(49 days)
Not Found
No
The document describes a surgical mesh kit and instruments, focusing on material composition, mechanical properties, and design modifications. There is no mention of AI, ML, image processing, or data-driven analysis.
Yes
The device is a surgical mesh kit intended for transvaginal surgical treatment to correct different types of prolapse, which are medical conditions, thus making it a therapeutic device.
No
Explanation: The device is described as a surgical mesh kit intended for transvaginal surgical treatment to correct prolapse. It is a therapy device, not a diagnostic one.
No
The device description explicitly states that the system consists of a permanently-implanted graft and non-implantable surgical instruments, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse" and similar conditions. This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device consists of a permanently-implanted graft and surgical instruments for placement. This is consistent with a surgical device, not an IVD which would typically involve reagents, analyzers, or test kits for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Elevate Prolapse Repair System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Elevate Anterior and Apical Prolapse Repair System: The Elevate Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse.
Elevate Apical and Posterior Prolapse Repair System: The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse.
Elevate Apical and Posterior Prolapse Repair System with InteXen® LP: The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse.
Product codes (comma separated list FDA assigned to the subject device)
OTP, PAI
Device Description
Each Elevate System consists of a permanently-implanted graft and non-implantable surgical instruments that can be used as aids to transvaginally place the graft assembly in the pelvic floor. The graft assemblies for the Elevate Anterior & Apical Prolapse Repair System and Elevate Apical & Posterior Prolapse Repair System are made from polymeric mesh (IntePro Lite), and in the case of the Elevate Apical & Posterior Prolapse Repair System with InteXen LP, the graft assembly is made from a combination of lyophilized porcine dermis and polymeric mesh (IntePro Lite).
The devices are identical to the predicate devices, AMS Elevate Prolapse Repair Systems, with the exception of the modification to the Apical Needle Passer Sheath. There are no changes to the implant graft design, shape, size, and material. The revisions to the indications for use of the modified devices are to further clarify the intended use of Elevate System as a kit for transvaginal surgical treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor, anterior wall, vaginal apical, posterior wall, posterior vaginal wall
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)
The modified sheath of the Elevate Anterior and Apical Prolapse Repair System, Elevate Apical & Posterior Prolapse Repair System, and Elevate Apical & Posterior Prolapse Repair System with InteXen LP has been tested for design verification and biocompatibility (cytotoxicity & physiochemical testing). Design verification testing of the sheath included the following tests:
- sheath compression strength and depth stop strength,
- trigger/sheath locking interface push strength,
- sheath cutout shear off strength and trigger/sheath locking interface pull strength.
- sheath engagement force into lock.
There were no modifications made to the packaging or sterilization of the devices as a result of the change; thus, no additional testing was required. There was no change to the intended use or the implant procedure as a result of the change: thus the Elevate Prolapse Repair Systems have equivalent clinical performance to the predicate devices and no clinical testing was required to support the sheath modification
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.
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.
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AMS
an oracle health solution
JUL 20 2012
Section 5
510(k) Summary
Submitter's Name and Address
Ngoc Linh Pham Latchman Sr. Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 952-939-7056 (telephone) 952-930-5785 (fax) Linh PhamLatchman@AmericanMedicalSystems.com
Alternate Contact Name and Information
Josh Clarin Manager, Regulatory Affairs American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343 952-939-7072 (telephone) 952-930-5785 (fax) Josh. Clarin@AmericanMedicalSystems.com
Date the Summary was Prepared
July 20, 2012
Device Classification Name
Mesh, surgical, gynecologic, for pelvic organ prolapse, transvaginally placed (OTP) Mesh, surgical, non-synthetic; urogynecologic, for pelvic organ prolapse, transvaginally placed (PAI)
Device Common/Usual Name
Surgical Mesh
Device Trade/Proprietary Name
Elevate® Anterior and Apical Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP
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(12/617 lage 2 of 5
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510(k) Summary
Device Trade/Proprietary Name
Elevate® Anterior and Apical Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP
Product Code
OTP & PAI :
Classification of Device
Class II / 21 CFR § 878.3300
Predicate Device(s)
| Device Name | Submission Number |
|---|---|
| AMS Elevate Anterior and Apical Prolapse Repair System with | |
| IntePro Lite | K082677 |
| AMS Elevate Apical and Posterior Prolapse Repair System with | |
| IntePro Lite | K082730 |
| AMS Elevate Apical and Posterior Prolapse Repair System with | |
| InteXen LP |
Device Description
Each Elevate System consists of a permanently-implanted graft and non-implantable surgical instruments that can be used as aids to transvaginally place the graft assembly in the pelvic floor. The graft assemblies for the Elevate Anterior & Apical Prolapse Repair System and Elevate Apical & Posterior Prolapse Repair System are made from polymeric mesh (IntePro Lite), and in the case of the Elevate Apical & Posterior Prolapse Repair System with InteXen LP, the graft assembly is made from a combination of lyophilized porcine dermis and polymeric mesh (IntePro Lite).
The devices are identical to the predicate devices, AMS Elevate Prolapse Repair Systems, with the exception of the modification to the Apical Needle Passer Sheath. There are no changes to the implant graft design, shape, size, and material. The revisions to the indications for use of the modified devices are to further clarify the intended use of Elevate System as a kit for transvaginal surgical treatment.
2
Image /page/2/Picture/0 description: The image shows the logo for AMS. The logo consists of a stylized image of two hands cradling something, followed by the letters "AMS" in a bold, sans-serif font. Below the letters, there is a tagline in a smaller font that reads "an agile health solution."
510(k) Summary
Existing Intended Use & Proposed Indication for Use
Existing indications for use
Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior & Apical Repair System is intended for the treatment of anterior and/or apical vaginal prolapse.
Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is intended for the treatment of apical and/or posterior vaginal prolapse.
Elevate Apical and Posterior Prolapse Repair System with InteXen® LP The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.
Proposed indications for use
The following are revisions to the indications for use to further clarify that the Elevate System Repair Systems are intended for transvaginal surgical treatment.
Elevate Anterior and Apical Prolapse Repair System
The Elevate Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse.
Elevate Apical and Posterior Prolapse Repair System
The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse.
Elevate Apical and Posterior Prolapse Repair System with InteXen® LP The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse.
Summary of the Technological Characteristics to the Predicate Device(s)
The modification to the Elevate Prolapse Repair Systems are deemed equivalent to the current device and there are no changes to the device intended use and/or device functional scientific technology.
The subject devices use the same surgical approach and implant placement procedures as the predicate devices.
3
510(k) Summary
11121617
Bage 4 of 5
Summary of Non-Clinical & Clinical Testing
The modified sheath of the Elevate Anterior and Apical Prolapse Repair System, Elevate Apical & Posterior Prolapse Repair System, and Elevate Apical & Posterior Prolapse Repair System with InteXen LP has been tested for design verification and biocompatibility (cytotoxicity & physiochemical testing). Design verification testing of the sheath included the following tests:
- sheath compression strength and depth stop strength, .
- trigger/sheath locking interface push strength, ●
- sheath cutout shear off strength and trigger/sheath locking interface pull . strenath
- sheath engagement force into lock .
There were no modifications made to the packaging or sterilization of the devices as a result of the change; thus, no additional testing was required. There was no change to the intended use or the implant procedure as a result of the change: thus the Elevate Prolapse Repair Systems have equivalent clinical performance to the predicate devices and no clinical testing was required to support the sheath modification
American Medical Systems considers the Elevate Anterior & Elevate Posterior devices' product performance to be substantially equivalent to the predicate devices.
Substantial Equivalence
The modified Elevate Anterior and Elevate Posterior devices use the same surgical approach and implant placement procedures as the predicate devices, Elevate Anterior & Elevate Posterior.
The modified Elevate Anterior and Elevate Posterior devices have identical intended use, identical implant materials, identical sterilization methods; and similar delivery tool materials/characteristics as the predicate.
The proposed Elevate Anterior and Elevate Posterior device performance and fundamental scientific technology remains unchanged. The differences between the proposed device and the predicate device do not negatively affect the safety and effectiveness of the device.
Conclusion
AMS considers the modified Elevate Anterior and Elevate Posterior devices to be substantially equivalent to the predicate devices.
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510(k) Summary
Manufacturing Facility
American Medical Systems, Inc. 10700 Bren Road West Minnetonka, MN 55343
Establishment Registration Number: 2183959
Sterilization Facility
Sterigenics US, Inc. 7775 S Quincy St. Willowbrook, IL 60527
Establishment Registration Number: 1450293
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three stylized lines forming the body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Ngoc Linh Pham Latchman Senior Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West MINNETONKA MN 55343
JUL 20 2012
Re: K121612
Trade/Device Name: Elevate® Anterior and Apical Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP
Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTP, PAI Dated: May 31, 2012 Received: June 28, 2012
Dear Ms. Latchman:
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related
6
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 yours,
Benjamin R. Fisher, Ph.D.
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
7
Statement of Indications for Use
Section 6
510(k) Number: K121612
Device Name: Elevate® Anterior and Apical Prolapse Repair System
Indications for Use:
Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse.
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) |
|---|
| -------------------------------------------------------- |
| 7/20/12 | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K121612 |
8
Section 6
510(k) Number: K121612
Elevate® Apical and Posterior Prolapse Repair System Device Name:
Indications for Use:
Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse.
Prescription Use __ X (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 !F NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division/Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K121612
9
Section 6
Statement of Indications for Use,
510(k) Number: K121612
Device Name: Elevate® Apical and Posterior Prolapse Repair System with InteXen® LP
Indications for Use:
Elevate Apical and Posterior Prolapse Repair System with InteXen® LP The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse.
Prescription Use _ X (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)
Beutun R. Fuch 20 July 2012
vision Sign-Off of Reproductiv