(60 days)
No
The summary describes a biological surgical graft and does not mention any computational or algorithmic components, let alone AI/ML.
Yes
Explanation: The device is intended for implantation to reinforce soft tissue and repair damaged or ruptured soft tissue, which directly treats or alleviates a condition, aligning with the definition of a therapeutic device.
No
Explanation: The device is described as a surgical graft intended for implantation to reinforce and repair soft tissue. Its intended use and description focus on treatment and reconstruction, not on diagnosing medical conditions.
No
The device description clearly states it is a "porcine dermal matrix packed hydrated in sterile saline," which is a physical implantable material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for implantation to reinforce and repair soft tissue. This is a surgical procedure performed in vivo (within the body).
- Device Description: The device is described as a "porcine dermal matrix packed hydrated in sterile saline for use in the reconstruction of soft tissue deficiencies." This is a biological material intended for physical repair, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.
Product codes
FTM, OWV, OXH
Device Description
XenMatrix™ Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix packed hydrated in sterile saline for use in the reconstruction of soft tissue deficiencies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, abdominal, femoral, diaphragmatic, scrotal, umbilical, incisional
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)
Bench and pre-clinical testing was performed on the XenMatrix™ Surgical Graft to support substantial equivalence. Bench testing on the proposed device included burst strength, tensile strength, and suture retention strength. Packaging testing included seal strength and ship testing. Pre-clinical testing includes histology examination. Results of testing demonstrate that the XenMatrix™ Surgical Graft of the expanded sizes meets the same product specifications and intended uses.
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
Davol Inc. Subsidiary of C.R. Bard, Inc. 100 Crossings Blvd. Warwick, RI 02886 (401) 463-7000
Image /page/0/Picture/2 description: The image shows the logo for BARD DAVOL INC. The word "BARD" is in large, bold, sans-serif font, with each letter connected to the next. Below "BARD" is the text "DAVOL INC.", in a smaller, sans-serif font. The logo is black and white.
TECHNOLOGY TECHNIQUE TRAINING ពេជ្យនេះ
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
APR 2 8 2014
This 510(k) Summary is provided per the requirements of section 807.92(c).
Submitter Information:
| Submitter's Name: | Tony John, MS
Regulatory Affairs Specialist |
|------------------------|------------------------------------------------|
| Company Name: | Davol Inc., Subsidiary of C. R. Bard, Inc |
| Company Address: | 100 Crossings Boulevard
Warwick, RI 02886 |
| Telephone: | (401) 825-8692 |
| Fax: | (401) 825-8763 |
| Email: | tony.john@crbard.com |
| Date Summary Prepared: | April 8, 2014 |
| Device Name: | |
| Trade Name: | XenMatrix™ Surgical Graft |
| Product Code: | FTM |
| Classification Name: | Mesh, Surgical |
| Regulation Number: | 21 CFR 878.3300 |
| Device Class: | II |
Predicate Device:
Panel:
K081272 "Porcine Dermal Matrix Surgical Mesh" FDA cleared on 31 July 2008 from Brennen Medical, LLC . Davol, Inc. acquired the 510(k) product line in June 2009 and listed it as XenMatrix™ Surgical Graft.
General & Plastic Surgery
Device Descriptions:
XenMatrix™ Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix packed hydrated in sterile saline for use in the reconstruction of soft tissue deficiencies.
Intended Use:
. Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.
PREMARKET NOTIFICATION FOR XENMATRIX™ SURGICAL GRAFT K140501 PAGE 1 OF 2
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Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Uses:
The XenMatrix™ Surgical Graft has the same intended use and fundamental scientific technology as the predicate device. The following technological characteristics of the XenMatrix™ Surgical Graft are the same as the predicate device: material, biocompatibility, and sterilization.
The difference between the predicate device and the proposed device is the proposed device has larger sizes and smaller sizes than the currently cleared predicate. Performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device.
Davol has also conducted a risk analysis to address the potential clinical risks that are associated with meshes that are larger than our previously cleared sizes. Based on our analysis and the results of our validation testing Davol does not expect any different clinical risks due to the larger mesh sizes being proposed.
Summary of Non-Clinical Testing:
Bench and pre-clinical testing was performed on the XenMatrix™ Surgical Graft to support substantial equivalence. Bench testing on the proposed device included burst strength, tensile strength, and suture retention strength. Packaging testing included seal strength and ship testing. Pre-clinical testing includes histology examination. Results of testing demonstrate that the XenMatrix™ Surgical Graft of the expanded sizes meets the same product specifications and intended uses.
Statement of Equivalence:
The test results and risk analysis provided in this submission support the safety and effectiveness of the device for its intended use and demonstrate that the proposed device is substantially equivalent to its predicate devices.
PREMARKET NOTIFICATION FOR XENMATRIX™ SURGICAL GRAFT K140501 PAGE 2 OF 2
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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles an abstract bird or human figure. The symbol is composed of three curved lines that converge at the bottom.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
April 28, 2014
C.R. Bard Mr. Tony John Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K140501
Trade/Device Name: XenMatrix" Surgical Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OWV, OXH Dated: April 9, 2014 Received: April 10, 2014
Dear Mr. John:
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 (2 1 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 – Mr. Tony John
forth in the quality systems (OS) 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 vou 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/ResourcesforYou/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/ReportalProblem/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
for
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation . Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
510(k) Number (if known): K140501
Device Name: XenMatrix™ Surgical Graft
Indications for Use:
Intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, including: abdominal plastic and reconstructive surgery; muscle flap reinforcement; hernia repair including abdominal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias.
Prescription Use (Part 2) CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of_
Peter L. Hudson -S