(72 days)
Is intended for the repair of hernias and other abdominal fascial deficioncies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. . Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
TyRx Surgical Mesh is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. TyRx Surgical Mesh is constructed of a non-resorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh. The resorbable coating represents approximately 10% of the total weight of the device. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.
This document describes a 510(k) premarket notification for a new surgical mesh and does not contain detailed information about specific acceptance criteria or an analytical study with performance metrics in the way a diagnostic algorithm or AI device submission would. The submission focuses on demonstrating substantial equivalence to predicate devices for its intended use.
However, I can extract the relevant information that is available and indicate when specific details are not provided in the document.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific numerical acceptance criteria and corresponding performance values for the TyRx Surgical Mesh are not explicitly stated in terms of a table with quantitative metrics. The submission focuses on demonstrating comparability and biocompatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Demonstrated to be biocompatible (TyRx Surgical Mesh and polyarylate polymer) |
| Satisfactory tissue ingrowth | Animal testing demonstrated satisfactory tissue ingrowth compared to control, evidenced by histopathology. |
| Comparability to predicate devices for intended use | Non-clinical laboratory testing performed in accordance with FDA guidance document "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" demonstrated that the device is comparable to standard surgical mesh devices. |
| Proper handling (stiffness facilitation) | Resorbable coating provides additional stiffness to the mesh to facilitate intraoperative handling during placement. |
| Resorption properties | Polymer resorbs in approximately 90 days. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document only mentions "animal testing" and "non-clinical laboratory testing." It does not specify the sample size (number of animals or test replicates) for either of these.
- Data Provenance: The document does not specify the country of origin of the data. It indicates the company is based in Monmouth Junction, NJ, USA, but this doesn't confirm where the testing took place. The testing was "non-clinical laboratory testing" and "animal testing," which are typically considered prospective in nature for evaluating a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions "histopathology" for evaluating tissue ingrowth. This implies expert assessment. However, the number of experts and their specific qualifications (e.g., "veterinary pathologist with 10 years of experience") are not specified in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information regarding an adjudication method for establishing ground truth or evaluating the test results.
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
- MRMC Study Done? No. This device is a surgical mesh, not a diagnostic imaging device or an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study as described (human readers with/without AI assistance) is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance? No. This device is a physical surgical mesh, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal testing evaluating tissue ingrowth, the ground truth was established through histopathology, which typically involves examination and interpretation by a pathologist.
8. The sample size for the training set
This is not applicable as the device is a physical surgical mesh and not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical surgical mesh and not an algorithm that requires a training set.
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TyRx Pharma Inc.
TyRx Surgical Mesh - Premarket Notification [510(k)] Submission
K052864 Page
November 9, 2005 1/2
SECTION 2. 510(K) SUMMARY
510(k) Summary (as required by 21 CFR 807.92)
Pursuant to Section 12, Part (a)(i)3A of the Safe Medical Devices Act of 1990, TyRx Pharma, Inc. is providing a summary of the safety and effectiveness information available for TyRx Surgical Mesh, as well as the substantial equivalence decision making process used for TyRx Surgical Mesh.
Sponsor/Applicant Name and Address: TyRx Pharma, Inc. 1 Deer Park Drive, Suite G Monmouth Junction, NJ 08852
Sponsor Contact Information: Mason Diamond, DDS Vice President, Clinical and Regulatory Affairs Phone: 732-246-8676 Fax: 732-246-8677 E-mail: mason@tyrxpharma.com
Date of Preparaton of 510(k) Summary: October 6, 2005
New Device Trade/Proprietary Name: TyRx Surgical Mesh
Device Common/Classification Name: Polymeric Surgical Mesh
Predicate Devices Name and 510(k) Numbers: VYPRO Mesh VICRYL-PROLENE partially absorbable synthetic surgical mesh (K002672) PROLENE polypropylene mesh nonabsorbable synthetic mesh (K962530) GORE POLYPROPYLENE HERNIA Mesh (K043081)
Device Description:
TyRx Surgical Mesh is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. TyRx Surgical Mesh is constructed of a non-resorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh. The resorbable coating represents approximately 10% of the total weight of the device. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue. In
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TyRx Pharma Inc. TyRx Surgical Mesh - Premarket Notification [510(k)] Submission
K052864 Page
November 9, 2005 2/2
addition, animal testing demonstrated that TyRx Surgical Mesh would achieve satisfactory tissue ingrowth compared to commercial surgical mesh.
Intended Use:
TyRx Surgical Mesh is intended for the repair of hernias and other abdominal fascial deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
Performance Data:
Non-clinical laboratory testing was performed in accordance with the FDA guidance document "Guidance for the Preparation of a Premarket Notification for a Surgical Mesh" demonstrating that the device is comparable to standard surgical mesh devices that are indicated for hernia repair and other abdominal fascial or muscular deficiencies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. The TyRx Surgical Mesh and the polyarylate polymer have been demonstrated to be biocompatible. In addition, animal testing demonstrated that TyRx Surgical Mesh will achieve satisfactory tissue ingrowth compared to control as evidenced by histopathology.
Conclusions:
Based on the 510(k) summaries (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food Drug and Cosmetic Act.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol.
DEC 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mason W. Diamond, D.D.S. Vice President, Clinical & Regulatory Affairs TyRx Pharma, Inc. 1 Deer Park Drive, Suite G Monmouth Junction, New Jersey 08852
Re: K052864
Trade/Device Name: TyRx Surgical Mesh, Model SMPC-0501 Regulatory Number: 21 CFR 878.3300 Regulatory Name: Implantable clip Regulatory Class: II Product Code: FTL Dated: December 2, 2005 Received: December 6, 2005
Dear Dr. Diamond:
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. 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.
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Dr. Diamond
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icher will anow you to ough marketing of substantial equivalence of your device to a legally premits to the are month 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 If you desire specific at (240) 276-0115. Also, please note the regulation entitled, Contact the Office of Compullier as (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination on Jour respumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Barbara Richards
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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November 9, 2005
TyRx Pharma Inc. TyRx Surgical Mesh - Premarket Notification [510(k)] Submission
SECTION 1. INDICATION FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K052864
Device Name: _________________ TyRx Surgical Mesh
Indications for Use:
Is intended for the repair of hernias and other abdominal fascial deficioncies requiring the addition of a reinforcing or bridging material to obtain the desired surgical result. . Examples of applications where TyRx Surgical Mesh may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anbare Bnchmp for Xxm
Division Sign Off
Page 1 of \
Division of General. Restorative. and Neurological Devices
510(k) Number K052864
CONFIDENTIAL - PROPRIETARY INFORMATION
§ 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.