(15 days)
Not Found
Not Found
No
The summary describes a surgical mesh system and instruments, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is intended for the repair and reinforcement of soft tissues in various anatomical areas, including pubourethral support and vaginal prolapse repairs, which are therapeutic interventions.
No
The device is described as an implantable mesh assembly and surgical instruments used for reinforcing soft tissues and repairing prolapse, indicating a therapeutic or reconstructive purpose rather than diagnosis.
No
The device description explicitly states it consists of "permanently-implanted mesh assemblies and non-implanted surgical instruments," indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical system for reinforcing soft tissues and repairing prolapse in the urological, gynecological, and gastroenterological anatomy. This involves direct surgical intervention on the patient's body.
- Device Description: The device consists of permanently-implanted mesh assemblies and surgical instruments used for placement. This is a physical implant and surgical tool, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are typically used in laboratories or point-of-care settings to diagnose diseases or conditions.
Therefore, the Elevate Prolapse Repair System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Elevate Prolapse Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Product codes (comma separated list FDA assigned to the subject device)
OTP
Device Description
The Elevate System is part of the AMS Pelvic Floor Repair System family of devices. It consists of permanently-implanted mesh assemblies and non-implanted surgical instruments that are used as aids to place the mesh assembly in the pelvic floor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological, gynecological, and gastroenterological anatomy; pelvic floor
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)
A Design Failure Mode Effects and Criticality Analysis (dFMECA) was used to assess the impact of the modification. The performance parameters which were identified as potentially able to be affected by the modification were tested as mitigation. The testing demonstrated that the risks identified have been mitigated and that no new issues related to safety or efficacy were raised.
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.
Elevate Prolapse Repair System with IntePro Lite
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
§ 884.5980 Surgical mesh for transvaginal pelvic organ prolapse repair.
(a)
Identification. Surgical mesh for transvaginal pelvic organ prolapse repair is a prescription device intended to reinforce soft tissue in the pelvic floor. This device is a porous implant that is made of synthetic material, non-synthetic material, or a combination of synthetic and non-synthetic materials. This device does not include surgical mesh for other intended uses (§ 878.3300 of this chapter).(b)
Classification. Class III (premarket approval).(c)
Date premarket application approval or notice of completion of a product development protocol is required. A premarket application approval or notice of completion of a product development protocol for a device is required to be filed with the Food and Drug Administration on or before July 5, 2018, for any surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 5, 2018, been found substantially equivalent to a surgical mesh described in paragraph (a) of this section that was in commercial distribution before May 28, 1976. Any other surgical mesh for transvaginal pelvic organ prolapse repair shall have an approved premarket application or declared completed product development protocol in effect before being placed in commercial distribution.
0
APR - 2 2009
Image /page/0/Picture/1 description: The image shows the text "K090713 page 1 of 2" in a handwritten style. The text appears to be a page number or document identifier. The first line contains the alphanumeric string "K090713", and the second line indicates that it is "page 1 of 2".
| 2.6 | 510(k) Summary |
|---|---|
| Submitter: | American Medical Systems |
| 10700 Bren Road West | |
| Minnetonka, MN 55343 | |
| Phone: 952-933-4666 | |
| Fax: 952-930-6496 | |
| Contact Person: | Denise Thompson |
| Date Summary Prepared: | March 17, 2009 |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | Elevate Prolapse Repair System with PC |
| Coated IntePro Lite | |
| Device Classification Name: | Surgical Mesh, polymeric |
| Predicate Device: | Elevate Prolapse Repair System with IntePro Lite |
Device Description
The Elevate System is part of the AMS Pelvic Floor Repair System family of devices. It consists of permanently-implanted mesh assemblies and non-implanted surgical instruments that are used as aids to place the mesh assembly in the pelvic floor.
Indications for Use
The Elevate Prolapse Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Comparison to Predicate Devices
The Elevate System is identical to the previous version with the exception of a synthetic phosphorylcholine (PC) polymer coating being added to the center IntePro Lite section of the mesh assembly.
Supporting Information
A Design Failure Mode Effects and Criticality Analysis (dFMECA) was used to assess the impact of the modification. The performance parameters which were identified as potentially able to be affected by the modification were tested as mitigation. The testing demonstrated that the risks identified have been mitigated and that no new issues related to safety or efficacy were raised.
1
Image /page/1/Picture/0 description: The image shows handwritten text on a white background. The top line reads "K090713", with each character clearly written in black ink. Below this, the phrase "page 2 of 2" is written in a similar style, indicating it is the second page of a two-page document. The handwriting appears to be consistent throughout both lines.
3. Labeling
- Draft Labeling and Instructions for Use for the Elevate System with PC coated . IntePro Lite are provided in Appendix A.
- A copy of the predicate Labeling and Instructions for Use for the Elevate System . with IntePro Lite are provided in Appendix B.
Special 510(k) - AMS Elevate with PC Coated ELPP
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing another. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
American Medical Systems % Ms. Denise Thompson Sr. Regulatory Affairs Specialist 10700 Bren Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K090713 Trade/Device Name: Elevate Prolapse Repair System with PC Coated IntePro Lite Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP Dated: March 17, 2009 Received: March 18, 2009
Dear Ms. Thompson:
This letter corrects our substantially equivalent letter of April 2, 2009.
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 (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.
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
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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" (21 CFR 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.
Sincerely yours,
Benjamin R. Perkins
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
Page 1 of 1.
INDICATIONS FOR USE STATEMENT
K090713 510(k) Number (if known):
Device Name: Elevate Prolapse Repair System with PC Coated IntePro Lite
Indications For Use:
The AMS Elevate Prolapse Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Divisi: .. . gri-gii) Division of General, Restorative, Division of General, Restorative, and Neurological Devices and Neurological Devices
510(k) Number: K90115
Special 510(k) - AMS Elevate with PC Coal
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