(107 days)
No
The summary describes a surgical mesh and needle passer system for pelvic floor repair and does not mention any AI or ML components or functionalities.
Yes
The device is intended to treat conditions like incontinence, vaginal wall prolapse, and to reinforce soft tissues, which are therapeutic medical interventions.
No
The device is described as an implantable mesh assembly used to reinforce soft tissues, not to diagnose conditions. Its intended use is for repairing ruptured connective tissue or reinforcing weak soft tissues.
No
The device description explicitly states that the device consists of "stainless steel, curved needle passers and an implantable mesh assembly," which are physical hardware components.
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 implant used to reinforce soft tissues in the body for conditions like incontinence and prolapse. This is a therapeutic device, not a diagnostic one.
- Device Description: The device consists of surgical tools (needle passers) and an implantable mesh. This aligns with a surgical device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
AMS Pelvic Floor 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 for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Product codes
OTP, PAI
Device Description
The Apogee and Perigee Systems with IntePro Lite and InteXen LP are sterile, single use procedure kits that consist of stainless steel, curved needle passers and an implantable mesh assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological, gynecological and gastroenterological anatomy
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
The components of the Apogee and Perigee Systems with IntePro Lite and InteXen LP have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Apogee and Perigee Systems with IntePro Lite and InteXen LP (K051485)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 0 4 2008
510(k) Summary Statement
| Submitter: | American Medical Systems (AMS)
10700 Bren Road West
Minnetonka, MN 55343 |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sarah Peterson
Phone: 952.930.6431
Fax: 952.930.5785 |
| Device Common Name: | Surgical Mesh |
| Device Trade Name: | Apogee and Perigee Systems with IntePro Lite and
InteXen LP, Part of the AMS Pelvic Floor Repair
System |
| Device Classification/
Classification Name: | Class II, 21 CFR Part 878.3300
Surgical Mesh, polymeric (OTP, PAI) |
| Predicate Device: | Apogee and Perigee Systems with IntePro Lite and
InteXen LP (K051485), Part of the AMS Pelvic
Floor Repair System |
Indications for Use
AMS Pelvic Floor 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 for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
Device Description
The Apogee and Perigee Systems with IntePro Lite and InteXen LP are sterile, single use procedure kits that consist of stainless steel, curved needle passers and an implantable mesh assembly.
Summary of Testing
The components of the Apogee and Perigee Systems with IntePro Lite and InteXen LP have been tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices.
Page 1 of 1
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
American Medical Systems (AMS) %. Ms. Sarah Peterson 10700 Bren Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K082387
Trade/Device Name: Apogee and Perigee Systems with IntePro Life and InteXen LP, Part of the AMS Pelvic Floor Repair System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI Dated: November 3, 2008 Received: November 4, 2008
Dear Ms. Anderson:
This letter corrects our substantially equivalent letter of December 4, 2008.
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
2
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
3
Indications for Use Statement
| 510(k) Number: (If known) | |
|---|---|
| Device Name: | Apogee and Perigee Systems with IntePro Lite and InteXen LP, Part of the AMS Pelvic Floor Repair System |
| Indications For Use: | AMS Pelvic Floor 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 for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nitho Dyln for man
08238
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number
Page 1 of 1