(76 days)
Not Found
No
The description focuses on the material and design of a surgical mesh, with no mention of AI or ML capabilities.
Yes.
The device is indicated for use in surgical treatment for vaginal vault prolapse, which is a therapeutic intervention.
No
Explanation: The device description states that Restorelle Y Contour is a "bridging material" for surgical treatment of vaginal vault prolapse. It is a sterile mesh used for repair, not for diagnosing a condition.
No
The device description explicitly states it is a "sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene," indicating it is a physical hardware 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 it's a "bridging material for sacrocolposuspension / sacrocolpopexy" for treating vaginal vault prolapse. This is a surgical procedure performed in vivo (within the body).
- Device Description: The device is described as a "sterile mesh" made of polypropylene, designed for surgical implantation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not perform any such function.
Therefore, the Restorelle Y Contour is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Restorelle Y Contour is indicated for use as a bridging material for sacrocolposuspension / 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-Mesh, Surgical, Gynecological, For Apical Vaginal Prolapse, Transabdominally Placed., OTO
Device Description
Restorelle R Contour is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a Y shaped mesh that is designed for the treatment of apical vaginal prolapse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal
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)
Non-clinical performance testing, biocompatibility testing, shelf life and sterilization validations were not required for the Restorelle Y Contour since the proposed mesh is identical in materials and design as that used in the predicate Restorelle Y device. The results and data from these studies are applicable to the Restorelle Contour device.
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
K123914
Page 1 of 2
510(k) Summary
ﺎ ﺳﺮ
MAR 0 5 2013
| Submitter: | Coloplast A/S
Holtedam 1
Humlebaek Denmark |
|--------------------|-------------------------------------------------------------------------------------------------------------|
| Company Contact: | Tim Crabtree
Regulatory Affairs Manager
Phone: 612.302.4922 Fax: 612.287.4138
usticr@coloplast.com |
| Date Prepared: | December 14, 2012 |
| Device Name: | Restorelle® Y Contour |
| Common Name: | Surgical Mesh |
| Regulation: | 21 CFR §878.3300 |
| Regulatory Class: | Class II |
| Product Code: | OTO-Mesh, Surgical, Gynecological, For Apical Vaginal
Prolapse, Transabdominally Placed. |
| Predicate Devices: | Restorelle® Y (K112322) |
Description of Device: Restorelle L Contour is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a Y shaped mesh that is designed for the treatment of apical vaginal prolapse.
Indication for Use: Restorelle Y Contour is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Technological Characteristics Summary: The Coloplast Restorelle Y Contour shares the same materials, features, intended use, and technological characteristics as Restorelle Y. Restorelle Y Contour differs in the sacral flap dimension which is 3 cm wide versus the 4 cm wide of the original Restorelle Y. All other properties, materials, packaging, shelf life and sterilization remain unchanged.
1
K123914
page 2 of 2
| Property | Subject Device
Restorelle Y Contour | Predicate Device
Restorelle Y |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Restorelle L Polypropylene
Mesh is indicated for use as a
bridging material for
sacrocolposuspension /
sacrocolpopexy (laparotomy
laparoscopic or robotic
approach) where surgical | Restorelle Y Polypropylene
Mesh is indicated for use as a
bridging material for
sacrocolposuspension /
sacrocolpopexy (laparotomy
laparoscopic or robotic
approach) where surgical |
| | treatment for vaginal vault
prolapse is warranted. | treatment for vaginal vault
prolapse is warranted. |
| Material | Non-absorbable, monofilament
polypropylene mesh | Non-absorbable, monofilament
polypropylene mesh |
| Dimensions | 24x 3cm | 24 x 4cm & 27 x 4cm |
| Shape | Y | Y |
| Pore Size
(mm) | 1.80 x 1.83 | 1.80 x 1.83 |
| Sterilization
Method | Ethylene Oxide | Ethylene Oxide |
| Product
Code | OTO | OTO |
The only difference in properties between the subject and predicate devices is size. Since the subject device falls in the range between the predicated devices, no new issues, regarding safety and efficacy, have been identified. Therefore the subject device is substantially equivalent to the cited predicate devices for indications, materials and technological features.
Performance Summary: Non-clinical performance testing, biocompatibility testing, shelf life and sterilization validations were not required for the Restorelle Y Contour since the proposed mesh is identical in materials and design as that used in the predicate Restorelle Y device. The results and data from these studies are applicable to the Restorelle Contour device.
Conclusions: The performance and non-clinical cited supporting this submission demonstrates that the Restorelle Y Contour is substantially equivalent to Restorelle Y mesh.
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 eagle with three lines representing its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2013
Coloplast A/S % Mr. Tim Crabtree Regulatory Affairs Manager Coloplast Corporation 1601 West River Road North MINNEAPOLIS MN 55411
Re: K123914
Trade/Device Name: Restorelle® Y Contour Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: February 4, 2013 Received: February 7, 2013
Dear Mr. 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.
3
Page 2 – Mr. Tim Crabtree
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 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,
Image /page/3/Picture/9 description: The image shows the name "Benjamin R Fisher-S" in a stylized font. The words are written in black ink on a white background. The letters "R" and "F" are stylized with a geometric pattern.
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
Indications for Use Statement
510(k) Number (if known): K123914
Device Name: Restorelle® Y Contour
Indications for Use: Restorelle Y Contour is indicated for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Benjamin Bestisky
2013.03.05 05 03.03 05 0
uctive, Gastro-Renal, and k) Number
2