(105 days)
Not Found
No
The document describes a surgical mesh made from porcine skin and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes," indicating its use in treating a medical condition.
No
The device is a surgical mesh intended for reinforcing soft tissue, not for diagnosing medical conditions.
No
The device description clearly states it is a surgical mesh derived from porcine skin, which is a physical, implantable 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 "soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes." This describes a device used in vivo (within the body) for surgical repair and reinforcement.
- Device Description: The description details a "surgical mesh that is derived from porcine skin" and is "terminally sterilized." This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The device is directly implanted into the patient.
Therefore, the LTM-BPS Surgical Mesh is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
LTM-BPS 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 which wouldred blass of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissues in plastic and reconstructive surgery.
LTM-BPS is intended for single patient, one time use only.
Product codes
FTM
Device Description
The LTM-BPS is a surgical mesh that is derived from porcine skin. The LTM-BPS 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
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-BPS 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-BPS matrix possesses sufficient strength and suture retention for the intended use.
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.
LTM Surgical Mesh (K070560), PelviSoft™ (K031332), Permacol® (K013625)
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.
Not Found
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
K082176
pg 192
NOV 1 4 2008
510(K) SUMMARY
LifeCell Corporation's LTM-BPS Surgical Mesh
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
LifeCell Corporation One Millennium Way Branchburg, NJ 08869 (908) 947-1115 Phone: (908) 947-1095 Facsimile:
Lorraine T. Montemurro, R.N., R.A.C. Contact Person: Date Prepared: October 23, 2008
Name of Device and Name/Address of Sponsor
LTM-BPS Surgical Mesh
LifeCell Corporation One Millennium Way Branchburg, NJ 08876
Common or Usual Name
Surgical Mesh
Classification Name
Surgical Mesh
Predicate Devices
LTM Surgical Mesh (K070560)
PelviSoft™ (K031332)
Permacol® (K013625)
Intended Use / Indications for Use
LTM-BPS 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 which wouldred blass of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissues in plastic and reconstructive surgery.
LTM-BPS is intended for single patient, one time use only.
1
K082176
pg 2n2
Technological Characteristics
The LTM-BPS is a surgical mesh that is derived from porcine skin. The LTM-BPS 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-BPS 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-BPS matrix possesses sufficient strength and suture retention for the intended use.
Substantial Equivalence
LTM-BPS is substantially equivalent to legally marketed predicate devices, such as the LTM Surgical Mesh (K070560), PelviSoft™ (K031332) and Permacol® Implant (K013625) surgical mesh devices. LTM-BPS 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-BPS functions equivalently to the predicate devices. Thus, LTM-BPS is substantially equivalent.
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 its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LifeCell Corporation % Ms. Lorraine T. Montemurro, R.N., RAC Senior Regulatory Affairs Manager One Millennium Way Branchburg, New Jersey 08876-3876
NOV 1 4 2008
Re: K082176 Trade/Device Name: LTM-BPS Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: October 23, 2008 Received: October 29, 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 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. Lorraine T. Montemurro, R.N., RAC
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 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 Compliation 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 a its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1682176
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: LTM-BPS Surgical Mesh
Indications for Use:
LTM-BPS 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 which require the use of reinforcing or bridging material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissues in plastic and reconstructive surgery.
LTM-BPS 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)
Nil K.E.Olsen for mxm
(Division Sign. Division of General, Restorative, and Neurological Devices
510(k) Number K082176
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