(119 days)
Not Found
No
The summary describes a physical mesh device made of polypropylene and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
No
The device is a surgical mesh used for structural repair and does not actively treat a disease or condition.
No
The device, IntePro® Y-Mesh, is described as a surgical mesh constructed of polypropylene intended for use in vaginal prolapse repair via sacrocolpopexy procedures. Its purpose is to repair, not diagnose, a medical condition.
No
The device description explicitly states it is constructed of polypropylene suture knitted together to form a mesh, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- IntePro® Y-Mesh Function: The IntePro® Y-Mesh is a surgical implant used to physically repair vaginal prolapse. It is placed within the body during a surgical procedure. It does not analyze or test any bodily specimens.
The provided information clearly describes a surgical mesh used for structural support, not a device for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The IntePro® Y-Mesh is intended for use in vaginal prolapse repair via abdominal sacrocolpopexy procedures, including but not limited to open, laparoscopic, and robotically assisted surgical approaches.
Product codes
OTO
Device Description
The IntePro® Y-Mesh is constructed of polypropylene suture (fibers) knitted together to form a mesh. The mesh has bi-directional elasticity and resists unraveling. The mesh is provided as a sterile, single use device in a pre-formed Y-shape for sacrocolpopexy procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal, uterine
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)
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.
0
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510(k) Summary As required by 21CFR 807.92
| 510(k) Number: | K121805 | OCT 16 2012 |
|---|---|---|
| Date Prepared: | August 29, 2012 | |
| Submitter's Name/ | ||
| Address: | American Medical Systems | |
| 10700 Bren Road W. | ||
| Minnetonka, MN 55343 | ||
| Contact Person: | Laura Moen-Ftacek | |
| Principal Regulatory Affairs Specialist | ||
| Tel: 952-930-6426 | ||
| Fax: 952-930-5785 | ||
| Laura.Moen-Ftacek@AmericanMedicalSystems.com | ||
| Alternate Contact: | Melanie Hess | |
| Director, Regulatory Affairs | ||
| Tel: 952-939-6094 | ||
| Fax: 952-930-5785 | ||
| Melanie.Hess@AmericanMedicalSystems.com | ||
| Device Information: | ||
| Trade Name: | ||
| Common Name: | ||
| Classification Name: | IntePro® Y-Mesh | |
| Surgical Mesh | ||
| Mesh, surgical, synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed |
Predicate Device:
IntePro® AMS Large Pore Polypropylene Mesh (K040521)
Product Code:
Device Description:
The IntePro® Y-Mesh is constructed of polypropylene suture (fibers) knitted together to form a mesh. The mesh has bi-directional elasticity and resists unraveling. The mesh is provided as a sterile, single use device in a pre-formed Y-shape for sacrocolpopexy procedures.
ото
Indications for Use:
The IntePro® Y-Mesh is intended for use in vaginal prolapse repair via abdominal sacrocolpopexy procedures, including but not limited to open, laparoscopic, and robotically assisted surgical approaches.
Summary of the Technical Characteristics to the Predicate Device(s):
All technical characteristics of the proposed device are identical to those of the predicate, including device design, materials of construction, manufacturing process and intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 16 2012
Ms. Renee Mellum Senior Regulatory Affairs Associate American Medical Systems 10700 Bren Road West MINNETONKA MN 55343
Re: K121805
Trade/Device Name: IntePro® Y-Mesh Regulation Number: 21 CFR& 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: October 1, 2012 Received: October 3, 2012
Dear Ms. Mellum:
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 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
2
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. Firkle
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
Indications for Use
510(k) Number (if known): K121805
Device Name: IntePro® Y-Mesh
Indications for Use: The IntePro® Y-Mesh is intended for use in vaginal prolapse repair via abdominal sacrocolpopexy procedures, including but not limited to open, laparoscopic, and robotically assisted surgical approaches.
X 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)
Jopph K. Khaz
(Division Sign-Off) ( vision of Reproductive, Gastro-Renal, an Urological Devices 510(k) Number =
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