(251 days)
Not Found
No
The summary describes a physical mesh implant and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to treat a medical condition (stress urinary incontinence, mixed incontinence) by providing support in the pelvic region.
No
Explanation: The device is a surgical implant (mesh) used to treat stress urinary incontinence, not to diagnose it. It provides physical support rather than detecting or identifying a medical condition.
No
The device description clearly states it is a sterile, single-use pubourethral sling manufactured from monofilament polypropylene yarn, which is a physical mesh implant, not software.
Based on the provided information, the Desara® Mesh 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 within the body.
- Device Description: The device is described as a "sterile, single-use pubourethral sling used to provide support in the pelvic region." This further reinforces its nature as a physical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Desara® Mesh does not interact with or analyze such specimens.
Therefore, the Desara® Mesh is a surgical implant, not an in vitro diagnostic device.
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.
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 (comma separated list FDA assigned to the subject device)
OTN
Device Description
The Caldera Desara Mesh is 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 sleeve and sutures to assist the surgeon in placement of the device. The sleeve 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)
Not Found
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
CALDERA DESARA 510(K) SUMMARY
| Date of Summary: | July 29, 2013 |
|---|---|
| ------------------ | --------------- |
- l. Applicant: Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills. CA 91301 Tel: (805) 879-6555 Fax: (818) 879-6556
- Christine Emanuel Contact: Caldera Medical, Inc. 28632 Roadside Drive, Suite 260 Agoura Hills, CA 91301 Tel: (866) 422-5337 Fax: (818) 879-6556 cemanuel@west.net
- Surgical Mesh (878.3300) 2. Device Name: Trade Name: Desara Common Name: Surgical Mesh Class II. Product Code OTN, 21 CFR 878.3300, Device Class: Gynecologic, For Stress Urinary Incontinence, Female, Obstetrics/Gynecology Panel
- Caldera T-Sling, K050516, Feb 3, 2006 3. Predicate Device
4. Description of Device
The Caldera Desara Mesh is 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 sleeve and sutures to assist the surgeon in placement of the device. The sleeve and sutures are removed after placement of the device.
The Desara Mesh device is a modification to the Caldera T-Sling, used for the same Indications for Use and manufactured out of the same mesh material, a monofilament polypropylene mesh
5. 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.
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6. Summary of Technological Characteristics
The Caldera Desara device has the same materials and design as the Caldera T-Sling and has the same technological characteristics. The changes to the Desara Mesh are minor and are primarily related to changes in suppliers as well as minor changes to mesh configuration.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2013
Caldera Medical, Inc. % Mara Korsunsky Quality Assurance and Regulatory Affairs Manager 28632 Roadside Drive, Suite 260 Agoura Hills, CA 91301
- K072456 Re:
Trade/Device Name: Desara™ Implant Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated (Date on orig SE ltr): April 7, 2008 Received (Date on orig SE Itr): April 8, 2008
Dear Mara Korsunsky,
This letter corrects our substantially equivalent letter of May 8, 2008.
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, listing 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
3
Page 2 - Mara Korsunsky
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
4
Indications for Use
510(k) Number (if known): K072456
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.
Image /page/4/Picture/5 description: The image shows the words "Prescription Use (21 CFR 801 Subpart D)" with a box to the right of the words "Prescription Use". There is an "X" in the box, indicating that the prescription use option has been selected. The text is in black font and the box is outlined in black.
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
Page 1 of 1
Confidential