(28 days)
The SurgASSIST™ Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
The devices described here are reloadable Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) with Reloads for single patient use. All have a maximum diameter of .596" and can be used within a 15 mm cannula. The DLUs are supplied pre-sterilized and ready for use upon removal from their packaging. Reloadable stapling and cutting cartridges are referred to as "Reloads". Each DLU contains a staple-forming anvil. The anvil acts with the staple cartridge to compress and position layers of tissue in readiness for stapling and cutting. At the same time, the anvil provides support and a means for correctly forming staples while they are closed sequentially along the tissue, followed by the cutting blade, when included. The 15 mm diameter DLUs are axial to the FlexShaft, forming a straight extension to the FlexShaft, to which they are connected. Loaded Straight Linear Stapler and Straight Linear 4 Row No Knife DLUs are used to close otomies and other common and uncommon openings by applying staples through the tissue and forming the staples to a controlled closed condition to secure the layers of tissue together. Straight Linear Stapler and Straight Linear 4 Row No Knife Reloads contain staples and the means to sequentially force staples toward the anvil. The cutting blade, when included, is advanced immediately behind the staple pushers so that tissue is sequentially stapled and then cut, proceeding from one end of the cartridge to the other. Straight Linear Stapler DLUs, 55 mm with Blue and Green Reloads have 2 staggered rows of staples on one side of the cutter, coded Blue (1.2 mm) for normal tissue and Green (2.0 mm) for thick tissue. DLUs are available with Blue or Green Reloads installed. Individual Blue and Green Reloads are available. Straight Linear 4 Row No Knife DLUs, 55 mm with Gray Reloads have two, double-staggered rows of staples, coded Gray (1.2 mm) for normal tissue (same as 55 mm Blue Straight Linear Cutter without the blade). DLUs are available with Gray cartridges installed. "No Knife" distinctively labeled. Individual Gray Reloads are available. The DLUs are attached to the end of the flexible shaft assembly that contains a pair of flexible rotary drive shafts within an overall flexible tube called the FlexShaft, hereafter referred to as FS. The other end of the FS is connected to a Power Console (PC), which applies mechanical power to the drive shafts. DLUs have all functions powered by the PC. The FS has a short steerable section at the distal end (near the attached DLU) so that the angle of attack (attitude) of the DLU can be adjusted by the surgeon to optimize patient accessibility. The surgeon operates a DLU via a hand held electronic Remote Control Unit (RCU) that is plugged into the front panel of the PC. The DLUs have quick attach and release means of coupling to the FS. No tools are required. DLUs are pushed onto the FS end, snapping and locking into place. To remove a DLU from the FS, a sleeve on the DLU at the junction with the FS, is rotated by hand. DLU designs allow for attachment of Reloads, but will inhibit attachment of incompatible Reloads. Each Reload has an integral electronic memory module. This identifies the type and size of the Reload being used and prevents a used Reload from being refired.
The provided documentation describes a Special 510(k) Device Modification for the SurgASSIST™ Straight Linear Stapler and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads. This type of submission is typically for modifications to an already cleared device and often relies on demonstrating substantial equivalence to a predicate device rather than conducting a full de novo study with explicit acceptance criteria and performance metrics.
Based on the provided text, there is no explicit mention of quantitative acceptance criteria or a dedicated study (e.g., a clinical trial or a formal performance study with statistical endpoints) designed to prove the device meets specific performance targets beyond demonstrating substantial equivalence to predicate devices.
Instead, the document focuses on:
- Device Description: Detailing the components and function of the modified staplers and reloads.
- Indications for Use: Stating the surgical procedures for which the device is intended.
- Comparison to Predicate Devices: Highlighting similarities and differences with previously cleared staplers (K020719 and K020779). This comparison forms the primary basis for demonstrating safety and effectiveness for a 510(k) submission.
Therefore, many of the requested items related to acceptance criteria and study details cannot be fully extracted from this document, as they were likely not part of this specific submission's scope.
Here's a breakdown of the information that can be gleaned:
1. Table of Acceptance Criteria and Reported Device Performance:
As explicitly stated above, the document does not provide a table of quantitative acceptance criteria or reported device performance in terms of specific metrics (e.g., stapling success rate, leak rates, tissue compression consistency) from a dedicated study. The "acceptance criteria" for a 510(k) modification are typically met by demonstrating that the modified device is as safe and effective as (substantially equivalent to) the predicate device, which is primarily done through detailed comparison of features, materials, and intended use.
The comparison tables (pages 3-6) focus on comparing device features like:
| Features & Description | SurgASSIST™ Straight Linear Stapler DLUs with Reloads (Subject Device) | Predicate SurgASSIST™ Straight Linear Cutter DLUs | Predicate Ethicon Endo-Surgery, Inc. Endopath ETS Flex45 No-Knife Articulating Linear Stapler |
|---|---|---|---|
| Intended Use | General and endoscopic surgery... resection, transection, anastomoses. | General and endoscopic surgery... resection, transection, anastomoses. | Transection, resection, and/or creation of anastomoses. |
| Number of Staples | SLS55B, SLSR55B - 28 staples | ||
| SLS55G, SLSR55G - 28 staples | |||
| SLS55B4, SLSR55B4 - 56 staples | SLC55B, SLCR55B - 56 staples | ||
| SLC55G, SLCR55G - 56 staples | |||
| SLC30B, SLCR30B - 32 staples | |||
| SLC30G, SLCR30G - 32 staples | NAB - 44 staples | ||
| NAG - 44 staples | |||
| Rows of Staples | SLS55B, SLSR55B - 2 rows | ||
| SLS55G, SLSR55G - 2 rows | |||
| SLS55B4, SLSR55B4 - 4 rows | SLC55B, SLCR55B - 4 rows | ||
| SLC55G, SLCR55G - 4 rows | |||
| SLC30B, SLCR30B - 4 rows | |||
| SLC30G, SLCR30G - 4 rows | NAB - 4 rows | ||
| NAG - 4 rows | |||
| Knife/Scalpel | SLS55B, SLSR55B - scalpel included | ||
| SLS55G, SLSR55G - scalpel included | |||
| SLS55B4, SLSR55B4 - NO KNIFE | SLC55B, SLCR55B - scalpel included | ||
| SLC55G, SLCR55G - scalpel included | |||
| SLC30B, SLCR30B - scalpel included | |||
| SLC30G, SLCR30G - scalpel included | NAB - NO KNIFE | ||
| NAG - NO KNIFE | |||
| Staple Diameter | SLS55B, SLSR55B - .21 mm | ||
| SLS55G, SLSR55G - .23 mm | |||
| SLS55B4 - .21 mm | SLC55B, SLCR55B - .21 mm | ||
| SLC55G, SLCR55G - .23 mm | |||
| SLC30B, SLCR30B - .23 mm | |||
| SLC30G, SLCR30G - .23 mm | NAB - .23 mm | ||
| NAG - .23 mm | |||
| Staple Height | SLS55B, SLSR55B - 1.2 mm | ||
| SLS55G, SLSR55G - 2.0 mm | |||
| SLS55B4 - 1.2 mm | SLC55B, SLCR55B - 1.2 mm | ||
| SLC55G, SLCR55G - 2.0 mm | |||
| SLC30B, SLCR30B - 1.2 mm | |||
| SLC30G, SLCR30G - 2.0 mm | NAB - 1.5 mm | ||
| NAG - 2.0 mm | |||
| How Supplied | Sterile - Single Patient Use | Sterile - Single Patient Use | Sterile - Single Patient Use |
| Method of Sterilization | Ethylene Oxide Gas (ETO) | Ethylene Oxide Gas (ETO) | Irradiation |
The document states "The DLUs have all functions powered by the PC" and "The surgeon operates a DLU via a hand held electronic Remote Control Unit (RCU)". This indicates performance relies on the entire system. Limitations for use based on tissue thickness are also provided in a comparative table.
2. Sample size used for the test set and the data provenance: Not applicable. No dedicated "test set" or clinical study is described within this document for performance evaluation. This is a 510(k) modification where substantial equivalence is demonstrated through comparison to predicates and likely engineering testing (not detailed here).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No specific expert review for establishing ground truth for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical stapler, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Summary from the document's perspective:
The "study" that proves the device meets the (implicit) acceptance criteria for substantial equivalence is the comparison to predicate devices (K020719 and K020779) as detailed in the submission. The acceptance criterion for this 510(k) modification is that the modified device is as safe and effective as legally marketed predicate devices. This is demonstrated by showing that the subject device shares the same intended use, similar technological characteristics (staple length, diameter, rows, knife presence, sterilization method), and comparable performance characteristics (though specific performance metrics from new studies are not provided in this excerpt). The FDA's letter (K030653) confirms that they reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices.
§ 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.