(82 days)
No
The device description and performance studies focus on the physical properties and surgical placement of a mesh sling, with no mention of AI or ML technologies.
Yes.
The device is used for the treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence, which indicates a therapeutic purpose.
No.
Explanation: The device description states it is a "mid-urethral sling used to provide support ... to treat stress urinary or mixed incontinence," indicating a therapeutic rather than diagnostic function.
No
The device description clearly states it is a sterile, single-use mid-urethral sling made of monofilament polypropylene yarn, which is a physical mesh and not software.
Based on the provided information, the Desara® and Desara® Blue devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that these devices are surgical implants used to support the pelvic region for treating stress urinary incontinence. They are placed within the body, not used to analyze samples from the body.
- The device description focuses on the physical properties and surgical placement of the mesh. There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory tests.
Therefore, the Desara® and Desara® Blue devices fall under the category of surgical implants or medical devices used for treatment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Desara® and Desara® Blue devices are 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
Desara and Desara® Blue devices are sterile, single-use mid-urethral slings used to provide support in the pelvic region to treat stress urinary or mixed incontinence. The devices are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices have integral sleeves, tips and sutures to assist the surgeon in placement of the mesh, which are removed after placement of the device.
Desara® and Desara® Blue are designed to work with Caldera Medical's reusable introducers, which utilize a Universal Connection System offering surgeons the flexibility to choose their preferred surgical approach.
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
Results of both mechanical bench and validation testing demonstrate equivalent device function based upon its intended use to the predicate device, Desara® Mesh, (#K112609).
Key Metrics
Not Found
Predicate Device(s)
Desara® Mesh , K112609
Reference Device(s)
Ascend® Blue, (#K101462)
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
DERA MEDICAL
K132069 Paqe 1 of 3
SEP 2 3 2013
510(k) Summarv
Date of Summary: June 27, 2013
Applicant:
Contact:
F
Caldera Medical, Inc. 5171 Clareton Drive Agoura Hills, CA 91301 P (818) 879-6555 F (818) 879-6556
Vicki Gail QA/RA and Operations Manager P (818) 483-7602 F (818) 736-9083 E ygail@calderamedical.com
Desara®
Desara® Blue
Trade Name:
Device Class: Product Code: C.F.R Section: Common name:
Class II · OTN 21 CFR 878.3300 Surgical Mesh, Gynecologic, For Stress Urinary Incontinence, Female Obstetrics/Gynecology Panel
Desara® Mesh , K112609 Predicate Device:
Description of Device:
Classification Panel:
Desara and Desara® Blue devices are sterile, single-use mid-urethral slings used to provide support in the pelvic region to treat stress urinary or mixed incontinence. The devices are manufactured out of monofilament polypropylene yarn, which is knitted into a mesh. The devices have integral sleeves, tips and sutures to assist the surgeon in placement of the mesh, which are removed after placement of the device.
Desara® and Desara® Blue are designed to work with Caldera Medical's reusable introducers, which utilize a Universal Connection System offering surgeons the flexibility to choose their preferred surgical approach.
Intended Use of Device:
Desara® and Desara® Blue devices are 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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Image /page/1/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a circular graphic on the left and the text "CALDERA MEDICAL" on the right. The graphic appears to be a stylized representation of a medical symbol. The text is in a bold, sans-serif font.
Summary of Technological Characteristics
Desara® and Desara® Blue devices submitted herein contain changes in polypropylene mesh resin, a decrease to the size of the junction tip and an optional design which contains blue colorant. Desara® and Desara® Blue are the same shape and size, utilize the same mesh knit and limited contact raw materials as the predicate device, Desara® Mesh (#K112609).
Desara® and Desara® Blue have a more specific intended use than that of the predicate device, Desara® Mesh (#K112609) and the same fundamental scientific technology.
Performance Summary
Desara® and Desara® Blue submitted herein are comprised of the same mesh resin as the reference device, Ascend® Blue, (#K101462), also a product of Caldera Medical. In accordance with the FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh, the following mesh characteristics were assessed: mesh thickness, mesh knit characteristics, pore size, mesh density, tensile strength, mesh stiffness, flexural rigidity, tear resistance, burst strength, suture pullout and pyrogen levels.
Desara® Mesh (#K112609) and Ascend® Blue, (#K101462) were used as a reference for Desara® and Desara® Blue devices for biocompatibility since thev are comprised of the same materials. Desara® Mesh (#K112609) and Ascend® Blue, (#K101462) have passed all biocompatibility testing as indicated per the FDA guidance documents, FDA Device Advice, Guidance Documents (Medical Device and Radiation Emitting Product), 3. Biocompatibility and FDA Draft Guidance Entitled "Use of International Standard ISO-10993. "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing", dated April 23, 2013.
Results of both mechanical bench and validation testing demonstrate equivalent device function based upon its intended use to the predicate device, Desara® Mesh, (#K112609).
Testing documentation from Desara® Mesh (#K112609) and Ascend® Blue, (#K101462) were used to support the aging, sheif life, transportation and sterilization of Desara® and Desara® Blue submitted herein in, was performed in accordance with the FDA Guidance, Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry, FDA, FDA Device Advice, Guidance Documents (Medical Device and Radiation Emitting Product), 4. Labeling and FDA Consensus standard, ASTM F-1980-07, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices as the devices are comprised of the same or similar materials, and utilized the same packaging, manufacturing and sterilization processes as that of Desara® Mesh (#K112609).
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Image /page/2/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a circular graphic to the left of the company name. The company name, "CALDERA MEDICAL", is written in all capital letters and in a bold font.
Summary of Substantial Equivalence
The conclusions drawn from the non-clinical and clinical tests demonstrate that Desara® and Desara® Blue submitted herein are substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 23, 2013
Caldera Medical, Inc. % Vicki Gail QA/RA and Operations Manager 5171 Clareton Drive Agoura Hills, CA 91301
Re: K132069
Trade/Device Name: Desara and Desara Blue Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OTN Dated: June 27, 2013 Received: July 3, 2013
Dear Vicki Gail,
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 or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Vicki Gail
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 toll-free 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/ReportalProblem/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,
Benjamin R. Fisher -S
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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Image /page/5/Picture/0 description: The image shows the logo for Caldera Medical. The logo consists of a circular graphic on the left, followed by the text "CALDERA MEDICAL" in bold, uppercase letters. The graphic appears to be a stylized representation of a medical symbol or emblem.
Indications for Use
510(k) Number (if known): K132069
Device Name: Desara® Desara® Blue
Indications for Use:
Desara® and Desara® Blue are 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)
Benjamin R. Fisher -S 2013.09.23 16:52:16 -04'00'
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