(86 days)
Not Found
No
The device description and intended use focus on the material composition and mechanical properties of a tissue reinforcement matrix. There is no mention of any computational or analytical functions that would typically involve AI/ML. The performance studies described are focused on demonstrating equivalence to predicate devices through material and mechanical testing, not on evaluating the performance of an AI/ML algorithm.
Yes
The device is indicated for the management and protection of soft tissue and tendon injuries, and for reinforcement of soft tissues repaired by suture anchors, which are therapeutic interventions.
No
The device is a non-resorbable surgical mesh used for reinforcement and protection of soft tissues and tendons, not for diagnosing conditions.
No
The device description explicitly states it is a "sterile product composed of microbial-derived cellulose" and an "implantable device," indicating it is a physical material, not software.
Based on the provided information, the Securian™ Tissue Reinforcement Matrix is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "management and protection of soft tissue and tendon injuries" and "reinforcement of soft tissues repaired by suture anchors during tendon repair surgery." This describes a device used in vivo (within the body) for surgical repair and support.
- Device Description: The device is described as an "implantable device" and a "surgical mesh." These are characteristics of devices used directly on or within the body during surgery.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health. The Securian™ Tissue Reinforcement Matrix does not perform this function.
Therefore, the Securian™ Tissue Reinforcement Matrix is a surgical implant or medical device used for tissue repair and reinforcement, not an IVD.
N/A
Intended Use / Indications for Use
The Securian™ Tissue Reinforcement Matrix is indicated for the management and protection of soft tissue and tendon injuries in which there has been no substantial loss of tendon tissue. Securian™ Tissue Reinforcement Matrix minimizes tissue attachment to the device in case of direct contact with overlying tissues. Securian™ Tissue Reinforcement Matrix is also indicated for reinforcement of soft tissues repaired by suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Securian™ Tissue Reinforcement Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. Securian™ Tissue Reinforcement Matrix reinforces and protects healing soft tissues. The device is indicated for open and endoscopic procedures. Securian™ Tissue Reinforcement Matrix is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
Securian™ Tissue Reinforcement Matrix is a sterile product composed of microbial-derived cellulose. The implantable device is presented in a sterile double-pouched package for appropriate removal in preparation for surgery. The non-resorbable surgical mesh is used for trauma and reconstructive surgical procedures involving tendons or other soft tissues. Securian™ Tissue Reinforcement Matrix maintains the relative position and stability of soft tissues during the healing period.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue and tendon injuries, rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
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)
Securian™ Tissue Reinforcement Matrix was subjected to a panel of tests to demonstrate its equivalence to predicate devices. Additional performance testing was performed to support the modified 'Indications for Use' statement. Securian™ Tissue Reinforcement Matrix met the test requirements, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.
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.
K081882 / XYLOS Surgical Mesh, K023237 Ortho-Wrap® Bioresorbable Sheet, K072190, K021056 Permacol™ Biological Implant
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
MAR 1 8 2009
Section 5: 510(k) Summary
paye K083823
The following information is provided as required by 21 CFR § 807.87 for Securian™ Tissue Reinforcement Matrix 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.
The safety and effectiveness of Securian™ Tissue Reinforcement Matrix is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.
Sponsor:
Contact:
Xylos Corporation 838 Town Center Drive Langhorne, PA 19047
Joyce Elkins 838 Town Center Drive Langhorne, PA 19047 Phone: 215-867-0220 ext. 642 Facsimile: 215-741-4804 joyce.elkins@xyloscorp.com
Date of Submission: December 19, 2008 Proprietary Name: Securian™ Tissue Reinforcement Matrix Common Name: Surgical Mesh Regulatory Class: Class II Product Codes: FTM XYLOS® Surgical Mesh, K081882 / XYLOS Surgical Mesh, Predicate Device(s): K023237 Ortho-Wrap® Bioresorbable Sheet, K072190 (Ortho-Wrap® Trademark of MAST Biosurgery, Inc.) Permacol™, K021056 (Permacol™ Biological Implant Trademark of Tissue
Science Laboratories, PLC)
Device Description:
Securian™ Tissue Reinforcement Matrix is a sterile product composed of microbial-derived The implantable device is presented in a sterile double-pouched package for cellulose.
CONFIDENTIAL
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1
appropriate removal in preparation for surgery. The non-resorbable surgical mesh is used for trauma and reconstructive surgical procedures involving tendons or other soft tissues. Securian™ Tissue Reinforcement Matrix maintains the relative position and stability of soft tissues during the healing period.
Indications for Use:
Securian™ Tissue Reinforcement Matrix is indicated for the management and protection of soft tissue and tendon injuries in which there has been no substantial loss of tendon tissue. SecurianTM Tissue Reinforcement Matrix minimizes tissue attachment to the device in case of direct contact with overlying tissues. Securian™ Tissue Reinforcement Matrix is also indicated for reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Securian™ Tissue Reinforcement Matrix is NOT intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. Securian™ Tissue Reinforcement Matrix reinforces and protects healing soft tissues. The device is indicated for open and endoscopic procedures. Securian™ Tissue Reinforcement Matrix is intended for one-time use.
Technological Characteristics and Substantial Equivalence:
Securian™ Tissue Reinforcement Matrix is identical to previously cleared K081882 XYLOS Surgical Mesh. Therefore Securian™ Tissue Reinforcement Matrix has the same biocompatibility and performance characteristics to those cited in K081882. For this 510(k) submission, the device name is changed from "XYLOS® Surgical Mesh" K081882 to "Securian™ Tissue Reinforcement Matrix" and the 'Indications for Use' are modified from those cleared in K081882.
The Securian™ Tissue Reinforcement Matrix is substantially equivalent to legally marketed predicate devices and has the same intended uses and the same or similar indications, technological characteristics, and principles of operation as the predicate devices. Performance data demonstrate that Securian™ Tissue Reinforcement Matrix functions
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2
08383 3
equivalently to the predicate devices. Thus, Securian™ Tissue Reinforcement Matrix is substantially equivalent to the predicate devices.
Discussion of performance testing:
Securian™ Tissue Reinforcement Matrix was subjected to a panel of tests to demonstrate its equivalence to predicate devices. Additional performance testing was performed to support the modified 'Indications for Use' statement.
Securian™ Tissue Reinforcement Matrix met the test requirements, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.
Conclusion:
Securian™ Tissue Reinforcement Matrix is substantially equivalent to all the predicate devices. The modified 'Indications for Use' in this submission do not pose new questions of safety and effectiveness.
CONFIDENTIAL
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2009
Xylos Corporation % Ms. Joyce Elkins Director Regulatory Affairs/Quality Assurance 838 Town Center Drive Langhorne, Pennsylvania 19047
Re: K083823
Trade/Device Name: Securian™ Tissue Reinforcement Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: December 30, 2008 Received: January 5, 2009
Dear Ms. Elkins:
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
4
Page 2 - Ms. Joyce Elkins
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 yours.
L.Aymed for.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K083823 510(k) Number (if known):
Device Name: Securian™ Tissue Reinforcement Matrix
Indications For Use:
The Securian™ Tissue Reinforcement Matrix is indicated for the management and protection of soft tissue and tendon injuries in which there has been no substantial loss of tendon tissue. Securian™ Tissue Reinforcement Matrix minimizes tissue attachment to the device in case of direct contact with overlying tissues. Securian™ Tissue Reinforcement Matrix is also indicated for reinforcement of soft tissues repaired by suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Securian™ Tissue Reinforcement Matrix is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. Securian™ Tissue Reinforcement Matrix reinforces and protects healing soft tissues. The device is indicated for open and endoscopic procedures. Securian™ Tissue Reinforcement Matrix is intended for one-time use.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) | X |
| ------------------------------------------------- | --- | -------- | ------------------------------------------------ | --- |
|---|
Daniel Kra for MXM March 13, 2009
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K083823