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.

Summary

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September 2, 2020

Aesculap Inc. Sierra Mertz Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K202124

Trade/Device Name: Aesculap PAS-Port Proximal Anastomosis System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: July 30, 2020 Received: July 31, 2020

Dear Sierra Mertz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Actinclude requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202124

Device Name

Aesculap PAS-Port Proximal Anastomosis System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY (K202124)

PAS-Port Proximal Anastomosis System August 20, 2020

COMPANY:	Aesculap, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Sierra M. Mertz484-635-8513 (phone)sierra.mertz@aesculapimplants.com610-791-6882 (fax)
TRADE NAME:	Aesculap® PAS-Port Proximal Anastomosis System
COMMON NAME:	Implantable clip and delivery system
CLASSIFICATION NAME:	Clip, Implantable
REGULATION NUMBER:	878.4300
PRODUCT CODE:	FZP
DEVICE CLASS:	Class II per 21 CFR 878.4300

PREDICATE DEVICE

PAS-Port Proximal Anastomosis System (K091017)

DEVICE DESCRIPTION

INDICATIONS FOR USE

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

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TECHNOLIGICAL CHARACTERISTICS (compared to predicate devices)

The table below provides a summary of the device technological characteristics comparing the subject device and predicate device. The only change to the change in packaging.

	Subject Device - PAS-Port SystemProduct Code: FZPK202124	Predicate Device- PAS-Port SystemProduct Code: FZPK091017
Intended Use	The PAS-Port® System is designed tocreate an anastomosis between the aortaand a venous conduit.	The PAS-Port® System is designed tocreate an anastomosis between the aortaand a venous conduit.	Same
Indications for Use	The PAS-Port® System is intended tocreate the aortic anastomosis of aorticautologous vein grafts.	The PAS-Port® System is intended tocreate the aortic anastomosis of aorticautologous vein grafts.	Same
Device Deployment	A knob is rotated to deploy the device.The first part of the rotation creates theaortotomy and the second part of therotation deploys the implant.	A knob is rotated to deploy the device.The first part of the rotation creates theaortotomy and the second part of therotation deploys the implant.	Same
Introducer Tip	The material for the Introducer Tip ismade of SCLAIR 2714 HDPE (HighDensity Polyethylene).	The material for the Introducer Tip ismade of SCLAIR 2714 HDPE (HighDensity Polyethylene).	Same
Packaging	The PAS-Port® device is packagedwithin a tray (PETG).The tray is then placed in a blister withTyvek lid foil and sealed.The blister is placed in a carton.	The PAS-Port® device is packagedwithin a tray (PETG).The tray is then packed in Tyvek headerpouch and sealed.The pouch is placed in a carton.	Different
Sterilization	Gamma radiation (25 - 40 kGy)	Gamma radiation (25 - 40 kGy)	Same
Shelf Life	21 Months	21 Months	Same

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PERFORMANCE TESTING

Non-clinical testing was conducted to meet the requirements outlined in ISO 11607-1. Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. All samples met predefined acceptance criteria and passed the packaging validation test activities. The successful results demonstrate that the subject device meets the established acceptance criteria and performs as well as or better than the legally marketed predicate device.

Non-Clinical Testing

Test	Acceptance Criteria	Results
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 rangeof 1.2 - 10 N/15 mm	Pass
Transport Simulation(verification via visualinspection,product evaluation,and verification via bubble test)	• There must be no fatal damages of the packagingwhich could cause product damage• The product must remain in its intended position• The product must function and must not havevisible 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

CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that the Aesculap PAS-Port Proximal Anastomosis System is as safe, as effective, and performs as well as or better than the legally marketed predicate device.

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.