(115 days)
No
The document describes a collagen dermal matrix and associated surgical kits, which are physical implants and delivery systems. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as treating conditions such as hernias, urinary incontinence, and prolapse, and is explicitly referred to as a "therapeutic device" in the context of its indicated uses.
No
This device, the AMS collagen dermal matrix and associated systems, is intended for the treatment and reinforcement of soft tissues, such as in hernia repair, support for urinary incontinence, and treatment of pelvic organ prolapse. It is a surgical implant designed to reinforce or repair tissue, not to diagnose a condition.
No
The device description clearly states it is a collagen dermal matrix derived from porcine dermis and includes needles and connectors, indicating it is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being implanted into the body to reinforce soft tissues and treat conditions like hernias, prolapse, and incontinence. This is a therapeutic and structural function within the body.
- Device Description: The device is described as a collagen dermal matrix (porcine dermis) and kits containing needles and mesh for implantation. This is a physical implantable material and delivery system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any such use or interaction with bodily specimens outside the body.
The device described is a surgical implant used for structural support and tissue reinforcement in vivo.
N/A
Intended Use / Indications for Use
The AMS collagen dermal matrix is intended for use in the treatment of hernias where the The AMS collagen ochharmania in to implantation to reinforce soft tissues where weakness Connective lissoc has ruptured of for implanations of this includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacral colposuspension and reinforcement in the repair of Peyronie's disease. By providing pubourethral support, the AMS collagen dermal matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix are intended for the placement of a pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The AMS Perigee System with Pre-Connected Collagen Dermal Matrix is intended for the placement of graft material in the anterior vaginal wall via the obturator foramen for the treatment of anterior wall prolapse.
The AMS Apogee System with Pre-Connected Collagen Dermal Matrix is intended for use in vaginal vault suspension to treat pelvic organ prolapse.
Product codes (comma separated list FDA assigned to the subject device)
DTP, PAI, PAJ, OTN, PAG
Device Description
The AMS collagen dermal matrix is decellularized porcine dermis that is lyophilized and terminally sterilized. The product is available in a range of sizes.
The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix consist of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis for use as a urethral sling.
The Perigee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the anterior vaginal wall.
The AMS Apoqee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the vaginal vault.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor, urethral, vaginal, colon, rectal
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 AMS collagen dermal matrix and all of the pre-connected devices have been tested in accordance with the requirements of FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh and has been shown to be equivalent to the listed predicate devices.
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.
K040538, K041948, K040623, K040537
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.
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JUN 17 2005
510(k) Summary AMS Collagen Dermal Matrix
510(k) Number
Date of Summary Preparation: February 18, 2005
Submitter/Contact Person: Elsa A. Linke Regulatory Affairs Specialist American Medical Systems 10700 Bren Rd. W Minnetonka, MN 55343
Phone: (952) 930-6000 Fax: (952) 930-6496
Device Name and Classification:
Trade Name(s):
AMS Collagen Dermal Matrix
AMS Apogee System with Pre-Connected Collagen Dermal Matrix AMS Apogee Oyetom with Pre-Connected Collagen Dermal Matrix AMS Fenger Systems TO with Pre-Connected Collagen Dermal Matrix
Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh Product Code: DTP, PAI
Classification: Class II
Manufacturing Location:
American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343
Predicate Devices:
For AMS Collagen Dermal Matrix : DermMatrix/InteXen - K021160 Surgisis Sling - K992159
For AMS Bioarc SP & Bioarc TO with Pre-Connected Collagen Dermal Matrix : AMS Bioarc SP - K040538 AMS Bioarc TO -- K041948
For AMS Perigee System with Pre-Connected Collagen Dermal Matrix : AMS Perigee System - K040623
For AMS Apogee System with Pre-Connected Collagen Dermal Matrix : AMS Apogee System - K040537
Indications for Use:
The AMS collagen dermal matrix is intended for use in the treatment of hernias where the The AMS collagen ochharmania in to implantation to reinforce soft tissues where weakness Connective lissoc has ruptured of for implanations of this includes but is
1
КОТОШИГ
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not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacral colposuspension and reinforcement in the repair of Peyronie's disease. By providing pubourethral support, the AMS collagen dermal matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix are intended for the placement of a pubourethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
The AMS Perigee System with Pre-Connected Collagen Dermal Matrix is intended for the placement of graft material in the anterior vaginal wall via the obturator foramen for the treatment of anterior wall prolapse.
The AMS Apogee System with Pre-Connected Collagen Dermal Matrix is intended for use in vaginal vault suspension to treat pelvic organ prolapse.
Device Description:
The AMS collagen dermal matrix is decellularized porcine dermis that is lyophilized and terminally sterilized. The product is available in a range of sizes.
The Bioarc SP Sling Kit with Pre-connected Collagen Dermal Matrix and Bioarc TO Sublascial Hammock with Pre-connected Collagen Dermal Matrix consist of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis for use as a urethral sling.
The Perigee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the anterior vaginal wall.
The AMS Apoqee System with Pre-Connected Collagen Dermal Matrix consists of needles and connectors used to pass a polypropylene mesh preconnected to porcine dermis in support of the vaginal vault.
Summary of Testing
The AMS collagen dermal matrix and all of the pre-connected devices have been tested in accordance with the requirements of FDA's Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh and has been shown to be equivalent to the listed predicate devices.
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 name encircling a symbol. The symbol is a stylized representation of a human figure, with three faces overlapping each other. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Elsa A. Linke Regulatory Affairs Specialist American Medical Systems Incorporated 10700 Bern Road West MINNETONKA MN 55343
SEP 2 8 2012
Re: K050445
Trade/Device Name: AMS Collagen Dermal Matrix, AMS Apogee System with Pre-Connected AMS Collagen Dermal Matrix, AMS Perigee System with Pre-Connected AMS Collagena Dermal Matrix, AMS BioArc™ SP Sling Kit and BioArc To Subfascial Hammock with Pre-connected AMS Collagen Dermal Matrix
Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTP, PAI, PAJ, OTN, PAG Dated: May 24, 2005 Received: May 25, 2005
Dear Ms. Linke:
This letter corrects our substantially equivalent letter of June 17, 2005.
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
3
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 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/ReportalProblem/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
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КОГОЧИГ
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: AMS Collagen Dermal Matrix
Indications For Use:
The AMS collagen dermal matrix is intended for use in the treatment of The AMO onliagon connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, reinforce contineerological anatomy. This includes but is gynecological and gaol.com procedures: pubourethral support including nor limited to the following prolapse repair, colon and rectal urethnul Silings, are.narruction of the pelvic floor, bladder support, prolapse repair, sacral colposuspension and reinforcement in the repair of the Peyronie's disease. By providing pubourethral support, the AMS collagen demal matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Prescription Use______________________________________________________________________________________________________________________________________________________________ Use (Per 21 CFR 801 Subpart D)
Over-The Counter
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
( Division of General, Restorative and Neurological Devices
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5.29(c) Number KOS0445