(27 days)
No
The device description focuses on the material and manufacturing process of a hernia mesh, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No
The device is a mesh used for surgical repair of hernias, which reinforces tissue rather than providing therapy.
No
Explanation: The device is a surgical mesh used for the reinforcement of soft tissue in hernia repair, which is a therapeutic rather than a diagnostic function.
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.
- Device Function: The T-Line Hernia Mesh is a surgical implant used to reinforce soft tissue during hernia repair. It is physically placed within the body and does not analyze biological samples.
- Intended Use: The intended use clearly states it's for "reinforcement of soft tissue where weakness exists for the repair of ventral hernias." This is a surgical procedure, not a diagnostic test.
- Device Description: The description details the material and construction of a physical mesh, not a device 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 sublay approach in adults (greater than 21 years of age).
Product codes
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue where weakness exists for the repair of ventral hernias; 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 (non-clinical testing) have shown 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
2/23/2023
Deep Blue Medical Advances, Inc. % Nancy Lince President and CEO Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583
Re: K230227
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: January 25, 2023 Received: January 27, 2023
Dear Nancy Lince:
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. 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 located 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 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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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. 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,
Deborah A. Fellhauer -S
Deborah Fellhauer RN, BSN Assistant Director Plastic Surgery Skin and Wound Devices Team DHT4B: Division of Infection Control and Plastic Surgerv Devices | OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality CDRH | Food and Drug Administration
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
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 sublay 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 January 25, 2023
- Deep Blue Medical Advances, Inc. SUBMITTER 701 W Main Street, Suite 410 Durham, NC 27701 Phone: (919) 914-6039 Establishment Registration No.: 3017492634
CONTACT PERSON
Nancy Lincé Lincé Consulting, LLC Phone: (650) 759-6186 Email: nlince@linceconsulting.com
- DEVICE T-Line® Hernia Mesh Common Name: Surgical MeshProduct Code(S): FTL CFR Classification and Name: 21 CFR§878.3300 Mesh, Surgical, Polymeric
- PREDICATE DEVICE K221556, K193144 T-Line® Hernia Mesh
Reference Device: K172636 VitaMESH Macroporous PP Surgical Mesh
- The T-Line® Hernia Mesh is manufactured by knitting and heat pressing DEVICE DESCRIPTION standard medical grade polypropylene monofilament yarn using wellestablished 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 The T-Line® Hernia Mesh is substantially equivalent to the T-Line® Hernia PREDICATE Mesh cleared under K221556 and K193144. The subject and predicate TECHNOLOGICAL devices are identical in terms of intended use, indications for use, function, technology, safety, performance as well as procedural steps and CHARACTERISTICS labeling. This 510(k) was limited to a change in contract manufacturer of the T-Line® Hernia Mesh, including the supplier of the raw materials used.
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- PERFORMANCE A risk analysis was conducted and confirmed there are no new risks DATA associated with the subject T-Line® Hernia Mesh. Appropriate evaluations (non-clinical testing) have shown 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.