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.

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 K182255.

AI/ML Overview

The provided text describes a 510(k) submission for the CanGaroo Envelope, which is a surgical mesh envelope intended to securely hold cardiac implantable electronic devices or implantable neurostimulators. This submission (K192616) is a Special 510(k) application based on a change in the labeled shelf life of the device, rather than a new device or significant modification to its design or indications for use.

Therefore, the document does not contain information typically found in a clinical study report for an AI/ML device, such as:

Acceptance criteria related to AI performance (e.g., sensitivity, specificity, AUC)
A test set of medical images or patient data
Information on expert readers, ground truth establishment, or adjudication methods
Details of a multi-reader, multi-case (MRMC) study or standalone algorithm performance
Training set details for an AI model

Instead, the "testing" mentioned in this document refers to non-clinical testing (specifically, shelf-life testing and seam strength testing of aged products) to support the extended shelf life.

Based on the provided text, it is not possible to fill out the requested table or answer the questions related to AI device performance evaluation. The device described is a physical medical device (surgical mesh), not an AI/ML software device.

However, if we were to interpret the "device" as a product undergoing a 510(k) pathway, and map the available information to the request (even if it doesn't perfectly fit), here's what could be inferred, focusing on the concept of 'acceptance criteria' for the shelf-life change:

Simulated "Acceptance Criteria" for Shelf Life Extension (based on inference):

Given the context of a Special 510(k) for shelf-life extension, the "acceptance criteria" and "study" would relate to the physical properties of the device over its proposed new shelf life.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance (from text)
Shelf Life Stability	Device maintains physical integrity and functionality at the end of the extended shelf life (30 months).	"Testing of real-time aged CanGaroo Envelopes was complement the accelerated aging results for the device..."
Seam Strength	Seam strength of the device remains above a pre-defined minimum threshold after real-time aging for 30 months.	"...and included seam strength testing of the aged devices to ensure the requirements for seam strength were met at 30 months."
Material Properties	ECM material properties (e.g., structural integrity, biological activity - implicitly assumed to not degrade beyond acceptable limits) are maintained over 30 months.	(Implied by positive outcome of real-time aging and seam strength tests)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated, but for shelf-life testing of physical products, samples from specific manufacturing lots would have been used for real-time aging studies. This would typically be a pre-defined statistical sample size based on relevant standards (e.g., ISO, ASTM) and risk assessment.
Data Provenance: The testing was "real-time aged product," implying the device was stored for the full 30-month period under specified conditions, then tested. This is prospective testing for the shelf-life study itself. The country of origin of the data/testing is not specified but would typically be performed at the manufacturer's facility or a contract testing lab.

3. Number of Experts Used and Qualifications:

Not Applicable. This is a physical product shelf-life test, not an AI/ML diagnostic performance study involving human readers or expert consensus on medical images. The "experts" would be analytical chemists or material scientists performing laboratory tests.

4. Adjudication Method for the Test Set:

Not Applicable. This is a laboratory test with objective, measurable outcomes (e.g., force measured for seam strength). There is no "adjudication" in the sense of reconciling subjective expert opinions.

5. MRMC Comparative Effectiveness Study:

Not Applicable. This is a physical medical device, not an AI/ML software.

6. Standalone Algorithm Performance:

Not Applicable. This is a physical medical device, not an AI/ML algorithm.

7. Type of Ground Truth Used:

For shelf-life testing, the "ground truth" is the measured physical properties of the aged device (e.g., measured seam strength, visual inspection for degradation, etc.) compared against pre-defined specifications. This is an objective, laboratory-derived "truth."

8. Sample Size for the Training Set:

Not Applicable. This device does not involve a "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable.

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device, focusing on a shelf-life extension. It does not provide the information requested about AI/ML device performance or associated clinical studies.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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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 1200Roswell, 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 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

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.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
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.(b)
Classification. Class II.