(203 days)
Not Found
No
The document describes a physical surgical scaffold made of silk and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies, facilitating a desired surgical outcome. This function of aiding in tissue repair and reinforcement for therapeutic purposes aligns with the definition of a therapeutic device.
No
The device is a surgical scaffold used for soft tissue support and repair, and its description focuses on its physical and biological properties for this purpose, not on diagnostic capabilities.
No
The device description clearly states it is a "knitted, multifilament, bioengineered, long-term bioresorbable scaffold" derived from silk, indicating it is a physical implantable 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 the device is a "transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist". This describes a device used in vivo (within the body) for surgical repair.
- Device Description: The description details a "knitted, multifilament, bioengineered, long-term bioresorbable scaffold" derived from silk, designed for physical and mechanical stabilization of tissue defects and eventual replacement by native tissue. This is consistent with a surgical implant or scaffold.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for structural support and repair.
N/A
Intended Use / Indications for Use
SERI™ Surgical Scaffold 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
OXF
Device Description
SERI™ Surgical Scaffold is a knitted, multifilament, bioengineered, long-term bioresorbable scaffold. It is derived from silk that has been BIOSILK™ purified to yield ultra pure fibroin. The device is a mechanically strong and biocompatible bioprotein. SERI™ Surgical Scaffold 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™ Surgical Scaffold provides immediate physical and mechanical stabilization of a tissue defect through its strength and porous (scaffold-like) construction.
SERITM Surgical Scaffold is designed to slowly bioresorb in parallel to neovascularization and native tissue ingrowth which results in eventual replacement of As bioresorption occurs, load bearing responsibility is SERI™ with native tissue. transferred to the new tissue ingrowth such that mechanical integrity is maintained at the site.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080442 SERITM Surgical Scaffold, K083898 TEI Biosciences SurgiMend Collagen Matrix, K810428 Ethicon Vicryl Knitted Mesh
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
page 4
APR 2 5 2013
510(K) SUMMARY
SUBMITTED BY:
Company Name: Address:
Telephone: Fax:
Allergan 200 Boston Avenue, Suite 3700 Medford, MA 02155 781-658-2800 781-723-7790
CONTACT PERSON: DATE PREPARED: TRADE NAME: COMMON and CLASSIFICATION NAME: Connie H. Garrison, MBA, RAC March 7, 2013 SERI™ Surgical Scaffold Mesh, surgical, absorbable, plastic and reconstructive surgery CFR §878.3300 / General and Plastic Surgery OXF
PROCODE:
PREDICATE DEVICES:
CLASSIFICATION REG/PANEL:
K080442 SERITM Surgical Scaffold K083898 TEI Biosciences SurgiMend Collagen Matrix K810428 Ethicon Vicryl Knitted Mesh
DEVICE DESCRIPTION:
SERI™ Surgical Scaffold is a knitted, multifilament, bioengineered, long-term bioresorbable scaffold. It is derived from silk that has been BIOSILK™ purified to yield ultra pure fibroin. The device is a mechanically strong and biocompatible bioprotein. SERI™ Surgical Scaffold 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™ Surgical Scaffold provides immediate physical and mechanical stabilization of a tissue defect through its strength and porous (scaffold-like) construction.
SERITM Surgical Scaffold is designed to slowly bioresorb in parallel to neovascularization and native tissue ingrowth which results in eventual replacement of As bioresorption occurs, load bearing responsibility is SERI™ with native tissue. transferred to the new tissue ingrowth such that mechanical integrity is maintained at the site.
INDICATIONS FOR USE/INTENDED USE:
SERI™ Surgical Scaffold 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.
21
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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 is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Allergan % Ms. Connie Garrison 200 Boston Avenue, Suite 3700 Medford, Massachusetts 02155-0000
Re: K123128
Trade/Device Name: Seri Surgical Scaffold Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OXF Dated: March 08, 2013 Received: March 18, 2013
Dear Ms. Garrison:
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. Iisting 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
April 25, 2013
2
Page 2 - Ms. Connie Garrison
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours, FOR
Peter DJJRumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K123128
Device Name: SERI™ Surgical Scaffold
Indications for Use:
SERI Surgical Scaffold 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.
Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krauses
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123128
Allergan Traditional 510(k) SERI™ Surgical Scaffold
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