(415 days)
No
The device description and performance studies focus on the material properties and mechanical strength of a biological matrix, with no mention of AI or ML.
Yes
The device is intended to reinforce soft tissue, treat urinary incontinence, and provide pubourethral support, all of which address medical conditions and aim to restore function.
No
Explanation: The device is intended for implantation to reinforce soft tissue where weakness exists, not for identifying or diagnosing a condition.
No
The device description explicitly states the device is composed of "porcine-derived extracellular matrix scaffolds" and is supplied in "multi-layer sheet configurations," indicating it is a physical implant, 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 that the devices are for "implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery." This describes a surgical implant used directly on the patient's body.
- Device Description: The device is described as "porcine-derived extracellular matrix scaffolds" supplied in "multi-layer sheet configurations." This is a physical material intended for surgical placement.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any such use or interaction with patient specimens for diagnostic purposes.
The device is a surgical implant used for tissue reinforcement, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
MatriStem® Surgical Matrix RS (2-layer) and PSM (3-layer) are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hemia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
MatriStem® Surgical Matrix PSMX (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
MatriStem® Pelvic Floor Matrix (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological or gynecological surgery. Reinforcement of soft tissue within urological and gynecological surgery includes, but is not limited to, the following procedures: pubourethral support, urethral repair, transabdominal reconstruction of pelvic floor and vaginal prolapse, bladder support, and sacrocolposuspension. By providing pubourethral support, MatriStem Pelvic Floor Matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency.
Product codes
FTM, OXH
Device Description
MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix devices are composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in multi-layer sheet configurations in sizes up to 10 cm x 15 cm, and packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, urological, gastroenterological, plastic & reconstructive surgery, pelvic floor, vaginal, bladder, pubourethral.
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)
Biocompatibility Testing
MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix underwent the following biocompatibility testing on sterilized devices per ISO-10993-1 standard: cytotoxicity. sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subacute and subchronic toxicity and implantation, genotoxicity, hemocompatibility, and LAL endotoxin. The results of these tests provided evidence that the MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem Pelvic Floor Matrix meet biocompatibility requirements of the ISO standard.
Mechanical Testing
The MatriStem Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix material were tested for the following: tensile strength, suture retention strength, delamination strength, tear strength, and stiffness test. The mechanical testing provided evidence that MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix provide adequate mechanical strength for their respective applications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ACell UBM Surgical Mesh (K040621), ACell Surgical Mesh ML and ML Plus (K041140), SIS Plastic Surgery Matrix (K034039)
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.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo, which features a stylized human figure. The logo on the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the agency in blue text.
August 10, 2021
ACell, Inc. % Salman Elmi, VP/Deputy General Counsel, Chief Compliance Officer 6640 Eli Whitney Drive Columbia, MD 21046 Telephone: 410-953-8500 Email: salelmi4ace11.com
Re: K141084
Trade/Device Name: Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXH
Dear Mr. Salman Elmi:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 17, 2015. Specifically, FDA is updating this SE Letter to remove the indications for use for transvaginal repair of pelvic organ prolapse from the SE package and labeling in accordance with FDA's final rule, dated January 5, 2016 in which such devices were upclassified from Class II to Class III.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Jason Roberts, OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices, 240-402-6400, jason.roberts(@fda.hhs.gov.
Sincerely,
Jason Roberts -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, one behind the other, with a stylized bird above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2015
ACell Incorporated Mr. Miles Grody Senior Vice President, General Counsel 6640 Eli Whitney Drive, Suite 200 Columbia, Maryland 21046
Re: K141084
Trade/Device Name: MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM, OXH Dated: June 16, 2015 Received: June 17, 2015
Dear Mr. Grody:
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
2
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
for
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(K) SUMMARY
| Submission Date: | July 6, 2018 |
|---|---|
| Manufacturer Name: | ACell, Inc. |
| Submitted by: | 6640 Eli Whitney Drive |
| Columbia, MD 21046 | |
| Contact Person: | Andrea Pilon Artman |
| Sr. Regulatory Affairs Manager | |
| ACell, Inc. | |
| Phone: (410) 953-8549 | |
| Email: andreaartman@acell.com | |
| Fax: 410-715-4511 |
DEVICE NAME AND CLASSIFICATION
| 510 (k) Number: | K141084 |
|---|---|
| Trade/Proprietary Name: | MatriStem® Surgical Matrix RS, PSM, PSMX, |
| MatriStem® Pelvic Floor Matrix | |
| Common/Usual Name: | Surgical Mesh, ECM, Surgical Scaffold |
| Regulation Name: | Surgical Mesh |
| Device Class: | Class II, 21 CFR 878.3300 |
| Product Code: | FTM, OXH |
| Reviewing Panel: | General & Plastic Surgery |
| Predicate Devices: | ACell UBM Surgical Mesh (K040621) |
| ACell Surgical Mesh ML and ML Plus (K041140) | |
| SIS Plastic Surgery Matrix (K034039) |
DEVICE DESCRIPTION
MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix devices are composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in multi-layer sheet configurations in sizes up to 10 cm x 15 cm, and packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation.
INDICATIONS FOR USE
MatriStem® Surgical Matrix RS (2-layer) and PSM (3-layer) are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hemia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
MatriStem® Surgical Matrix PSMX (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery
4
includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
MatriStem® Pelvic Floor Matrix (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological or gynecological surgery. Reinforcement of soft tissue within urological and gynecological surgery includes, but is not limited to, the following procedures: pubourethral support, urethral repair, transabdominal reconstruction of pelvic floor and vaginal prolapse, bladder support, and sacrocolposuspension. By providing pubourethral support, MatriStem Pelvic Floor Matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency.
EQUIVALENCE TO MARKETED DEVICES
MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix have the same intended use as predicate surgical meshes, which is to reinforce or repair soft tissue. The additional indications are identical to those included in the identified predicate devices. The technological characteristics of the MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix are substantially similar to the cleared predicates, as all are comprised of animal tissuederived, collagen extracellular matrix (ECM) scaffolds supplied in a sheet configuration that are packaged and terminally sterilized. The available sizes of the subject device (8 - 150 cm) are consistent with the range of sizes of the predicate devices (16 - 1350 cm -). The minor differences between the MatriStem® Surgical Matrix RS. PSM, PSMX, and MatriStem® Pelvic Floor Matrix and the identified predicates do not raise different questions of safety or efficacy and performance testing demonstrates that the devices have comparable performance to the predicates.
Biocompatibility Testing
MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix underwent the following biocompatibility testing on sterilized devices per ISO-10993-1 standard: cytotoxicity. sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subacute and subchronic toxicity and implantation, genotoxicity, hemocompatibility, and LAL endotoxin. The results of these tests provided evidence that the MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem Pelvic Floor Matrix meet biocompatibility requirements of the ISO standard.
Mechanical Testing
The MatriStem Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix material were tested for the following: tensile strength, suture retention strength, delamination strength, tear strength, and stiffness test. The mechanical testing provided evidence that MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix provide adequate mechanical strength for their respective applications.
CONCLUSION
Based on direct testing and comparison to predicate devices, MatriStem® Surgical Matrix RS, PSM, PSMX, and MatriStem® Pelvic Floor Matrix do not raise different questions of safety and effectiveness and the results support a determination of substantial equivalence through this 510(k) Premarket Notification.
5
Indications for Use
510(k) Number (if known) K141084
Device Name
MatriStem Surgical Matrix RS, PSM, PSMX, and MatriStem Pelvic Floor Matrix
Indications for Use (Describe)
MatriStem Surgical Matrix RS (2-layer) are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
MatriStem Surgical Matrix PSMX (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
MatriStem Pelvic Floor Matrix (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological or gynecological surgery. Reinforcement of soft tissue within urological and gynecological surgery includes, but is not limited to, the following procedures: pubourethral repair, transabdominal reconstruction of pelvic floor and vaginal prolapse repair, bladder support, and sacrocolposuspension. By providing pubourethral support, Matristem Pelvic Floor Matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. |
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