(61 days)
Suzhou Beinuo surgical staplers are indicated for use as follows:
· Circular Stapler for Single Use
The Suzhou Beinuo Circular Staple Use is used throughout the alimentary tract for the reconstruction of the alimentary tract and the creation of end-to-end, end-to-side and side-to-side anastomoses.
· Hemorrhoidal Circular Stapler for Single Use
The Suzhou Beinuo Hemorthoidal Circular Staple Use is a Circular Stapler product, with accessories, that is indicated in anorectal surgical procedures for the treatment of hemorrhoids and anorectal wall defects.
· Linear Stapler and Reloads for Single Use
The Suzhou Beinuo Linear Stapler and Reloads for Single Use (and reloads) is indicated for the closure of tissue in abdominal, gynecological, and thoracic surgical procedures.
· Linear Cutter Stapler and Reloads for Single Use
The Suzhou Beinuo Linear Cutter Staple Use (and reloads) is indicated for use in the resection, transection, transection and anastomosis of tissue in gastrointestinal, gynecological, and thoracic surgical procedures.
The Suzhou Beinuo Staplers were designed in reference to the general principles of surgical staplers. Each stapler/ instrument is activated by squeezing the handle firmly as far as it will go or by pushing the firing knob as far as it will go. Specifics for each stapler include:
- The Suzhou Beinuo Circular Stapler for Single Use places a circular, double staggered row of titanium staples. Immediately after staple formation, the instrument's central knife blade resects the excess tissue, creating a circular anastomosis. The diameter of the staple line is determined by the selection of the 21mm, 28mm, or 32mm stapler. Note that there are two product codes for this stapler (SBW and SBCS L). The total length of SBW stapler is 420mm and the total length of SBCS L version is 520mm. The staplers are identical except for the length.
- The Suzhou Beinuo Hemorrhoidal Circular Staplers for Single Use places two circular peripheral lines of alternating and overlapping staples, thereby sealing off the rectal tissue above the anal canal. The central circular cutting blade cuts the surplus tissue after the sealing to reconstruct the rectal tissue. The diameter of the staple line is determined by the selection of the 32mm or 34mm stapler.
- The Suzhou Beinuo Linear Staplers and Reloads for Single Use places a double(or triple in the case of the SBF 30B) staggered row of titanium staples used for mechanical suturing and closure of tissue. The Linear Stapler is available in 32mm, 60mm, and 88mm line lengths for use in various applications. The instrument may be reloaded during a single procedure.
- The Suzhou Beinuo Linear Cutter Staplers and Reloads for Single Use delivers two doubled staggered rows of titanium staples and anastomoses the internal tissues and incisions during surgical procedures. The Linear Cutter stapler is available in three staple line lengths (61mm, 81mm, or 101mm). The instrument may be reloaded during a single procedure.
The provided text is a 510(k) summary for the Suzhou Beinuo family of Surgical Staplers, seeking substantial equivalence to the predicate device, the Suzhou Frankenman Surgical Staplers (K101378). The submission focuses on non-clinical performance data and does not involve a clinical study as typically understood for AI/ML devices or new medical treatments requiring human subject trials.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.) for a diagnostic or AI/ML device. Instead, it relies on demonstrating equivalence to a predicate device through adherence to voluntary standards and an evaluation of physical and performance characteristics.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance (Suzhou Beinuo Surgical Staplers) |
|---|---|---|
| Materials of Construction | ISO 5382-2-1999 (Surgical Instruments - Metallic Materials - Part 2 - Unalloyed titanium) | Complies with the standard. |
| Sterilization | ISO 11737-1:2006 (Determination of a population of microorganisms on products) | Complies with the standard. |
| Sterilization | ISO 11137-1:2006 (Requirements for the development, validation and routine control of a sterilization process for medical devices) | Complies with the standard. |
| Biocompatibility | AAMI / ANSI / ISO 10993-5:2009 (Tests for In Vitro cytotoxicity) | Complies with the standard. |
| Biocompatibility | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Complies with the standard. |
| Risk Management | ISO 14971:2007 (Application of risk management to medical devices) | Complies with the standard. |
| Packaging for Terminally Sterilized Devices | ISO 11607:2003 (Packaging for Terminally Sterilized Medical Products) | Complies with the standard. |
| Physical Characteristics | Appearance, dimensions, stapler compatibility with the cartridge | Evaluated to validate; output meets design inputs and specifications. |
| Performance Characteristics | Strength, closure performance | Evaluated to validate; output meets design inputs and specifications. |
| Comparative Performance (to predicate) | "Similar results (in terms of post-operative healing, pain management, anastomotic leakage, and bleeding) as compared to manual suturing and competitors' devices." | Non-statistically quantified claim. No specific metrics are provided, just a qualitative statement of "similar results." |
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states: "There was no prospective clinical studies required to support the medical device as the indications for use, technology, materials of construction are virtually identical to the predicate device." Therefore, there is no test set of clinical data from human subjects in the context of typical AI/ML or drug studies.
The "testing" mentioned refers to non-clinical tests (material, sterilization, biocompatibility, mechanical performance). The sample sizes for these engineering tests are not specified in the summary but would typically involve a certain number of units or material samples to ensure statistical validity for the specific test (e.g., burst pressure testing on a few devices, cytotoxicity testing on cell cultures). The provenance of this test data would be lab data generated internally or by contract testing organizations.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. As no clinical study was conducted in terms of patient data, there was no need for experts to establish ground truth for a test set based on patient outcomes or interpretations. The determination of device meeting engineering and material standards is typically done by engineers and quality assurance specialists.
4. Adjudication Method for the Test Set
Not applicable, as there was no test set requiring human adjudication for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. The device is a surgical stapler, not an AI/ML diagnostic tool that assists human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a hardware medical device (surgical stapler), not a software or AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Compliance with established voluntary standards (e.g., ISO standards for materials, sterilization, biocompatibility, risk management, packaging).
- Engineering specifications and design inputs for physical and performance characteristics (e.g., appearance, dimensions, strength, closure performance).
- Comparison to the predicate device's established performance and characteristics.
There is no "expert consensus," "pathology," or "outcomes data" ground truth established for a new clinical test set within this submission, as no new clinical study was performed.
8. Sample Size for the Training Set
Not applicable. This is a hardware device submission, not an AI/ML model. Therefore, there is no training set in the AI/ML context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.