The CanGaroo(R) Envelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.

Device Description

The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.

The CanGaroo Envelope is constructed from two 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 K140306.

AI/ML Overview

This document is a 510(k) submission for the CanGaroo Envelope, a surgical mesh device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device due to a change in suture supplier. As such, it does not detail a study involving AI or complex performance metrics typically associated with medical device software.

Based on the provided text, the device itself is a "Surgical Mesh Envelope" designed to hold cardiac implantable electronic devices. The clinical performance aspects discussed relate to the physical integrity of the envelope rather than diagnostic accuracy or AI-driven insights.

Here's an analysis of the provided information, addressing your questions where applicable, and noting when information is not present:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Seam strength	Met design input requirements for seam strength

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for seam strength testing. Given the nature of the test (material property), data provenance in terms of country of origin or retrospective/prospective is not directly relevant. It's a non-clinical, in-vitro test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a non-clinical, in-vitro material test, not a study involving human experts establishing ground truth for diagnostic or prognostic purposes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a non-clinical, in-vitro material test, not a study requiring adjudication of expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document does not pertain to an AI/ML-driven device or a study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This document does not pertain to an AI/ML-driven device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical testing was defined by the "design input requirements for seam strength," which represent pre-defined engineering specifications for the device's physical integrity.

8. The sample size for the training set

Not applicable. There is no AI/ML component described in this submission, so no training set is relevant.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML component described in this submission, so no training set or its ground truth establishment is relevant.

Additional Information from the document:

Device Name: CanGaroo® Envelope (Common Name: Surgical Mesh Envelope)
Intended Use: To securely hold a cardiac implantable electronic device (pacemaker pulse generators, defibrillators, or other CIEDs) to create a stable environment when implanted in the body.
Device Description: Constructed from two perforated, multilaminate sheets (4-ply) of decellularized, non-crosslinked, lyophilized ECM (extracellular matrix) derived from porcine small intestinal submucosa. Assembled into a pouch form using violet 5-0 polydioxanone suture (PDS).
Predicate Device: CorMatrix PROTECT ECM Envelope (K140306).
Reason for 510(k): Alternate supplier for the suture used to manufacture the device. The device design, materials (other than suture supplier), intended use, and labeling are not changing.
Conclusion: The CanGaroo Envelope manufactured with an alternate, equivalent suture from a new supplier is substantially equivalent to the predicate device based on meeting design input requirements for seam strength.

Summary

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October 25, 2017

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

Re: K173242

Trade/Device Name: CanGaroo Envelope Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTM Dated: October 5, 2017 Received: October 6, 2017

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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M& Willelemen

for 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) K173242

Device Name CanGaroo(R) 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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510(k) Summary: K173242

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:	October 5, 2017
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 CorMatrix PROTECT ECM Envelope referenced in the Substantially Equivalent letter issued by FDA for 510(k) application K140306.

The device cleared under K140306 is marketed under the name CanGaroo® ECM® Envelope or CanGaroo® Envelope. This Special 510(k) application describes an alternate supplier of the suture used to manufacture the device; there have been no modifications 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 action of the device are not changing.

Device Description

The device design is identical to the device cleared under K140306.

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CanGaroo® Envelope Special 510(k) Premarket Notification Alternate Material Supplier

Substantial Equivalence

The intended use of the CanGaroo Envelope to securely hold a CIED is identical to the intended use of the CorMatrix PROTECT ECM Envelope. The devices are of identical design and are manufactured from the same materials.

Non-clinical Testing

To ensure that the equivalent suture from a different supplier could be used to manufacture a product that continued to meet the design input requirements, seam strength testing of devices manufactured with the alternate suture was repeated; the CanGaroo Envelope manufactured with the alternate suture supplied by the new supplier met the design input requirements for seam strength.

Conclusion

The CanGaroo Envelope manufactured with an alternate, equivalent suture from a new supplier is substantially equivalent to the predicate device, the CorMatrix PROTECT ECM 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.