(70 days)
No
The summary describes a collagen matrix implant for surgical repair and does not mention any AI or ML components.
Yes
The device is described as an "implant for the surgical repair of soft tissue deficiencies" and is used in a variety of surgical procedures, indicating its use in treating or alleviating a condition.
No
Explanation: The Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies. Its purpose is to physically reinforce and buttress tissues, not to diagnose conditions or diseases.
No
The device is described as an "implantable surgical patch comprised of non-crosslinked bovine pericardium," 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 describes the device as an implant for the surgical repair of soft tissue deficiencies. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as an implantable surgical patch. This is a physical implant used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
- Focus on Surgical Repair: The entire description revolves around surgical procedures and reinforcing tissue.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
Vertas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following:
Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus.
Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.
Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).
Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.
Product codes
FTM, OXE, OXB, PAJ
Device Description
An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas® Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Buttressing and reinforcing staple lines during lung resection, Reinforcement of the gastric staple line, Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse, reconstruction of the pelvic floor, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).
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
An animal study was conducted, specific to the subject of this submission. The study concluded that Veritas ® Collagen Matrix demonstrates minimal tissue attachment to the viscera when compared to a named predicate.
Key Metrics
Not Found
Predicate Device(s)
Veritas® Collagen Matrix K002233, K030879 and K040119, PARIETEX® COMPOSITE Mesh, K002699, K040998, K050187, MacroPore Surgi-Wrap MAST Bioresorbable Sheet, K031955, GORE-TEX® Dualmesh® Biomaterial, K992189, Genzyme Serpramesh™ IP, K040868
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.
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Veritas® Collagen Matrix
3.0 SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitted by | Synovis Surgical Innovations
2575 University Ave. W.
St. Paul, MN 55114
Tel: 651-796-7300
Fax: 651-642-9018 | DEC - 6 2006 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person | Cynthia Lamarucciola
At address above | |
| Device Trade Name: | Veritas® Collagen Matrix | |
| Common Name | Surgical Mesh | |
| Classification Name | Mesh, Surgical
878.3300 | |
| Predicate devices | Veritas® Collagen Matrix K002233, K030879 and K040119
Synovis Surgical Innovations (Acting as its own predicate.)
PARIETEX® COMPOSITE Mesh, K002699, K040998, K050187
MacroPore Surgi-Wrap MAST Bioresorbable Sheet, K031955
GORE-TEX® Dualmesh® Biomaterial, K992189
Genzyme Serpramesh™ IP, K040868 | |
| Device Description | An implantable surgical patch comprised of non-crosslinked
bovine pericardium. Veritas® Collagen Matrix undergoes
proprietary processing that allows neo-collagen formation and neo-
vascularization of the implanted device and permits replacement
of the device with host tissue, or remodeling. | |
1
| Statement of
Intended use | Veritas Collagen Matrix is intended for use as an implant for the
surgical repair of soft tissue deficiencies, this includes but is not
limited to the following: |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Buttressing and reinforcing staple lines during lung
resection (e.g., wedge resection, blebectomy, lobectomy,
bullectomy, bronchial resection, segmentectomy,
pneumonectomy / pneumectomy, pneumoreduction) and
other incisions and excision of the lung and bronchus. |
| | Reinforcement of the gastric staple line during the bariatric
surgical procedures of gastric bypass and gastric banding. |
| | Abdominal and thoracic wall repair, muscle flap
reinforcement, rectal and vaginal prolapse repair, urinary
incontinence treatment, reconstruction of the pelvic floor,
and repair of hernias (e.g., diaphragmatic, femoral,
incisional, inguinal, lumbar, paracolostomy, scrotal,
umbilical). |
| | Veritas Collagen Matrix minimizes tissue attachment to
the device in case of direct contact with viscera. |
| Technological
Comparisons | Veritas Collagen Matrix is acting as its own predicate and is
therefore substantially equivalent, having the same technological
characteristics and intended use with the exception of the
additional intended use, which is the subject of this submission. |
| Technology/Device
Testing | Veritas Collagen Matrix is acting as its own predicate and is
therefore substantially equivalent in terms of testing. |
| Indication Testing | An animal study was conducted, specific to the subject of this
submission. The study concluded that Veritas ® Collagen Matrix
demonstrates minimal tissue attachment to the viscera when
compared to a named predicate. |
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines and two stylized feet.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Synovis Surgical Innovations % Ms. Cynthia Lamarucciola Regulatory Affairs Manager 2575 University Avenue, West St. Paul, Minnesota 55114-1024
May 2, 2013
Re: K062915
Trade/Device Name: Veritas® Collagen Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXE, OXB, PAJ Dated: October 31, 2006 Received: November 2, 2006
Dear Ms. Lamarucciola:
This letter corrects our substantially equivalent letter of December 6, 2006.
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.
3
Page 2 - Ms. Cynthia Lamarucciola
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance 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/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 Small Manufacturers, International and Consumer Assistance 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, FOR
Peter D. Rumm -S
Mark Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K062915 510(k) Number (if known):
Device Name:
Veritas Collagen Matrix
Indications For Use:
Vertas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following:
Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus.
Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.
Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).
Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.
Prescription Use (Part 21 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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K962915