(23 days)
No
The document describes a surgical mesh made from porcine dermis with no mention of software, algorithms, or any technology related to AI or ML. The changes described are limited to the Instructions for Use regarding fixation methods.
No
A therapeutic device is one that treats a disease or condition. This device, a surgical mesh, reinforces soft tissue and repairs damaged membranes, which is a supportive rather than a directly therapeutic function.
No
Explanation: The device is a surgical mesh intended for reinforcing and repairing soft tissue, not for diagnosing conditions.
No
The device is a physical surgical mesh made from porcine dermis, not a software program. The submission describes a modification to the Instructions for Use, but the device itself is hardware.
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 reinforcing or bridging material. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical mesh derived from porcine dermis, designed to be implanted as a scaffold for tissue repair. This is a physical implant used during surgery.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) during a surgical procedure for structural support and repair.
N/A
Intended Use / Indications for Use
LTM-Laparoscopic Surgical Mesh 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 bridging material to obtain the desired surgical outcome during open or laparoscopic procedures.
LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.
Product codes
OXK, FTM
Device Description
L TM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermis and is processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers. This device is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold to the patient. The device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses and is packaged in a double pouch configuration. The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, LTM-Laparoscopic Surgical Mesh (K121289).
The only change described in this submission is a minor modification to the Instructions for Use. There have been no changes made to the physical LTM-Laparoscopic Surgical Mesh device. The Instructions for Use have been modified to describe fixation of the device by sutures and surgical tacks, according to surgeon preference. The Instructions for Use previously provided as part of the cleared predicate device (K121289) described suturing LTM-Laparoscopic Surgical Mesh into position.
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)
The addition of language in the device Instructions for Use describes fixation the device using sutures and surgical tacks. Additional validation of the design was performed to ensure fixation using surgical tacks could be achieved. Testing included laparoscopic fixation of LTM-Laparoscopic Surgical Mesh by surgical tacks under simulated conditions, and the results have demonstrated that this method of fixation did not affect safety and efficacy of the device or raise any new questions of safety or efficacy . Thus, the proposed LTM-Laparoscopic Surgical Mesh continues to perform its intended use as a soft tissue patch to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes and is substantially equivalent to the predicate device LTM-Laparoscopic Surgical Mesh (K121289).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K130817 page 1/2
APR 1 7 2013
510(k) Summary LTM-Laparoscopic Surgical Mesh
Submitter's Name, Address, Telephone Number, Contact Person, and Date Prepared
LifeCell Corporation One Millennium Way Branchburg, NJ 08876
Contact Person: John Blewitt Senior Regulatory Affairs Associate Phone: (908) 947-1432 Fax: (908) 947-1095
Date Prepared:
March 21, 2013
Name of Device and Name and Address of Sponsor
LTM-Laparoscopic Surgical Mesh-Strattice Reconstructive Tissue Matrix (RTM) LifeCell Corporation One Millennium Way Branchburg, NJ 08876
Common or Usual Name
Surgical Mesh
Classification Name
Surgical Mesh-(21 C.F.R. §878.3300)
Device Class
II
Product Code OXK, FTM
OAK, TMI
Predicate Devices
LTM-Laparoscopic Surgical Mesh (K121289)—LifeCell Corporation
1
K130817 page 2/2
Intended Use/ Indications for Use
LTM-Laparoscopic Surgical Mesh 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 bridging material to obtain the desired surgical outcome during open or laparoscopic procedures.
LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.
Device Description and Technological Characteristics
L TM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermis and is processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers. This device is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold to the patient. The device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses and is packaged in a double pouch configuration. The proposed device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, LTM-Laparoscopic Surgical Mesh (K121289).
The only change described in this submission is a minor modification to the Instructions for Use. There have been no changes made to the physical LTM-Laparoscopic Surgical Mesh device. The Instructions for Use have been modified to describe fixation of the device by sutures and surgical tacks, according to surgeon preference. The Instructions for Use previously provided as part of the cleared predicate device (K121289) described suturing LTM-Laparoscopic Surgical Mesh into position.
Performance Data
The addition of language in the device Instructions for Use describes fixation the device using sutures and surgical tacks. Additional validation of the design was performed to ensure fixation using surgical tacks could be achieved. Testing included laparoscopic fixation of LTM-Laparoscopic Surgical Mesh by surgical tacks under simulated conditions, and the results have demonstrated that this method of fixation did not affect safety and efficacy of the device or raise any new questions of safety or efficacy . Thus, the proposed LTM-Laparoscopic Surgical Mesh continues to perform its intended use as a soft tissue patch to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes and is substantially equivalent to the predicate device LTM-Laparoscopic Surgical Mesh (K121289).
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an abstract human figure with outstretched arms, positioned to the right. Encircling the graphic is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
April 17, 2013
LifeCell Corporation % Mr. John Blewitt Senior Regulatory Affairs Associate One Millennium Way Branchburg, New Jersey 08876
Re: K130817
Trade/Device Name: LTM - Laparoscopic Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXK, FTM Dated: March 22, 2013 Received: March 25, 2013
Dear Mr. Blewitt:
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. Isting 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); medical device reporting (reporting of medical
3
Page 2 - Mr. John Blewitt
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/ucm115809.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 yours, FOR
Peter D清影视mm -S
Mark. N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K130817
Device Name: LTM-Laparoscopic Surgical Mesh
Indications For Use:
...
LTM-Laparoscopic Surgical Mesh 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 bridging material to obtain the desired surgical outcome during open or laparoscopic procedures.
LTM-Laparoscopic Surgical Mesh is intended for single patient one-time use only.
Prescription Use XX (21 CFR Part 801 Subpart D) AND/OR
Over the Counter Use 21 CFR Part 801 Subpart C
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Exemption (ODE)
David Krause
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130817