(228 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Bard CollaMend Implant:
Based on the provided document, the information regarding acceptance criteria and detailed study methodology is quite limited. This appears to be a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting full clinical trial results with explicit acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it makes general statements about performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-toxic and non-sensitizing | "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." (Awaiting results/not explicitly presented in this summary) |
| Functionality and in-growth characteristics (comparable to predicate) | "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." (Confirmation by study) |
| Meeting established specifications for consistent performance | "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." (General statement of meeting specifications) |
| Substantial Equivalence to Predicate Devices | The overall submission aims to demonstrate substantial equivalence to Permacol® Implant, Mersilene® Polyester Fiber Mesh, and FortaGen® Porcine Collagen Surgical Implant for the intended use of reinforcing soft tissue where weakness exists. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "An animal implant study" but does not specify the number of animals or implants used in this study.
- Data Provenance: The study was an "animal implant study." The country of origin is not specified, but it would have been conducted by or for Davol Inc., a US-based company. It is a prospective study as it involves implantation of the device as part of the study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. Given it was an animal study focused on functionality and in-growth, the "ground truth" would likely be based on histological analysis by veterinary pathologists or expert animal researchers, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set:
- This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No, an MRMC comparative effectiveness study was not reported. This device is a surgical implant (medical device, not an AI or imaging diagnostic tool), so such a study would not be applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No, a standalone algorithm performance study was not reported. This device is a surgical implant, not an algorithm.
7. The Type of Ground Truth Used:
- For the "animal implant study," the ground truth for evaluating "functionality and in-growth characteristics" would typically come from histopathological analysis of tissue samples from the implanted animals, along with macroscopic observations and possibly biomechanical testing.
8. The Sample Size for the Training Set:
- This information is not applicable as this is not an artificial intelligence/machine learning device that would require explicit training data. The "training" for this type of device development involves materials science, bioengineering, and preclinical testing to optimize the device design and manufacturing process.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable for the same reason as above. Device development in this context involves iterative design, bench testing, and potentially earlier animal studies to refine the product, rather than establishing "ground truth" for an AI training set based on expert consensus. The "ground truth" in manufacturing would be based on established material specifications and quality control measures.
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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.
.
000046
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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) | |
|---|---|
| -------------------------------------------------------- | -- |
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(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number_ K052322-Page 1 of 1
000011
§ 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.