(268 days)
No
The description focuses on the material properties and mechanical function of a surgical mesh, with no mention of AI or ML.
Yes
The device is described as a "transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist," which indicates its use in treating or managing a condition, thus making it a therapeutic device.
No
Explanation: The device is described as a surgical mesh used for soft tissue support and repair to reinforce deficiencies, acting as a scaffold. Its purpose is mechanical and structural, not to diagnose a condition.
No
The device description clearly states it is a "knitted, multi-filament, bioengineered, silk mesh" and describes its physical properties and use in surgical procedures, indicating it is a physical medical device, 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 SeriScaffold™ surgical mesh is for "soft tissue support and repair to reinforce deficiencies where weakness or voids exist". This describes a device used in vivo (within the body) during surgery.
- Device Description: The description details a "knitted, multi-filament, bioengineered, silk mesh" that is "mechanically strong, biocompatible, and long-term bioresorbable". This is consistent with a surgical implant, not a diagnostic test performed on samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. SeriScaffold surgical mesh does not fit this description.
N/A
Intended Use / Indications for Use
SeriScaffold™ surgical mesh 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.
Product codes
FTL
Device Description
SeriScaffold surgical mesh is a knitted, multi-filament, bioengineered, silk mesh. It is mechanically strong, biocompatible, and long-term bioresorbable. SeriScaffold surgical mesh is a sterile, single use only mesh and is supplied in a variety of shapes and sizes ready for use in open or laparoscopic procedures. The device is flexible and well suited for delivery through a laparoscopic trocar due to its strength, tear resistance, suture retention, and ability to be cut in any direction. SeriScaffold surgical mesh provides immediate physical and mechanical stabilization of a tissue defect through the strength and porous (scaffold-like) construction of its mesh.
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
Results from performance testing based on "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh", March 2, 1999 demonstrates substantial equivalence of SeriScaffold surgical mesh to predicate surgical mesh products. Results from an in vitro bioresorption study characterize the bioresorption properties of SeriScaffold surgical mesh versus Vicryl Mesh which support the long-term bioresorption property of SeriScaffold surgical mesh. Biocompatibility was conducted according to internationally recognized standards and all results indicate the device is biocompatible. Data from an in vivo rabbit study further support the bioresorption and biocompatibility properties of the device.
Key Metrics
Not Found
Predicate Device(s)
Bard Mesh® (pre-amendment), Vicryl™ Mesh (K810428), Mersilene™ Mesh (pre-amendment), Permacol® Surgical Implant (collagen) (K043366)
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
Ioxoyyz
Done (i) of (2)
NOV 1 3 2008
510(k) Summary
SUBMITTED BY:
| Company Name: | Serica Technologies, Inc. |
|---|---|
| Address: | 200 Boston Avenue, Suite 3700 |
| Medford, MA 02155 | |
| Telephone: | 781-395-5552 |
| Fax: | 781-395-3330 |
| CONTACT PERSON: | Connie H. Garrison, MBA, RAC |
CONT February 12, 2008 DATE PREPARED: SeriScaffold™ surgical mesh TRADE NAME: COMMON and CLASSIFICATION NAME: Surgical Mesh CLASSIFICATION REG/PANEL General and Plastic Surgery / CFR §878.3300 PROCODE FTL
SUBSTANTIALLY EQUIVALENT TO:
SeriScaffold surgical mesh is substantially equivalent to predicate surgical mesh products legally marketed in the United States as follows: Bard Mesh® (pre-amendment), VicryI™ Mesh (K810428), Mersilene™ Mesh (pre-amendment) and Permacol® Surgical Implant (collagen) (K043366). Any minor differences between SeriScaffold surgical mesh and the predicate devices do not introduce new safety or performance issues.
DESCRIPTION of the DEVICE:
SeriScaffold surgical mesh is a knitted, multi-filament, bioengineered, silk mesh. It is mechanically strong, biocompatible, and long-term bioresorbable. SeriScaffold surgical mesh is a sterile, single use only mesh and is supplied in a variety of shapes and sizes ready for use in open or laparoscopic procedures. The device is flexible and well suited for delivery through a laparoscopic trocar due to its strength, tear resistance, suture retention, and ability to be cut in any direction. SeriScaffold surgical mesh provides immediate physical and mechanical stabilization of a tissue defect through the strength and porous (scaffold-like) construction of its mesh.
INDICATIONS FOR USE/INTENDED USE:
SeriScaffold surgical mesh 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.
SUMMARY of TECNOLOGICAL CHARACTERISTICS:
Results from performance testing based on "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh", March 2, 1999 demonstrates substantial equivalence of SeriScaffold surgical mesh to predicate surgical mesh products. Results from an in vitro bioresorption study characterize the bioresorption properties of SeriScaffold surgical mesh versus Vicryl Mesh which support the long-term bioresorption property of SeriScaffold surgical mesh. Biocompatibility was conducted according to
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510(k) Summary-Continued
Page ② of ②
internationally recognized standards and all results indicate the device is biocompatible. Data from an in vivo rabbit study further support the bioresorption and biocompatibility properties of the device.
CONCLUSION:
Data from bench testing, biocompatibility testing, and an in vivo rabbit study demonstratc that SeriScaffold surgical mesh is safe and effective and is substantially equivalent to predicate devices.
2
Image /page/2/Picture/1 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 a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
NOV 1 3 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Serica Technologies, Inc. % Ms. Connie Garrison, MBA, RAC VP, Regulatory Affairs and Quality Assurance 200 Boston Avenue, Suite 3700 Medford, Massachusetts 02155
Re: K080442
Trade/Device Name: ScriScaffold" surgical mesh Regulation Number: 21 CFR 878.3300 Device Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: October 15, 2008 Received: October 16, 2008
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 tequirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 docs 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); good manufacturing practice requirements as set
3
Page 2 -- Ms. Denise Thompson
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,
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
SeriScaffold™ surgical mesh
Indications For Use:
SeriScaffold™ surgical mesh 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.
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)
244 Rfgd form
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
510(k) Number K030442