(100 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 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.
This document describes a 510(k) premarket notification for the "Standard Clamp, Disposable". This application asserts substantial equivalence to a predicate device, K170379, also named "Standard Clamp, Disposable". The core argument for substantial equivalence relies on the subject device having identical technological characteristics to the predicate and the performance data for the predicate device still being applicable.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria in measurable terms (e.g., a specific percentage of reduction in staple cartridges, a maximum adverse event rate). Instead, it discusses the study's findings qualitatively.
| Acceptance Criteria (Explicitly stated in doc) | Reported Device Performance (from study) |
|---|---|
| Not explicitly stated as pass/fail criteria. The study aimed to evaluate the number of staple cartridges used and safety. | Safety: "no significant difference in post-operative adverse event rate (9.5% vs. 5.6%, p = NS)" between Standard Clamp and no clamp group. |
| Adverse Events (Standard Clamp group): No readmission or additional intervention required. One patient seen for syncope unrelated to procedure. | |
| Adverse Events (No Clamp group): One patient admitted for IV hydration due to persistent nausea/emesis. | |
| Serious Adverse Events (Both groups): "no occurrences of postoperative leak, bleeding, or stricture formation noted in either group." | |
| Effect on Staple Cartridges: The document states the study "evaluated the number of staple cartridges used" but does not report specific performance data or a comparison result regarding staple cartridge usage. It implicitly suggests the clamp's use is safe and guides staplers, but the direct outcome on cartridge quantity isn't quantified here. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 30 subjects
- Data Provenance: Prospective, single-center, randomized controlled study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting U.S. or internationally applicable clinical trial standards. The study was performed independently of Standard Bariatrics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The study involves surgical procedures and post-operative follow-up, implying medical professionals were involved in assessing outcomes, but the specific number and qualifications of experts establishing ground truth (e.g., for adverse events) are not detailed.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The study described is a clinical study comparing the use of the device (Standard Clamp) against a control (no clamp) in a surgical setting. It does not involve human readers interpreting data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical surgical instrument, not an algorithm or AI system. Therefore, the concept of standalone algorithm performance does not apply.
7. The Type of Ground Truth Used
- The ground truth used was clinical outcomes data (e.g., post-operative adverse event rates, readmissions, interventions, specific complications like leak, bleeding, stricture formation). This would have been established through direct clinical observation, patient records, and follow-up examinations by medical professionals.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical surgical instrument, not an AI/ML algorithm that requires a training set. The performance testing relies on engineering bench tests and a clinical study.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of device.
§ 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.