(22 days)
No
The description focuses on the material and physical structure of the mesh device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as treating Genuine Stress Urinary Incontinence (SUI), mixed incontinence, and vaginal vault prolapse, which are medical conditions, and it provides support in the pelvic region.
No
The device, Desara® Mesh, is described as a surgical implant (pubourethral sling) used to treat stress urinary incontinence by providing support. Its intended use and device description focus on therapeutic intervention and physical support, not on diagnosing a condition.
No
The device description clearly states it is a physical mesh made of polypropylene yarn with integral sleeves, tips, and sutures, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency." This describes a surgical implant used to treat a physical condition, not a test performed on biological samples to diagnose or monitor a disease.
- Device Description: The description details a "sterile, single-use pubourethral sling used to provide support in the pelvic region." This is a physical device implanted in the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Desara Mesh is an implantable surgical device used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
The Desara® Mesh is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Product codes
OTN
Device Description
The Desara Mesh is a sterile, single-use pubourethral sling used to provide support in the pelvic region to treat stress urinary incontinence, mixed incontinence, and vaginal vault prolapse. The device is manufactured out of a monofilament polypropylene yarn, which is knitted into a mesh. The device has integral sleeves, tips and sutures to assist the surgeon in placement of the device. The sleeves, tips and sutures are removed after placement of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic region
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 Desara Mesh is produced from the same mesh material as the predicate device, Desara Mesh, #K101169, also a product of Caldera Medical. The mesh material has passed all testing requirements for biocompatibility, performance, shelf life and sterilization. The Desara Mesh material has been subjected to cadaver labs, bench and validation testing and has passed all testing criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Desara Mesh, K101169
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) Summary
| Date of Summary: | July 29, 2013 |
|---|---|
| Applicant: | Caldera Medical, Inc. |
| 5171 Clareton Drive | |
| Agoura Hills, CA 91301 | |
| P (818) 879-6555 | |
| F (818) 879-6556 | |
| Contact: | Vicki Gail |
| Quality and Operations Manager | |
| P (818) 483-7602 | |
| F (818) 736-9083 | |
| E vgail@calderamedical.com | |
| Device Name: | Surgical Mesh (878.3300) |
| Device Class: | Class II, Product Code OTN, 21 CFR 878.3300, Gynecologic, For |
| Stress Urinary Incontinence, Female, Obstetrics/Gynecology | |
| Panel | |
| Trade Name: | Desara Mesh |
| Common Name: | Surgical Mesh |
| Predicate Device: | Desara Mesh , K101169 |
Description of Device:
The Desara Mesh is a sterile, single-use pubourethral sling used to provide support in the pelvic region to treat stress urinary incontinence, mixed incontinence, and vaginal vault prolapse. The device is manufactured out of a monofilament polypropylene yarn, which is knitted into a mesh. The device has integral sleeves, tips and sutures to assist the surgeon in placement of the device. The sleeves, tips and sutures are removed after placement of the device.
Intended Use of Device:
The Desara Mesh is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence, resulting from urethral hypermobility or intrinsic sphincter deficiency.
Summary of Technological Characteristics
The Desara Mesh contains a change in the tip resin material only. The Desara Mesh and the predicate mesh are comprised of the same knit pattern, mesh and other component materials. The Desara Mesh is the same shape and size as the predicate mesh. The Desara Mesh has the same intended use and does not change the fundamental scientific technology of the predicate device.
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Performance Summary
The Desara Mesh is produced from the same mesh material as the predicate device, Desara Mesh, #K101169, also a product of Caldera Medical. The mesh material has passed all testing requirements for biocompatibility, performance, shelf life and sterilization. The Desara Mesh material has been subjected to cadaver labs, bench and validation testing and has passed all testing criteria.
Summary of Substantial Equivalence
The Desara Mesh is safe and effective for its intended use and is substantially equivalent to the predicate device, Desara Mesh, K101169, also a product of Caldera Medical.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings outstretched in a swooping motion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2013
Caldera Medical, Inc. % Vicki Gail Quality and Operations Manager 5171 Clareton Drive Agoura Hills, CA 91301
Re: K112609 Trade/Device Name: Desara® Mesh Regulation Number: 21 CFR8 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated (Date on orig SE Itr): September 7, 2011 Received (Date on orig SE ltr): September 8, 2011
Dear Vicki Gail,
This letter corrects our substantially equivalent letter of September 30, 2011.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional 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 may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Vicki Gail
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K112609
Device Name: Desara® Mesh
Indications for Use:
The Desara® Mesh is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
| Prescription Use
| (21 CFR 801 Subpart D) | X |
|---|---|
| -------------------------------------------- | --- |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S
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Confidential