REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH

K043191 · Angiologica B. M. Srl · FTL · May 16, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K043191
• Device Name: REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH
• Applicant: Angiologica B. M. Srl
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Monofilament polypropylene surgical mesh; available in various weights, rigidities, shapes, and sizes. Implanted by surgeons to reinforce soft tissue or repair inguinal hernia defects. Provides non-absorbable support to weakened tissue areas. Device functions as a mechanical scaffold for tissue reinforcement.

Clinical Evidence

No clinical data. The determination of substantial equivalence is not based on an assessment of performance data.

Technological Characteristics

Monofilament polypropylene mesh; various weights, rigidities, shapes, and sizes; implantable; sterile.

Indications for Use

Indicated for patients requiring repair of inguinal hernia defects or reinforcement of soft tissue where weakness exists due to hernia. Applicable to all hernia repairs requiring non-absorbable support material.

Regulatory Classification

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.

Predicate Devices

• BARD MESH (DAVOL INC., Subsidiary of C. R. BARD, INC.)

Submission Summary (Full Text)

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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: [phone] fax number: [phone] e-mail: [e-mail]

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K043191

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| 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.

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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.

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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 [phone] . 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 [phone] or [phone] 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

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# 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

K043191