(19 days)
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.
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.
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.
§ 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.