(141 days)
No
The document describes a biological graft with an antimicrobial coating and does not mention any computational or algorithmic components related to AI or ML.
Yes.
The device is intended for implantation to reinforce soft tissue where weakness exists and for surgical repair of damaged or ruptured soft tissue, which directly treats a condition and therefore qualifies as a therapeutic device.
No
The device is described as a surgical graft intended for implantation to reinforce and repair soft tissue, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a porcine dermal matrix, which is a physical implantable material, not software.
Based on the provided information, the XenMatrix™ AB Surgical Graft is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for surgical implantation to reinforce and repair soft tissue. This is a direct surgical intervention on the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is a surgical graft, a physical material implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (in glass, or outside the living organism) to analyze samples and provide diagnostic information. The XenMatrix™ AB Surgical Graft is an in vivo (in the living organism) device used for surgical repair.
N/A
Intended Use / Indications for Use
The XenMatrix™ AB Surgical Graft is 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, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.
Product codes
PIJ, FTM, OXH
Device Description
The XenMatrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix for use in the reconstruction of soft tissue deficiencies. The graft is packed dry and must be hydrated prior to use.
Product sizes when hydrated are:
- 6x8 cm
- 15x30 cm • •
- 20x40 cm
- · 30x30 cm
- 8x16 cm •
- 25x30 cm •
- 25x40 cm •
- 30x45 cm
The proposed XenMatrix™ AB Surgical Graft surfaces are coated with an antimicrobial coating, which is comprised of a bioresorbable L-tyrosine succinate polymer and antimicrobial agents Rifampin and Minocycline. The coating is shaded orange in color due to the color of the antimicrobial agents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, abdominal, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional regions for hernia repair.
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
The following performance data is provided in support of the substantial equivalence determination:
- Biocompatibility testing: The subject device is comprised of identical materials, processed by identical manufacturing methods, and has the same contact and duration as the cited predicate (K133223). Biocompatibility testing was conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1.
- Electrical safety and electromagnetic compatibility (EMC): Not applicable as the device is not an electro-mechanical medical device or system.
- Software Verification and Validation Testing: Not applicable as the device does not contain software.
- Product Testing: Non-clinical tests were completed for the subject and predicate device. The subject device passed all test requirements.
- Performance and Functional testing:
- Physical Characteristics: Device Thickness, Device (Flexural) Stiffness
- Functional Characteristics: Burst Strength, Suture Pullout Strength, Tear Resistance
- Analytical Testing: Drug Content, Drug Impurities
All samples tested met the established acceptance criteria.
- Performance and Functional testing:
- Animal Study: Animal study data was not required to demonstrate substantial equivalence.
- Clinical Studies: Clinical studies were not performed for the submission of this subject device nor for the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2016
C.R. Bard Mr. Tony John Senior Regulatory Affairs Specialist 100 Crossings Boulevard Warwick, Rhode Island 02886
Re: K162193
Trade/Device Name: Xenmatrix Ab Surgical Graft Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: PIJ, FTM, OXH Dated: November 28, 2016 Received: November 29, 2016
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162193
Device Name XenMatrix™ AB Surgical Mesh
Indications for Use (Describe)
The XenMatrix™ AB Surgical Graft is 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, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vitro and in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.
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) | ☐ |
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3
Davol Inc. Subsidiary of C.R. Bard, Inc. 100 Crossings Blvd. Warwick, RI 02886 (401) 463-7000
SECTION 7.0
Image /page/3/Picture/2 description: The image shows the logo for BARD DAVOL INC. The logo is green and has the word "BARD" in a stylized font. Below the word "BARD" is the text "DAVOL INC.". To the right of the logo is a vertical line, and to the right of the line are the words "TECHNOLOGY", "TECHNIQUE", "TRAINING", and "TRUST" stacked vertically.
510(k) Summary
This 510(k) Summary is provided per the requirements of section 807.92(c).
Submitter Information:
| Submitter's Name: | Tony John, MS |
|---|---|
| Senior Regulatory Affairs Specialist | |
| E-mail: | Tony.John@crbard.com |
| Company Name: | Davol Inc., Subsidiary of C. R. Bard, Inc. |
| Company Address: | 100 Crossings Boulevard |
| Warwick, RI 02886 | |
| Telephone: | (401) 825-8692 |
| Fax: | (401) 825-8765 |
| Date Summary Prepared: | August 3, 2016 |
Device Identification:
| Trade Name: | XenMatrix™ AB Surgical Graft |
|---|---|
| 1150608, 1150816, 1151530, 1152040, 1152530, 1152540, 1153030, 1153045 | |
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Collagen Surgical Mesh Containing Drugs |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.3300 |
| Product Code: | PIJ, FTM, OXH |
Predicate Device Names:
The predicate device for this submission is XenMatrix™ AB Surgical Graft (K133223 and K151177); marketed by C. R. Bard, Inc. This predicate has not been subject to a design-related recall.
The reference device XenMatrix™ Surgical Graft (K140501) is used in this submission.
PREMARKET NOTIFICATION FOR XENMATRIX™ AB SURGICAL GRAFT
4
Davol Inc. Subsidiary of C.R. Bard, Inc. 100 Crossings Blvd. Warwick. RI 02886 (401) 463-7000
Image /page/4/Picture/1 description: The image shows the logo for "BAIRD DAVOL INC." The word "BAIRD" is in large, bold, green font, with "DAVOL INC." in a smaller font below it. To the right of the company name are the words "TECHNOLOGY", "TECHNIQUE", "TRAINING", and "TRUST" stacked vertically in a smaller, lighter green font.
Device Description:
The XenMatrix™ AB Surgical Graft is an acellular, sterile, non-pyrogenic porcine dermal matrix for use in the reconstruction of soft tissue deficiencies. The graft is packed dry and must be hydrated prior to use.
Product sizes when hydrated are:
- 6x8 cm
- 15x30 cm • •
- 20x40 cm
- · 30x30 cm
- 8x16 cm •
- 25x30 cm •
- 25x40 cm •
- 30x45 cm
The proposed XenMatrix™ AB Surgical Graft surfaces are coated with an antimicrobial coating, which is comprised of a bioresorbable L-tyrosine succinate polymer and antimicrobial agents Rifampin and Minocycline. The coating is shaded orange in color due to the color of the antimicrobial agents.
Intended Use:
The XenMatrix™ AB Surgical Graft is 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, inguinal, femoral, diaphragmatic, scrotal, umbilical, and incisional hernias. The Rifampin and Minocycline coating has been shown in preclinical in vivo testing to reduce or inhibit microbial colonization on the device. The claim of reduction of bacterial colonization of the device has not been established with human clinical data, nor has a clinical impact associated with this claim been demonstrated.
The Indications for Use statement for the subject device is identical to the predicate device. Both the subject and predicate devices have the same intended use.
Comparison of Technological Characteristics With the Predicate Device
The proposed XenMatrix™ AB Surgical Graft that is the subject of this submission remains the same as the previous version of this device. The addition of 8 new product sizes has no impact to the XenMatrix AB Surgical Graft technological properties, safety, or performance of the existing XenMatrix AB device. Specifically the proposed device has the same; material. biocompatibility, packaging materials and sterilization as the currently cleared product. The cited predicate device size ranges from 6x6cm to 19x35cm. The reference predicate ranges from 6x6 to 30x45cm. The proposed device size range (as descrbied in the table above) is within the size range of the existing cited and reference predicates.
PREMARKET NOTIFICATION FOR XENMATRIX™ AB SURGICAL GRAFT
5
Davol Inc. Subsidiary of C.R. Bard, Inc. 100 Crossings Blvd. Warwick, RI 02886 (401) 463-7000
Image /page/5/Picture/1 description: The image contains the logo for BARD DAVOL INC. The logo is green and has the word "BARD" in large, bold letters. Below the word "BARD" is the text "DAVOL INC." To the right of the logo are the words "TECHNOLOGY", "TECHNIQUE", "TRAINING", and "TRUST" stacked vertically.
Performance Data:
The following performance data is provided in support of the substantial equivalence determination.
Performance standards
No performance standards have been established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
Biocompatibility testing
The subject device is comprised of identical materials, processed by identical manufacturing methods, and has the same contact and duration as the cited predicate. Therefore, the biocompatibility testing provided in the predicate (K133223) submission is being leveraged for the proposed device. The biocompatibility testing previously provided was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Electrical safety and electromagnetic compatibility (EMC)
The subject device is not an electro-mechanical medical device nor is it a medical system, therefore this section does not apply.
Software Verification and Validation Testing
The subject device does not contain software; therefore this section does not apply.
Product Testing
The following non-clinical tests were completed for the subject and predicate device. The subject device passed all the test requirements and demonstrated substantial equivalence to the test results of the predicate device.
- . Performance and Functional testing of the proposed XenMatrix™ AB Surgical Graft
- Phycial Characteristics O
- I Device Thickness
- " Device (Flexural) Stiffness
- Phycial Characteristics O
PREMARKET NOTIFICATION FOR XENMATRIX™ AB SURGICAL GRAFT
6
Davol Inc. Subsidiary of C.R. Bard, Inc. 100 Crossings Blvd. Warwick, RI 02886 (401) 463-7000
Image /page/6/Picture/1 description: The image shows the logo for BARD DAVOL INC. The logo is split into two sections, with the left side displaying the company name in a bold, green font. To the right of the company name, there is a vertical line separating it from a list of words: TECHNOLOGY, TECHNIQUE, TRAINING, and TRUST. These words are stacked vertically and are also in a green font, but smaller and less bold than the company name.
- Funtional Characterisitcs o
- I Burst Strength
- I Suture Pullout Strength
- Tear Resistance
- Analysical Testing O
- Drug Content ■
- I Drug Impurities
All samples tested met the established acceptance criteria.
Animal Study
The animal study data was not required to demonstrate substantial equivalence.
Clinical Studies
Clinical studies were not performed for the submission of this subject device nor were clinical studies performed for the predicate device.
Conclusion:
The proposed XenMatrix™ AB Surgical Graft maintains the same safety and performance as that of the previously cleared XenMatrix™ AB device. The proposed XenMatrix™ AB Surgical Graft has the same intended uses and the same indications, technological characteristics, and principles of operation as the previously cleared XenMatrix™ AB (K133223 and K151177). Additional bench testing adequately demonstrates that the proposed XenMatrix™ AB Surgical Graft has equivalent performance as the previously cleared version of the device. Thus, the XenMatrix™ AB Surgical Graft is substantially equivalent to the cited predicate device.