(30 days)
None
No
The description focuses on the material properties and mechanical function of a bioresorbable scaffold, with no mention of AI or ML.
No
The device is described as a 'transitory scaffold for soft tissue support and repair' and 'reinforcement of soft tissue', which falls under structural support and repair rather than a therapeutic function to actively treat a disease or condition.
No
Explanation: The device description and intended use indicate it is an implantable surgical scaffold for soft tissue support and repair, not a device used to diagnose medical conditions.
No
The device description clearly states it is a "knitted, multifilament, bioengineered, long-term bioresorbable scaffold" made from silk fibroin, which is a physical material, not software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that SERI® Contour is a "transitory scaffold for soft tissue support and repair to reinforce deficiencies." This describes a device used in vivo (within the body) for structural support and tissue repair.
- Device Description: The description details a "knitted, multifilament, bioengineered, long-term bioresorbable scaffold" that is "mechanically strong and biocompatible." This aligns with a surgical implant or scaffold, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. SERI® Contour's function is to physically support and reinforce tissue within the body during surgery and healing.
N/A
Intended Use / Indications for Use
SERI® Contour is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery and general soft tissue reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
OXF
Device Description
SERI® Contour is a knitted, multifilament, bioengineered, long-term bioresorbable scaffold. It is derived from pure silk fibroin. The device is a mechanically strong and biocompatible protein mesh. SERI® Contour is a sterile, single use only product and is supplied in a variety of sizes. ready for use in open or laparoscopic procedures. The scaffold is flexible and well-suited for delivery through a laparoscopic trocar. It is tear resistant, with excellent suture retention, and can be cut in any direction. SERI® Contour provides immediate physical and mechanical stabilization of a tissue defect through its strength and porous (scaffold-like) construction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue (specifically mentions reinforcement of soft tissue in plastic and reconstructive surgery and general soft tissue reconstruction, and references abdominal pressure in performance data).
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 differences in surgical mesh specifications between Contour and Scaffold do not affect production, biocompatibility, and intended use of the product. Introducing greater pore area into the Contour design reduces overall density and burst strength of the mesh compared to the Scaffold predicate. Burst strength specifications for both devices were established to exceed peak forces in the abdomen. The fully knitted construction of Contour increases the elasticity and drapability of the mesh compared to Scaffold. When evaluated in a large animal model. Contour supported tissue ingrowth and equivalent burst strength to Scaffold at 3, 6, and 12month evaluation.
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.
None
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 shows the logo for the U.S. Department of Health and 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 a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2017
Sofregen Medical, Inc. Anh Hoang, Ph.D. Chief Scientific Officer 200 Boston Avenue. Suite 1100 Medford, MA 02155
Re: K172545
Trade/Device Name: SERI® Contour Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXF Dated: August 14, 2017 Received: August 23, 2017
Dear Dr. Hoang:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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
2
Indications for Use
510(k) Number (if known) K172545
Device Name SERI® Contour
Indications for Use (Describe)
SERI® Contour is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery and general soft tissue reconstruction.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for the SERI® Contour is provided below.
SUBMITTER 1.
Sofregen Medical, Inc. 200 Boston Avenue, Suite 1100 Medford, MA 02155
Contact Person: Anh Hoang, Ph.D. Phone: 781-874-2352 Email: anh@sofregenmedical.com Date Prepared: August 16, 2017
2. DEVICE
Name of Device: SERI® Contour Common Name: Surgical Mesh Classification Regulation: 21 CFR 878.3300 Regulatory Class: II Product Code: OXF Panel: General and Plastic Surgery
PREDICATE DEVICE 3.
Predicate Device: SERI® Surgical Scaffold (K123128)
Reference Device: None
DEVICE DESCRIPTION 4.
SERI® Contour is a knitted, multifilament, bioengineered, long-term bioresorbable scaffold. It is derived from pure silk fibroin. The device is a mechanically strong and biocompatible protein mesh. SERI® Contour is a sterile, single use only product and is supplied in a variety of sizes. ready for use in open or laparoscopic procedures. The scaffold is flexible and well-suited for delivery through a laparoscopic trocar. It is tear resistant, with excellent suture retention, and can be cut in any direction. SERI® Contour provides immediate physical and mechanical stabilization of a tissue defect through its strength and porous (scaffold-like) construction.
INDICATION FOR USE 5.
SERI® Contour is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery and general soft tissue reconstruction.
4
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.
The subject SERI® Contour has undergone a design change to increase the pore size and knit construction of the mesh compared to the predicate SERI® Surgical Scaffold (K123128). All other material and processing parameters are the same for the production and sterilization of Contour and Scaffold, independent of the pore size and knit pattern. The increased pore size of Contour and knitted construction in both material directions increase the mesh's elasticity that results in a more pliable and drapable surgical mesh. The design change updates handleability in response to clinical feedback, but maintain performance characteristics to accommodate soft tissue repair and support.
PERFORMANCE DATA 7.
The differences in surgical mesh specifications between Contour and Scaffold do not affect production, biocompatibility, and intended use of the product. Introducing greater pore area into the Contour design reduces overall density and burst strength of the mesh compared to the Scaffold predicate. Burst strength specifications for both devices were established to exceed peak forces in the abdomen. The fully knitted construction of Contour increases the elasticity and drapability of the mesh compared to Scaffold. When evaluated in a large animal model. Contour supported tissue ingrowth and equivalent burst strength to Scaffold at 3, 6, and 12month evaluation.
CONCLUSIONS 8.
The design change for SERI Contour introduces larger pores into a fully knitted mesh format, increasing both pliability and drapability requested from clinical feedback of SERI Scaffold. Independent of the mesh pattern, silk processing, mesh production, sterilization, biocompatibility, and intended use are identical to the predicate Scaffold surgical mesh. Burst stress for Contour was verified to perform in excess of the maximum calculated, worst case scenario of abdominal pressure. In vivo performance testing in a large animal model resulted in equivalent burst stress for Contour and Scaffold, confirming soft tissue formation through 1-year evaluation.
In conclusion, based on the same intended use and design change introducing larger pores in a fully knitted mesh, the subject SERI® Contour is substantially equivalent to the predicate SERI® Surgical Scaffold (K123128).