appear to rely on objective mechanical measurements and observations against pre-defined performance metrics.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as the testing involves objective measurements rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not provided." The study presented is bench testing comparing the proposed device to its predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical surgical instrument, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for these bench tests is based on objective performance metrics and established engineering principles. For example, force measurements, tissue slippage observations, and safety margin calculations. For tissue compression and slippage, excised porcine stomach was used as a biological model.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical surgical instrument, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical surgical instrument, not an AI algorithm.
§ 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.