CALDERA MESH

K060004 · Caldera Medical, Inc. · FTL · Feb 22, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060004
• Device Name: CALDERA MESH
• Applicant: Caldera Medical, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Feb 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Caldera Polypropylene Mesh is a mesh sling implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

Device Story

Caldera Large Pore Monofilament Polypropylene Mesh is a sterile, single-use surgical implant; provides mechanical support to weakened tissues in urological, gynecological, and gastroenterological procedures. Available in pre-formed shapes or large sheets for physician-customized cutting. Used by surgeons in clinical settings to treat urinary incontinence (urethral hypermobility/ISD) and reinforce pelvic floor anatomy (e.g., prolapse repair, sacral-colposuspension). Device acts as a permanent scaffold for tissue ingrowth; benefits patients by restoring anatomical support and correcting incontinence. No accessory items included.

Clinical Evidence

Bench testing only. Biocompatibility and physical performance testing performed per FDA guidance for surgical mesh.

Technological Characteristics

Monofilament polypropylene mesh; sterile, single-use; various pre-formed sizes or cut-to-size sheets. Mechanical support device; no energy source or software components.

Indications for Use

Indicated for patients with urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency (ISD), and for patients requiring soft tissue reinforcement in urological, gynecological, or gastroenterological procedures, including pelvic floor reconstruction and prolapse repair.

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.

Submission Summary (Full Text)

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## (A)

# FEB 2 2 2006

## Caldera Medical, Inc. Caldera Large Pore Monofilament Polypropylene Mesh K060004

## 510(k) Summary of Safety & Effectiveness

| Date of Application: | December 30, 2005 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Bryon L. Merade, CEO<br>Caldera Medical, Inc.<br>28632 Roadside Drive, Suite 260<br>Agoura Hills, CA 91301<br>Tel: [phone] Fax: [phone] |
| Contact: | Marla Kengen<br>Caldera Medical, Inc.<br>28632 Roadside Drive, Suite 260<br>Agoura Hills, CA 91301<br>Tel: [phone] Fax: [phone]<br>[e-mail] |
| Device Name: | Surgical Mesh (878.3300) |
| Trade Name: | Caldera Large Pore Monofilament Polypropylene<br>Mesh |
| Common Name: | Surgical Mesh |
| Classification: | Class II |
| Registration Number: | 9054589 |
| Manufacturing Site: | Herniamesh s.r.l.<br>Via Cirie 22/A<br>San Mauro Torinese<br>Torino, Italy 10099<br>Tel: [phone]<br>Fax: [phone] |
| Sterilization Site: | Bioster S.p.a.<br>Via Cà Bertoncina 29<br>Seriate (BG), Italy 24068<br>Tel: [phone]<br>Fax: [phone] |

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## Caldera Medical, Inc. Caldera Large Pore Monofilament Polypropylene Mesh K060004

#### 510(k) Summary of Safety & Effectiveness

#### Device Description

The Caldera Polypropylene Mesh is made of monofilament polypropylene mesh. The Caldera Polypropylene Mesh is a sterile, single-use mesh used to provide additional support to weak muscle in specific urological, gynecological, or gastroenterological procedures.

It is provided in a variety of pre-formed sizes and shapes as well as a large size that can be cut to size by the physician.

The Caldera Polypropylene Mesh is available as the mesh only, without accessory items.

#### Statement of Indications for Use

The Caldera Polypropylene Mesh is a mesh sling implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

#### Testing

Testing has been performed on the Caldera Polypropylenc Mesh for biocompatibility as well as appropriate physical testing as outlined in the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh."

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DEPARTMENT OF HEALTH & HUMAN SERVICES

. .

Public Health Service

FEB 2 2 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Caldera Medical, Inc. c/o Ms. Marla Kengen Project Leader 28632 Roadside Drive, Suite 260 Agoura Hills, California 91301

Re: K060004

Trade/Device Name: Caldera Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: January 27, 2006 Received: January 30, 2006

Dear Ms. Kengen:

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 ass sured in the encreases 776, the enactment date of the Medical Device Amendments, or to conninered pror to that 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic recry the to nevice, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general volta on profitering 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 your device is elaborired (dis anal 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 ean or found in the overnments concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loase be actised that i Drivination that your device complies with other requirements of the Act that I DA has Intact a and regulations administered by other Federal agencies. You must or any I cactar stutures and registeries sincluding, but not limited to: registration and listing (21 Comply with an the Not of except 801); good manufacturing practice requirements as set Circle rate 607); accems (21 CFR Part 820); and if applicable, the electronic form in the quand by by and provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kengen

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to oegin maneeting your and equivalence of your device to a legally premarket notification: "The PDT Interlassification 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 acrise is. J at [phone]. Also, please note the regulation entitled, Colliact the Office of Comphalled at (21 ) == Part 807.97). You may obtain Misolanumg by Telefone to premainer notificantonews the Act from the Division of Small other general information on your respense Assistance at its toll-free number [phone] or Manufacturers, International and Consultip://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Malkerson

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Additional Information Requested: K060004 Caldera Large Porc Monofilament Polypropylene Mesh

(A) - Revised

Indications for Use Form

510(k) Number: KO60004

Device Name: Caldera Mesh

Indications For Use:

The Caldera Polypropylene Mesh is a mesh sling implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISID and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

Prescription Use - X (per 21 CFR 801 109)

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Over-The-Counter Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED! NEEDED)

Concurrence of CDRH, Of ice of Device Evaluation (ODE)

elame

Division of General, Restoral and Neurological Devices

510(k) Numbe K060004