(87 days)
Not Found
No
The device description and performance studies focus on the physical properties and surgical placement of a mesh implant and associated tools, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to treat stress urinary incontinence (SUI), which constitutes a therapeutic purpose.
No
The device description indicates that the GYNECARE TVT ABBREVO™ is a sterile, single-patient use device consisting of a polypropylene mesh and associated components for sub-urethral sling procedures. Its intended use is for the treatment of stress urinary incontinence, which is a therapeutic intervention, not a diagnostic one. There is no mention of the device being used to identify or determine a medical condition.
No
The device description clearly outlines physical components including mesh, sheaths, and passsers, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical treatment of stress urinary incontinence by implanting a sub-urethral sling. This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a physical implant (mesh) with associated delivery tools. It is not designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is mechanical support.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The GYNECARE TVT ABBREVO™ Continence System is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes (comma separated list FDA assigned to the subject device)
OTN
Device Description
GYNECARE TVT ABBREVO™ device is a sterile, single-patient use device which consists of one piece of blue (phtalocyanine blue, color index number 74160) PROLENE™ polypropylene mesh (mesh implant) approximately 1.1 cm x 12 cm covered by a polyethylene sheath.
The Helical Passer Sheaths (white polyethylene tube receptacles) are attached along with the mesh implant sheath by PROLENE polypropylene Positioning Lines to each end of the mesh implant to accommodate the Helical Passers. The Helical Passers come assembled to the GYNECARE TVT ABBREVO™ device and are used to deliver the mesh implant via the trans-obturator 'inside-out" approach.. Further, there is a GYNECARE TVT ABBREVO™ Placement Loop consisting of a loop of PROLENE Polypropylene Monofilament with an attached polypropylene button, pre-assembled as part of the GYNECARE TVT ABBREVO™ Implant Assembly at the center of the mesh to aid in symmetric placement of the mesh.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sub-urethral
Indicated Patient Age Range
women
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)
GYNECARE TVT ABBREVO™ underwent an extensive safety and performance testing program to support that GYNECARE TVT ABBREVO™ fulfills the device requirements defined in user specifications, functions as intended, and is substantially equivalent to the predicate device. The tests conducted include:
- Biocompatibility testing in accordance to the tests recommended in the ISO 10993-1 . standard
- Bench top physical/performance measurements including Length of Positioning Line + Mesh . and Attachment Strength
- Initial fixation force and anatomic pathway studies in cadaver model .
- Tissue in-growth studies in animal model
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
Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below.
Submitted by:
Susan Lin Manager, Regulatory Affairs Ethicon, Inc., A Johnson & Johnson Company
Route 22 West. PO Box 151 Somerville, NJ 08876
JUL - 1 2010
Name/Classification of Device:
Class II in 21 CFR § 878.3300, Surgical Mesh / OTN
Trade Name:
GYNECARE TVT ABBREVO™ Continence System
Predicate Devices:
GYNECARE TVT™ Obturator System (K033568), ETHICON, Inc.
Statement of Intended Use:
The GYNECARE TVT ABBREVO™ Continence System is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Device Description:
GYNECARE TVT ABBREVO™ device is a sterile, single-patient use device which consists of one piece of blue (phtalocyanine blue, color index number 74160) PROLENE™ polypropylene mesh (mesh implant) approximately 1.1 cm x 12 cm covered by a polyethylene sheath.
The Helical Passer Sheaths (white polyethylene tube receptacles) are attached along with the mesh implant sheath by PROLENE polypropylene Positioning Lines to each end of the mesh implant to accommodate the Helical Passers. The Helical Passers come assembled to the GYNECARE TVT ABBREVO™ device and are used to deliver the mesh implant via the trans-obturator 'inside-out" approach.. Further, there is a GYNECARE TVT ABBREVO™ Placement Loop consisting of a loop of PROLENE Polypropylene Monofilament with an attached polypropylene button, pre-assembled as part of the GYNECARE TVT ABBREVO™ Implant Assembly at the center of the mesh to aid in symmetric placement of the mesh.
1
Summary of Technological Characteristics of New Device to Predicate Devices:
The principle of operation and fundamental scientific technology of the proposed device are equivalent to the predicate devices. Both the GYNECARE TVT™ Obturator and the GYNECARE TVT ABBREVO™ function in the same manner - Introducing a sub-urethral synthetic mesh sling in the patient from a vaginal incision that provides mid-urethral support.
Performance Data:
GYNECARE TVT ABBREVO™ underwent an extensive safety and performance testing program to support that GYNECARE TVT ABBREVO™ fulfills the device requirements defined in user specifications, functions as intended, and is substantially equivalent to the predicate device. The tests conducted include:
- Biocompatibility testing in accordance to the tests recommended in the ISO 10993-1 . standard
- Bench top physical/performance measurements including Length of Positioning Line + Mesh . and Attachment Strength
- Initial fixation force and anatomic pathway studies in cadaver model .
- � Tissue in-growth studies in animal model
Conclusions:
GYNECARE TVT ABBREVO™ has the same indications for use, principle of operation, and fundamental scientific technology as its predicate device. Performance data demonstrates that the device is as safe and effective as the predicate device for the intended use. Thus we conclude that the proposed device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure with outstretched arms, resembling an eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ethicon, Inc. % Ms. Susan Lin Manager, Regulatory Affairs Route 22 West, P.O. Box 151 SOMERVILLE NJ 08876
SEP 2 8 2012
Re: K100936 Trade/Device Name: GYNECARE TVT ABBREVO™ Continence System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: April 2, 2010 Received: April 5, 2010
Dear Ms. Lin:
This letter corrects our substantially equivalent letter of July 7, 2010.
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 (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.
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
3
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Benjamin R. Perkins
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
K100936
SL-2010-002
Indications for Use
510(k) Number (if known):
Device Name: GYNECARE TVT ABBREVO™ Continence System
Indications for Use:
The GYNECARE TVT ABBREVO™ Continence System is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urelhral hypermobility and/or intrinsic sphincter deficiency.
Over-The-Counter Use Prescription Use X . AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kianefor MXM
(Division Sign-Off)
Division of Surgical, Orthopedic and Restorative Devices
510(k) Number: K100936