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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Bard 3DMAX Mesh. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, much of the requested information (such as specific performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this type of regulatory submission and is not present in the provided text.

The "study" referenced in the document is a comparison to predicate devices, focusing on technological characteristics, performance, and intended use, rather than a clinical trial with acceptance criteria for a new AI or diagnostic device.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific quantitative performance metrics like sensitivity, specificity, or accuracy. The "performance" assessment focuses on demonstrating substantial equivalence to predicate devices.

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Biocompatibility: Device materials must not cause adverse biological reactions.	"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."
Technological Characteristics: Must be similar to predicate devices.	"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." "The modified 3DMAX Device differs from the currently marketed 3DMAX device in medial marker material only. 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."
Intended Use: Must be the same as predicate devices.	"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."
Safety and Effectiveness: Must be safe and effective for its intended use.	"Therefore, based on laboratory testing and biocompatibility data, the modified 3DMAX device is safe and effective for its intended use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The "testing" mentioned refers to laboratory and biocompatibility tests, not a clinical test set with human subjects or data provenance in the context of AI.

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)

This information is not applicable and not provided. The assessment relies on laboratory and biocompatibility testing, not expert-adjudicated ground truth data for a diagnostic algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided.

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

This information is not applicable and not provided. The Bard 3DMAX Mesh is a surgical mesh, not an AI-powered diagnostic tool, so MRMC studies are irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" equivalent for this device is based on biocompatibility testing standards and laboratory tests comparing material properties and performance characteristics to the existing predicate devices.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of a physical surgical mesh.

9. How the ground truth for the training set was established

This information is not applicable and not provided.

Summary

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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 CrossroadCranston, 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

PREMARKET NOTIFICATION FOR THE BARD 3DMAX MESH

-CONFIDENTIAL-

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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-

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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.

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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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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

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510(k) Number

510(k) Number:

016

Regulation Number and Section

§ 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.