(27 days)
Not Found
No
The summary describes a physical mesh device and its intended use, with no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is indicated for use as bridging material for sacrocolposuspension/sacrocolpopexy, which are surgical treatments for vaginal vault prolapse. Its purpose is to restore anatomical structure and function, thereby providing a therapeutic benefit to the patient.
No
The document describes a surgical mesh used for treating vaginal vault prolapse, not a device used for diagnosing a medical condition.
No
The device description clearly states it is a physical mesh constructed of polypropylene, which is a hardware component.
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.
- Device Description: The Restorelle Y Contour Polypropylene Mesh is a surgical implant made of polypropylene. It is designed to be surgically placed within the body to support the vaginal vault.
- Intended Use: The intended use is as a "bridging material for sacrocolposuspension / sacrocolpopexy" to treat vaginal vault prolapse. This is a surgical procedure performed directly on the patient's anatomy.
The device is a surgical implant used in vivo (within the living body), not a device used to test in vitro (outside the living body) specimens.
N/A
Intended Use / Indications for Use
Restorelle Y Contour Polypropylene Mesh device is indicated for use as bridging material for sacrocolposuspension and/or sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Product codes (comma separated list FDA assigned to the subject device)
OTO
Device Description
Restorelle Y Contour Polypropylene Mesh is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It is designed for the treatment of vaginal vault prolapse. The Y shape design allows the two Y-leg segments to be attached to the anterior and posterior vaginal walls. The base of the Y segment is designed to attach to the sacral ligament.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal vault
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)
The changes proposed in this Special 510(K) were evaluated through sterilization validation and packaging integrity testing.
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
K140116 pg 1 of 2
510(k) Summary
FEB 12 2014
| 510(k) Owner's Name: | Coloplast A/S |
|---|---|
| Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Establishment Registration: 9610694 | |
| Owner/Operator: 8010144 | |
| Phone/Fax/Email: | Office: (612) 302-4922 |
| Fax: (612) 287-4138 | |
| Name of Contact Person: | Tim Crabtree |
| Regulatory Affairs Manager | |
| Date Prepared: | February 10, 2014 |
| Trade or Proprietary Name: | Restorelle Y Contour Polypropylene Mesh |
| Common or Usual Name: | Surgical mesh |
| CFR Number/Product Code: | 21 CFR §878.3300/OTO (mesh, surgical, |
| synthetic, urogynecologic, for apical vaginal | |
| and uterine prolapse, transabdominally | |
| placed) | |
| Predicate Devices: | Restorelle Y Contour (K123914) |
Description of Device: Restorelle Y Contour Polypropylene Mesh is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It is designed for the treatment of vaginal vault prolapse. The Y shape design allows the two Y-leg segments to be attached to the anterior and posterior vaginal walls. The base of the Y segment is designed to attach to the sacral ligament.
Indication for Use: Restorelle Y Contour Polypropylene Mesh device is indicated for use as bridging material for sacrocolposuspension and/or sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
1
The Indications for Use statement for the Restorelle Y Contour Polypropylene Mesh is identical to that of its proposed predicate device.
Technological Characteristics Summary: Restorelle Y Contour Polypropylene Mesh has the same technological characteristics as the proposed predicate device include material, dimensions, and design.
Performance Data: The changes proposed in this Special 510(K) were evaluated through sterilization validation and packaging integrity testing.
Conclusions: Restorelle Y Contour Polypropylene Mesh is substantially equivalent to its proposed predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2014
Coloplast A/S Timothy Crabtree Regulatory Affairs Manager 1601 West River Road Minneapolis, MN 55411
Re: K140116
Trade/Device Name: Restorelle® Y Contour Polypropylene Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: OTO Dated: January 14, 2014 Received: January 16, 2014
Dear Timothy Crabtree,
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
3
Page 2 - Timothy Crabtree
(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/ReportalProblem/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 vours.
Image /page/3/Picture/6 description: The image shows the name "Benjamin Fisher-S" with the letters "FDA" in between the first and last name. The letters "FDA" are stylized with a triple outline. The text is in black and the background is white.
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
- Statement of Indications for Use
Indications for Use
K140116 510(k) Number (if known):
Restorelle Y Contour Polypropylene Mesh Device Name:
Restorelle Y Contour Polypropylene Mesh device is indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
| (Prescription Use | X) |
|---|---|
| ------------------- | ---- |
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use
AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Benjamin Disk -S .
2014.02 -05'00'
Concurrence of CDRH, Office of Device Evaluation (ODE)