VascuCel

K162579 · Admedus Regen Pty, Ltd. · DXZ · Oct 14, 2016 · Cardiovascular

Device Facts

• Record ID: K162579
• Device Name: VascuCel
• Applicant: Admedus Regen Pty, Ltd.
• Product Code: DXZ · Cardiovascular
• Decision Date: Oct 14, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

VascuCel is indicated as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing.

Device Story

VascuCel is a sterile, bovine pericardial patch; manufactured using ADAPT TEP technology; glutaraldehyde-crosslinked acellular collagen. Available in 2x8 cm and 0.8x8 cm pre-cut sheets. Used by surgeons in clinical settings for great vessel repair, peripheral vascular reconstruction, and suture line buttressing. Device serves as a structural patch to repair or reinforce vascular anatomy. Benefits include reduced need for intraoperative free-hand trimming. Substantial equivalence based on predicate CardioCel (K130872), with modifications limited to device dimensions and a narrowed, specific indication for use.

Clinical Evidence

Clinical data demonstrating acute safety of VascuCel provided to support the specific indication. Safety and effectiveness of bovine pericardial patches for cardiac/vascular reconstruction are established in clinical literature and standard of care. Verification and validation testing conducted on the predicate (CardioCel) supports the subject device's performance for the proposed indications.

Technological Characteristics

Bovine pericardium; glutaraldehyde-crosslinked; ADAPT TEP technology; acellular collagen. Sterile, light yellow to beige, moist, pre-cut sheet. Dimensions: 2x8 cm and 0.8x8 cm. No electronic components or software.

Indications for Use

Indicated for patients requiring great vessel repair, peripheral vascular reconstruction, or suture line buttressing. No specific age or gender restrictions provided. Contraindicated for uses other than those indicated; use must be considered on an individual patient basis.

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

• CardioCel (K130872)

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 14, 2016

Admedus Regen Pty Ltd % Ms. Mary Donlin Director Regulatory Affairs and Compliance Admedus Corporation 860 Blue Gentian Road, Ste 295 Eagan, Minnesota 55121

Re: K162579 Trade/Device Name: VascuCel 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: September 14, 2016 Received: September 15, 2016

Dear Ms. Donlin,

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 (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 vours.

Mude Jellman
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) K162579 KHANKA

Device Name VascuCel

Indications for Use (Describe)

VascuCel is indicated as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing.

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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# 5. 510(k) SUMMARY of Safety and Effectiveness

(In accordance with SMDA of 1990 and pursuant with 21 CFR 807.92)

#### I. Applicant Information:

| Date Prepared:<br>Submitter: | September 14, 2016<br>Admedus Regen Pty Ltd |
|-----------------------------------|---------------------------------------------------------------|
| Address: | 26 Harris Road<br>Malaga, Western Australia 6090<br>Australia |
| Establishment<br>Registration No. | 3010805634 |
| Contact Person: | Mary E. Donlin<br>Director Regulatory Affairs and Compliance |
| Telephone Number:<br>Fax Number: | [phone] Ext 1008<br>[phone] |

# II. Device Information:

| Trade Name: | VascuCel™ |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiovascular Patch |
| Classification Name: | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE,<br>POLYPROPYLENE |
| Classification: | Class II, 21 CFR § 870.3470 |
| Product Code: | DXZ |
| Predicate Device: | K130872 CardioCel |
| Predicate Device<br>Intended Use: | CardioCel is indicated for use as a patch in pericardial<br>closure and the repair of cardiac and vascular defects including<br>intracardiac defects; septal defects, valve and annulus repair; great<br>vessel reconstruction, peripheral vascular reconstruction and suture<br>line buttressing. |
| Device Description: | The VascuCel device is a bovine pericardial patch prepared from<br>glutaraldehyde-crosslinked bovine pericardium using the ADAPT®<br>TEP technology. It is a sterile, light yellow to beige colored,<br>moist, pre-cut sheet of acellular collagen. It is offered in a 2 x 8<br>cm size and a 0.8 x 8 cm size. |
| Intended Use: | VascuCel is indicated as a patch in great vessel repair, peripheral<br>vascular reconstruction and suture line buttressing. |
| Contraindications: | VascuCel is not designed, sold or intended for use except as<br>indicated.<br>The use of a tissue bioprosthesis must be considered on an<br>individual patient basis. |
| Comparison to<br>Predicate Device: | CardioCel was cleared by the FDA (K130872) for use as a patch in<br>pericardial closure and the repair of cardiac and vascular defects<br>including intracardiac defects; septal defects, valve and annulus<br>repair; great vessel reconstruction, peripheral vascular<br>reconstruction and suture line buttressing. The additional sizes<br>added to the existing CardioCel product line are within the current<br>product specification range for CardioCel. The minor change to<br>the dimensions of the device (from 5 cm x 8 cm to 2 cm x 8 cm<br>and 0.8cm x 8 cm respectively) is also included in this submission.<br>The purpose of the dimensional change is to manufacture a device<br>that meets the current needs of the surgeon and to reduce the free<br>hand trimming of the device during the surgical procedure. The<br>primary purpose for this submission is to modify the indication for<br>use from a general to specific indication to denote the use as a<br>patch for great vessel reconstruction, peripheral vascular<br>reconstruction and suture line buttressing. |
| Test Data: | The safety and effectiveness of bovine pericardial patches for the<br>reconstruction and repair of cardiac and vascular anatomy is well<br>established in clinical literature and is the current standard of care<br>in clinical practice.<br>The verification and validation testing conducted on CardioCel has<br>demonstrated that the device is safe and effective for the proposed<br>indication for use as a patch for peripheral vascular reconstruction<br>and suture line buttressing. Clinical data demonstrating the acute<br>safety of VascuCel is also provided to support the proposed<br>specific indication. |
| Summary: | The accumulated technical information, intended use, laboratory<br>verification tests and clinical performance data that was performed<br>on CardioCel as provided in K130872, demonstrates that VascuCel<br>is substantially equivalent to the currently marketed predicate<br>device. |

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