(130 days)
Not Found
No
The summary describes a surgical mesh with an antimicrobial coating and does not mention any computational or analytical functions that would suggest the use of AI or ML.
No
The device is a surgical mesh primarily intended for structural support, reinforcement, and repair of soft tissue deficiencies and hernias, not for treating a disease or condition in a therapeutic manner beyond structural repair. While it incorporates antimicrobial agents, this is to prevent microbial colonization of the device itself during implantation, rather than directly treating an infection in the patient.
No
The device is described as a soft tissue patch or prosthesis intended for the surgical repair of damaged or ruptured soft tissue, such as hernias or body wall defects. Its purpose is to reinforce or bridge tissue, not to diagnose a condition.
No
The device description clearly states it is a "dual component (resorbable and non-resorbable), sterile prosthesis" constructed of "knitted filaments of polypropylene and a bioresorbable polyarylate coating." This describes a physical medical 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 the device is a "soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue." It is used in vivo (within the body) during surgery.
- Device Description: The description details a surgical prosthesis made of mesh and a resorbable coating with antimicrobial agents. This is a physical implant used for structural support and protection within the body.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The device is a surgical implant used for tissue repair, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
PIVIT A/B ST is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. 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.
PIVIT A/BTM ST is intended for single patient one-time use only.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
PIVIT A/B ST is identical to the PIVIT A/B device cleared via K053656. This filing is meant to provide for a line extension to the PIVIT A/B device and provide for uses consistent with other surgical mesh devices. This summary is repeated from the original PIVIT A/B clearance as reference.
PIVIT A/B ST is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PIVIT A/B ST is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh containing the antimicrobial agents, rifampin and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement and act as a carrier for antimicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, hernias and/or body wall defects
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)
Performance data on the enclosed devices are provided by reference to the previously cleared PIVIT A/B device per K053656.
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
K093524
Page 1/2
510(K) Summary
. .
MAR 2 3 2010
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 Inc. is providing a summary of the safety and effectiveness information available for PIVIT A/B ST as well as the information used in the substantial equivalence decision making process for PIVIT A/B ST.
Sponsor/Applicant Name and Address TYRX Pharma, Inc. 1 Deer Park Drive, Suite G Monmouth Junction, N.J. 08852 Registration Number: 3005619263
Sponsor Contact Information:
Mark Citron Vice President Regulatory Affairs and Quality Systems Phone: 732-246-8676 Fax: 732-246-8677 E-mail: mark@tyrx.com
Date of preparation of 510(k) summary: March 24, 2010
New Device Trade/Proprietary Name: PIVIT A/B ST
Device Common/Classification Name: Polymeric Surgical Mesh
Predicate Devices Name and 510(k) Numbers:
| PIVIT A/B | (K053656) |
|---|---|
| Strattice | (K070560) |
| HydroCoat Mesh | (K090271) |
Device Description:
PIVIT A/B ST is identical to the PIVIT A/B device cleared via K053656. This filing is meant to provide for a line extension to the PIVIT A/B device and provide for uses consistent with other surgical mesh devices. This summary is repeated from the original PIVIT A/B clearance as reference.
PIVIT A/B ST is dual component (resorbable and non-resorbable), sterile prosthesis designed for the reconstruction of soft tissue deficiencies. PIVIT A/B ST is constructed of a nonresorbable mesh comprised of knitted filaments of polypropylene and a bioresorbable polyarylate coating on the mesh containing the antimicrobial agents,
1
K093524¢ page 2/2
rifampin and minocycline. The purpose of the resorbable coating is to provide additional stiffness to the mesh in order to facilitate interoperative handling during placement and act as a carrier for antimicrobial agents. Once placed, the polymer resorbs in approximately 90 days leaving a lighter permanent mesh incorporated into the tissue.
Intended Use:
PIVIT A/B ST is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
PIVIT A/B 100 ST is intended for single patient one-time use only.
Performance Data :
Performance data on the enclosed devices are provided by reference to the previously cleared PIVIT A/B device per K053656.
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird in flight, composed of three curved lines that suggest the wings and body of the bird.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR 2 3 2010
TYRX Pharma, Inc. % Mr. Mark Citron VP, Regulatory Affairs and Quality Systems 1 Deer Park Drive, Suite G Monmouth Junction, New Jersey 08852
Re: K093524
Trade/Device Name: PIVIT A/B™ ST Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: March 16, 2010 Received: March 17, 2010
Dear Mr. Citron:
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. 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 requirements, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Mark Citron
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely yours,
For
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication For Use Statement
Indications for Use
| 510(k) Number ( If known): | K093524 |
|---|---|
| Device Name: | PIVIT A/B ST |
Indications for Use:
PIVIT A/B ST is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. 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.
PIVIT A/BTM ST is intended for single patient one-time use only.
Prescription Use
AND/OR
Over the Counter Use
( 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-O Concurrence of CDRH, Office of Device Everying (Drivision Sign-Off) 0
Concurrence of CDRH, Office of Device Everified, Orthopedic, and Restorative Devices
510(k) Number K093524