(180 days)
Not Found
No
The device description and intended use are for a standard surgical mesh, and there is no mention of AI, ML, image processing, or performance studies based on data analysis.
Yes
The device is intended for "repair of inguinal hernia defects" and "reinforce soft tissue where weakness exists," which are therapeutic applications.
No
The device is described as a "Monofilament polypropylene mesh" intended for "repair of inguinal hernia defects" or to "reinforce soft tissue where weakness exists," indicating it is a surgical implant used for structural repair, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Monofilament polypropylene mesh," which is a physical hardware component used in surgery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is consistently described as "Repair of inguinal hernia defects" or "To reinforce soft tissue where weakness exists, i.e., repair of hernias." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "Monofilament polypropylene mesh," which is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
Angimesh Pre: "Repair of inguinal hernia defects."
Folded Mesh: "Repair of inguinal hernia defects."
Repol Plug Basic: "Repair of inguinal hernia defects."
Repol Plug Cap: "Repair of inguinal hernia defects."
Repol Plug Flower: "Repair of inguinal hernia defects."
Repol Angimesh: "To reinforce soft tissue where weakness exists, i.e., repair of hernias."
Wings Mesh: "Use in all kind of hernia repair requiring reinforcement with nonabsorbable support material."
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
Mooofilament polypropylene mesh, available in various weights, rigidity, shapes and sizes, to allow an easy use in surgical techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 determination of substantial equivalence is not based on an assessment of performance data.
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.
Not Found
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
pg 1 out of 2
ANGIOLOGICA B.M. Srl
510(K) NOTIFICATION Surgical Mesh
Revision: 1 Date: 02/18/2005
Section 10: 510(K) SUMMARY
510(K) Summary of Safety and effectiveness
Trade names:
REPOL ANGIMESH; ANGIMESH PRE; FOLDED MESH; REPOL PLUG BASIC; REPOL PLUG CAP; REPOL PLUG FLOWER; WINGS MESH;
Common name:
SURGICAL MESH
Classification name:
MESH, SURGICAL, POLYMERIC
Official contact:
ANGIOLOGICA B.M. S.r.I.
Via Giovanni XXIII, 4 - 27028 S. Martino Siccomario (PV) - Italy contact person: Roberto Manca (Quality Manager) telephone: +39 0382 556616 fax number: +39 0382 556191 e-mail: quality@angiologica.com
1
Image /page/1/Picture/1 description: The image contains three figures, which appear to be handwritten numbers. The first figure is a somewhat distorted number 6. The second figure is the number 2, and the third figure is the number 2 as well.
| ANGIOLOGICA B.M. Srl |
|---|
| ---------------------- |
510(K) NOTIFICATION Surgical Mesh
Revision: 1 Date: 02/18/2005
Date:
02/18/2005
Predicate devices:
The SURGICAL MESH - produced by ANGIOLOGICA B.M. S.r.I. - is substantially equiva-I no OURGICAL MESH "BARD MESH", produced by DAVOL INC., Subsidiary of C. R. BARD, INC.
Description:
Mooofilament polypropylene mesh, available in various weights, rigidity, shapes and sizes, to allow an easy use in surgical techniques.
Intended use:
Intended aso:
REPOL PLUG, ANGIMESH PRE and FOLDED MESH are indicated for the repair of inguinal hernia defects.
REPOL ANGIMESH is indicated to reinforce soft tissue where weakness exists, i.e. repair of hernias.
WINGS MESH is indicated for use in all kind of hernia repair requiring reinforcement with non-absorbable support material.
Comparison to predicate devices:
These devices have the same intended use, the same target population, the same kind of contact (both are implantable devices) and the same technological characteristics (materials, sterility, general shape).
Differences between ANGIOLOGICA B.M. S.r.I. SURGICAL MESH and the predicate device should not affect the safety and effectiveness.
The determination of substantial equivalence is not based on an assessment of performance data.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2005
Mr. Roberto Manca Quality Manager Angiologica B.M. S.R.L 4, via Giovanni XXIII San Martino Siccomario, Pavia Italy 27028
Re: K043191
K043171
Trade/Device Name: Repol Angimesh Pre, Folded, Plug Basic, Plug Cap, Plug Flower, Wings Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 18, 2005 Received: April 20, 2005
Dear Mr. Manca:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of the enactment date of the Medical Device Amendments, or 10 conimered process to they 2011 de nees mat have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelere, mains of the Act include requirements for annual registration, listing of general controls profitive 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 it may of subject to sach admissiral Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the over ents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease of arribed that it that your device complies with other requirements of the Act that I Drinas Intactions and regulations administered by other Federal agencies. You must or any I carated statutes and equirements, including, but not limited to: registration and listing (21 Comply with an the Hot 81equinements)01); good manufacturing practice requirements as set Of IT an 0077, adoling (21 CFR Part 820); and if applicable, the electronic forth in the quality by control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Roberto Manca
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you we our mading of substantial equivalence of your device to a legally premation notificate 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 If you desire specific acresliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K043191
Indications for Use
510(k) Number (if known): K043191
Device Name: Repol Angimesh Pre, Folded, Plug Cap, Plug Cap, Plug Flower, Wings Mesh
Indications For Use:
Angimesh Pre: "Repair of inguinal hernia defects."
Folded Mesh: "Repair of inguinal hernia defects."
Repol Plug Basic: "Repair of inguinal hernia defects."
Repol Plug Cap: "Repair of inguinal hernia defects."
Repol Plug Flower: "Repair of inguinal hernia defects."
Repol Angimesh: "To reinforce soft tissue where weakness exists, i.e., repair of hernias."
Wings Mesh: "Use in all kind of hernia repair requiring reinforcement with nonabsorbable support material."
Prescription Use × (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)
Sign-Off)
on of General, Restorative
Societ Devices