(19 days)
Not Found
No
The document describes a passive implantable device made of biological material, with no mention of software, data processing, or any terms related to AI/ML.
No.
This device is designed to hold cardiac implantable electronic devices and create a stable environment, not to directly treat a disease or medical condition.
No
The device is described as an envelope intended to securely hold cardiac implantable electronic devices, such as pacemakers and defibrillators, to create a stable environment when implanted. Its function is to support and stabilize other implanted devices, not to diagnose medical conditions or analyze bio-signals.
No
The device description clearly states it is constructed from physical materials (decellularized, non-crosslinked, lyophilized ECM derived from porcine small intestinal submucosa) and is a physical envelope intended to hold a cardiac implantable electronic device. It is a physical medical device, not software.
Based on the provided information, the CanGaroo(R) Envelope is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body." This describes a device used within the body to support another implanted device.
- Device Description: The description details a pouch made from biological material (porcine small intestinal submucosa) designed to hold cardiac implantable electronic devices. This is a physical implantable device.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) outside the body to diagnose a condition, monitor a treatment, or screen for a disease. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
The CanGaroo Envelope is clearly an implantable medical device designed for surgical use, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FTM
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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
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.
1
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
2
Indications for Use
510(k) Number (if known) K173242
Device Name CanGaroo(R) Envelope
Indications for Use (Describe)
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.
| 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: K173242
| Company Information | |
|---|---|
| Company Name: | Aziyo Biologics, Inc. |
| Contact Name: | Wendy Perreault |
| Contact Title: | Regulatory Affairs Consultant |
| Address: | 1100 Old Ellis Road, Suite 1200 |
| Roswell, 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 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.
4
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.