(32 days)
Not Found
Not Found
No
The summary describes a surgical mesh, a physical implant, and contains no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an "unabsorbable supportive material" for reinforcement in surgical repair, which functions as a structural component rather than actively treating a disease or condition.
No
The provided text describes the Atrium CentriFX Mesh as a material for surgical reinforcement in procedures like hernia repair and chest wall reconstruction. This indicates a therapeutic or reparative function, not a diagnostic one.
No
The intended use describes a physical mesh material used in surgical procedures, which is a hardware device, not software.
Based on the provided information, the Atrium CentriFX Mesh is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in vivo (within the body) for surgical procedures like hernia repair and wound reconstruction. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor conditions.
- Device Description (Not Found): While the description is missing, the intended use clearly points to a surgical implant, not a diagnostic test kit or instrument.
- Lack of IVD-related terms: The provided text does not mention any terms typically associated with IVDs, such as "specimen," "assay," "reagent," "diagnosis," or "monitoring of disease."
Therefore, the Atrium CentriFX Mesh is a surgical implant used for reinforcement during various surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Atrium CentriFX Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.
Product codes
FTL
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Atrium Medical Corporation % Mr. Raymond J. Kelly VP, Regulatory and Clinical Affairs 5 Wentworth Drive Hudson, New Hampshire 03051
FEB 15 201
Re: K110110
Trade/Device Name: Atrium CentriFX Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 10, 2011 Received: February 10, 2011
Dear Mr. Kelly:
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
and the comments of the comments of the comments of the comments of
and the same of the same of the same of the same
1
Page 2 - Mr. Raymond J. Kelly
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" (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,
Aiz B. 12 h
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
KUBIOO AbD
Kiloilo
510(k) Number (if known):
Device Name: Atrium CentriFX Mesh
Indications For Use
510(k) Number (if known):
The Atrium CentriFX Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.
Prescription Use X (Part 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)
Page 1 of
Daniel Kurefu MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices arsh