(181 days)
No
The device description focuses on the material and manufacturing process of a hernia mesh, and there are no mentions of AI, ML, or image processing. The performance studies are based on animal models and histological evaluations, not data-driven algorithms.
No.
The device is a hernia mesh intended for the reinforcement of soft tissue to repair ventral hernias, not for therapeutic treatment.
No
The T-Line® Hernia Mesh is indicated for the reinforcement of soft tissue for hernia repair. It is a surgical implant, not a device used to diagnose a medical condition.
No
The device description clearly states it is a physical mesh manufactured from polypropylene monofilament yarn, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The T-Line® Hernia Mesh is a surgical implant used to reinforce soft tissue during hernia repair. It is physically placed within the body.
- Lack of Specimen Analysis: The provided information does not mention the device being used to analyze any biological specimens outside of the body.
The device is a surgical mesh intended for direct implantation into the body, which is not the function of an IVD.
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 (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 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 incorporatescontinuous, 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 (implied by "surgeons akin to how sutures are sewn into fascia")
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)
in vivo GLP chronic animal study in a simulated use porcine model. "There were no biologically significant differences between histological and gross findings for up to 6 months post-operatively. All animals showed good bioincorporation and there was no evidence of adverse local or systemic effects of either mesh in any animal. The results revealed a normal inflammatory response to the polypropylene meshes." "At 1-, 3-, and 6- month post-operative endpoints, histological evaluation of inflammation, bioincorporation and fibrosis at the T-Line® Hernia Mesh and Bard Mesh control sites was conducted and associated cellular populations were scored and compared. Additionally, potential mesh contraction was assessed for both test and control mesh over time. Results showed no biologically significant differences between the T-Line® Hernia Mesh and reference Bard Soft Mesh throughout the duration of the study. No clinical observations, changes in clinical pathology parameters, or changes in bodyweights were linked to either the test or control meshes during the study. Microscopically, the same tissue reactions were seen with both the test and control reference mesh. consisting of both inflammatory and reparative processes. From a biological standpoint, the test and control reference mesh samples elicited an equivalent overall tissue response. Finally, there were no differences in mesh stability between the test and control reference mesh at any time point. Results therefore demonstrated equivalent safety and performance between the T-Line® Hernia Mesh and reference Bard Soft Mesh when surgically implanted via a sublay approach into Yucatan pigs for upto 6 months."
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.
K193144 T-Line® Hernia Mesh
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.
K052155 Bard Soft Mesh, K133356 Ethicon, Inc. PROLENE Polypropylene Suture
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
11/28/2022
Deep Blue Medical Advances, Inc. % Nancy Lincé President and CEO Lincé Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583
Re: K221556
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 9, 2022 Received: September 12, 2022
Dear Nancy Lincé:
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
1
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 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 DHT4B: Division of Infection Control and Plastic 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) K221556
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 September 8, 2022
- 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
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 K193144 T-Line® Hernia Mesh
Reference Devices: K052155 Bard Soft Mesh; K133356 Ethicon, Inc. PROLENE Polypropylene Suture
- DEVICE The T-Line® Hernia Mesh is manufactured by knitting and heat pressing 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 incorporatescontinuous, 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 identical to the T-Line® Hernia Mesh cleared PREDICATE under K193144, which is the primary predicate device. The intended use TECHNOLOGICAL and technological characteristics are identical to the predicate T-Line® CHARACTERISTICS Hernia Mesh. This 510(k) was limited to an expansion in the Indications for Use to include an open sublay approach. This 510(k) also references the Bard Soft Mesh (K052155) and the Ethicon, Inc. PROLENE Polypropylene Suture (K133356) which were used as the controls in the
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in vivo GLP chronic animal study to support the open sublay approach.
PERFORMANCE Based on the results of in vivo testing, the T-Line® Hernia Mesh DATA demonstrated substantially equivalent safety and performance characteristics when compared to the control mesh when performing open hernia repair via a sublav approach in a simulated use porcine model. There were no biologically significant differences between histological and gross findings for up to 6 months post- operatively. All animals showed good bioincorporation and there was no evidence of adverse local or systemic effects of either mesh in any animal. The results revealed a normal inflammatory response to the polypropylene meshes.
At 1-, 3-, and 6- month post-operative endpoints, histological evaluation of inflammation, bioincorporation and fibrosis at the T-Line® Hernia Mesh and Bard Mesh control sites was conducted and associated cellular populations were scored and compared. Additionally, potential mesh contraction was assessed for both test and control mesh over time. Results showed no biologically significant differences between the T-Line® Hernia Mesh and reference Bard Soft Mesh throughout the duration of the study. No clinical observations, changes in clinical pathology parameters, or changes in bodyweights were linked to either the test or control meshes during the study. Microscopically, the same tissue reactions were seen with both the test and control reference mesh. consisting of both inflammatory and reparative processes. From a biological standpoint, the test and control reference mesh samples elicited an equivalent overall tissue response. Finally, there were no differences in mesh stability between the test and control reference mesh at any time point. Results therefore demonstrated equivalent safety and performance between the T-Line® Hernia Mesh and reference Bard Soft Mesh when surgically implanted via a sublay approach into Yucatan pigs for upto 6 months.
Since the design of the T-Line® Hernia Mesh submitted under K193144 is unchanged, no additional performance testing was required as the test results previously submitted remain applicable to the subject T-Line® Hernia Mesh and demonstrated that the device meets functional, performance, and design requirements as well as safety standards.
- CONCLUSION Based on the indications for use, technological characteristics, performance testing, and comparison to the predicate and reference devices, substantial equivalence of the T-Line® Hernia Mesh used via a sublay approach has been demonstrated.