(28 days)
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 and sacral nerve stimulators.
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.
The provided text is a 510(k) summary for the CanGaroo Envelope, a surgical mesh device intended to securely hold implantable electronic devices. This document describes a "Special 510(k)" application, which means it addresses changes to a previously cleared device (K192616), specifically regarding its packaging.
Crucially, this document does not describe a study related to acceptance criteria for an AI/algorithm-based medical device. It focuses on demonstrating that changes in the product's packaging do not alter its fundamental scientific technology, intended use, or performance. Therefore, most of the information requested in your prompt regarding AI/algorithm performance, ground truth, expert consensus, and multi-reader studies is not applicable to this document.
However, I can extract information related to the device's validation for the packaging changes:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for new packaging) | Reported Device Performance (with new packaging) |
|---|---|
| Maintain product sterility during storage and shipment. | Product manufactured with new packaging met design input requirements for packaging and sterilization. |
| Protect the product during transportation. | Product manufactured with new packaging met design input requirements for packaging and sterilization. |
| Comply with suture manufacturer's recommendations for storage. | New packaging introduced to comply with suture manufacturer's recommendations. |
| Device performance unchanged compared to predicate (K192616). | "The CanGaroo Envelope manufactured with the new packaging met the design input requirements for packaging and sterilization." "The operating principle(s) and mechanism of the device are not changing." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated in the document. The text mentions "packaging testing and sterilization adoption testing of product manufactured with the new packaging was repeated," implying a test set was used, but the number of units tested is not provided.
- Data Provenance: Not applicable. The testing is described as non-clinical, likely internal testing performed by Aziyo Biologics, Inc.
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, packaging-focused submission, not an AI/algorithm study requiring expert ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/algorithm study requiring clinical adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document is about a physical medical device (surgical mesh envelope) and packaging changes, not an AI/algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This document is about a physical medical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the packaging validation, the "ground truth" would be the pre-defined design input requirements for packaging and sterilization performance (e.g., maintaining sterility, physical integrity). These are engineering and quality control standards, not clinical ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/algorithm study requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/algorithm study.
In summary: The provided text is a regulatory submission for a physical medical device (a surgical mesh envelope) specifically addressing changes to its packaging. It does not contain information about an AI/algorithm-based device, its performance, or associated studies like those you've inquired about.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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:
-
- 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;
-
- Reduce the overall size of the Display Envelope; and
-
- 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.
§ 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.