(87 days)
Not Found
No
The device description and performance studies focus on the physical properties and biomechanics of the envelope, with no mention of AI or ML technologies.
No.
The device is described as an envelope intended to hold other implantable devices, not to provide therapy itself. Its purpose is to create a stable environment for therapeutic devices.
No
The device is described as an "Envelope" intended to securely hold cardiac implantable neurostimulators or other electronic devices to create a stable environment. It does not measure or analyze biological parameters to determine the presence or absence of a disease or condition.
No
The device description clearly states it is a sterile, physical envelope constructed from biological material (porcine small intestinal submucosa) and suture, intended to hold implantable devices. It is a hardware device, not software.
Based on the provided text, the CanGaroo® Envelope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to securely hold an implantable medical device (cardiac or neurostimulator) within the body to create a stable environment. This is a direct interaction with the body for a therapeutic or supportive purpose.
- Device Description: The description details a sterile, implantable pouch made from biological material (porcine small intestinal submucosa) designed to physically contain another device within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CanGaroo Envelope does not perform any such analysis of bodily specimens.
Therefore, the CanGaroo® Envelope is an implantable medical device, not an IVD.
N/A
# Intended Use / Indications for Use
The CanGaroo(R) Envelope is intended to securely hold a cardiac 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 neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.
# Product codes (comma separated list FDA assigned to the subject device)
FTM
# Device Description
The CanGaroo Envelope is a sterile device intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator device to create a stable environment when implanted in the body. It is for single use in a single patient. The cardiac 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 perforated, multi-laminate sheets (4- ply) of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) derived from porcine small intestinal submucosa. The perforations are spaced evenly to allow exit of any exudate. The ECM is assembled into pouch form using violet 5-0 polydioxanone (PDS) suture.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
Not Found
# Indicated Patient Age Range
Not Found
# Intended User / Care Setting
Not Found
# Description of the training set, sample size, data source, and annotation protocol
Not Found
# Description of the test set, sample size, data source, and annotation protocol
Not Found
# Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance testing that supports the CanGaroo Envelope includes seam strength testing. The testing demonstrates that the design of the CanGaroo Envelope provides adequate biomechanical properties for use in the intended application.
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
[K173242](https://510k.innolitics.com/search/K173242)
# Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 15, 2018
Aziyo Biologics, Inc. Wendy Perreault Regulatory Affairs Consultant 1100 Old Ellis Road, Suite 1200 Roswell, Georgia 30076
Re: K182255
Trade/Device Name: CanGaroo® Envelope Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: August 17, 2018 Received: August 20, 2018
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 mav, 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 avare 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
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 A. Marjenin -S
For Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
CanGaroo(R) Envelope
Indications for Use (Describe)
The CanGaroo(R) Envelope is intended to securely hold a cardiac 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 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary: K182255
| Company Information | |
|---|---|
| Company Name: | Aziyo Biologics, Inc. |
| Contact Name: | Wendy Perreault |
| Contact Title: | Regulatory Consultant |
| Address: | 1100 Old Ellis Rd., Suite 1200 |
| Roswell, GA 30076 | |
| Phone (office): | 678-566-2628 |
| Phone (mobile): | 404-542-5854 |
| Fax: | 678-736-5082 |
| Date Prepared: | August 17, 2018 |
| Product Information | |
| Trade Name: | CanGaroo® Envelope |
| Common Name: | Surgical Mesh Envelope |
| Classification Name: | Surgical Mesh, 21 CFR 878.3300 |
| Product Code FTM, Class II | |
| Classification Panel: | Cardiovascular and/or Neurological and Physical Medicine Devices |
Predicate Devices
The CanGaroo® Envelope is substantially equivalent to the following device:
- CanGaroo® Envelope (K173242) ●
Device Description
The CanGaroo Envelope is a sterile device intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator device to create a stable environment when implanted in the body. It is for single use in a single patient. The cardiac 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 perforated, multi-laminate sheets (4- ply) of decellularized, non-crosslinked, lyophilized extracellular matrix (ECM) derived from porcine small intestinal submucosa. The perforations are spaced evenly to allow exit of any exudate. The ECM is assembled into pouch form using violet 5-0 polydioxanone (PDS) suture.
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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 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.
Substantial Equivalence
The intended use of the CanGaroo Envelope to securely hold a cardiac implantable electronic device or an implantable neurostimulator is identical to the CanGaroo Envelope cleared in K173242. All devices are constructed as Envelopes. The subject CanGaroo Envelope is of identical design and manufactured from the same materials (SIS-ECM and polydioxanone suture) as the CanGaroo Envelope cleared in K173242.
Non-clinical Testing
The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator device. The performance testing that supports the CanGaroo Envelope includes seam strength testing. The testing demonstrates that the design of the CanGaroo Envelope provides adequate biomechanical properties for use in the intended application.
Conclusion
The CanGaroo® Envelope is substantially equivalent to the predicate CanGaroo® Envelope (K173242).