(294 days)
No
The description focuses on the material properties, intended use for tissue reinforcement, and biodegradation of a surgical sheet. There is no mention of any computational analysis, image processing, or learning algorithms.
No
The device is described as a surgical sheet for temporary wound support and reinforcement of soft tissues, not a direct therapeutic treatment for a disease or condition.
No
Explanation: The Mesofol® Surgical Sheet is described as an implantable, resorbable, polymeric surgical sheet used for temporary wound support and reinforcement of soft tissues. Its function is to physically support and reinforce tissues, minimizing tissue attachment, and it biodegrades over time. It does not perform any diagnostic function such as detecting, identifying, or monitoring medical conditions or diseases.
No
The device description clearly states that Mesofol® Surgical Sheet is an implantable, resorbable, polymeric surgical sheet, which is a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
- Mesofol® Surgical Sheet's Intended Use: The intended use of Mesofol® Surgical Sheet is for temporary wound support to reinforce soft tissues during surgical procedures. It is an implantable device used directly within the body.
- Device Description: The description clearly states it is an implantable, resorbable, polymeric surgical sheet. It is physically placed within the body to provide structural support.
- Lack of Specimen Examination: There is no mention of this device being used to examine any specimens (blood, tissue, etc.) outside of the body.
Therefore, based on the provided information, Mesofol® Surgical Sheet is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Mesofol® Surgical Sheet is indicated when temporary wound support is required to reinforce soft tissues where weakness exists, or in conjunction with hernia repair or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable protective sheet minimizes tissue attachment to the device in case of direct contact with the viscera.
Product codes
FTM
Device Description
Mesofol® Surgical Sheet is an implantable, resorbable, polymeric surgical sheet manufactured by ITV Denkendork in Germany. Mesofol® Surgical Sheet is offered in various sizes 4cm x 4cm to 20cm x 25cm and is 40jum in thickness. Mesofol® Surgical Sheet can be cut into different sizes and shapes by the end user. The sheet can be fixed with degradable suture material in situations where the anatomical conditions of the wound area are not suited to adequately fix the sheet.
Mesofol® Surgical Sheet is manufactured from a lactide-caprolactone copolymer. Mesofol® Surgical Sheet is chemically broken down by hydrolytic cleavage of the polymer, giving rise to three monomers: 6-hydroxycaproic acid, D-lactic acid, and Llactic acid. 6-Hydroxycaproic acid is broken down to acetyl-CoA units via ß-oxidation (fatty acid metabolism) for further dearadation via the Krebs cycle. L-Lactate is broken down in the Cori cycle (lactic acid cycle) to qlucose via pyruvate. These two monomers are thus degraded to products that are physiologically metabolized by the body.
In vitro studies have shown that Mesofol® Surgical Sheet is impermeable to microorganisms and large molecules until it starts to biodegrade. Degradation is likely to involve adhesion molecule and fibrin attachment to both sides of the sheet.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, hernia, fascial defects, wound area, viscera
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 Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MacroPore Surqi-Wrap MAST Bioresorbable Sheet K031955, Polyganics VivoSorb® Sheet K042811
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K062.558 page 1
510(k) Summary
JUN 2 0 2007
| Preparation Date: | March 15, 2006 |
|---|---|
| Applicant/Sponsor: | Biomet Orthopedics Inc. |
| 56 East Bell Drive | |
| P.O. Box 587 | |
| Warsaw, IN 46581 | |
| Contact Person: | Erika Martin |
| Proprietary Name: | Mesofol® Surgical Sheet |
| Common Name: | Mesh, Surgical, Polymeric |
| Classification Name: | FTL 878 3300 |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Mesofol® Surgical Sheet is substantially equivalent to MacroPore Surqi-Wrap MAST
Bioresorbable Sheet K031955 and Polyganics VivoSorb® Sheet K042811.
Device Description: Mesofol® Surgical Sheet is an implantable, resorbable, polymeric surgical sheet manufactured by ITV Denkendork in Germany. Mesofol® Surgical Sheet is offered in various sizes 4cm x 4cm to 20cm x 25cm and is 40jum in thickness. Mesofol® Surgical Sheet can be cut into different sizes and shapes by the end user. The sheet can be fixed with degradable suture material in situations where the anatomical conditions of the wound area are not suited to adequately fix the sheet.
Mesofol® Surgical Sheet is manufactured from a lactide-caprolactone copolymer. Mesofol® Surgical Sheet is chemically broken down by hydrolytic cleavage of the polymer, giving rise to three monomers: 6-hydroxycaproic acid, D-lactic acid, and Llactic acid. 6-Hydroxycaproic acid is broken down to acetyl-CoA units via ß-oxidation (fatty acid metabolism) for further dearadation via the Krebs cycle. L-Lactate is broken down in the Cori cycle (lactic acid cycle) to qlucose via pyruvate. These two monomers are thus degraded to products that are physiologically metabolized by the body.
In vitro studies have shown that Mesofol® Surgical Sheet is impermeable to microorganisms and large molecules until it starts to biodegrade. Degradation is likely to involve adhesion molecule and fibrin attachment to both sides of the sheet.
1
K062,558 page 2/2
Preclinical in vitro and in vivo studies have shown that Mesofol® Surgical Sheet takes approximately 4 to 6 weeks to biodegrade.
Intended Use: Mesofol® Surgical Sheet is indicated when temporary wound support is required to reinforce soft tissues where weakness exists, or in conjunction with hernia repair or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable protective sheet minimizes tissue attachment to the device in case of direct contact with the viscera.
Summary of Technologies: Similar to the predicate devices, Mesofol® Surgical Sheet is substantially equivalent to other surgical films or meshes with respect to its design as a thin, flexible, polymeric sheet that is used where temporary wound support is required to reinforce soft tissues or for the addition of a reinforcing bridging material to obtain the desired surgical result. Biocompatibility testing was performed and demonstrated that Mesofol® Surgical Sheet is biocompatible as a surgical sheet.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet, Inc. % Ms. Erika Martin Manager, Human Tissue and Applied Technology Regulation P.O. Box 587 Warsaw, Indiana 46581-0587
JUN 2 0 2007
Re: K062558
Trade/Device Name: Mesofol® Surgical Sheet Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: May 10, 2007 Received: May 16, 2007
Dear Ms. Martin:
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 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. Erika Martin
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 vou
F. Pely
Mark N. Melkerson Director 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): KOG ZSSS
Device Name: Mesosfol® Surgical Sheet
Indications For Use:
Mesofol® Surgical Sheet is indicated when temporary wound support is required to reinforce soft tissues where weakness exists, or in conjunction with hernia repair or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable protective sheet minimizes tissue attachment to the device in case of direct contact with the viscera.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (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) (Division Sign-Off) Division of General, Restorative, and Neurological Devices Page 1 of 1 510(k) Number_