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K Number
K160969
Device Name
ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler
Manufacturer
SHINEMED LLC
Date Cleared
2016-12-12

(250 days)

Product Code
GDW
Regulation Number
878.4750
Type
Traditional
Panel
SU
Reference & Predicate Devices
K111825,K062850
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ShineMed Reloadable Open Cutting Staplers (ROCS) have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

ShineMed Curved Intraluminal Cutting Staplers (CICS) 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, including bariatric surgery.

Device Description

Both ShineMed Reloadable Open Cutting Staplers and predicate DST Series™ GIA™ Staplers place two, double-staggered rows of titanium staples and simultaneously divide the tissues between the two double rows. The size of the staples is determined by the selection of the appropriate single use loading unit that is available in 60mm, 80mm, and 100mm lengths:

  • . 3.8mm staple size single use loading unit (blue cartridge) (60mm, 80mm, and 100mm lengths)
  • . 4.8mm staple size single use loading unit (green cartridge) (60mm, 80mm, and 100mm lengths)

Both ShineMed Curved Intraluminal Cutting Staplers and predicate Autosuture™ Circular EEA™ Surgical Staplers place a circular, double staggered row of titanium staples and resect the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries. The stapler is offered in 25mm (white), 28mm (blue), and 31mm (green) diameters and with 4.8mm staple size.

AI/ML Overview

The provided text describes the 510(k) premarket notification for two medical devices: the ShineMed Reloadable Open Cutting Stapler (ROCS) and the ShineMed Curved Intraluminal Cutting Stapler (CICS). The document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical bench testing. There is no information about an AI/algorithm-based device, nor is there data from a clinical trial or a multi-reader multi-case (MRMC) study involving human readers.

Therefore, the following information is extracted and presented as per the request, acknowledging the absence of AI/clinical/MRMC data.

Acceptance Criteria and Device Performance

The devices (ShineMed Reloadable Open Cutting Stapler and ShineMed Curved Intraluminal Cutting Stapler) were evaluated against the performance of their respective predicate devices. The acceptance criteria are implicit in the comparison studies and aim to demonstrate substantial equivalence to the legally marketed predicates.

Acceptance Criteria and Reported Device Performance

Feature/TestAcceptance Criteria (Implied: Substantially Equivalent to Predicate)Reported Device Performance
ShineMed Reloadable Open Cutting Stapler
Functionality TestingDevice features function as intended and are identical to the predicate device. Safety lockout, locking lever handle, and shipping wedge functioning correctly.- Safety lockout in cartridge deployed successfully (identical to predicate).
  • Locking lever handle ensured proper tissue compression (identical to predicate).
  • Shipping wedge prevented misfiring (identical to predicate). |
    | Performance Comparison Testing | | |
    | Integrity of stapler line | Stapler line integrity equivalent to predicate devices. | - Integrity confirmed via visual inspection of stapling, equivalent to predicate devices. |
    | Anastomosis Leak & Bursting Test | Performance of anastomosis (leak and bursting) substantially equivalent to predicate devices. | - Evaluated; comparison confirmed performance of ShineMed products is substantially equivalent to predicate devices. |
    | Dimensional Tests (Staple Formation Heights) | Staple formation heights statistically identical to predicate devices. | - Conducted; confirmed staple formation heights are statistically identical to those of the predicate devices. |
    | Reliability Testing | Can fire 8 times with consistent functionality and performance. | - Performed; confirmed the device can fire 8 times with consistent functionality and performance. |
    | Package Testing | Primary package integrity, seal strength meet design requirements and are not compromised by sterilization/shipping. | - Integrity confirmed through Visual Inspection and Dye Penetration Testing.
  • Seal strength testing confirmed meeting design requirements and no compromise from sterilization/shipping. |
    | Shelf-Life Testing | Passed in accordance with ASTM F1980. | - Completed and passed in accordance with ASTM F1980. |
    | ShineMed Curved Intraluminal Cutting Stapler | | |
    | Functionality Testing | Device features function as intended and are identical to the predicate device. Safety mechanism deployed successfully. | - Device features functioned as intended and identically to the predicate device.
  • Safety mechanism deployed successfully to prevent improper use (identical to predicate, preventing firing when tissue thickness is outside specified range). |
    | Performance Comparison Testing | | |
    | Integrity of stapler line | Stapler line integrity equivalent to predicate devices. | - Integrity confirmed via visual inspection of stapling, equivalent to predicate devices. |
    | Anastomosis Leak & Bursting Test | Performance of anastomosis (leak and bursting) substantially equivalent to predicate devices. | - Evaluated; comparison confirmed performance of ShineMed products is substantially equivalent to predicate devices. |
    | Dimensional Tests (Staple Formation Heights) | Staple formation heights statistically identical to predicate devices. | - Conducted; confirmed staple formation heights are statistically identical to those of the predicate devices. |
    | Package Testing | Primary package integrity, seal strength meet design requirements and are not compromised by sterilization/shipping. | - Integrity confirmed through Visual Inspection and Dye Penetration Testing.
  • Seal strength testing confirmed meeting design requirements and no compromise from sterilization/shipping. |
    | Shelf-Life Testing | Passed in accordance with ASTM F1980. | - Completed and passed in accordance with ASTM F1980. |
    | Biocompatibility Testing | Conforms to ISO 10993-1, 10993-5, 10993-10, 10993-11, and USP 38-NF33. Meets pyrogen limits. | - All components are in accordance with relevant parts of ISO Standard 10993. Tested for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogen (ISO 10993-11), and Bacterial Endotoxins (USP 38-NF33). Devices are biocompatible and meet pyrogen specifications. |

Study Details

This submission is a 510(k) premarket notification primarily relying on non-clinical bench testing to demonstrate substantial equivalence to predicate devices, not on AI/algorithmic performance or human clinical studies.

  1. Sample size used for the test set and the data provenance:

    • The document does not specify a distinct "test set" in terms of patient data. The evaluation was done using non-clinical bench tests on the devices themselves.
    • Data Provenance: The data is from laboratory bench testing of the ShineMed devices and comparisons against predicate devices. Country of origin for the testing data is not explicitly stated, but the submission is to the U.S. FDA. The data is prospective as it pertains to the evaluation of the new ShineMed devices.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • This is not applicable as the evaluation was non-clinical bench testing. Ground truth in a clinical sense (e.g., expert consensus on medical images) was not established. Performance was directly measured or visually inspected against engineering specifications and predicate device performance.

  3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not applicable, as this was non-clinical bench testing, not a clinical study requiring adjudication of expert interpretations.

  4. 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:

    • No MRMC comparative effectiveness study was done. The device is a surgical stapler, not an AI software/device that assists human readers.

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

    • Not applicable. The device is a physical surgical stapler, not an algorithm.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • For performance metrics (e.g., staple integrity, leak/burst pressure, dimensional measurements), the "ground truth" or reference was based on engineering specifications, direct measurements, visual inspections compared to predicate device performance, and adherence to recognized standards (e.g., ASTM F1980 for shelf-life, ISO 10993 for biocompatibility).

  7. The sample size for the training set:

    • Not applicable. This is not an AI/machine learning device.

  8. How the ground truth for the training set was established:

    • Not applicable. This is not an AI/machine learning device.

§ 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.