(339 days)
Not Found
No
The summary describes a physical surgical sling made of mesh and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The T-Sling is used to treat medical conditions (Genuine Stress Urinary Incontinence, mixed incontinence, and vaginal vault prolapse) by positioning a mesh. This direct treatment purpose classifies it as a therapeutic device.
No
The device is described as a surgical sling for treating incontinence and prolapse, not for diagnosing conditions.
No
The device description explicitly states it is made of "monofilament polypropylene warp knitted into composite mesh construction," indicating it is a physical implant, not software.
Based on the provided information, the T-Sling is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the T-Sling is used in females to position a mesh for the treatment of medical conditions (stress urinary incontinence, mixed incontinence, vaginal vault prolapse). This is a surgical implant used in vivo (within the body).
- Device Description: The description details the material and construction of a surgical sling, not a reagent, instrument, or system intended for use in the in vitro examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The T-Sling is a therapeutic device implanted inside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OTN
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Herniamesh T-Sling - K020652, Tyco Healthcare IVS Tunneller - K010035, Ethicon TVT - K012628
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 Medical, Inc. T-Sling K020216 2 510(k) Summary
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. . . . . .
FEB # 2006
| FEB 3 2006 | |
|---|---|
| Date of Summary: | January 19, 2006 |
| 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, Project Leader |
| 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: | T-Sling |
| Common Name: | Surgical Mesh |
| Classification: | Class II |
| Predicate Devices: | Herniamesh T-Sling - K020652 |
| Tyco Healthcare IVS Tunneller - K010035 | |
| Ethicon TVT - K012628 | |
| Device Description: | 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). | |
| Indications for Use: | 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. |
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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.
2
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
3
Image /page/3/Picture/0 description: The image is a black and white logo. The logo features a figure of a person with their arms outstretched, holding a pole across their shoulders. The figure is inside of a circle, and there is a banner across the middle of the circle with the word "HERNIAMESH" written on it. The logo has a vintage or distressed look.
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