(215 days)
Not Found
No
The description focuses on the material properties and biological function of a surgical mesh, with no mention of AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device is a surgical mesh intended to reinforce soft tissue and repair defects, providing a scaffold for healing, which is a supportive rather than directly therapeutic function.
No
Explanation: The device is described as a surgical mesh used for reinforcing soft tissue and repairing defects, providing a scaffold for cellular infiltration. It is a therapeutic device, not a diagnostic one, as it does not diagnose or detect medical conditions.
No
The device description clearly states it is a surgical mesh made from porcine dermis, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical repair of soft tissue, specifically hernias and body wall defects, by providing a reinforcing material. This is a therapeutic and structural function performed in vivo (within the body).
- Device Description: The device is a surgical mesh made from porcine dermis, designed to act as a scaffold for tissue regeneration in vivo.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of SurgiPure® XD does not involve any such in vitro testing of patient specimens.
Therefore, SurgiPure® XD Reconstructive Tissue Matrix is a surgical implant/device used directly in the body for structural support and tissue repair, not an IVD.
N/A
Intended Use / Indications for Use
SurgiPure® XD Reconstructive Tissue Matrix 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 membranes. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or buttressing material to obtain the desired surgical outcome.
SurgiPure® XD Reconstructive Tissue Matrixis intended for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
SurqiPure™ XD Reconstructive Tissue Matrix is a surgical mesh made from porcine dermis which then undergoes a decellularisation process. The collagen matrix is subsequently packed into a double pouch and then sterillsed by irradiation. SurgiPure™ XD acts as a surgical mesh for soft tissue repair to provide a scaffold to the patient to allow cellular infiltration, neovascularisation and collagen deposition.
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)
SurgiPure™ XD Reconstructive Tissue Matrix has undergone extensive biocompatibility testing, animal testing, viral inactivation testing and biomechanical testing. The data indicates that the device is biocompatible and that the manufacturing process is capable of inactivating any viral components that may come from the starting material. Cellular material and residual DNA is removed from the device whilst preserving the quality of the collagen structure. Bench testing data demonstrates that SurgiPure™ XD Reconstructive Tissue Matrix will meet the established specifications necessary for consistent performance in accordance with its intended use.
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.
LTM Surgical Mesh, LifeCell Corporation, K070560
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles forming its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2016
Tissue Regenix Group, PLC Mr. Mike Izon Head of Quality, Regulatory & Clinical Affairs The BioCentre, Innovation Way, Heslington York, Yorkshire YO10 5NY UK
Re: K152206
Trade/Device Name: SurgiPure XD Reconstructive Tissue Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: January 28, 2016 Received: February 1, 2016
Dear Mr. Izon:
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 CFR Part 807); labeling (21 CFR Part 801 and 809); medical device reporting
1
(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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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 yours,
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for TRX Wound Care Limited. The logo features the text "TRX Wound Care" in a sans-serif font, with the word "Limited" in a smaller font size below. Above the text is a curved, blue graphic element that resembles a swoosh or a stylized wave.
PRIVATE AND CONFIDENTIAL
SECTION 4 - INDICATIONS FOR USE STATEMENT
Indications for Use
K152206 510(k) Number (if known):
SurgiPure® XD Reconstructive Tissue Matrix Device Name:
Indications For Use:
SurgiPure® XD Reconstructive Tissue Matrix 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 membranes. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or buttressing material to obtain the desired surgical outcome.
SurgiPure® XD Reconstructive Tissue Matrixis intended for single patient use only.
| Prescription Use x | _________________ |
|---|---|
| -------------------- | ------------------- |
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
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Image /page/3/Picture/0 description: The image shows the logo for TRX Wound Care Limited. The logo features the text "TRX Wound Care" in a sans-serif font, with the word "Limited" in a smaller font size below. Above the text, there are three curved lines in a gradient of blue, creating a visual element that resembles an arc.
510(k) Summary
TRX Woundcare Ltd.
Submitter's Name and Address:
TRx Woundcare Ltd Astley Way Swillington Leeds LS26 8XT
| Contact Person: | Mike Izon |
|---|---|
| Telephone: | +44 03304303061 |
| Date Prepared: | 8th March 2016 |
| Common or Usual Name: | SurgiPure™ XD Reconstructive Tissue Matrix |
| Classification Name: | Mesh, Surgical |
| Regulation Number: | 878.3300 |
| Device Product Code: | FTM |
| Predicate Device: | LTM Surgical Mesh, LifeCell Corporation, K070560 |
Intended Use/Indications for Use:
SurgiPure™ XD Reconstructive Tissue Matrix 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 membranes. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or buttressing material to obtain the desired surgical outcome. The device is intended for single use (single patient one-time use) only.
Technological Characteristics:
SurqiPure™ XD Reconstructive Tissue Matrix is a surgical mesh made from porcine dermis which then undergoes a decellularisation process. The collagen matrix is subsequently packed into a double pouch and then sterillsed by irradiation. SurgiPure™ XD acts as a surgical mesh for soft tissue repair to provide a scaffold to the patient to allow cellular infiltration, neovascularisation and collagen deposition.
Performance Data:
SurgiPure™ XD Reconstructive Tissue Matrix has undergone extensive biocompatibility testing, animal testing, viral inactivation testing and biomechanical testing. The data indicates that the device is biocompatible and that the manufacturing process is capable of inactivating any viral components that may come from the starting material. Cellular material and residual DNA is removed from the device whilst preserving the quality of the collagen structure. Bench testing data demonstrates that SurgiPure™ XD Reconstructive Tissue Matrix will meet the established specifications necessary for consistent performance in accordance with its intended use.
Substantial Equivalence:
SurqiPure™ XD Reconstructive Tissue Matrix is substantially equivalent to the legally marketed predicate, LTM Surgical Mesh - K070560. SurgiPure™ XD Reconstructive Tissue Matrix has the same intended uses and the same or similar indications, technological characteristics and principles of operation as the predicate device. Performance data demonstrates that SurgiPure™ XD Reconstructive Tissue Matrix functions equivalently to the predicate device. Thus, SurgiPure™ XD Reconstructive Tissue Matrix is substantially equivalent.