(16 days)
Restorelle polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
Restorelle is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Restorelle polypropylene mesh is constructed using a warp-knit process that permits the mesh to be cut into desired shape or size without unraveling. It maintains excellent isotropic properties arising from its knitted construction. Restorelle polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability properties which permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.
The provided text is a 510(k) summary for the Restorelle™ polypropylene mesh and does not contain information about a study that proves the device meets specific acceptance criteria in the manner of a performance study with a test set, ground truth, or human reader evaluations.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's a breakdown based on the information available:
Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (like accuracy, sensitivity, specificity, etc.) with numerical targets for a device under evaluation. Instead, the "acceptance criteria" appear to be broadly demonstrating that the device is "substantially equivalent" to predicate devices through various technical and material properties.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility comparable to predicate devices | "The components of the Restorelle device have been subjected to biocompatibility... testing and are substantially equivalent to the predicate Restorelle (K092207) and Minimesh devices (K041632 & K053361)." |
| Mechanical properties (strength, flexibility, durability) | "The device has been subjected to in-vitro testing which demonstrate the ability of the device to adequately permit correct adaptation to the various stresses encountered in the body during normal clinical use." Specifically, "In vitro (bench) tests: Retention, Mechanical, Mass density testing" were conducted. The device "has the necessary strength, flexibility, durability and surgical adaptability properties." |
| Material and manufacturing process (polypropylene mesh, warp-knit) | "Restorelle polypropylene mesh is constructed from knitted monofilaments of extruded polypropylene," similar to the predicate. The "warp-knit process... permits the mesh to be cut into desired shape or size without unraveling." "It maintains excellent isotropic properties arising from its knitted construction." The device has the "same intended use, general design, material and fundamental scientific technology as the predicate Restorelle polypropylene mesh device (K092207)." |
| Sterility | "The device is supplied sterile." (This is a statement of status, not a direct performance outcome from the listed tests, but a requirement for such devices.) |
| Indicated Use | "Restorelle polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route." This is stated to be the "same intended use" as the predicate, therefore demonstrating equivalence. |
Study Details for this 510(k) Submission:
This 510(k) summary describes a submission for substantial equivalence based on non-clinical (bench) testing and comparison to predicate devices, not a clinical performance study involving patient data, ground truth labels, or human reader evaluations in the context of AI/diagnostic device assessment.
Here's why many of the requested items are not applicable or cannot be answered from this document:
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Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the physical mesh samples subjected to in-vitro (bench) mechanical and biocompatibility tests, not a dataset of patient images or clinical cases. The document does not specify the number of samples used for these bench tests, nor does it discuss data provenance in terms of country of origin or retrospective/prospective for clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" established by experts in the context of this bench testing for a polypropylene mesh. The "truth" is determined by the physical properties measured in the lab.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There is no adjudication method described as this is not a diagnostic or AI performance study with expert readers.
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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. This is not a study involving human readers or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or software device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of clinical "ground truth." The "ground truth" for the non-clinical tests would be the established physical properties and biocompatibility standards required for medical devices of this type, as demonstrated by the predicate devices.
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The sample size for the training set: Not applicable. There is no AI algorithm being trained.
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How the ground truth for the training set was established: Not applicable.
In summary: This document clearly states, under "Summary Of Clinical Tests Submitted (As Applicable)," that it is "Not applicable." The entire submission is based on non-clinical (in-vitro bench) tests and comparison of technological characteristics to already-approved predicate devices to demonstrate substantial equivalence, rather than a clinical performance study involving patient data or AI algorithm validation.
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KIOSS68 レ.. . .
Image /page/0/Picture/1 description: The image shows the logo for Coloplast. The logo consists of a circular graphic on the left and the word "Coloplast" on the right. The circular graphic is divided into horizontal lines, with the bottom half being solid black and the top half being white lines on a black background. The word "Coloplast" is written in a bold, sans-serif font.
3 510(k) Summary
'
DEC 2 2 2010
:
| 510(k) Owner/SUBMITTER | Coloplast A/S |
|---|---|
| Holtedam 1 | |
| Humlebaek 3050 - Denmark | |
| CONTACT PERSON | Janell A. Colley |
| Coloplast Corp | |
| 1601 West River Road North | |
| Minneapolis, Minnesota 55411 USA | |
| DATE PREPARED | 20 December 2010 |
| CLASSIFICATION | Polymeric Surgical Mesh (Product Code FTL) is a Class II device per 21 CFR878.3300 |
| COMMON NAME | Polymeric Surgical Mesh |
| PROPRIETARY NAME | Restorelle™ polypropylene mesh |
| PREDICATE DEVICE | K092207 - Restorelle |
| K041632 & K053361 - Minimesh (Mpathy Medical Ltd) | |
| DEVICE DESCRIPTION | Restorelle is a non-absorbable polypropylene mesh constructed from knitted |
| monofilaments of extruded polypropylene. | |
| Restorelle polypropylene mesh is constructed using a warp-knit process that | |
| permits the mesh to be cut into desired shape or size without unraveling. | |
| It maintains excellent isotropic properties arising from its knitted construction. | |
| Restorelle polypropylene mesh has the necessary strength, flexibility, | |
| durability and surgical adaptability properties which permit the correct | |
| adaptation to the various stresses encountered in the body. | |
| The device is supplied sterile. | |
| INDICATIONS | Restorelle polypropylene mesh may be used for the repair of abdominal wall |
| hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse | |
| and other fascial deficiencies that require support material. It may be used in | |
| open or laparoscopic abdominal procedures or for repair by the vaginal route. | |
| TESTING | The components of the Restorelle device have been subjected to |
| biocompatibility and mechanical testing and are substantially equivalent to the | |
| predicate Restorelle (K092207) and Minimesh devices (K041632 & K053361). | |
| TECHNOLOGICALCHARACTERISTICS | Restorelle polypropylene mesh has the same intended use, general design, |
| material and fundamental scientific technology as the predicate Restorelle | |
| Summary Of The NonclinicalTests Submitted | polypropylene mesh device (K092207).In vitro (bench) tests: Retention, Mechanical, Mass density testing |
| Summary Of Clinical TestsSubmitted (As Applicable) | Not applicable |
| Conclusions Drawn From TheNonclinical And Clinical Tests | The device has been subjected to in-vitro testing which demonstrate the |
| ability of the device to adequately permit correct adaptation to the various | |
| stresses encountered in the body during normal clinical use. |
.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Coloplast A/S % Coloplast Corporation Ms. Janell A. Colley 1601 West River Road N Minneapolis, Minnesota 55411
DEC 2 2 200
Re: K103568
Trade/Device Name: Restorelle Polypropylene Mesh Regulation Number: 21 CFR 878,3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: December 3, 2010 Received: December 6, 2010
Dear Ms. Colley:
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. Iisting 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
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Page 2 - Ms. Janell A. Colley
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 vours.
AK B. Nh
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEC 2 2 2010
Statement of Indications for Use 2
Indications for Use
510(k) Number (if known):
Device Name:
Restorelle Polypropylene Mesh
Indications for Use:
Restorelle polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
Prescription Use X
Over-The-Counter Use
(Part 2) CFR 80T Subpart D)
AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ae us-nch fmxn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number /C103568
§ 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.