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

K192616 · Aziyo Biologics, Inc. · FTM · Oct 21, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K192616
• Device Name: CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
• Applicant: Aziyo Biologics, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Oct 21, 2019
• 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 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.

Device Story

CanGaroo Envelope is a surgical mesh pouch designed to hold cardiac implantable electronic devices (CIEDs) or neurostimulators. Constructed from 4-ply decellularized, non-crosslinked, lyophilized porcine small intestinal submucosa (ECM) with 3 mm perforations for exudate drainage; assembled using violet 5-0 polydioxanone (PDS) suture. Used by surgeons during implantation procedures to create a stable environment for the pulse generator or stimulator. Device is implanted with the stimulator/generator. This submission specifically updates the labeled shelf life to 30 months based on real-time aging and seam strength testing.

Clinical Evidence

No clinical data. Bench testing only, consisting of real-time aging studies and seam strength testing to validate the 30-month shelf life.

Technological Characteristics

Material: 4-ply decellularized, non-crosslinked, lyophilized porcine small intestinal submucosa (ECM). Design: Perforated (3 mm holes, 10 mm spacing) pouch. Assembly: Violet 5-0 polydioxanone (PDS) suture. Sterilization: Not specified.

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 (K182255)

Submission Summary (Full Text)

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October 21, 2019

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

# Re: K192616

Trade/Device Name: CanGaroo Envelope Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: September 19, 2019 Received: September 23, 2019

# 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.

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

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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 (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 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,

Timothy Marjenin Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine 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)

#### K192616

Device Name

CanGaroo Envelope

#### Indications for Use (Describe)

The CanGaroo Envelope is intended to securely hold a cardiac 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 neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Aziyo Biologics, Inc.

### 510(k) Summary: K192616

| Company Information | |
|----------------------|------------------------------------------------------------|
| Company Name: | Aziyo Biologics, Inc. |
| Contact Name: | Wendy Perreault |
| Contact Title: | Regulatory Affairs Consultant |
| Address: | 1100 Old Ellis Road, Suite 1200<br>Roswell, GA 30076 |
| Phone (mobile): | 404-542-5854 |
| Phone (office): | 470-514-4085 |
| Date Prepared: | September 19, 2019 |
| Product Information | |
| Trade Name: | CanGaroo® Envelope |
| Common Name: | Surgical Mesh Envelope |
| Classification Name: | Surgical Mesh, 21 CFR 878.3300, Product Code FTM, Class II |

#### 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 K182255.

This Special 510(k) application describes a change in the labeled shelf life for the device based on results of shelf life testing of real-time aged product; there have been no modifications to the indications for use of the CanGaroo device and no changes to labeling are proposed (other than the expiration date that is populated on the product labels), and the change does not have the potential to alter the fundamental scientific technology of the device. The operating principle(s) and mechanism of action 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

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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 K182255.

## 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.

### 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 K182255. The devices are of identical design and are manufactured from the same materials.

### Non-clinical Testing

Testing of real-time aged CanGaroo Envelopes was complement the accelerated aging results for the device, and included seam strength testing of the aged devices to ensure the requirements for seam strength were met at 30 months.

# Conclusion

The CanGaroo Envelope labeled with a shelf life of 30 months is substantially equivalent to the predicate CanGaroo Envelope.