(125 days)
Not Found
No
The device description and intended use clearly define it as a surgical mesh derived from porcine dermis for soft tissue repair, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes, which are therapeutic actions.
No
Explanation: The device is described as a surgical mesh intended for reinforcing soft tissue, not for diagnosing medical conditions. Its function is to repair and reinforce tissue, not to identify or monitor diseases.
No
The device description clearly states it is a surgical mesh derived from porcine dermis, 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 HPTM 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 structural support and repair.
- Device Description: The description details a "surgical mesh that is derived from porcine dermis" and is "designed to perform as a surgical mesh for soft tissue repair." This further reinforces its use as an implantable material.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is implanted directly into the body for structural support.
N/A
Intended Use / Indications for Use
HPTM 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 material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery.
HPTM is intended for single patient, one-time use only.
Product codes (comma separated list FDA assigned to the subject device)
FTM, OXH
Device Description
HP Tissue Matrix 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. 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 device is considered a single use device which is to be used in a healthcare facility or hospital. It is sterilized via Gamma irradiation. The subject device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, LTM-BPS Surgical Mesh (K082176).
The changes described in this submission are the replacement and addition of solutions used during the processing of the LTM-BPS device.
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
healthcare facility or hospital
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)
Bench testing was performed on the subject HPTM device to support substantial equivalence. Testing included relevant elements of the FDA "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" Table 1 includes the applicable tests used to demonstrate substantial equivalence and applicable guidance documents or standard.
Table 1: Substantial Equivalence Testing Conducted
| Test or Evaluation | Applicable guidance document or FDA recognized consensus standard |
|---|---|
| Mesh Thickness | N/A |
| Tensile Strength | N/A |
| Suture Pullout Strength | N/A |
| Tear Strength | ASTM D5735-95 |
| Burst Strength | ASTM D6797-07(2011) |
| Device Stiffness | N/A |
| Biocompatibility | ISO 10993 -1, ISO 14971:2007 |
| Drape | N/A |
The results of the tests performed demonstrated that the modifications did not affect safety and efficacy of the device or raise any new questions of safety or efficacy.
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.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2014
LifeCell Corporation Ms. Mira Leiwant Director, Quality Engineering and Regulatory Affairs One Millennium Way Branchburg, New Jersey 08876
Re: K142326
Trade/Device Name: HPTM Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM and OXH Dated: November 21, 2014 Received: November 24, 2014
Dear Ms. Leiwant:
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 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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142326
Device Name HPTM
Indications for Use (Describe)
HPTM 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 material to obtain the desired surgical outcome. The implant is intended for reinforcement of soft tissue in plastic and reconstructive surgery.
HPTM is intended for single patient, one-time use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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510(k) Summary K142326
I. SUBMITTER
LifeCell Corporation One Millennium Way Branchburg, NJ 08876
Contact Person: Mira Leiwant Director, Quality Engineering and Regulatory Affairs Phone: (908) 809-7747 Fax: (908) 947-1095
Prepared by and Date: Keira Jessop December 19, 2014
II. DEVICE
Name of Device: HP Tissue Matrix (HPTM) Common or Usual Name: Surgical Mesh Classification Name: Surgical Mesh-(21 C.F.R. §878.3300) Device Class: II Product Code: FTM
III. PREDICATE DEVICES
LTM-BPS Surgical Mesh (K082176)—LifeCell Corporation This predicate has not been subject to a design-related recall
IV. DEVICE DESCRIPTION
HP Tissue Matrix 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. 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 device is considered a single use device which is to be used in a healthcare facility or hospital. It is sterilized via Gamma irradiation. The subject device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, LTM-BPS Surgical Mesh (K082176).
The changes described in this submission are the replacement and addition of solutions used during the processing of the LTM-BPS device.
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V. INDICATIONS FOR USE
HPTM 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 tissue in plastic and reconstructive surgery.
HPTM is intended for single patient one-time use only.
VI. COMPARISON OF TECHNOLOGICAL CHARCTERISTICS WITH THE PREDICATE DEVICE
The subject and predicate devices are both surgical meshes that are derived from porcine dermis and then processed and preserved in a phosphate buffered aqueous solution containing matrix stabilizers. Both devices are designed to perform as a surgical mesh for soft tissue repair. Both devices consist of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses and are packaged in a double pouch configuration. The subject device has the same scientific technology, principles of operation, Intended Use, and Indications for Use as the cleared predicate device, LTM-BPS Surgical Mesh (K082176).
The changes described in the submission are the replacement and addition of solutions used during the processing of the LTM-BPS device.
VII. PERFORMANCE DATA
Performance Data
Bench testing was performed on the subject HPTM device to support substantial equivalence. Testing included relevant elements of the FDA "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh" Table 1 includes the applicable tests used to demonstrate substantial equivalence and applicable guidance documents or standard.
| Table 1: Substantial Equivalence Testing Conducted | |
|---|---|
| Test or Evaluation | Applicable guidance document or FDA |
| recognized consensus standard | |
| Mesh Thickness | N/A |
| Tensile Strength | N/A |
| Suture Pullout Strength | N/A |
| Tear Strength | ASTM D5735-95 |
| Burst Strength | ASTM D6797-07(2011) |
| Device Stiffness | N/A |
| Biocompatibility | ISO 10993 -1, ISO 14971:2007 |
| Drape | N/A |
The results of the tests performed demonstrated that the modifications did not affect safety and efficacy of the device or raise any new questions of safety or efficacy.
Clinical Tests
No clinical testing was included in this submission.
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VIII. CONCLUSIONS
The subject device, HPTM, meets the requirements to perform its intended use as a soft tissue patch and is substantially equivalent to the predicate device LTM-BPS Surgical Mesh (K082176).