(76 days)
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.
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.
The provided text is a 510(k) summary for a medical device (Restorelle® Y Contour, a surgical mesh) and does not contain information about acceptance criteria or a study proving device performance using AI or clinical outcomes data. This document is focused on demonstrating substantial equivalence to a predicate device based on material, design, and intended use.
Therefore, many of the requested categories related to AI models and clinical studies cannot be populated from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance in the context of an AI model or clinical trial with specific performance metrics are provided. The document focuses on demonstrating equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set for an AI model or clinical study data is reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No ground truth established by experts for a test set is reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is reported.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth in the context of an AI model or clinical study is reported. The regulatory filing establishes "ground truth" through comparison to an existing predicate device based on its established safety and efficacy.
8. The sample size for the training set
Not applicable. No training set for an AI model is mentioned.
9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is mentioned.
Summary of available information from the document:
This 510(k) submission for the Restorelle® Y Contour surgical mesh demonstrates substantial equivalence to a predicate device (Restorelle® Y), rather than providing novel performance data from a specific study against acceptance criteria.
The basis for equivalence is primarily due to:
- Identical materials: Non-absorbable, monofilament polypropylene mesh.
- Identical intended use: As a bridging material for sacrocolposuspension/sacrocolpopexy for vaginal vault prolapse.
- Identical technological characteristics except for a minor dimension change (sacral flap reduced from 4 cm to 3 cm).
- Identical pore size and sterilization method.
The manufacturer states: "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."
Therefore, the "proof" the device meets implied safety and effectiveness criteria is by demonstrating it is functionally the same as a previously cleared device. No new studies were conducted or reported for this submission to establish new performance metrics.
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K123914
Page 1 of 2
510(k) Summary
ﺎ ﺳﺮ
MAR 0 5 2013
| Submitter: | Coloplast A/SHoltedam 1Humlebaek Denmark |
|---|---|
| Company Contact: | Tim CrabtreeRegulatory Affairs ManagerPhone: 612.302.4922 Fax: 612.287.4138usticr@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 VaginalProlapse, 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.
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K123914
page 2 of 2
| Property | Subject DeviceRestorelle Y Contour | Predicate DeviceRestorelle Y |
|---|---|---|
| Indications | Restorelle L PolypropyleneMesh is indicated for use as abridging material forsacrocolposuspension /sacrocolpopexy (laparotomylaparoscopic or roboticapproach) where surgical | Restorelle Y PolypropyleneMesh is indicated for use as abridging material forsacrocolposuspension /sacrocolpopexy (laparotomylaparoscopic or roboticapproach) where surgical |
| treatment for vaginal vaultprolapse is warranted. | treatment for vaginal vaultprolapse is warranted. | |
| Material | Non-absorbable, monofilamentpolypropylene mesh | Non-absorbable, monofilamentpolypropylene 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 |
| SterilizationMethod | Ethylene Oxide | Ethylene Oxide |
| ProductCode | 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.
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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.
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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
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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
§ 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.