The CanGaroo® RM Antibacterial 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 Caroo RM Antibacterial Envelope include pacemaker pulse generators, defibrillators, and other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo RM Antibacterial Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, and other neurostimulator devices.

The CanGaroo RM Antibacterial Envelope contains the antibiotics rifampin and minocycline, which have been shown in preclinical testing to reduce bacterial colonization on the envelope. Overall clinical benefit has not yet been evaluated.

Device Description

The CanGaroo® RM Antibacterial Envelope consists of decellularized, non-crosslinked, Iyophilized extracellular matrix (ECM) and resorbable ring-shaped poly(lactide-co-qlycolide) (PLGA) discs containing the antibiotics rifampin and minocycline. The ECM material is derived from porcine small intestinal submucosa (SIS). The envelope is constructed with four multilaminate sheets, perforated to allow for exudate. The drug-eluting polymer discs are secured between the multilaminate sheets on each side of the envelope.

The CanGaroo RM Antibacterial Envelope is intended to securely hold an implantable electronic device (IED) to create a stable environment when implanted in the body, while reducing bacterial colonization with rifampin and minocycline eluted from resorbable polymer discs in the envelope. The CanGaroo RM Antibacterial Envelope is based on the existing CanGaroo Envelope (K201313), with the addition of drug-eluting disc components with the antibiotics rifampin and minocvoline.

The CanGaroo RM Antibacterial Envelope is provided sterile in two sizes and is intended for single use in a single patient only.

AI/ML Overview

The provided text is a 510(k) summary for the CanGaroo RM Antibacterial Envelope. This document describes the device, its intended use, and substantial equivalence to a predicate device, supported by performance data. However, it does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance in the typical sense of AI model testing (like accuracy, F1-score, etc.).

Instead, this document focuses on demonstrating that the device is safe and effective and performs at least as well as a predicate device through various types of non-clinical testing. The "acceptance criteria" here would be the successful completion of these tests, meeting certain pre-defined thresholds for physical, functional, antibacterial, and biocompatibility properties.

Therefore, I cannot directly provide the information in the format requested for AI/software-based device performance. The document describes a medical device (surgical mesh envelope), not an AI/software device that would typically have specific accuracy or similar metrics.

However, I can interpret the available information to address some of your points in the context of this physical medical device:

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

Based on the document, the "acceptance criteria" are implied by the successful completion of various tests. The "reported device performance" are the qualitative results of these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Device must be biocompatible according to ISO 10993 series and FDA guidance.	"Biocompatibility testing... was conducted on the subject device and the results indicate that the device is biocompatible per these standards. The testing included cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, and implantation studies."
Physical Characteristics: Device must meet visual and dimensional specifications.	"The subject device passed all test requirements" for "Appearance" and "Dimensional" characteristics.
Functional Characteristics: Device must meet seam strength specifications.	"The subject device passed all test requirements" for "Seam Strength."
Antibacterial Effectiveness (in vitro): Device must demonstrate bacterial reduction against tested organisms.	"Utilizing AATCC methodology, CanGaroo RM demonstrated bacterial reduction against a panel of 4 gram positive and 3 gram-negative organisms."
Drug Elution: Device must demonstrate appropriate drug assay and release kinetics.	"Drug assay and drug elution/release testing" was conducted. (Implied success as "The subject device passed all test requirements" mentioned broadly for bench testing.)
Bacterial Challenge Model (in vivo): Device must show clearance of bacteria in an animal model.	"A bacterial challenge model in rabbits showed clearance at day 7 following implantation for a panel of 3 gram positive and 3 gram negative organisms."
Pharmacokinetics (in vivo): Drug concentrations in vivo must be characterized.	"Pharmacokinetics, in vivo" testing was conducted. (Implied success as part of the overall conclusion that the device is safe and effective.)
Overall Safety and Effectiveness: The device must be as safe and effective as the predicate device and raise no new questions of safety or effectiveness.	"The results demonstrate that CanGaroo RM does not raise any new questions of safety and effectiveness." and "The CanGaroo RM device is as safe and as effective, with equivalent performance, to the legally marketed predicate device."

2. Sample sizes used for the test set and the data provenance

Sample Sizes: The document does not specify exact sample sizes for each test (e.g., number of animals in in-vivo studies, number of envelopes for bench testing). It uses general terms like "a panel" for organisms.
Data Provenance: The document does not state the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of pre-clinical testing for medical device clearance, these would inherently be prospective studies conducted according to specific protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The "ground truth" for this device's performance is established through objective laboratory and animal testing following standardized protocols (e.g., ISO, AATCC methods), not through expert consensus on medical images or clinical outcomes.

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

Not applicable. This concept applies to human interpretation of data, typically in clinical trials or image labeling, not to the objective results of bench and animal testing.

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

Not applicable. This is not an AI-assisted device for diagnostic interpretation; it is a physical implantable medical device.

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

Not applicable. This is not an AI algorithm. Its performance is inherent to the physical and chemical properties of the device itself.

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

The "ground truth" for this device's performance is based on:

Standardized laboratory tests: (e.g., AATCC 100 for antibacterial activity, physical and functional bench tests).
Biocompatibility standards: (ISO 10993 series).
In-vivo animal model results: (bacterial clearance, pharmacokinetics).
These are objective, empirical measures, not subjective expert consensus or clinical outcomes data in humans for this pre-market submission.

8. The sample size for the training set

Not applicable. This refers to an AI/machine learning model. This is a physical medical device; there is no "training set."

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

Not applicable, as there is no training set for a physical medical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

Elutia Inc. Erica Elchin Vice President, Quality & Regulatory Affairs 1100 Old Ellis Road Suite 1200 Roswell, Georgia 30076

Re: K233991

Trade/Device Name: CanGaroo RM Antibacterial Envelope Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: May 17, 2024 Received: May 17, 2024

Dear Erica Elchin:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Digitally signed by Jessica L. Batista -S Date: 2024.06.14 16:31:50 Batista -S -04'00

for

Sara Royce Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Jessica L

Enclosure

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Indications for Use

510(k) Number (if known) K233991

Device Name CanGaroo RM Antibacterial Envelope

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

This 510(K) Summary is provided per the requirements of Section 807.92(c)

Company Name:	Elutia Inc.1100 Old Ellis Road, Suite 1200, Roswell, GA 30076
Contact Name:	Erica Elchin
Contact Email:	eelchin@elutia.com
Contact Title:	VP, Quality & Regulatory Affairs
Phone:	877-651-2628
Date Prepared:	June 14, 2024
Device Information
Trade Name:	CanGaroo® RM Antibacterial Envelope
Common Name:	Surgical Mesh Envelope
Classification Name:	Surgical Mesh
Regulation Number:	21 CFR 878.3300
Product Code:	FTM
Device Class:	Class II

Predicate Device

The CanGaroo® RM Antibacterial Envelope is substantially equivalent to the following device:

. TYRX™ Absorbable Antibacterial Envelope, K192389
CanGaroo® (K201313), LUOFUCON® PHMB Alginate Dressing (K201016), and XenMatrix™ AB Surgical Graft (K162193) are reference devices.

Device Description

The CanGaroo RM Antibacterial Envelope is provided sterile in two sizes and is intended for single use in a single patient only.

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CanGaroo RMAntibacterial Envelope	Envelope SizeW x L	# ofdiscs	Rifampin	Minocycline
Medium	6.9 cm x 6.5 cm	2	10.5 mg	9.3 mg
Large	6.9 cm x 8.0 cm	2	10.5 mg	9.3 mg

Indications for Use

The CanGaroo RM Antibacterial 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 RM Antibacterial Envelope include pacemaker pulse generators, defibrillators, and other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo RM Antibacterial Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators, sacral nerve stimulators, and other neurostimulator devices.

Summarv of Technological Characteristics

The CanGaroo RM Antibacterial Envelope is designed to hold IEDs securely to create a stable environment when implanted in the body. The intended use of the CanGaroo RM Antibacterial Envelope is identical to the predicate device (K192389) and its technical characteristics are substantially equivalent.

The CanGaroo RM Antibacterial Envelope is based on the CanGaroo Envelope (K201313), with the addition of rifampin and minocycline druq-eluting discs. The envelope is made of the same material, porcine SIS, as the predicate CanGaroo Envelope. CanGaroo RM is a resorbable device, as is the predicate device.

The drug eluting discs contain the same antibacterial drugs, rifampin and minocycline, as the predicate device K192389. Antibiotic concentrations for CanGaroo RM span the range of the predicate device K192389 and the reference device K162193.

The device and the predicate are all terminally sterilized (e-beam or gamma irradiation).

The performance of CanGaroo RM and the predicate device all have been assessed through bench, in vitro, and in vivo testing. The results demonstrate that CanGaroo RM does not raise any new questions of safety and effectiveness.

Performance Data

The following performance data is provided in support of the substantial equivalence determination.

Performance Standards:

No performance standards have been established for this device under Section 514 of the Federal Food, Druq, and Cosmetic Act.

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Biocompatibility Testing:

Biocompatibility testing in accordance with the current ISO 10993 series and FDA guidance was conducted on the subject device and the results indicate that the device is biocompatible per these standards. The testing included cytotoxicity, sensitization, acute systemic toxicity, pyrogenicity, and implantation studies.

Bench Testing:

Bench testing was completed for the CanGaroo RM Antibacterial Envelope. The subject device passed all test requirements. The following tests were conducted for the subject device:

. Physical Characteristics
- Appearance o
- Dimensional o
. Functional Characteristics
- Seam Strength o
. Antibacterial Effectiveness
- Antibacterial Activity, in vitro (Modified AATCC 100) o Utilizing AATCC methodology, CanGaroo RM demonstrated bacterial reduction against a panel of 4 gram positive and 3 gram-negative organisms.
Drug Elution
- o Drug assay and drug elution/release testing.

Animal Testing:

. Pharmacokinetics, in vivo
. Bacterial Challenge model, in vivo

A bacterial challenge model in rabbits showed clearance at day 7 following implantation for a panel of 3 gram positive and 3 gram negative organisms.

Conclusion

Performance data utilizing in vivo testing demonstrates substantial equivalence to the predicate device (K192389). The CanGaroo RM device is as safe and as effective, with equivalent performance, to the legally marketed predicate device.

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.

Re: K233991

Dear Erica Elchin:

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

510(k) Summary

Company Information

Predicate Device

Device Description

Indications for Use

Summarv of Technological Characteristics

Performance Data

Performance Standards:

Biocompatibility Testing:

Bench Testing:

Animal Testing:

Conclusion

§ 878.3300 Surgical mesh.