(52 days)
Not Found
No
The document describes a biological surgical mesh and does not mention any computational or algorithmic components, including AI or ML.
No.
The device is a surgical mesh intended for reinforcing soft tissue repairs and body wall defects, not for directly treating or curing a disease or condition in a therapeutic manner.
No
The device is a surgical mesh intended for reinforcing soft tissue repairs, not for diagnosing medical conditions.
No
The device description clearly states it is a surgical mesh derived from porcine skin, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a surgical mesh for the reinforcement of soft tissue during tendon repair surgery and repair of body wall defects. This is a surgical implant used in vivo (within the body) during a surgical procedure.
- Device Description: The description confirms it's a surgical mesh derived from porcine skin, intended for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used directly on the patient's tissue during surgery.
N/A
Intended Use / Indications for Use
The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The device 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.
LTM is intended for single patient, one time use only.
Product codes
FTM, FTL
Device Description
The LTM is a surgical mesh that is derived from porcine skin. The LTM device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses, and 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, rotator cuff, patellar, Achilles, biceps, quadriceps, other tendons, body wall
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 LTM has undergone extensive biocompatibility testing, animal testing, viral inactivation testing, and biomechanical testing. The data indicate 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 biomechanical data show that the LTM matrix possesses sufficient strength and suture retention for the intended use.
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
K080353
Page 1/2
510(K) SUMMARY
ﭘﻮ
LifeCell Corporation's LTM Surgical Mesh
APR - 3 2008
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
LifeCell Corporation One Millennium Way Branchburg, NJ 08876 (908) 947-1115 Phone: (908) 947-1095 Facsimile:
Lorraine T. Montemurro, R.N., R.A.C. Contact Person: February 08, 2008 Date Prepared:
Name of Device and Name/Address of Sponsor
LTM 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
LifeCell Corporation's LTM Surgical Mesh (K070560) Pegasus Biologics, Inc.'s OrthADAPT™ (K071065)
Intended Use / Indications for Use
1
K080353
page 4/2
The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The device 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.
LTM is intended for single patient, one time use only.
Technological Characteristics
The LTM is a surgical mesh that is derived from porcine skin. The LTM device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses, and packaged in double pouch configuration.
Performance Data
The LTM has undergone extensive biocompatibility testing, animal testing, viral inactivation testing, and biomechanical testing. The data indicate 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 biomechanical data show that the LTM matrix possesses sufficient strength and suture retention for the intended use.
Substantial Equivalence
LTM is substantially equivalent to the legally marketed predicate devices, LifeCell Corp.'s LTM Surgical Mesh (K070560) and Pegasus Biologics, Inc.'s OrthADAPT™ (K071065) surgical mesh devices. LTM has the same intended uses and the same or similar indications, technological characteristics, and principles of operation as these predicate devices. Performance data demonstrate that LTM functions equivalently to the predicate devices. Thus, LTM is substantially equivalent.
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LifeCell Corporation % Ms. Lorraine T. Montemurro, R.N., R.A.C. Manager, Regulatory Affairs One Millennium Way Branchburg, New Jersey 08876-3876
APR - 3 2008
Re: K080353
Trade/Device Name: LTM Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 8, 2008 Received: February 11, 2008
Dear Ms. Montemurro:
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 r ou may yours is 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 he 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 1 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. Sharon Alexander
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,
Mark M. Mulhausen
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 STATEMENT
510(k) Number (if known):
Device Name: LTM Surgical Mesh
Indications for Use:
The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The device 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.
LTM is intended for single patient, one time use only.
Prescription Use X (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Boyle for mxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K080353