PremiPatch PTFE Pledget

K151865 · Aesculap, Inc. · DXZ · Oct 27, 2015 · Cardiovascular

Device Facts

• Record ID: K151865
• Device Name: PremiPatch PTFE Pledget
• Applicant: Aesculap, Inc.
• Product Code: DXZ · Cardiovascular
• Decision Date: Oct 27, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 non-absorbable suture is indicated. Pledgets are also used to aid in suture buttressing.

Device Story

PremiPatch PTFE Pledgets are pre-cut, non-absorbable, undyed polytetrafluoroethylene (PTFE) sections supplied sterile. Used by surgeons in cardiovascular procedures as a suture buttress to mechanically secure and support sutures in fragile tissue or organ parenchymas. Available in firm and soft styles in various shapes and sizes. Device functions as a physical reinforcement for sutures to prevent tissue tearing. Supplied in peel pouches and sterilized via ethylene oxide.

Clinical Evidence

No clinical data. Safety and performance established via bench testing, including flexibility and bridge rupture tests. Biocompatibility supported by data from reference device (K133890) per ISO-10993, as material composition, manufacturing, and sterilization processes are identical.

Technological Characteristics

Material: Non-absorbable undyed polytetrafluoroethylene (PTFE). Form factor: Pre-cut sections in firm or soft styles, various shapes/sizes. Sterilization: Ethylene oxide. Biocompatibility: Evaluated per ISO-10993.

Indications for Use

Indicated for use in cardiovascular tissue to mechanically secure and support sutures in fragile tissue and organ parenchymas when non-absorbable sutures are required; used for suture buttressing.

Regulatory Classification

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.

Predicate Devices

• PTFE Felts and Pledgets, Boston Scientific Corporation (K041716)

Reference Devices

• Optilene Nonabsorbable Surgical Suture (K133890)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10pt;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10pt;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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

### PremiPatch PTFE Pledgets October 21, 2015

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034<br>Establishment Registration Number: 2916714 |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Kathy A. Racosky<br>610-984-9291 (phone)<br>610-791-6882 (fax)<br>[e-mail] |
| 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

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.

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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.