Aesculap PAS-Port Proximal Anastomosis System

• K Number: K202124
• Device Name: Aesculap PAS-Port Proximal Anastomosis System
• Manufacturer: Aesculap Inc.
• Date Cleared: 2020-09-02 ( 33 days)
• Product Code: FZP
• Regulation Number: 878.4300
• Type: Special
• Panel: SU
• Reference & Predicate Devices: K091017

Intended Use

The PAS-Port Proximal Anastomosis System is intended to create the aortic anastomosis of aortic autologous vein grafts.

Device Description

The Aesculap® PAS-Port Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent, and reproducible anastomosis. The PAS-Port system consists of a connector and a delivery system and is contained in a package that is designed to facilitate attachment of the conduit to the implant, as well as to ensure that the venous conduit (after attachment to the system and before deployment) is kept moist and vital.

AI/ML Overview

The information provided describes the acceptance criteria and the study conducted for the Aesculap PAS-Port Proximal Anastomosis System, focusing on non-clinical performance testing related to packaging.

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance
Microbial Barrier Verification	- The packaging must not be damaged

• The complete sterile barrier must be intact
• All sealed seams must be intact | Pass |
  | Seal Strength Verification | The seal strength must be within the defined range of 1.2 - 10 N/15 mm | Pass |
  | Transport Simulation | - There must be no fatal damages of the packaging which could cause product damage
• The product must remain in its intended position
• The product must function and must not have visible damages
• The sterile barrier must be intact | Pass |
  | Labeling Visual Inspection | All labeling contents must be intact and legible | Pass |
  | Scanning Verification | All codes must be read using bar code scanner | Pass |

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

• The document does not explicitly state the specific numerical sample size used for each of the performance tests. It generally refers to "All samples."
• Data Provenance: The study is non-clinical testing, conducted to meet requirements outlined in ISO 11607-1. The data provenance is internal testing performed by the manufacturer, Aesculap Inc., for regulatory submission in the United States (FDA). It is a prospective study in the sense that the tests were designed and executed to evaluate the new packaging.

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

• This information is not applicable to this type of non-clinical, performance-based testing for a medical device's packaging. Ground truth in this context is established by objective measurements and adherence to specified physical and mechanical standards (e.g., seal strength, visual inspection criteria, microbial barrier integrity). Experts typically establish ground truth in diagnostic or clinical efficacy studies where human interpretation is involved.

4. Adjudication method for the test set:

• This information is not applicable as the tests are non-clinical performance evaluations with objective pass/fail criteria, rather than subjective assessments requiring adjudication.

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:

• This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance, typically in imaging or diagnostic fields. The submitted document pertains to the non-clinical performance and packaging of a surgical device, not a diagnostic AI system.

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

• This information is not applicable. This submission is for a physical medical device (a surgical system), not a software algorithm or AI. The tests performed are physical and functional evaluations of the device and its packaging.

7. The type of ground truth used:

• The "ground truth" for this non-clinical testing is based on objective, predefined acceptance criteria and internationally recognized standards (ISO 11607-1). For example:
  • Seal Strength: Measured objectively against a numerical range (1.2 - 10 N/15 mm).
  • Microbial Barrier/Transport Simulation: Visual inspections for damage, integrity of sterile barrier, and product position/functionality as per established test protocols.
  • Labeling/Scanning: Objective verification that content is intact/legible and codes are scannable.

8. The sample size for the training set:

• This information is not applicable as there is no "training set" in the context of this non-clinical packaging performance study. Training sets are used in machine learning and AI model development.

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

• This information is not applicable, again because there is no training set involved in this type of non-clinical device testing.

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.