(95 days)
No
The summary describes a surgical mesh made from porcine dermal tissue. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties and biomechanical strength.
No.
A therapeutic device is one that treats a disease or condition. This device is a surgical mesh primarily used for reinforcement or repair of tissue, not for treating a disease in itself.
No
The device is a surgical mesh intended for reinforcing soft tissue and repairing defects, not for diagnosing conditions.
No
The device description clearly states it is a surgical mesh derived from porcine dermal tissue, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The LTM-Laparoscopic Surgical Mesh is a physical implantable device used to reinforce soft tissue and repair hernias/body wall defects during surgery. It is directly applied to the patient's body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, laboratory testing, or diagnostic purposes. The performance studies focus on the physical properties of the mesh (strength, tear resistance, etc.) and its biocompatibility, which are relevant to an implantable surgical device, not an IVD.
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
FTM, OXK
Device Description
The LTM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermal tissue. The LTM-Laparoscopic Surgical Mesh device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and sizes ranging from 10 cm x 16 cm to 20 cm x 20 cm, with future sizes planned ranging from 2 cm x 2 cm to 20 cm x 30 cm. It will be packaged in double pouch configuration.
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)
LTM-Laparoscopic Surgical Mesh is within the existing specification window and is manufactured with, the same process as LTM Surgical Mesh (K070560) (e.g., material source, processing methods to ensure purity, and packaging). LTM Surgical Mesh (K070560) 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 with the starting material. The LTM-Laparoscopic Surgical Mesh went through the same biomechanical testing after laparoscopic handling (Attachment 1) and possesses sufficient strength and suture retention for the intended use. This fully supports use during open or laparoscopic procedures.
The laparoscopic conditioning data (Attachment 1) show that LTM-Laparoscopic Surgical Mesh meets Tensile Strength, Tear Resistance, Suture Pull-out Strength, and Burst Strength specifications as established for the predicate device (K070560). The laparoscopic conditioning of LTM-Laparoscopic Surgical Mesh (rolling, introduction into abdomen, and grasper interface) is consistent with the handling of the reference laparoscopic surgical meshes (i.e. Restorelle Polypropolene Mesh (K 103568), Surgimesh XD (K092233), and Surgimesh WN (K061445), which have all been cleared for the laparoscopic use indication). LTM-Laparoscopic Surgical Mesh maintains its biomechanical integrity before and after laparoscopic conditioning making it substantially equivalent for open or laparoscopic procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LTM Surgical Mesh (K070560)
Reference Device(s)
Restorelle Polypropolene Mesh (K103568), Surgimesh XD (K092233), Surgimesh WN (K061445)
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
LTM-Laparoscopic Surgical Mesh - 510(k) Pre Market Notification
III. 510(K) SUMMARY
- 3 2012 AUG
LifeCell Corporation's LTM-Laparoscopic Surgical Mesh
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
LifeCell Corporation One Millennium Way Branchburg, NJ 08876
Contact Persons: Mark R. Jakubowski Phone: (908) 809-7719 Facsimile: (908) 947-1095 Or Sadhana Kalinani Phone: (908) 947-1114 Facsimile: (908) 947-1095
Date Prepared: April 27, 2012
Name of Device and Name and Address of Sponsor
LTM-Laparoscopic Surgical Mesh LifeCell Corporation One Millennium Way Branchburg, NJ 08876
Common or Usual Name Surgical Mesh
Classification Name Surgical Mesh .
Classification Class II
Product Code FTM
Predicate Devices LTM Surgical Mesh (K070560) – LifeCell Corporation
1
LTM-Laparoscopic Surgical Mesh - 510(k) Pre Market Notification
Reference Devices
Restorelle Polypropolene Mesh (K103568) -- C.R. Bard Surgimesh XD (K092233) - Aspide Medical Surgimesh WN (K061445) - Aspide Medical
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.
Technological Characteristics
The LTM-Laparoscopic Surgical Mesh is a surgical mesh that is derived from porcine dermal tissue. The LTM-Laparoscopic Surgical Mesh device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and sizes ranging from 10 cm x 16 cm to 20 cm x 20 cm, with future sizes planned ranging from 2 cm x 2 cm to 20 cm x 30 cm. It will be packaged in double pouch configuration.
Performance Data
LTM-Laparoscopic Surgical Mesh is within the existing specification window and is manufactured with, the same process as LTM Surgical Mesh (K070560) (e.g., material source, processing methods to ensure purity, and packaging). LTM Surgical Mesh (K070560) 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 with the starting material. The LTM-Laparoscopic Surgical Mesh went through the same biomechanical testing after laparoscopic handling (Attachment 1) and possesses sufficient strength and suture retention for the intended use. This fully supports use during open or laparoscopic procedures.
Substantial Equivalence.
LTM-Laparoscopic Surgical Mesh is substantially equivalent to the legally marketed predicate device, LifeCell Corporation's LTM Surgical Mesh (K070560), which has been cleared by the FDA for use as a surgical mesh to be implanted to reinforce soft tissue where weakness exists in abdominal wall procedures.
LTM-Laparoscopic Surgical Mesh is technologically similar to LifeCell's recently cleared LTM Surgical Mesh (K070560). The laparoscopic conditioning data (Attachment 1) show that LTM-Laparoscopic Surgical Mesh meets Tensile Strength, Tear Resistance, Suture Pull-out Strength, and Burst Strength specifications as
2
established for the predicate device (K070560). The laparoscopic conditioning of LTM-Laparoscopic Surgical Mesh (rolling, introduction into abdomen, and grasper interface) is consistent with the handling of the reference laparoscopic surgical meshes (i.e. Restorelle Polypropolene Mesh (K 103568), Surgimesh XD (K092233), and Surgimesh WN (K061445), which have all been cleared for the laparoscopic use indication). LTM-Laparoscopic Surgical Mesh maintains its biomechanical integrity before and after laparoscopic conditioning making it substantially equivalent for open or laparoscopic procedures.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
3 2012 AUG
Lifecell Corporation % Mr. Mark R. Jakubowski 1 Millenium Way Branchburg, New Jersey 08876
Re: K121289
Trade/Device Name: LTM-Laparoscopic Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXK Dated: June 27, 2012 Received: June 28, 2012
Dear Mr. Jakubowski:
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 or any I vathar sthates 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
4
Page 2 - Mr. Mark R. Jakubowski
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millican
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
II. Indications For Use Statement
510(K) Number (if known):
Device Name: LTM-Laparoscopic Surgical Mesh
Indication 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 Evaluation (ODE)
Daniel Kramer MM
Division Sign Off
(Division Sign-Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121289
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