(101 days)
No
The summary describes a surgical mesh made of polypropylene and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for surgical treatment of vaginal vault prolapse, which is a therapeutic intervention.
No
The device is a surgical mesh used for treating vaginal vault prolapse, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene," indicating it is a physical medical 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 describes a surgical implant used in vivo (within the body) during a surgical procedure.
- Device Description: The description confirms it's a "sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene." This is a physical implant, not a reagent or instrument used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Restorelle L 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.
Product codes
OTO
Device Description
Restorelle L Polypropylene Mesh is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a flat mesh measuring 24cm x 8cm and 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
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)
Non-clinical performance testing, biocompatibility testing, shelf life and sterilization validations were not required for the Restorelle L 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 L device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Restorelle® Y (K112322), Vertessa™ Polypropylene Mesh (K120327)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Page 1 of 2
510(k) Summary
K122440
| Submitter: | Coloplast A/S
Holtedam 1
Humlebaek Denmark | | NOV 1 9 2012 |
|--------------------|-------------------------------------------------------------------------------------------------------------|--|--------------|
| Company Contact: | Tim Crabtree
Regulatory Affairs Manager
Phone: 612.302.4922 Fax: 612.287.4138
usticr@coloplast.com | | |
| Date Prepared: | November 6, 2012 | | |
| Device Name: | Restorelle® L | | |
| 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), Vertessa™ Polypropylene Mesh
(K120327) | | |
Description of Device: Restorelle L Polypropylene Mesh is provided as a sterile mesh that is constructed of knitted non-absorbable monofilaments of polypropylene, a synthetic polymer. It consists of a flat mesh measuring 24cm x 8cm and is designed for the treatment of apical vaginal prolapse.
Indication for Use: Restorelle L 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.
Technological Characteristics Summary: The Coloplast Restorelle L shares the same materials, features, intended use, and technological characteristics as Restorelle Y. Restorelle L also shares the same materials, intended use and shape of the Vertessa Polypropylene Mesh. The follow table lists the properties associated with the subject and predicate devices.
1
K122440
Page 2 of 2
| Property | Subject Device
Restorelle L | Predicate Device
Restorelle Y | Predicate Device
Vertessa
Polypropylene Mesh |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | Restorelle L
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. | 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. | Vertessa may be used
for the repair of uterine
or vaginal vault
prolapse that requires
support material. It
may be used in open or
laparoscopic abdominal
procedures. |
| Materials of
Construction | Non-absorbable,
monofilament
polypropylene mesh | Non-absorbable,
monofilament
polypropylene mesh | Non-absorbable,
monofilament
polypropylene mesh |
| Dimensions | 24x8cm | 24 x 4cm & 27 x 4cm | 12x20cm / Flat |
| Shape | Flat | Y | Flat |
| Pore Size (mm) | 1.80 x 1.83 | 1.80 x 1.83 | 1.47 x 0.64 |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Product Code | OTO | 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 L 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 L device.
Conclusions: The performance and non-clinical cited supporting this submission demonstrates that the Restorelle L is substantially equivalent to Restorelle Y and Vertessa Polypropylene Mesh.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 19, 2012
Coloplast A/S % Mr. Tim Crabtree Regulatory Affairs Manager Coloplast Corp. 1601 West River Road North MINNEAPOLIS MN 5541 I
Re: K122440
Trade/Device Name: Restorelle® L Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: October 10, 2012 Received: October 11, 2012
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 vour 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.
ff 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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): K122440
Device Name: Restorelle® L
Indications for Use: Restorelle L is indicated for use as a bridging material for Indications for Use: Resiorene L Is millementomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use (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)
Benjamin R. Fisher -S 2012.11.19 15:12:57,05500'
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and Urological Devices | |
| 510(k) Number | K122440 |
Colopiast Restorelle L
18