(30 days)
Not Found
No
The summary describes a physical mesh device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a surgical mesh used to provide mechanical support and bridging material, not to treat a disease or condition therapeutically.
No
The device is a surgical mesh used for treating vaginal vault prolapse, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a "sterile mesh constructed of knitted non-absorbable monofilaments of polypropylene," which is a physical 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 testing is done outside of the body (in vitro).
- Device Description: The Restorelle M and XL Polypropylene Mesh devices are described as surgical implants made of polypropylene mesh. They are used within the body during surgery to support the vaginal vault.
- Intended Use: The intended use is as a bridging material for surgical procedures (sacrocolposuspension / sacrocolpopexy) to treat vaginal vault prolapse. This is a surgical intervention, not a diagnostic test performed on a specimen.
The information provided clearly indicates this is a surgical implant device, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
OTO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
apical vaginal prolapse
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)
Not Found
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.
Restorelle L (K122440)
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
2 2013
AUG
2. 510(k) Summary
| 510(k) Owner's Name: | Coloplast A/S | |
|---|---|---|
| Address: | Holtedam 1 | |
| 3050 Humlebaek, Denmark | ||
| Establishment Registration: 9610694 | ||
| Owner/Operator: 8010144 | ||
| Phone/Fax: | Office: (612) 302-4922 | |
| Fax: (612) 287-4138 | ||
| Name of Contact Person: | Tim Crabtree | |
| Regulatory 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 Vaginal | |
| Prolapse, 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.
1
| Property | Subject Devices
Restorelle M & XL | Predicate Device
Restorelle L |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | 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 | Non-absorbable, monofilament
polypropylene mesh | Non-absorbable, monofilament
polypropylene 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 |
| Sterilization
Method | Ethylene Oxide | Same |
| Regulatory
Status | 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.
2
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
3
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
4
- 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 ------
!
:
. -
--
- . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(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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