(82 days)
No
The summary describes a surgical mesh implant and its physical properties and biocompatibility, with no mention of AI or ML technology.
Yes
The device is intended for the treatment of urinary incontinence and for implantation to reinforce soft tissues, which are therapeutic applications.
No
The device is a surgical mesh intended for reinforcing soft tissues, not for diagnosing conditions. Its purpose is treatment, not diagnosis.
No
The device description clearly states it is an "implant" and a "pre-cut piece" of "material," indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "implant that is intended for the treatment of urinary incontinence... and for implantation to reinforce soft tissues". This describes a device that is surgically placed within the body for therapeutic or supportive purposes.
- Device Description: The description details a "pre-cut piece" of mesh, which is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is an implant used inside the body for structural support and treatment.
N/A
Intended Use / Indications for Use
The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to pubourethral support and bladder support.
Product codes
OTN
Device Description
The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ is available in the size 4 cm x 7 cm. This pre-cut piece is mmbileono -------------------------------------------------------------------------------------------------------------------------------------------------------------------procedures.
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
The material used in the AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ has been demonstrated to be biocompatible.
The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ has been tested for a variety of physical characteristics including tensile strength and suture pull strength and has been shown to be equivalent to the listed predicate device. Testing was also conducted to evaluate the response of tissues to the antibiotics.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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DEC 1 4 2004
American Medical
510(k) Summary AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ ળીને વિવ 510(k) Number K
Submitter/Contact Person:
Kristyn M. Benson Sr. Regulatory Affairs Specialist American Medical Systems 10700 Bren Road West Minnetonka, MN 55343
Phone: (952) 930-6072 Fax: (952) 930-6496 Email: kristyn benson@americanmedicalsystems.com
Device Name and Classification:
Trade Name: AMS InteMesh TM Silicone-Coated Sling and Surgical Mesh with InhibiZone™ Common/Usual Name: Surgical Mesh, Sling, Urethral Sling Classification Name: Surgical Mesh, polymeric Product Code: OTN Classification: Class II
Manufacturing Location:
American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343
Predicate Device:
AMS Triangle™ Silicone-Coated Sling and Surgical Mesh - K002721 Mentor SUSPEND™ Sling - K980483
Indications for Use:
The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to pubourethral support and bladder support.
1
K042592 page 2/2
Device Description:
escription:
The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ is available in the size 4 cm x 7 cm. This pre-cut piece is mmbileono -------------------------------------------------------------------------------------------------------------------------------------------------------------------procedures.
Summary of Testing
/ or Testing
The material used in the AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ has been demonstrated to be biocompatible.
The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ has been tested for a variety of physical characteristics including tensile strength and suture pull strength and has been shown to be equivalent to the listed predicate device. Testing was also conducted to evaluate the response of tissues to the antibiotics.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Kristyn M. Benson Senior Regulatory Affairs Specialist American Medical Systems. Inc. 10700 Bren Road, West MINNETONKA MN 55343
SEP 2 8 2012
Re: K042592 Trade/Device Name: Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: November 11, 2004 Received: November 12, 2004
Dear Ms. Benson:
This letter corrects our substantially equivalent letter of December 14, 2004.
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
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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/CDRH0ffices/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,
Sincerely yours,
Benjamin R. Fuchs
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/4/Picture/0 description: The image shows the logo for American Medical Systems. The logo consists of a stylized graphic to the left of the text. The text "American Medical Systems" is in a bold, sans-serif font.
INDICATIONS FOR USE STATEMENT
(Pending) 510(k) Number:
InteMesh™ Silicone-Coated Sling and Surgical Mesh Device Name: with Inhibizone™
Indications for Use:
The AMS InteMesh™ Silicone-Coated Sling and Surgical Mesh with InhibiZone™ The AMS Intellest -- Sillconc-Oouted only and Stinary incontinence resulting is an ifriplant that is intended for the troundation to reinforce soft tissues from themial hypermobility of 102 ailed on gastroenterological or gastroenterological where weakless exists in the drological gynoseres
anatomy. This includes, but is not limited to pubourethral support and bladder support.
Prescription Use
(Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter-Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number K642592