(26 days)
The SurgASSIST™ System with Circular Stapler Digital Loading Unit™ (DLU), has applications throughout the alimentary tract for end-to-end and side-to-side anastomosis.
The SurgASSIST™ System with Right Angle Linear Cutter DLU has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomosis.
The FlexShaft 2 resembles a colonoscope and provides the mechanical and electrical interface between the PC and the DLU. The FlexShaft 2 has a rigid mechanical assembly at the proximal end that provides the mechanical interface between the FlexShaft 2 and PC. The remainder of the FlexShaft 2 is flexible throughout its length and incorporates an articulation section near the distal end that allows for remote positioning of the DLU. The distal tip of the FlexShaft 2 has features that allow for the attachment and removal of various configurations of a DLU.
The FlexShaft 2 contains two drive shafts that couple two motors in the PC to the two inputs of a DLU. Rotary motion provided by the motors located in the PC is delivered to the DLU through these drive shafts for various purposes such as clamping tissue or forming staples.
The distal assembly of the FlexShaft 2 contains a printed circuit board that has two pairs of hall-effect transistors mounted. Each pair of hall-effect transistors is arranged for quadrature output to enable tracking of the rotation of the two drive shafts at the distal end. This tracking provides the signal to the PC to insure that the appropriate number of shaft revolutions is delivered to the DLU.
Internal to the FlexShaft 2 are four braided (steering) cables. The purpose of these cables is to provide the means for articulating the steering section of the FlexShaft 2. Articulation is achieved when tension is applied to the cable or cables located in the desired articulation direction. Rotary motion, provided by motors in the PC, is translated into linear "cable pull" motion through a pairs of bevel gears that are coupled to capstans.
Since the DLU contains an electronic "chip" carrying its identification and usage status, it must be able to communicate with the micro controller within the PC. The FlexShaft 2 incorporates two electrical contacts that mate with corresponding contacts on the DLU when the DLU is attached to the FlexShaft 2.
Internal to the FlexShaft 2 is a usage counter. The purpose of this counter is to allow the storage of information relating to the number of DLU's fired and the number of FlexShaft 2 attachments to the PC. Each memory module has a unique serial number that will be used for FlexShaft 2 identification.
This Special 510(k) Device Modification for the SurgASSIST™ System with FlexShaft 2 is a submission for a modified device, not a new device. Therefore, the document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a full clinical study with acceptance criteria.
The submission highlights changes in manufacturing and the addition of a usage counter memory module while asserting that the device's indications for use and most physical characteristics remain identical to the predicate. As such, direct "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial for efficacy or diagnostic performance are not present in this document.
However, based on the information provided, we can infer some "acceptance criteria" through the comparison to the predicate devices, focusing on functional and physical equivalence.
Here's an attempt to structure the information as requested, though some sections will indicate "Not Applicable" or "Not Provided" due to the nature of a 510(k) modification submission for an already cleared device:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a device modification, the "acceptance criteria" are generally tied to demonstrating substantial equivalence to the predicate device in terms of design, materials, and functional performance. The "reported device performance" is primarily presented as meeting or being equivalent to the predicate specifications.
| Feature / Criterion | Acceptance Criteria (Implied from Predicate Equivalence) | Reported Device Performance (SurgASSIST™ w/ FlexShaft 2) |
|---|---|---|
| Indications for Use | Identical to predicate devices (K003277 & K012809) | Applications throughout the alimentary tract for end-to-end and side-to-side anastomosis. Also, applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses. |
| Length of FlexShaft | 2 meters ± 3cm | 2 meters ± 3cm |
| Length of Articulation Section | 10cm ± 2cm | 10cm ± 2cm |
| Diameter of Articulation Section | 15mm ± .25mm | 15mm ± .25mm |
| Articulated tip Steering | 4 Braided Cables | 4 Braided Cables |
| Diameter of flexible non-articulation section | 13.5mm ± .25mm | 13.5mm ± .25mm |
| Weight | 2.15 lbs ± .25 lbs | 2.15 lbs ± .25 lbs |
| Electrical Contacts | 2 | 2 |
| Internal Power | None | None |
| Usage Counter | Addition of usage counter memory module | Yes - Usage counter memory module relating to the # of DLUs fired. (This is a new feature, the acceptance would be that it functions as intended and does not negatively impact existing functions). |
| Sterilization Method Recommendation | ETO; Cold liquid sterilant (FDA cleared) | Steam (Flash) Sterilization; ETO; Cold liquid sterilant (FDA cleared); and Gas plasma sterilization. (This is an expanded method; acceptance would be validation of these new methods). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission does not involve a "test set" from a patient population for clinical efficacy or diagnostic performance. The testing would have been engineering verification and validation of the device components and functions against specifications.
- Data Provenance: Not provided, but given the nature of the submission (device modification), testing would have involved engineering performance evaluations specific to the modified components and overall system functionality to ensure it performs as intended and equivalently to the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This submission is for a medical device (surgical stapler system) modification, not an AI/diagnostic device that requires expert ground truth establishment for patient data. Expert input would relate to surgical use cases and device functionality, but not "ground truth" for a test set in a diagnostic context.
4. Adjudication Method for the Test Set
- Not applicable. There is no clinical "test set" requiring adjudication in this context.
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 system, not an AI or diagnostic device that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a surgical stapler system, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable. The "ground truth" for this type of device modification would be its engineering specifications, functional performance requirements (e.g., proper stapling, articulation, electrical communication), and safety standards, rather than expert consensus on diagnostic images or pathology.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve machine learning or a "training set" in the context of data used for algorithm development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
§ 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.