(33 days)
Not Found
No
The description focuses on a mechanical device for creating surgical anastomoses and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is described as a "mechanical device used to facilitate an aortic vein graft anastomosis" which "replaces sutures to create a secure, patent, and reproducible anastomosis." This describes a direct therapeutic action on the body by creating an anastomosis, which is a surgical connection.
No
The device is described as a mechanical system to create a surgical anastomosis, replacing sutures. Its intended use is to facilitate a surgical procedure, not to diagnose a condition.
No
The device description explicitly states it is a "mechanical device" and consists of a "connector and a delivery system," indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create the aortic anastomosis of aortic autologous vein grafts." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as a "mechanical device used to facilitate an aortic vein graft anastomosis" that "replaces sutures." This is a surgical tool/implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The PAS-Port Proximal Anastomosis System is intended to create the aortic autologous vein grafts.
Product codes (comma separated list FDA assigned to the subject device)
FZP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aortic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PAS-Port Proximal Anastomosis System (K091017)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 Parkway
Center Valley, PA 18034
Establishment Registration Number: 2916714 |
|----------------------|-------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Sierra M. Mertz
484-635-8513 (phone)
sierra.mertz@aesculapimplants.com
610-791-6882 (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
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.
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 System
Product Code: FZP
K202124 | Predicate Device- PAS-Port System
Product Code: FZP
K091017 | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Intended Use | The PAS-Port® System is designed to
create an anastomosis between the aorta
and a venous conduit. | The PAS-Port® System is designed to
create an anastomosis between the aorta
and a venous conduit. | Same |
| Indications for Use | The PAS-Port® System is intended to
create the aortic anastomosis of aortic
autologous vein grafts. | The PAS-Port® System is intended to
create the aortic anastomosis of aortic
autologous vein grafts. | Same |
| Device Deployment | A knob is rotated to deploy the device.
The first part of the rotation creates the
aortotomy and the second part of the
rotation deploys the implant. | A knob is rotated to deploy the device.
The first part of the rotation creates the
aortotomy and the second part of the
rotation deploys the implant. | Same |
| Introducer Tip | The material for the Introducer Tip is
made of SCLAIR 2714 HDPE (High
Density Polyethylene). | The material for the Introducer Tip is
made of SCLAIR 2714 HDPE (High
Density Polyethylene). | Same |
| Packaging | The PAS-Port® device is packaged
within a tray (PETG).
The tray is then placed in a blister with
Tyvek lid foil and sealed.
The blister is placed in a carton. | The PAS-Port® device is packaged
within a tray (PETG).
The tray is then packed in Tyvek header
pouch 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 range | |
| of 1.2 - 10 N/15 mm | Pass | |
| Transport Simulation | ||
| (verification via visual | ||
| inspection, | ||
| product evaluation, | ||
| and verification via bubble test) | • 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 |
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.