(88 days)
Not Found
Not Found
No
The description focuses on the material and physical form of surgical implants for tissue reinforcement, with no mention of AI or ML technologies.
Yes
The device is described as an implant intended to reinforce soft tissue, which is a therapeutic action aimed at treating or alleviating a condition (e.g., prolapse, weakness).
No
Explanation: The device is described as an implantable surgical fabric for reinforcing tissue and repairing prolapse, not for diagnosing medical conditions. Its intended use is therapeutic/reconstructive.
No
The device description explicitly states the device is "woven or knitted from polymer fibers, and precut into patches," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an implant intended to reinforce soft tissue during surgical procedures. This is a therapeutic and structural function within the body.
- Device Description: The description confirms it's a physical implant made of polymer fibers for surgical repair.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This is the core function of an IVD.
IVDs are used outside the body to analyze samples and provide diagnostic information. This device is implanted inside the body for structural support.
N/A
Intended Use / Indications for Use
The proposed Surgical Fabrics are implants which are intended to reinforce soft tissue where weakness exists for the urological, gynecological and gastroenterological anatomy inclusive but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair. colon and rectal prolapse repair. reconstruction of the pelvic floor, bladder support, and sacro-colposuspension.
Product codes
Not Found
Device Description
The Surgical Fabrics are woven or knitted from polymer fibers, and precut into patches for soft tissue reinforcement in surgical repair procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, urological, gynecological and gastroenterological anatomy, pubourethral, urethral, vaginal, colon, rectal, pelvic floor, bladder
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 proposed devices have been tested and compared to the predicate devices. The results indicate that the proposed devices are Substantially Equivalent to the predicate devices in terms of performance characteristics tested.
Key Metrics
Not Found
Predicate Device(s)
Trelex Natural® Mesh, Supple Peri-Guard®, Gore-Tex® Soft Tissue Patch, Marlex® Mesh, Mersilene® 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
510(k) Premarket Notification Surgical Fabrics August 12, 1996
Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
NOV 1 5 1996
SECTION VII
Summary of Safety and Effectiveness
Proprietary and Confidential Information of Boston Scientific Corporation
1
510 (k) Summary Of Safety And Effectiveness
| Sponsor: | Boston Scientific Corporation
One Scientific Place
Natick, MA 01760-1537 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Carol J. Holloway
Regulatory Affairs Specialist |
| Submission Date: | August 12, 1996 |
| Predicate Devices: | Trelex Natural® Mesh
Supple Peri-Guard®
Gore-Tex® Soft Tissue Patch
Marlex® Mesh
Mersilene® Mesh |
| Description of
Device: | The Surgical Fabrics are woven or knitted from polymer fibers,
and precut into patches for soft tissue reinforcement in surgical repair
procedures. |
| Intended Uses: | The proposed Surgical Fabrics are implants which are intended to
reinforce soft tissue where weakness exists for the urological,
gynecological and gastroenterological anatomy inclusive but not
limited to the following procedures: pubourethral support,
urethral and vaginal prolapse repair. colon and rectal prolapse
repair.
reconstruction of the pelvic floor, bladder support, and sacro-
colposuspension. |
| Substantial
Equivalence: | The proposed devices are Substantially Equivalent to the predicate
currently marketed devices indicated for use for reinforcement of soft
tissue areas where weakness exists. |
| Product Testing: | The proposed devices have been tested and compared to the predicate
devices. The results indicate that the proposed devices are
Substantially Equivalent to the predicate devices in terms of
performance characteristics tested. |