DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER

• K Number: K121474
• Device Name: DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER
• Manufacturer: CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD.
• Date Cleared: 2012-07-16 ( 59 days)
• Product Code: GDW
• Regulation Number: 878.4750
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K020779 , K111825
• Predicate For: K172538

Intended Use

Disposable Linear Stapler, Model KYFB-30 / 60 / 90: The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues.
Disposable Linear Cutter, Model KYQII-60 / 80 / 100: The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

Device Description

General Disposable Linear Stapler: The Disposable Linear Stapler delivers two staggered rows of titanium staples to approximate internal tissues. The instrument is available in three sizes to accommodate different tissues. Staple height is adjustable to compensate for various tissue thickness .The 30 mm instruments create a 30 mm staple line, the 60 mm instruments create a 60 mm staple line, the 90 mm instruments create a 90 mm staple line.
Disposable Linear Cutter: The disposable linear cutter and the cartridge for disposable linear cutter have applications in abdominal gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Disposable Linear Stapler and Disposable Linear Cutter). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device through clinical studies in the way an AI/ML device submission would.

Therefore, the requested information in the prompt, such as acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, is not applicable to this document, as it describes a traditional medical device submission for a stapler/cutter, not an AI/ML device.

The study described is a set of bench tests and biocompatibility tests to demonstrate substantial equivalence to existing predicate devices, not to establish novel performance criteria for an AI/ML system.

Here's a breakdown of the "studies" mentioned, as they relate to a traditional device submission:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of submission. The performance is assessed against the predicate device through bench tests.

   • Bench Testing:
     • Acceptance Criteria (Implied): Energy to deliver staples and energy to remove staples should be consistent with the predicate device.
     • Reported Performance: "Bench testing was performed to demonstrate the energy to deliver staples and also to remove staples was consistent with the predicate device."
   • Biocompatibility Testing:
     • Acceptance Criteria (Implied): Construction material passes ISO 10993 benchmarks.
     • Reported Performance: "The devices successfully passed tests for ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO 10993-11."
   • Sterility Testing:
     • Acceptance Criteria (Implied): Sterilization methodology is sufficient and packaging maintains sterility for 3-year shelf life.
     • Reported Performance: "Testing was performed to ISO 11137-1:2006, ISO 11137-2:2006, ISO 11737-1:2006 and ISO 11737-2:2009, ISO 11607-1:2006, ASTM F1929-98 (2004), ASTM F1980-01 and ASTM D3078-02 (2008) with the products successfully passing all tests."

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device. For a physical device, samples would refer to the number of devices tested in bench studies. The document does not specify the number of individual staplers/cutters tested, only that "bench testing was performed." Data provenance is from internal testing by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance often comes from engineering specifications and testing against established standards, not expert adjudication in the clinical sense.

4. Adjudication method: 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/cutter, not an imaging or diagnostic AI 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: For the bench and biocompatibility tests, the "ground truth" is defined by the requirements of the international and ASTM standards cited (e.g., ISO 5832-2:1999, ASTM F67-06, ISO 10993 series, ISO 11137 series, ISO 11737 series, ISO 11607-1:2006, ASTM F1929-98, ASTM F1980-01, ASTM D3078-02). These standards establish mechanical properties, material safety, and sterility assurance levels.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Regulation Number and Section

§ 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.