(36 days)
No
The summary describes a physical surgical mesh made of microbial-derived cellulose for tendon repair and protection, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
A therapeutic device is typically involved in the treatment or diagnosis of a disease or condition. This device, a non-resorbable surgical mesh, is primarily used for protection and management of tendon injuries and does not actively treat or diagnose a disease.
No
The device is a surgical mesh used for the management and protection of tendon injuries, not for diagnosing conditions.
No
The device description explicitly states it is a "non-resorbable surgical mesh" composed of "microbial-derived cellulose" and is an "implantable device," indicating it is a physical hardware device, not software.
Based on the provided information, the MTA Protective Sheet is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "management and protection of tendon injuries." This is a therapeutic and protective function performed in vivo (within the body).
- Device Description: The description details a "surgical mesh" that is "implantable." This further confirms its use within the body during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a patient's health, diagnose a condition, or monitor treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. The MTA Protective Sheet is a surgical implant used directly on the injured tendon.
N/A
Intended Use / Indications for Use
The MTA Protective Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures. MTA Protective Sheet is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
FTM
Device Description
MTA Protective Sheet is composed of microbial-derived cellulose. The non-resorbable surgical mesh is used for the management and protection of tendon injuries. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The implantable device is presented in a sterile double-pouched package for appropriate removal in preparation for surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tendon injuries
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)
MTA Protective Sheet was subjected to various performance tests typical for its product code such as material property and suture pull out testing. Testing demonstrated its biomechanical equivalence to the predicate device, MAST Biosurgery Ortho-Wrap Bioresorbable Sheet. The MTA Protective Sheet 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.
XYLOS® Surgical Mesh, K081882, MAST Biosurgery Ortho-Wrap™ Bioresorbable Sheet, K072190
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.
Securian Tissue Reinforcement Matrix, K083823
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
510(k) Premarket Notification
XYLOS Corporation
Section 5: 510(k) Summary
APR 2 8 2009
The safety and effectiveness of MTA Protective Sheet is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.
| Sponsor: | Xylos Corporation
838 Town Center Drive
Langhorne, PA 19047 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | 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: | March 20, 2009 |
| Proprietary Name: | MTA™ Protective Sheet |
| Common Name: | Surgical Mesh |
| Regulatory Class: | Class II |
| Product Codes: | FTM |
| Predicate Device(s): | XYLOS® Surgical Mesh, K081882
MAST Biosurgery Ortho-Wrap™ Bioresorbable Sheet,
K072190
(Ortho-Wrap™ is a Trademark of MAST Biosurgery, Inc.) |
Device Description:
MTA Protective Sheet is composed of microbial-derived cellulose. The non-resorbable surgical mesh is used for the management and protection of tendon injuries. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The implantable device is presented in a sterile double-pouched package for appropriate removal in preparation for surgery.
CONFIDENTIAL
Page 13 of 36
1
Indications for Use:
The MTA Protective Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures. MTA Protective Sheet is intended for one-time use.
Technological Characteristics and Substantial Equivalence:
The MTA Protective Sheet is biocompatible since it is biologically and chemically identical to Securian Tissue Reinforcement Matrix previously cleared in K083823 and very similarly manufactured. In addition, the MTA Protective Sheet has similar indications for use to Securian Tissue Reinforcement Matrix as released in K083823.
Discussion of Performance Testing:
MTA Protective Sheet was subjected to various performance tests typical for its product code such as material property and suture pull out testing. Testing demonstrated its biomechanical equivalence to the predicate device, MAST Biosurgery Ortho-Wrap Bioresorbable Sheet. The MTA Protective Sheet met the test requirements, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence.
Conclusion:
MTA Protective Sheet is substantially equivalent to the previously cleared devices since it is:
-
- Biologically and chemically identical and therefore has equivalent biocompatibility to the Securian Tissue Reinforcement as previously released in K083823.
- Biomechanically equivalent as demonstrated via the above bench performance testing to 2. MAST Biosurgery Ortho-Wrap Bioresorbable Sheet.
CONFIDENTIAL
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2009
Xylos Corporation % Ms. Joyce Elkins Director Regulatory Affairs and Quality Assurance 838 Town Center Drive Langhorne, Pennsylvania 19047
Re: K090778
Trade/Device Name: MTA Protective Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: March 20, 2009 Received: March 23, 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.
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); 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.
3
Page 2 - Ms. Joyce Elkins
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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
for
Der
Mark N. Melkerso Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KO90778
Device Name: MTA Protective Sheet
Indications For Use:
The MTA Protective Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. MTA Protective Sheet minimizes tissue attachment to the device in case of direct contact with the tissues. The device is indicated for open and endoscopic procedures. MTA Protective Sheet is intended for one-time use.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for MXM
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number KD90778