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The CQ ENCE Circular Staplers have application throughout the alimentary tract for the creation of end-to-end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries.

The REACH™ and SeCQure CO'ENCE™ Circular Staplers (CO'ENCE™ Circular Staplers) are sterile, single-use, hand-held, non-powered stapling devices used during general surgical procedures for the creation of end-to-end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries. The Circular Staplers place a double-staggered, circular row of titanium staples while simultaneously resecting tissue when the device is manually activated. The device is provided in five head diameter sizes: 34mm, 31mm, 28mm, 25mm, and 21mm (product codes CS34, CS31, CS28, CS25, and CS21 respectively). Each size device can be purchased with a standard 27cm length shaft. The CS21 and SC25 can also be purchased with a longer, 35cm shaft (product codes CS21L, CS25L) to facilitate surgeon access to desired tissues. The CQ 'ENCE™ Circular Stapler allows the surgeon to control tissue compression by varying the closed staple height. The CQ ENCE Circular Stapler forms traditional B-shaped staples that are comprised of titanium. Safe removal of the device is facilitated by opening the instrument one full the Audible Indicator makes a clicking sound.

The provided document is a 510(k) summary for the Reach™ and CQ'ENCE™ Circular Staplers, seeking to demonstrate their substantial equivalence (SE) to a predicate device. The document primarily focuses on establishing SE based on comparison of technological characteristics and performance bench testing, rather than a clinical study with human subjects for efficacy or diagnostic performance. Therefore, many of the typical elements of an AI/ML device study (like MRMC studies, expert adjudication for ground truth of an imaging dataset, training set details) are not applicable or described in this document.

However, based on the information provided, here's an attempt to extract and interpret the relevant details regarding acceptance criteria and performance, as they relate to the mechanical device testing presented:

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details (Bench Testing):

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document states "Reach™ Circular Stapler performance bench testing was provided in K120179. Testing for the Reach™ and CQ 'ENCE™ Circular Stapler is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Reach™ Circular Stapler previously provided in K120179." It does not specify the exact number of devices or test repetitions used for the bench testing.
   • Data Provenance: The testing was conducted as part of the submission process, presumably by the manufacturer (Reach Surgical, Inc. / SeCQure Surgical). The location of the testing is not explicitly stated, but the company is based in China with a US contact. This would be considered prospective internal testing.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

   • Not Applicable. This is a mechanical device, and the "ground truth" is established by engineering specifications, physical measurements, and functional performance tests (e.g., measuring staple form, activation of safety mechanisms). "Experts" in the sense of radiologists interpreting images are not involved.

3. Adjudication Method for the Test Set:

   • Not Applicable. As this is mechanical testing against engineering specifications, there is no need for human adjudication of subjective interpretations. Measurements and functional checks are performed against defined criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This document describes a surgical stapler, a mechanical device.

5. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is not an AI/ML algorithm. The performance of the stapler itself is the focus, without an "algorithm-only" or "human-in-the-loop" distinction typical of AI medical devices. The device's operation is purely mechanical, and performance relates directly to its physical characteristics and activation.

6. The Type of Ground Truth Used:

   • The "ground truth" for this medical device is based on engineering specifications, design requirements, and established functional performance metrics for surgical staplers. This includes parameters like staple formation, dimensions, safety mechanism activation, material properties (biocompatibility, endotoxin limits), and sterilization effectiveness.

7. The Sample Size for the Training Set:

   • Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for one.

Summary of the Study Proving Acceptance Criteria were Met:

The study proving the device meets the acceptance criteria was primarily a performance bench testing program. The document explicitly states:

• "Performance bench testing was provided in K120179 [for the predicate device]."
• "Testing for the Reach™ and CQ 'ENCE™ Circular Stapler is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Reach™ Circular Stapler previously provided in K120179."
• "The data demonstrates that the Reach™ and CQ ENCE™ Circular Stapler meets the same specifications for visual inspection, dimensional analysis, staple form and safety mechanism performance."

This indicates that the manufacturer conducted a series of laboratory tests to assure that the new device's physical characteristics and functional performance matched those of the predicate device and met predefined engineering and quality specifications. The comparison table of technological characteristics further supports the demonstration of substantial equivalence by highlighting design similarities and explaining minor differences.

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The Circular Staplers with Staples have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The Linear Staplers with Single Use Loading Units have application in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

The Procedure Sets for Prolapse and Hemorrhoids have application for general surgical treatment of hemorrhoids.

The Endoscopic Linear Cutting Staplers with Single Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.

The Linear Cutting Staplers with Single Use Loading Units have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.

The proposed device, Circular Staplers with Staples, is a sterilized and disposable surgical instrument intended to be used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

It places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, so a circular anastomosis is created.

The staple is available in two specifications which are 4.8 mm and 3.5 mm to be used per different thickness of the tissue.

The proposed device, Linear Staplers with Single Use Loading Units (SULU) is a sterilized and disposable surgical instrument intended to beused in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

It places a double staggered row of titanium staples and isavailable in 30 mm, 45 mm, 60 mm and 90 mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.5 mm and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 7 times for total 8 firings.

The proposed device, Procedure Sets for Prolapse and Hemorrhoids is a sterilized and disposable surgical instrument, which has application for general surgical treatment of hemorrhoids.

It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The sets are commonly used in the procedures for prolapsed and hemorrhoids. They are also used for other applications when circular or semicircular stapling of anorectic tissue is required.

The proposed device, Endoscopic Linear Cutting Staplers with Single Use Loading Units (SULU)is a sterilized and disposable surgical instrument, which has applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.

It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The size of the staples is decided by selecting 2.0 mm, 2.5 mm, 4.0 mm or 4.8 mm SULU.

The Endoscopic Linear Cutting Staplers are available in two kinds, which are Articulating and Straight. In addition, the Single Use Loading Units are also available in Articulating and Straight types. The Articulating Staplers could adjust the direction of the Single Use Loading Units (SULU) within a specified range if used together with Articulating SULU. The Articulating Staplers could also be used together with straight SULU without articulating features. The Straight stapler could only be used together with straight SULU.

When using the Endoscopic Linear Cutting Staplers with the 2.0, 2.5, 3.5 and 4.0 SULU, a 12 mm or larger trocar sleeve with a converter should be used. When using the Endoscopic Linear Cutting Staplers with the 4.8 SULU, a 15 mm trocar sleeve should be used. Endoscopic Linear Cutting Staplers may be reloaded and fired no more than 25 times in a single procedure. Each instrument can accommodate the following SULU specifications: 30-2.0, 30-2.5, 45-2.0, 45-2.5, 45-3.5, 45-4.0, 45-4.8,60-2.5, 60-3.5, 60-4.0, 60-4.8.

The proposed device, Linear Cutting Staplers with Single Use Loading Units(SULU)is a sterilized and disposable surgical instrument, which has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.

It places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Linear Cutting Staplers and SULU are available in 60 mm, 80 mm, and 100 mm lengths. SULU'are available in two staple sizes to accommodate various tissue thicknesses: 3.8 mm and 4.8 mm.

The provided text describes surgical staplers and their intended use, along with a statement of substantial equivalence to predicate devices based on non-clinical bench testing. However, it does not include the information typically associated with establishing acceptance criteria and proving a device meets those criteria through a clinical or algorithmic study, especially in the context of AI or imaging devices.

Specifically, the document focuses on:

• Device Identification and Description: Detailing different types of surgical staplers (circular, linear, endoscopic linear cutting, etc.) and their intended surgical applications (anastomoses, tissue resection, treatment of hemorrhoids).
• Predicate Devices: Identifying previously cleared devices for comparison.
• Non-Clinical Test Conclusion: Stating that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. These tests include: Package Integrity Testing, Physical Performance Testing, Sterilization Validation and Endotoxin Testing."
• Substantial Equivalence Conclusion: Affirming that the proposed devices are substantially equivalent to the predicate devices in safety and effectiveness.

Based on the provided text, the requested information regarding acceptance criteria, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set), and comparative effectiveness for AI-assisted performance is absent.

The document describes a traditional 510(k) submission for a physical medical device (surgical staplers), where the safety and effectiveness are established through bench testing and comparison to a predicate device, rather than through clinical studies involving human subject data or algorithmic performance metrics. Therefore, I cannot extract the requested information.

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The REACH™ RCS Circular Stapler has applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The REACH™ RCS Circular Stapler is a single patient use device which places a double staggered row of titanium staples. During staple formation, the instrument knife blade resects the excess tissue, creating a circular anastomosis.

This information is not available in the provided text. The document is a 510(k) summary for a medical device (REACH™ RCS Circular Stapler) and declares substantial equivalence to a predicate device (Auto Suture PREMIUM PLUS CEEA Disposable Stapler).

A 510(k) summary typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not usually include detailed acceptance criteria, performance studies with specific sample sizes, ground truth establishment, or multi-reader multi-case studies as these are often part of the original predicate device's clearance or pre-market approval, or may be conducted when significant new claims are made.

Based on the provided text, the relevant sections state:

• "All device functions, scientific concepts, significant physical and performance characteristics (i.e. device design, materials, physical properties, etc.) are identical to the design and manufacture described in 510(k) K024275"
• "The REACH™ RCS Circular Stapler's technological and safety characteristics are identical to those described in 510(k) K024275"
• "The REACH™ RCS Circular Stapler's performances is identical to those described in 510(k) K024275"
• "The data submitted in this 510(K) Premarket Notification supports the finding that this product is substantially equivalent with respect to the intended use, technology, functionality, and safety features to the legally marketed predicate device."

Therefore, the document does not contain the specific information requested about acceptance criteria and the study proving the device meets those criteria, as it relies on the predicate device's established equivalence. To find such information, one would need to review the 510(k) submission for the predicate device (K024275).

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