(28 days)
Not Found
No
The device description focuses on the physical properties and design of a surgical mesh, with no mention of software, algorithms, or AI/ML terms.
No
The device is a mesh used for the reinforcement of soft tissue and repair of inguinal hernias; it does not claim to treat or cure a disease or condition in a therapeutic manner.
No
Explanation: The device description states its purpose is to reinforce soft tissue and repair inguinal hernias, not to diagnose a condition. It is a surgical implant.
No
The device description clearly states it is a mesh constructed of knitted polypropylene monofilaments, which is a physical hardware component.
Based on the provided information, the Bard® 3DMax™ Mesh is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias." This describes a surgical implant used directly on the patient's body during a procedure.
- Device Description: The description details a physical mesh made of polypropylene, designed to be implanted. It does not mention any components or processes related to testing samples of blood, tissue, or other bodily fluids in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Bard® 3DMax™ Mesh is a surgical implant used for structural support.
No
Explanation: The letter explicitly states, "However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction." This clearly indicates that the device was not authorized as a PCCP device through this submission.
Intended Use / Indications for Use
Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The Bard® 3DMax™ Mesh is anatomically designed to fit the inquinal 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
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)
No non-clinical or clinical testing was provided in support of this Special 510(k).
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.
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).
Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction.
§ 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
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
June 30, 2024
Davol Inc., Subsidiary of C.R. Bard, Inc. Richard Spaziano Staff Regulatory Affairs Specialist 100 Crossings Boulevard Warwick. Rhode Island 02886
Re: K233402
Trade/Device Name: Bard 3DMax Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL
Dear Richard Spaziano:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on November 1, 2023. Specifically, FDA is updating this SE Letter because FDA inadvertently indicated that the SE determination also included review and clearance of a predetermined change control plan (PCCP). However, your 510(k) submission did not include a PCCP, so FDA is providing this administrative correction. Please see the attached revised clearance letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Tek N. Lamichhane, Office of Surgical and Infection Control Devices, 301-796-8983, Tek.Lamichhane@fda.hhs.gov
Sincerely,
Digitally signed by
Tek N.
Tek N. Lamichhane -S
Lamichhane -S Date: 2024.06.30
21:43:08 -04'00'
Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B Division of Infection Control
and Plastic and Reconstructive Surgery Devices
OHT4: Office of Surgical
and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue.
June 30, 2024
Davol Inc., Subsidiary of C.R. Bard, Inc. Richard Spaziano Staff Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K233402
Trade/Device Name: Bard 3DMax Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: October 4, 2023 Received: October 4, 2023
Dear Richard Spaziano:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on November 1, 2023.
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
2
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A ) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.
3
See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tek N.
Lamichhane -S
Digitally signed by
Tek N. Lamichhane -S
Date: 2024.06.30
21:46:47 -04'00'
Tek N. Lamichhane, Ph.D. Assistant Director DHT4B Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known) K233402
Device Name Bard 3DMax Mesh
Indications for Use (Describe)
Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5
510(k) Summary K233402
Submitter:
Davol Inc., Subsidiary of C.R. Bard, Inc. 100 Crossinas Blvd. Warwick, RI 02886 United States
Phone: (401) 825-8566
Contact: Richard Spaziano Title: Staff Regulatory Affairs Specialist Email: richard.spaziano@bd.com
Date of Submission: October 31, 2023
Subject Device:
| Device Trade Name: | Bard® 3DMax™ Mesh |
|---|---|
| Common Name: | Surgical mesh |
| Classification Name: | Mesh, Surgical, Polymeric |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 878.3300 |
| Product Code: | FTL |
Predicate Device:
| Device Trade Name: | Bard® 3DMax™ Mesh (K081010), cleared on October 7, 2008 |
|---|---|
| Common Name: | Surgical mesh |
| Classification Name: | Mesh, Surgical, Polymeric |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 878.3300 |
| Product Code: | FTL |
Device Description:
The purpose of this Special 510(k) is to notify FDA of the changes to the Bard® 3DMax™ Mesh labeling. There are no changes to the device itself. The device description is identical to the device description for the predicate device, Bard® 3DMax™ Mesh (K081010).
The Bard® 3DMax™ Mesh is anatomically designed to fit the inquinal 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.
6
Indications for Use:
Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.
Indications for Use Comparison to Predicate Device:
The subject device and predicate device have identical intended uses, which is for use in soft tissue reinforcement where weakness exists. The subject device indications specify use in the repair of inquinal hernias while the predicate device indications are broad hernia repair indications. The differences between the subject device and predicate device indications do not constitute a new intended use, as both the subject and predicate device are indicated for the same tissue type (soft tissue) and disease entity (repair of hernias).
Technological Comparison to Predicate Device:
The subject device is identical to the predicate device in terms of design, materials, manufacturing, packaging, sterilization, biocompatibility, and shelf-life. The purpose of this Special 510(k) is to notify FDA of labeling updates to the Bard® 3DMax™ Mesh that are being made to comply with the requirements of the European medical device regulation (EU) 2017/745, as well as to align the labeling with other hernia mesh devices across the Davol Inc. portfolio. These labeling modifications do not impact the substantial equivalence between the subject and predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions:
No non-clinical or clinical testing was provided in support of this Special 510(k).
Conclusion:
The subject device and predicate device have the same intended use and technological characteristics. The only differences between the subject and predicate device are modifications to the labeling for the subject device. These labeling modifications do not impact the safety or effectiveness of the subject device, nor do they impact the substantial equivalency between the subject and predicate devices. Therefore, the subject device, Bard® 3DMax™ Mesh, is substantially equivalent to the predicate device. Bard® 3DMax™ Mesh (K081010).