(196 days)
Not Found
No
The summary describes a surgical mesh with an antimicrobial coating and does not mention any AI or ML components or functionalities.
Yes.
The device is intended for the repair of hernias and other abdominal fascial deficiencies, which is a therapeutic purpose.
No
Explanation: The device description clearly states that PivitAB™ is a "sterile prosthesis designed for the reconstruction of soft tissue deficiencies" and is intended for the "repair of hernias and other abdominal fascial deficiencies". This indicates a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states that PivitAB™ is a physical prosthesis constructed of non-resorbable mesh and a resorbable coating, making it a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that PivitAB™ is for the repair of hernias and other abdominal fascial deficiencies requiring a reinforcing or bridging material. This is a surgical procedure performed in vivo (within the body).
- Device Description: The device is described as a sterile prosthesis constructed of mesh and a coating, designed for reconstruction of soft tissue deficiencies. This further reinforces its use in surgical repair within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. PivitAB™ is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
PivitAB™ 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. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation. Examples of applications where PivitAB™ may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
PivitAB™ is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PivitAB™ is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a biorsonable polyarylate coating on the mesh containing the antimicrobial agents, rifampir and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the nesh in order to facilitate interoperative handling during placement and act a carrier for the imicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a ermanent mesh incorporated into the tissue. In addition, animal testing PivitABTM would achieve satisfactory tissue ingrowth compared to commercial surgical mesh.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal
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)
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 PivitABTM and the polyarylate polymer have been demonstrated to be biocompatible. In addition, animal testing demonstrated that PivitAB™ will achieve satisfactory tissue ingrowth compared to control as evidenced by histopathology. PivitAB™ has demonstrated effectiveness in an in vivo experiment in which PivitAB™ and a nonantimicrobial coated Control (PROLENE, Ethicon, Sommerville, NJ) were inoculated with 105 CFUs of S aureus and implanted into rabbits. Result demonstrated that there were significantly fewer colonized implants with PivitAB (13%) than with the PROLENE Mesh control (43%).
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.
K052864, K042592, K000343, K000185
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
crobial Mesh - Premarket Notification [510(k)] Submission (K053656)
Revised 510(K) Summary
July 11, 2006
i/2
2001 1 4 1 JUG
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. TVRx Pharma, Inc. is providing a summary of the safety and effectiveness information available for PivitAB™, as well as the substantial equivalence decision making process used for PivitAB™.
Sponsor/Applicant Name and Address: TyRx Pharma, Inc. 1 Deer Park Drive, Suite G Monmouth Junction, NJ 08852 Registration Number: 3005619263
Sponsor Contact Information: Mason Diamond, IDDS Vice President, Clinical and Regulatory Affairs Phone: 732-246-8676 Fax: 732-246-8677 E-mail: mason(@tvrxpharma.com
Date of Preparaton of 510(k) Summary: December 29, 2005
New Device Trade/Proprietary Name: PivitABTM
Device Common/Classification Name: Polymeric Surgical Mesh
Predicate Devices Name and 510(k) Numbers:
TyRx Surgical Mesh (K052864)
AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InibiZone ™ (K042592) Spectrum® Central Venous Catheter with or without Hydrophilic Coating (K000343) GORE-TEX® DualMesh® PLUS Biomaterial (1 mm and 2 mm) (K000185)
Device Description:
PivitAB™ is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PivitAB™ is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a biorsonable polyarylate coating on the mesh containing the antimicrobial agents, rifampir and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the nesh in order to facilitate interoperative handling during placement and act a carrier for the imicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a ermanent mesh incorporated into the tissue. In addition, animal testing PivitABTM would achieve satisfactory tissue ingrowth compared to
1
TyRx Pharma Inc.
TyRx Antimicrobial Mesh - Premarket Notification [510(k)] Submission (K053656)
July 11, 2006
21
commercial surgical mesh.
Intended Use:
PivitAB™ 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. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation. Examples of applications where PivitAB™ may be used include, but are not limited to: inguinal, femoral, umbilical, abdominal, incisional and intramuscular hernias and muscle flap reinforcement.
VOS3616
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 PivitABTM and the polyarylate polymer have been demonstrated to be biocompatible. In addition, animal testing demonstrated that PivitAB™ will achieve satisfactory tissue ingrowth compared to control as evidenced by histopathology. PivitAB™ has demonstrated effectiveness in an in vivo experiment in which PivitAB™ and a nonantimicrobial coated Control (PROLENE, Ethicon, Sommerville, NJ) were inoculated with 105 CFUs of S aureus and implanted into rabbits. Result demonstrated that there were significantly fewer colonized implants with PivitAB (13%) than with the PROLENE Mesh control (43%).
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 Devices under the Federal Food Drug and Cosmetic Act.
TE: KEY INFORMATION
2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2006
TyRx Pharma, Inc. % Mason W. Diamond, D.D.S. Vice President, Clinical and Regulatory Affairs 1 Deer Park Drive, Suite G Monmouth Junction, New Jersey 08852
Re: K053656 Trade/Device Name: PivitAB™ Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: May 15, 2006 Received: May 16, 2006
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
3
Page 2 - Mason W. Diamond, D.D.S.
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Obobera Anichump
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
TyRx Pharma Inc. TyRx Antimicrobial Mesh - Premarket Notification {510(k)] Submission (K053656) May 15, 2006
(5650)
Attachment 2: Revised Indication For Use Statement
Indications for Use
510(k) Number (if known): _ _ K.053656
PivitAB™ Device Name: _____________________
Indications for Use:
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. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation. Examples of applications where PivitAB™ 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)
Barbara Bruhn
Division of General, Restorative. and Neurological Devices
Page of
510(k) Number K053654