(181 days)
Not Found
Not Found
No
The description focuses on the physical properties and design of a surgical mesh, with no mention of AI or ML capabilities.
No.
The device is a mesh used to reinforce soft tissue, which is a structural repair and not inherently therapeutic in the sense of actively treating a disease or condition for therapeutic effect.
No
The device is described as a sterile, single-use device indicated to reinforce soft tissue, specifically for the repair of hernias and chest wall defects. Its function is to reinforce existing tissue, not to diagnose a medical condition.
No
The device description clearly states it is a physical mesh constructed of knitted polypropylene monofilaments, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states the Bard 3DMAX Mesh is a sterile, single-use device indicated to reinforce soft tissue for the repair of hernias and chest wall defects. This is a device that is implanted or used directly on the body during a surgical procedure.
The device's function is structural support within the body, not diagnostic testing of samples taken from the body.
N/A
Intended Use / Indications for Use
The Bard 3DMAX Mesh is a sterile, single use device indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The modified Bard 3DMAX Mesh is anatomically designed to fit the inguinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inguinal anatomy, hernias and chest wall defects
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)
Biocompatibility testing was performed on the modified 3DMAX device. Testing performed to date indicates that changes made to the 3DMAX device do not impact its biocompatibility profile. In addition, laboratory testing was performed to compare the modified 3DMAX Mesh device to the currently marketed 3DMAX Mesh and Bard Mesh devices. The results show that the modified device is substantially equivalent to the currently marketed predicate devices. Therefore, based on laboratory testing and biocompatibility data, the modified 3DMAX device is safe and effective for its intended use.
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.
Not Found
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
.
SECTION 7.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
A. Submitter Information
| Submitter's Name: | Davol Inc. |
|---|---|
| Address: | Subsidiary of C. R. Bard, Inc. |
| 100 Sockanossett Crossroad | |
| Cranston, RI 02920 | |
| Telephone: | (401) 215-2252 |
| Fax: | (401) 215-2031 |
| Contact Person: | Stephanie Baker |
| Date of Preparation: | March 20, 2008 |
B. Device Name
| Trade Name: | Bard 3DMAX Mesh |
|---|---|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh |
C. Predicate Device Name
Trade name: Bard Mesh (Davol Inc.) Trade name: Bard 3DMAX Mesh (Davol Inc.) Trade name: Usher's Marlex Tubular Mesh (Davol Inc.)
D. Device Description
The modified Bard 3DMAX Mesh is anatomically designed to fit the inguinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.
PREMARKET NOTIFICATION FOR THE BARD 3DMAX MESH
-CONFIDENTIAL-
1
K081010
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ட். Intended Use
The modified Bard 3DMAX Mesh is a sterile, single use device indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects. The intended use for the modified device is exactly the same as the predicate devices, 3DMAX Mesh, Bard Mesh and Usher's Marlex Tubular Mesh.
Summary of Similarities and Differences in Technological ட் Characteristics, Performance and Intended Use
The modified 3DMAX Mesh device and the currently marketed 3DMAX Mesh and Bard Mesh devices are all indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects. Usher's Marlex Tubular Mesh is also indicated for use in hernia repair.
In addition, all products are similar in technological characteristics and performance. The modified 3DMAX Device differs from the currently marketed 3DMAX device in medial marker material only. The medial marker material used in the modified 3DMAX device will be purchased from a different vendor. The main components of the medial marker, polypropylene and Phthalocyaninato(2-) copper dye will remain the same. However, these items will be purchased from a different vendor and extruded to form a dyed polypropylene monofilament. As a result, there may be slight variations in the medial marker material formulation used in the modified device as compared to the currently marketed 3DMAX Mesh medial marker. These slight variations were evaluated through biocompatibility testing as well as laboratory testing.
G. Performance Data
Biocompatibility testing was performed on the modified 3DMAX device. Testing performed to date indicates that changes made to the 3DMAX device do not impact its biocompatibility profile. In addition, laboratory testing was performed to compare the modified 3DMAX Mesh device to the currently marketed 3DMAX Mesh and Bard Mesh devices. The results show that the modified device is substantially equivalent to the currently marketed predicate devices. Therefore, based on laboratory testing and biocompatibility data, the modified 3DMAX device is safe and effective for its intended use.
PREMARKET NOTIFICATION FOR THE BARD 3DMAX MESH
-CONFIDENTIAL-
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle.
Public Health Service
OCT 0 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Stephanie Baker Senior Regulatory Affairs Associate Davol Incorporated Subsidiary of C.R. Bard, Incorporated 100 Sockanossett Crossroad Cranston, Rhode Island 02920
Rc: K081010
Trade/Device Name: Bard 3DMAX Mesh Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: August 6, 2008 Received: August 7, 2008
Dear Ms. Baker;
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 may 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.
3
Page 2- Ms. Baker
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Scctions 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millican
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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Image /page/4/Picture/0 description: The image shows a sequence of handwritten characters, which appear to be alphanumeric. The sequence reads 'K081010'. The characters are written in a simple, clear style, making them easily readable. The image seems to be a close-up of the characters, possibly extracted from a larger document or label.
INDICATION FOR USE STATEMENT
2081010 510(k) Number (if known): Not Know
Device Name: Bard 3DMAX Mesh
Indications for Use: The Bard 3DMAX Mesh is a sterile, single use device indicated to reinforce soft tissue where weakness exists e.g. for repair of hernias and chest wall defects.
Prescription Use X Use (Part 21 CFR 801 Subpart D) Subpart C)
AND/OR
Over-The-Counter
(21 CFR 801
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ryder Sr. mkr
(Division Sign-Off) Division of Anesthesiology, General H Infection Control, Dental Devices
sion of Ceneral, Restorative, ogled Devices and Neuro!
510(k) Number
510(k) Number:
016