(50 days)
Not Found
Not Found
No
The 510(k) summary describes a physical mesh implant and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for the treatment of urinary incontinence and to reinforce soft tissues, indicating a direct therapeutic purpose.
No
The device is described as a mesh sling implant intended for the treatment of urinary incontinence and to reinforce soft tissues, functioning as a repair or supportive material rather than a tool for diagnosis.
No
The device description explicitly states it is a "mesh sling implant" made of "monofilament polypropylene mesh," which is a physical material and not software.
Based on the provided information, the Caldera Polypropylene Mesh is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that the Caldera Polypropylene Mesh is an implantable mesh used to reinforce soft tissues within the body. It is not used to analyze blood, urine, tissue samples, or any other specimen taken from the body.
- The device description focuses on the physical properties and intended surgical use. There is no mention of reagents, calibrators, controls, or any other components typically associated with IVD tests.
- The performance studies mentioned relate to biocompatibility and physical testing of the mesh itself, not the accuracy or performance of a diagnostic test.
Therefore, the Caldera Polypropylene Mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
FTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological, gynecological or gastroenterological anatomy (specifically: pubourethral, bladder, urethral, vaginal, colon, rectal, pelvic floor, sacral-colposuspension)
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)
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."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
1/2
(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 |
| Caldera Medical, Inc. | |
| 28632 Roadside Drive, Suite 260 | |
| Agoura Hills, CA 91301 | |
| Tel: (866) 422-5337 Fax: (818) 879-6556 | |
| Contact: | Marla Kengen |
| Caldera Medical, Inc. | |
| 28632 Roadside Drive, Suite 260 | |
| Agoura Hills, CA 91301 | |
| Tel: (866) 422-5337 Fax: (818) 879-6556 | |
| marla@calderamedical.com | |
| Device Name: | Surgical Mesh (878.3300) |
| Trade Name: | Caldera Large Pore Monofilament Polypropylene |
| Mesh | |
| Common Name: | Surgical Mesh |
| Classification: | Class II |
| Registration Number: | 9054589 |
| Manufacturing Site: | Herniamesh s.r.l. |
| Via Cirie 22/A | |
| San Mauro Torinese | |
| Torino, Italy 10099 | |
| Tel: +39 100 8227300 | |
| Fax: +39 011 8221396 | |
| Sterilization Site: | Bioster S.p.a. |
| Via Cà Bertoncina 29 | |
| Seriate (BG), Italy 24068 | |
| Tel: +39 35 302729 | |
| Fax: +39 35 302515 |
1
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."
2
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.
3
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 (240) 276-0115. 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 (800) 638-2041 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
4
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)
( ) [ર
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