(228 days)
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No
The device description focuses on the material properties and physical characteristics of a collagen implant, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies described are related to biocompatibility and animal implant studies, not algorithmic performance.
Yes
The device is intended to reinforce soft tissue, such as for the repair of hernias and chest wall defects, which directly addresses a medical condition to restore function or provide therapy.
No
The device is described as an implant used to reinforce soft tissue, such as in hernia repair, not to identify or diagnose a condition.
No
The device description clearly states it is a sterile, solid sheet of lyophilized, accellular porcine dermal collagen, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reinforce soft tissue where weakness exists, e.g., for repair of hernia and chest wall defects, and for the surgical repair of damaged or ruptured soft tissue membranes." This describes a device that is surgically implanted into the body to provide structural support and facilitate tissue repair.
- Device Description: The device is a "sterile, solid, sheet of lyophilized, accellular porcine dermal collagen and its constituent elastin fibers." It is designed to be implanted and allow cellular infiltration and replacement by host tissue.
- Lack of Diagnostic Function: There is no mention of this device being used to test samples from the body (like blood, urine, tissue biopsies) to diagnose a condition, monitor a disease, or screen for health issues. IVDs are used in vitro (outside the body) for diagnostic purposes.
This device is clearly intended for surgical implantation and tissue repair, which falls under the category of a surgical implant or medical device used for structural support and tissue regeneration, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Bard CollaMend Implant is indicated to reinforce soft tissue where weakness exists, e.g., for repair of hernia and chest wall defects, and for the surgical repair of damaged or runtured soft tissue membranes.
Product codes
FTM
Device Description
The proposed device is a sterile, solid, sheet of lyophilized, accellular porcine dermal collagen and its constituent elastin fibers. It is processed to remove all non-collagenous cellular components and is cross-linked to increase strength and endurance. The proposed device allows cellular infiltration and replacement by host tissue, forming a strong repair of soft tissue defects. The proposed device will be made available in various sizes and shapes, ranging from a 4" x 6" ellipse to a 10" x 14" rectangle. The thickness of the devices will be approximately 1mm. Surgeons will need to rehydrate the product before implanting it into the patient. The proposed device will be marketed as a sterile, single use device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Soft tissue, e.g., for repair of hernia and chest wall defects
Indicated Patient Age Range
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Intended User / Care Setting
Surgeons
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
Biocompatibility testing will be completed and passed before the Bard CollaMend Implant is released. These biocompatibility test results will show that the material used in the design and manufacture of the proposed device is non-toxic and non-sensitizing to biological tissues consistent with its intended use.
An animal implant study was performed to confirm the functionality and in-growth characteristics of the Bard CollaMend Implant as compared to the predicate Permacol Implant.
Laboratory test results demonstrate that the material chosen, the manufacturing process, and the design utilized for the Bard CollaMend Implant will meet the established specifications necessary for consistent performance during its intended use.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS FOR THE BARD® COLLAMEND™ IMPLANT
A. Submitter Information
Submitter's Name: Address:
Telephone: Fax: Contact Person: Date of Preparation:
Davol Inc. Subsidiary of C. R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920 401-463-7000 ext. 2389 401-463-3845 Robin Drago August 12, 2005
B. Device Name
Trade Name: Common/Usual Name: Classification Name:
Bard CollaMend Implant Surgical Mesh Surgical Mesh
C. Predicate Device Name
| Trade name: | Permacol® Implant (Tissue Science Laboratories, PLC.) |
|---|---|
| Trade name: | Mersilene® Polyester Fiber Mesh (Ethicon, Inc.) |
| Trade name: | FortaGen® Porcine Collagen Surgical Implant (Organogenesis, Inc.) |
D. Device Description
. .
The proposed device is a sterile, solid, sheet of lyophilized, accellular porcine dermal collagen and its constituent elastin fibers. It is processed to remove all non-collagenous cellular components and is cross-linked to increase strength and endurance. The proposed device allows cellular infiltration and replacement by host tissue, forming a strong repair of soft tissue defects. The proposed device will be made available in various sizes and shapes, ranging from a 4" x 6" ellipse to a 10" x 14" rectangle. The thickness of the devices will be approximately 1mm. Surgeons will need to rehydrate the product before implanting it into the patient. The proposed device will be marketed as a sterile, single use device.
and the comments of the management of the first and the first and the many of the many of the many of the many of the many of the many of the many of the many of the many of
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E. Intended Use
The Bard CollaMend Implant is indicated to reinforce soft tissue where weakness exists, e.g., for repair of hernia and chest wall defects, and for the surgical repair of damaged or runtured soft tissue membranes.
K. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The proposed device and the three predicate devices are all generally intended for use in the repair of soft tissue deficiencies, including hermas
The proposed device is similar to the three predicate devices in principle of operation and general design. The key differences in the proposed device to the predicate devices are in the details of the device design.
Both the proposed device and the predicate Permacol Implant are manufactured from accllular porcine dermal collagen and its constituent clastin fibers. The predicate FortaGen Implant is manufactured from layers of purified porcine intestine, and the predicate Mersilene Mesh is manufactured from multifilament polyester.
The manufacturing processes for the proposed device, predicate Permacol Implant and FortaGen Implant are unique, but each of these processes contains decontamination/viral inactivation, cross-linking of the material, and sterilization of the device.
The proposed device must be completely hydrated before use by immersion in sterile saline solution or sterile lactated ringers solution for 3-5 minutes. The predicate Permacol Implant and FortaGen Implants are packaged moist for sterilization. The predicate Permacol Implant requires that the user rinse the implant before implantation in a patient, whereas the predicate FortaGen Implant does not require rinsing or rehydration of the implant unless the implant becomes dehydrated before implantation in a patient.
G. Performance Data
Biocompatibility testing will be completed and passed before the Bard CollaMend Implant is released. These biocompatibility test results will show that the material used in the design and manufacture of the proposed device is non-toxic and non-sensitizing to biological tissues consistent with its intended use.
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An animal implant study was performed to confirm the functionality and in-growth characteristics of the Bard CollaMend Implant as compared to the predicate Permacol Implant.
Laboratory test results demonstrate that the material chosen, the manufacturing process, and the design utilized for the Bard CollaMend Implant will meet the established specifications necessary for consistent performance during its intended use.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES" written around the perimeter. In the center of the circle is an abstract image of an eagle, with three lines representing the eagle's wings. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2006
Davol Inc. Subsidary of C.R. Bard, Inc. c/o Ms. Robin Drago VP of Regulatory and Clinical Affairs 100 Sockanossett Crossroad P.O. Box 8500 Cranston, Rhode Island 02920
Rc: K052322
Trade/Device Name: Bard® CollaMend Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: March 27, 2006 Received: March 28, 2006
Dear Ms. Drago:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Ms. Robin Drago
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours
Mark N. Melkerson Director Division of General, Restorative and Neurological 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: | Bard® CollaMend™ Implant |
|---|---|
| Indications for Use: | The Bard CollaMend Implant is indicated to reinforce soft tissue where weakness exists, e.g., for repair of hernia and chest wall defects, and for the surgical repair of damaged or ruptured soft tissue membranes. |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
el.mee
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number_ K052322-Page 1 of 1
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