(91 days)
None
No
The summary describes a surgical mesh made from porcine skin, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is a surgical mesh intended for reinforcement and repair of soft tissues, not for therapeutic treatment.
No
The provided text explicitly states that LTM-RC Surgical Mesh is "intended for use as a soft tissue patch to reinforce soft tissue" and "for the surgical repair of damaged or ruptured soft tissue membranes." This describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly states that the LTM-RC 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 used to reinforce soft tissue during surgical repair. This is a therapeutic and structural function within the body.
- Device Description: The description confirms it's a physical surgical mesh derived from porcine skin.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of disease. IVDs are used in vitro (outside the body) to analyze samples like blood, urine, or tissue.
- Anatomical Site: The device is used in vivo (within the body) at specific anatomical sites.
Therefore, the LTM-RC Surgical Mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
LTM-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff surgery. Indications for use also 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.
The device is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and the sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair.
LTM-RC is intended for single patient, one time use only.
Product codes
FTM
Device Description
The LTM-RC is a surgical mesh that is derived from porcine skin. The LTM-RC 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
Rotator cuff; 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 LTM-RC 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-RC 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
K071986 page1/2
III. 510(K) SUMMARY
LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh
007 1 9 2007
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
| LifeCell Corporation
| One Millennium Way | |
|---|---|
| Branchburg, NJ 08869 | |
| Phone: | (908) 947-1115 |
| Facsimile: | (908) 947-1095 |
| Contact Person: | Lorraine T. Montemurro, R.N., R.A.C. |
| Date Prepared: | July 19, 2007 |
Name of Device and Name/Address of Sponsor
LTM-RC 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)
Permacol® Implant (K050355)
Permacol® (K021056)
Intended Use / Indications for Use
LTM-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors, during rotator cuff surgery. Indications for use also 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.
1
The device is not intended to replace normal body structure or provide the full
mechanical strength to repair the rotator cuff. Sutures used to repair the tear, and the sutures or
bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator
cuff repair.
LTM-RC is intended for single patient, one time use only.
Technological Characteristics
The LTM-RC is a surgical mesh that is derived from porcine skin. The LTM-RC 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-RC 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-RC matrix possesses sufficient strength and suture retention for the intended use.
Substantial Equivalence
LTM-RC is substantially equivalent to legally marketed predicate devices, such as the LTM Surgical Mesh (K070560) and Permacol® Implant (K050355) surgical mesh devices. LTM-RC 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-RC functions equivalently to the predicate devices. Thus, LTM-RC is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2007
LifeCell Corporation % Lorraine T. Montemurro, R.N, R.A.C. Manager, Regulatory Affairs One Millennium Way Branchburg, New Jersey 08876
Re: K071986
Trade/Device Name: LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: September 24, 2007 Received: September 26, 2007
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 - Lorraine T. Montemurro, R.N, R.A.C.
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 your
For
Mark N. Melkerson
DEB
D.R
1.19.07
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
II. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K071986
Device Name: LifeCell Tissue Matrix-Rotator Cuff (LTM-RC) Surgical Mesh
Indications for Use:
LTM-RC 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. The implant is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during rotator cuff repair surgery. Indications for use also 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.
The device is not intended to replace normal body structure or provide full mechanical strength to repair the rotator cuff. Sutures used to repair the tear and the sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the rotator cuff repair.
LTM-RC is intended for single patient, one time use only.
Prescription Use X (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE) Sion Sign-Division of General, Restorative, Page _________________________________________________________________________________________________________________________________________________________________________ of and Neurological Devices
510(k) Number L01194