(29 days)
Not Found
No
The description focuses on the material and manufacturing process of a physical mesh device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a hernia mesh indicated for the reinforcement of soft tissue in the repair of ventral hernias, which is a therapeutic intervention aimed at treating a medical condition.
No
The device is a hernia mesh intended for the reinforcement of soft tissue, not for diagnosis.
No
The device description clearly states it is a physical mesh manufactured from polypropylene yarn, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The T-Line Hernia Mesh is a physical implantable device used to reinforce soft tissue during hernia repair surgery. It is directly applied to the patient's body during a surgical procedure.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device itself is the therapeutic intervention, not a tool for analyzing samples.
Therefore, based on the provided information, the T-Line Hernia Mesh is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sub lay approach in adults (greater than 21 years of age).
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The T-Line Hernia Mesh is manufactured by knitting and heat pressing standard medical grade polypropylene monofilament yarn using well-established standard processes that are used to manufacture other commercially available hernia meshes. Mesh extensions are used to apply the device to the abdominal wall. The extensions of the T-Line Hernia Mesh are incorporated directly into the mesh body. The mesh design incorporates continuous, uninterrupted, seamless extensions from the mesh body to facilitate mesh securement to tissue. After knitting, needles are swaged onto the ends of the extensions to allow the extensions to be sewn into the abdominal fascia by surgeons akin to how sutures are sewn into fascia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue; abdominal wall; abdominal fascia
Indicated Patient Age Range
adults (greater than 21 years of age)
Intended User / Care Setting
surgeons
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)
A risk analysis was conducted and confirmed there are no new risks associated with the subject T-Line Hernia Mesh. Appropriate evaluations DATA have demonstrated that the modified T-Line Hernia Mesh continues to meet the same pre-determined functional and performance requirements and external standard requirements as the predicate device and do not raise any new questions of safety or effectiveness.
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).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 18, 2023
Deep Blue Medical Advances, Inc. % Diana Degregorio Regulatory Affairs Consultant Lince Consulting, LLC 111 Deerwood Road Suite 200 San Ramon, California 94583
Re: K232924
Trade/Device Name: T-Line® Hernia Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: September 19, 2023 Received: September 19, 2023
Dear Diana Degregorio:
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 (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.
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
1
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 QS 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); 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-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 mediation-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.
2
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. Digitally signed by Tek N. Lamichhane -S Lamichhane -S Date: 2023.10.18 22:28:45 -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
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Indications for Use
510(k) Number (if known) K232924
Device Name T-Line Hernia Mesh
Indications for Use (Describe)
The T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sub lay approach in adults (greater than 21 years of age).
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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510(k) SUMMARY
| DATE PREPARED | October 18, 2023 | |
|---|---|---|
| SUBMITTER | Deep Blue Medical Advances, Inc. | |
| 701 W Main Street, Suite 410 | ||
| Durham, NC 27701 | ||
| Phone: (919) 914-6039 | ||
| Establishment Registration No.: 3017492634 | ||
| CONTACT PERSON | Diana DeGregorio | |
| Lincé Consulting, LLC | ||
| Phone: (925) 980-8047 | ||
| Email: ddegregorio@linceconsulting.com | ||
| DEVICE | T-Line® Hernia Mesh | |
| Common Name: Surgical Mesh | ||
| Product Code(s): FTL | ||
| CFR Classification and Name: 21 CFR§878.3300 | ||
| Mesh, Surgical, Polymeric | ||
| PREDICATE DEVICE | T-Line Hernia Mesh (K230227, K221556, K193144) | |
| Product Code(s): FTL | ||
| CFR Classification and Name: 21 CFR§878.3300 | ||
| Mesh, Surgical, Polymeric | ||
| DEVICE DESCRIPTION | The T-Line Hernia Mesh is manufactured by knitting and heat pressing | |
| standard medical grade polypropylene monofilament yarn using well- | ||
| established standard processes that are used to manufacture other | ||
| commercially available hernia meshes. Mesh extensions are used to | ||
| apply the device to the abdominal wall. The extensions of the T-Line | ||
| Hernia Meshare incorporated directly into the mesh body. The mesh | ||
| design incorporates continuous, uninterrupted, seamless extensions from | ||
| the mesh body to facilitate mesh securement to tissue. After knitting, | ||
| needles are swaged onto the ends of the extensions to allow the | ||
| extensions to be sewn into the abdominal fascia by surgeons akin to how | ||
| sutures are sewn into fascia. | ||
| INTENDED USE | The T-Line Hernia Mesh is indicated for the reinforcement of soft tissue | |
| where weakness exists for the repair of ventral hernias performed via an | ||
| open onlay or sublay approach in adults (greater than 21 years of age). | ||
| COMPARISON TO | ||
| PREDICATE | ||
| TECHNOLOGICAL | ||
| CHARACTERISTICS | The T-Line Hernia Mesh is substantially equivalent to the T-Line Hernia | |
| Mesh cleared under K230227, K221556 and K193144. The subject and | ||
| predicate devices are identical in terms of intended use, indications for | ||
| use, function, technology, safety, performance as well as procedural | ||
| steps and labeling. This 510(k) was limited to the addition of a smaller |
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size of the T-Line Hernia Mesh based on customer feedback.
PERFORMANCE A risk analysis was conducted and confirmed there are no new risks associated with the subject T-Line Hernia Mesh. Appropriate evaluations DATA have demonstrated that the modified T-Line Hernia Mesh continues to meet the same pre-determined functional and performance requirements and external standard requirements as the predicate device and do not raise any new questions of safety or effectiveness.
- CONCLUSION Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate and reference devices, substantial equivalence of the modified T-Line Hernia Mesh has been demonstrated.