PremiPatch PTFE Pledgets are indicated for use in cardiovascular tissue. Pledgets are used to mechanically secure and support sutures in fragile tissue and organ parenchymas, when a non-absorbable suture is indicated. Pledgets are also used to aid in suture buttressing.

Device Description

The PremiPatch PTFE Pledgets are pre-cut sections of non-absorbable undyed polytetrafluorothylene (PTFE) which are supplied sterile. The PremiPatch PTFE Pledgets are used as a suture buttress for nonabsorbable sutures. The pledgets are available in two application styles: firm and soft and various shapes and sizes. Depending on the size they are available package two or six per pouch.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for the PremiPatch PTFE Pledgets. It is a regulatory document and, as such, does not describe the acceptance criteria or a study that proves the device meets specific performance acceptance criteria in the way a clinical or performance study report would for an AI/machine learning device.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is the primary pathway for 510(k) clearance. The performance data mentioned is primarily non-clinical bench testing to ensure the new device performs similarly to the predicate and meets its own specifications, rather than a study against a specific set of clinical performance metrics.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable to this type of medical device submission.

Here's a breakdown of what can be extracted and how it relates to your request:

1. A table of acceptance criteria and the reported device performance

The document states: "The non-clinical test data provided in this submission demonstrated that the PremiPatch PTFE Pledgets meet the performance specifications."

While specific numeric acceptance criteria and detailed performance results are not provided in this summary document, the types of tests conducted are mentioned:

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance:
Flexibility	Met performance specifications
Bridge rupture	Met performance specifications
Material Biocompatibility:
ISO-10993 compliance	Deemed supportive based on prior evaluation of PTFE material in predicate device (K133890)
Sterility & Packaging:
Package integrity	Demonstrated through accelerated aging data
Shelf life	Demonstrated through accelerated aging data

Note: The actual numerical specifications and results would be in the full submission, not this summary. The "acceptance criteria" here are implied by the types of tests performed to establish equivalence and safety/performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This device is a physical medical device (pledgets), not an AI/ML diagnostic or predictive system. Therefore, there is no "test set" in the context of image data or patient records with specific sample sizes for AI model evaluation.

Sample Size for Physical Testing: Not explicitly stated in this summary. The bench testing would have involved a sufficient number of device samples to establish performance specifications based on engineering and quality control standards.
Data Provenance: Not applicable in the context of AI/ML data provenance. The data comes from internal non-clinical bench testing performed by Aesculap, Inc. (Pennsylvania, USA-based company).

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

Not applicable. This is not an AI/ML device requiring expert-established ground truth for a diagnostic task. The "ground truth" for a physical device like a pledget is its material properties and mechanical performance as measured against engineering standards.

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

Not applicable. There is no concept of adjudication for this type of device and testing.

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 is not an AI/ML device.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical performance evaluations, the "ground truth" would be objective measurements from laboratory equipment and established engineering benchmarks/standards for material properties (e.g., tensile strength, flexibility, rupture force) and biocompatibility (e.g., ISO-10993 standards).

8. The sample size for the training set

Not applicable. This is not an AI/ML device with a "training set."

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

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 27, 2015

Aesculap, Inc. Ms. Kathy Racosky Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K151865 Trade/Device Name: PremiPatch PTFE Pledget Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac Patch or Pledget made of Polypropylene, Polyethylene Terephthalate, or Polytetrafluoroethylene Regulatory Class: Class II Product Code: DXZ Dated: August 31, 2015 Received: August 31, 2015

Dear Ms. Racosky:

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. The general controls provisions of the Act include 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 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrenner

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151865

Device Name PremiPatch PTFE Pledgets

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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B. 510(k) SUMMARY (as required by 21 CFR 807.92)

PremiPatch PTFE Pledgets October 21, 2015

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
CONTACT:	Kathy A. Racosky610-984-9291 (phone)610-791-6882 (fax)kathy.racosky@aesculap.com
TRADE NAME:	PremiPatch PTFE Pledgets
COMMON NAME:	Intracardiac patch or pledget made of polytetrafluorothylene
CLASSIFICATION:	Class II
CLASSIFICATION NAME:	Patch, Pledget and Intracardiac, Petp, Ptfe, Polypropylene
REGULATION NUMBER:	870.3470
PRODUCT CODE:	DXZ

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the PremiPatch PTFE Pledgets are substantially equivalent to: · PTFE Felts and Pledgets, Boston Scientific Corporation (K041716)

DEVICE DESCRIPTION

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INDICATIONS FOR USE

PremiPatch PTFE Pledgets are indicated for use in cardiovascular tissue. Pledgets are used to mechanically secure and support sutures in fragile tissue and organ parenchymas, when a nonabsorbable suture is indicated. Pledgets are also used to aid in suture buttressing.

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The PremiPatch PTFE Pledgets are substantially equivalent to other pledgets cleared by FDA. PremiPatch PTFE Pledgets are offered in the same styles and similar sizes. The subject device is shown to be substantially equivalent and has the same performance characteristics to the predicate devices through comparison in design, intended use, material and function with the exception of the packaging.

PERFORMANCE DATA

The safety and performance of the PremiPatch PTFE Pledgets was evaluated through nonclinical testing. The non-clinical test data provided in this submission demonstrated that the PremiPatch PTFE Pledgets meet the performance specifications. The submission includes bench testing, including: flexibility and bridge rupture tests.

The biocompatibility evaluation that was previously conducted on the PTFE material for the pledgets cleared in the Optilene Nonabsorbable Surgical Suture (K133890) per ISO-10993. "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" is deemed supportive of the proposed device, PremiPatch PTFE Pledgets. There are no changes to the material composition and the manufacturing and sterilization processes are identical to the reference predicate, therefore, no additional biocompatibility testing was conducted.

The PremiPatch PTFE Pledgets are package in a peel pouch and sterilized by ethylene oxide. Accelerated aging data for the PremiPatch PTFE Pledgets has been generated to demonstrate package integrity and shelf life of the PremiPatch device.

CONCLUSION:

Based on the nonclinical testing PremiPatch PTFE Pledgets have been demonstrated to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).