(30 days)
Restorelle M and XL Polypropylene Mesh devices are indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Restorelle M and Restorelle XL Polypropylene Mesh are provided as sterile mesh constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. Restorelle M is a flat mesh measuring 10cm x 15cm. Restorelle XL is a flat mesh measuring 30cm. Both are designed for the treatment of apical vaginal prolapse.
The provided document is a 510(k) summary for a medical device (surgical mesh), which focuses on demonstrating substantial equivalence to a predicate device. This type of regulatory submission does not typically contain the detailed information requested regarding acceptance criteria and a study proving a device meets those criteria in the way a clinical trial or performance study report would.
510(k) submissions, especially for devices claiming substantial equivalence based on material and design similarities, often rely on non-clinical data (e.g., material properties, dimensions) and comparison to a legally marketed predicate. They don't usually involve acceptance criteria related to AI/algorithm performance, human reader studies, or detailed ground truth establishment as would be present for AI/ML-based medical devices or devices with novel performance claims requiring rigorous clinical validation.
Therefore, many of your requested points cannot be answered from the provided text.
Here's an analysis of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies that the acceptance criteria for the subject devices (Restorelle M & XL) are that they are "substantially equivalent" to the predicate device (Restorelle L) in terms of indications, materials, and technological characteristics. The specific metrics for "performance" are based on physical properties, not clinical outcomes in a comparative study.
- Reported Device Performance: The document reports the physical characteristics of both the subject and predicate devices. The "performance" is demonstrated by the equivalence of these characteristics.
| Property | Acceptance Criteria (Equivalent to Predicate) | Reported Subject Device Performance (Restorelle M & XL) | Reported Predicate Device Performance (Restorelle L) |
|---|---|---|---|
| Indications | Must be equivalent to predicate: "Indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted." | "Restorelle M & XL Polypropylene Mesh devices are indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted" | "Restorelle L Polypropylene Mesh is indicated for use as bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic, or robotic approach) where surgical treatment for vaginal vault prolapse is warranted" |
| Materials of Construction | Must be equivalent to predicate: "Non-absorbable, monofilament polypropylene mesh" | "Non-absorbable, monofilament polypropylene mesh" | "Non-absorbable, monofilament polypropylene mesh" |
| Dimensions | Not specified as "equivalent" but rather that differences are acceptable if other properties are equivalent and safety/effectiveness maintained. (The subject devices have different dimensions from the predicate). | 10cm x 15cm (M), 30cm x 30cm (XL) | 24cm x 8cm (L) |
| Shape | Must be equivalent to predicate: "Flat" | "Flat" | "Flat" |
| Pore Size (mm) | Must be equivalent to predicate: "1.80 x 1.83" | "1.80 x 1.83" | "1.80 x 1.83" |
| Sterilization Method | Must be equivalent to predicate: "Ethylene Oxide" | "Ethylene Oxide" | "Same" (meaning Ethylene Oxide as per previous submission) |
| Regulatory Status | Implied: Pending | Pending | Cleared K122440 (L) |
| Product Code | Must be equivalent to predicate: "OTO" | OTO | OTO |
The overarching "acceptance criterion" as explicitly stated in the Conclusions: "The performance and non-clinical referenced demonstrate that the Restorelle M and XL Polypropylene Mesh devices are substantially equivalent to Restorelle L Polypropylene Mesh."
The following information cannot be found in the provided 510(k) summary:
- 2. Sample size used for the test set and the data provenance: Not applicable here as this is a physical device comparison, not a data-based algorithm.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- 4. Adjudication method for the test set: Not applicable.
- 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, as this is not an AI/ML device or an imaging device requiring human reader interpretation.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not applicable as this is not an AI/ML device requiring clinical ground truth for performance. The "ground truth" for this submission is the established properties and safety of the predicate device.
- 8. The sample size for the training set: Not applicable (no AI/ML model).
- 9. How the ground truth for the training set was established: Not applicable (no AI/ML model).
Summary of the Study/Evidence Provided:
The "study" in this context is the submission for a 510(k) premarket notification. The company Coloplast A/S is seeking clearance for two new mesh sizes (Restorelle M and XL) by demonstrating their substantial equivalence to a previously cleared predicate device, Restorelle L (K122440).
The core of the study is a comparison of technological characteristics. The "performance" is proven by showing that the new devices share the "same materials, features, intended use, and technological characteristics" as the predicate device, with the only difference being the mesh size.
This is a non-clinical comparison study, relying on the established safety and effectiveness of the predicate device rather than new clinical trials on the subject devices themselves.
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2 2013
AUG
2. 510(k) Summary
| 510(k) Owner's Name: | Coloplast A/S | |
|---|---|---|
| Address: | Holtedam 13050 Humlebaek, DenmarkEstablishment Registration: 9610694Owner/Operator: 8010144 | |
| Phone/Fax: | Office: (612) 302-4922Fax: (612) 287-4138 | |
| Name of Contact Person: | Tim CrabtreeRegulatory Affairs Manager | |
| Date Prepared: | July 2, 2013 | |
| Trade or Proprietary Name: | Restorelle M & XL Polypropylene Mesh | |
| Common or Usual Name: | Surgical Mesh | |
| Classification Name/ | Mesh, Surgical, Gynecological, For Apical VaginalProlapse, Transabdominally Placed | |
| CFR Number/Product Code: | 21 CFR §878.3300/ OTO | |
| Predicate Devices: | Restorelle L (K122440) |
Description of Device: Restorelle M and Restorelle XL Polypropylene Mesh are provided as sterile mesh constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. Restorelle M is a flat mesh measuring 10cm x 15cm. Restorelle XL is a flat mesh measuring 30cm. Both are designed for the treatment of apical vaginal prolapse.
Indication for Use: Restorelle M and Restorelle XL Polypropylene Mesh devices are 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.
Technological Characteristics Summary: The Coloplast Restorelle M and Restorelle XL Polypropylene Mesh devices share the same materials, features, intended use, and technological characteristics as Restorelle L. The following table lists the properties associated with the subject and predicate devices.
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| Property | Subject DevicesRestorelle M & XL | Predicate DeviceRestorelle L |
|---|---|---|
| Indications | Restorelle M & XLPolypropylene Mesh devicesare indicated for use as bridgingmaterial forsacrocolposuspension /sacrocolpopexy (laparotomylaparoscopic or roboticapproach) where surgicaltreatment for vaginal vaultprolapse is warranted | Restorelle L PolypropyleneMesh is indicated for use asbridging material forsacrocolposuspension/sacrocolpopexy (laparotomy,laparoscopic, or roboticapproach) where surgicaltreatment for vaginal vaultprolapse is warranted |
| Materials ofConstruction | Non-absorbable, monofilamentpolypropylene mesh | Non-absorbable, monofilamentpolypropylene mesh |
| Dimensions | 10cm x 15cm (M)30cm x 30cm (XL) | 24cm x 8cm (L) |
| Shape | Flat | Flat |
| Pore Size (mm) | 1.80 × 1.83 | 1.80 x 1.83 |
| SterilizationMethod | Ethylene Oxide | Same |
| RegulatoryStatus | Pending | Cleared K122440 (L) |
| Product Code | OTO | OTO |
The only difference in between the subject and predicate devices is the mesh size. Therefore the proposed subject device is substantially equivalent to the referenced predicate devices for indications, materials and technological features.
Conclusions: The performance and non-clinical referenced demonstrate that the Restorelle M and XL Polypropylene Mesh devices are substantially equivalent to Restorelle L Polypropylene Mesh.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 2, 2013
Coloplast A/S % Tim Crabtree Regulatory Affairs Manager Coloplast Corp. 1601 West River Road Minneapolis, MN 55411
Re: K132061
Trade/Device Name: Restorelle M and Restorelle XL Polypropylene Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: July 2, 2013 Received: July 3, 2013
Dear Tim 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
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Page 2 - Tim 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 (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 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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Beniamin 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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- Statement of Indications for Use
Indications for Use
510(k) Number (if known): _ K132061
Restorelle M and Restorelle XL Polypropylene Mesh Device Name:
Restorelle M and XL Polypropylene Mesh devices are 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
Over-The-Counter Use ------
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(Part 21 CFR 801 Subpart D)
AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ooseeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P., Lerner -S
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K132061 510(k) Number_
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§ 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.