CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)

K201313 · Aziyo Biologics, Inc. · FTM · Jun 15, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K201313
• Device Name: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
• Applicant: Aziyo Biologics, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jun 15, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators.

Device Story

CanGaroo Envelope is a surgical mesh pouch designed to hold cardiac implantable electronic devices (CIEDs) or neurostimulators; provides stable environment post-implantation. Constructed from 4-ply decellularized, lyophilized porcine small intestinal submucosa (ECM) sheets; features 3 mm perforations spaced 10 mm apart for exudate drainage; assembled with 5-0 polydioxanone (PDS) suture. Used by surgeons during implantation procedures. Device acts as a physical containment system; no electronic or active components. Benefits include device stabilization within the body. This submission covers packaging modifications only (foil-to-foil pouch, display envelope size reduction, new five-pack carton).

Clinical Evidence

No clinical data. Bench testing only, specifically packaging and sterilization validation testing to ensure the new packaging configuration maintains product integrity and sterility.

Technological Characteristics

Material: 4-ply decellularized, non-crosslinked, lyophilized porcine small intestinal submucosa (ECM). Design: Perforated pouch (3 mm holes, 10 mm spacing). Assembly: 5-0 polydioxanone (PDS) suture. Sterilization: Not specified (sterilization adoption testing performed). Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring implantation of cardiac implantable electronic devices (pacemakers, defibrillators) or neurostimulators (vagus nerve, spinal cord, deep brain, sacral nerve stimulators) to provide a stable environment for the device.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• CanGaroo Envelope (K192616)

Submission Summary (Full Text)

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June 15, 2020

Aziyo Biologics, Inc. Wendy Perreault Regulatory Affairs Consultant 1100 Old Ellis Road. Suite 1200 Roswell, Georgia 30076

Re: K201313

Trade/Device Name: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubO) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: May 15, 2020 Received: May 18, 2020

Dear Wendy Perreault:

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 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.

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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 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 (OS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Hetal Odobasic Implantable Electrophysiology Devices Team Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICESsecial 510(K) Premarket Mortige of Online Reserve of 20 Food and Drug Administration Expiration Date: 06/30/2020

# Indications for Use

See PRA Statement below.

510(k) Number (if known)

Device Name CanGaroo(R) Envelope

#### Indications for Use (Describe)

The CarGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators.

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

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## 510(k) Summary: K201313

# Company Information

| Company Name: | Aziyo Biologics, Inc. |
|----------------------|------------------------------------------------------------|
| Contact Name: | Wendy Perreault |
| Contact Title: | Regulatory Consultant |
| Address: | 1100 Old Ellis Road, Suite 1200 |
| | Roswell, GA 30076 |
| Phone (mobile): | 404-542-5854 |
| Phone (office): | 470-514-4085 |
| Date Prepared: | June 15, 2020 |
| Product Information | |
| Trade Name: | CanGaroo® Envelope |
| Common Name: | Surgical Mesh Envelope |
| Classification Name: | Surgical Mesh, 21 CFR 878.3300, Product Code FTM, Class II |

#### Indications for Use

The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

### Predicate Devices

The CanGaroo Envelope is substantially equivalent to the CanGaroo Envelope referenced in the Substantially Equivalent letter issued by FDA for 510(k) application K192616.

This Special 510(k) application describes changes in the packaging for the CanGaroo Envelope as follows:

- 1. Introduce a single foil-to-foil pouch configuration to improve the packaging environment for the sterilized CanGaroo Envelope during storage and shipment, and to comply with suture manufacturer's recommendations for storage;
- 2. Reduce the overall size of the Display Envelope; and
- 3. Introduce a new Five Pack Carton to replace the current Five Pack Carton.

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There have been no modifications to the indications for use of the CanGaroo device and no changes to labeling are proposed, and the change does not have the potential to alter the fundamental scientific technology of the device. The operating principle(s) and mechanism of the device are not changing.

# Device Description

The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

The CanGaroo Envelope is constructed from two to four perforated, multilaminate sheets (4-ply) of decellularized, non-crosslinked, lyophilized ECM (extracellular matrix) derived from porcine small intestinal submucosa. The 3 mm perforations are spaced evenly at 10 mm apart to allow exit of any exudate. The ECM is assembled into pouch form using violet 5-0 polydioxanone suture (PDS). The device design is identical to the device cleared under K192616.

# Substantial Equivalence

The intended use of the CanGaroo Envelope to securely hold a CIED or neurostimulator is identical to the intended use of the CanGaroo Envelope cleared under K192616. The devices are of identical design and are manufactured from the same materials. The proposed packaging functions identically to the current packaging to protect and keep the product sterile during transportation and storage.

# Non-clinical Testing

To ensure that the new, equivalent packaging could be used to manufacture a product that continued to meet the design input requirements for the CanGaroo Envelope, packaging testing and sterilization adoption testing of product manufactured with the new packaging was repeated. The CanGaroo Envelope manufactured with the new packaging met the design input requirements for packaging and sterilization.

# Conclusion

The CanGaroo Envelope packaged in the new packaging components is substantially equivalent to the predicate CanGaroo Envelope.