(339 days)
The T-Sling 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, and vaginal vault prolapse.
The T-sling is intended to be used in females to position a polypropylene mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The T-Sling is made of monofilament polypropylene warp knitted into composite mesh construction. The T-Sling is a sterile, single-use pubourethral sling for the treatment of stress urinary incontinence (SUI).
The provided text is a 510(k) Summary for the Caldera Medical T-Sling, a surgical mesh device. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of design, materials, and intended use, rather than presenting clinical study data with acceptance criteria and performance metrics typically seen for AI/ML-based medical devices or devices that require extensive clinical efficacy studies.
Therefore, many of the requested items (acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission for this specific device.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy, or other clinical outcomes) in the way a clinical study report for an AI/ML device would. The "acceptance" for this type of device in a 510(k) submission primarily revolves around demonstrating substantial equivalence to legally marketed predicate devices, meaning it has the same intended use, fundamental technological characteristics, or, if different, those differences do not raise new questions of safety and effectiveness.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) Summary for a surgical mesh device, not an AI/ML device, and it does not present a clinical study with a "test set" in that context. The evaluation is based on material properties, design, and comparison to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment by experts is not a component of this type of regulatory submission for this device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not described as this is not a study involving human review of data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Clinical ground truth, in the sense of a diagnostic or predictive algorithm, is not directly discussed. The "truth" in this context is the safety and effectiveness profile established by the predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and no training set is mentioned.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary regarding the device and its regulatory pathway:
The Caldera Medical T-Sling is a surgical mesh made of monofilament polypropylene, warp knitted into a composite mesh. It is intended as a sterile, single-use pubourethral sling for the treatment of:
- Genuine Stress Urinary Incontinence (SUI) in females.
- Mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
- Vaginal vault prolapse.
The 510(k) submission (K050516) sought to demonstrate substantial equivalence to existing legally marketed predicate devices. The listed predicate devices are:
The FDA's review concluded that the T-Sling is substantially equivalent to these predicate devices for its stated indications for use. This means that based on comparison of materials, design, intended use, and potentially bench testing data (which is not detailed in this summary), the FDA determined the device is as safe and effective as a legally marketed device.
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Caldera Medical, Inc. T-Sling K020216 2 510(k) Summary
1/1
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FEB # 2006
| FEB 3 2006 | |
|---|---|
| Date of Summary: | January 19, 2006 |
| Applicant: | Bryon L. Merade, CEOCaldera Medical, Inc.28632 Roadside Drive, Suite 260Agoura Hills, CA 91301Tel: (866) 422-5337 Fax: (818) 879-6556 |
| Contact: | Marla Kengen, Project LeaderCaldera Medical, Inc.28632 Roadside Drive, Suite 260Agoura Hills, CA 91301Tel: (866) 422-5337 Fax: (818) 879-6556marla@calderamedical.com |
| Device Name: | Surgical Mesh (878.3300) |
| Trade Name: | T-Sling |
| Common Name: | Surgical Mesh |
| Classification: | Class II |
| Predicate Devices: | Herniamesh T-Sling - K020652Tyco Healthcare IVS Tunneller - K010035Ethicon TVT - K012628 |
| Device Description: | The T-Sling is made of monofilament polypropylenewarp knitted into composite mesh construction. The T-Sling is a sterile, single-use pubourethral sling for thetreatment of stress urinary incontinence (SUI). |
| Indications for Use: | The T-Sling is intended to be used in females to positiona mesh for the treatment of Genuine Stress UrinaryIncontinence (SUI), mixed incontinence resulting fromurethral hypermobility or intrinsic sphincter deficiency,and vaginal vault prolapse. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11, 2014
Marla Kengen Project Leader Caldera Medical, Inc. 28632 Roadside Drive, Suite 260 Agoura Hills, California 91301
Re: K050516
Trade/Device Name: T-Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OTN Dated (Date on orig SE ltr): November 28, 2005 Received (Date on orig SE ltr): December 19, 2005
Dear Marla Kengen:
This letter corrects our substantially equivalent letter of February 3, 2006.
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.
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Page 2 - Marla Kengen
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 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/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,
Image /page/2/Picture/7 description: The image shows the text "Herbert P. Lerner - S". The text is written in a bold, sans-serif font. The letters "FDA" are superimposed on the text, with the letters being in a stylized, geometric font. The letters "FDA" are also outlined in black.
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 Form
510(k) Number (if known) K050516
Device Name: T-Sling
Indications For Use:
The T-sling is intended to be used in females to position a polypropylene mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
(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 2014.03.27 13:33:36 -04'00'
Prescription Use x
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
HERNIAMESH SRL Sede legale Via Fratelli Meliga 1/C - 10034 Chivasso (TO) Cap. Soc. € 98.800 i.v. - P.I. 02791540616 - C. F. 02245180613 -N. Iscrizione Rea Torino TO-960622 Tel. +39-0119196236 - fax +39-0119196239 Mall: Info@hemiamesh.it - Mail certificata: amministrazione@pec.hemiamesh.it - Sito internet www.herniamesh.com
§ 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.