(416 days)
Not Found
Not Found
No
The summary describes a surgical mesh for soft tissue repair and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as a mesh used for reinforcement in surgical procedures, indicating it provides structural support rather than actively treating a disease or condition.
No
The device, Atrium C-QUR™ Mesh, is indicated for use in surgical reinforcement procedures ("soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material"). It is a supportive material, not a device used to identify, monitor, or diagnose a condition.
No
The device description and intended use clearly describe a physical mesh material used for surgical procedures, not a software application.
Based on the provided information, this device 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 to reinforce soft tissue. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: While the description is "Not Found," the intended use clearly points to a surgical implant, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, the Atrium C-QUR™ Mesh is a surgical mesh used for tissue repair, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Atrium C-QUR™ Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a 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
soft tissue deficiencies, hernia repair, chest wall reconstruction
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): 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.
Not Found
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
§ 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 seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2006
Atrium Medical Corporation c/o Mr. Joseph P. DePaolo Vice President, Regulatory Affairs 5 Wentworth Drive Hudson, New Hampshire 03051
Re: K050311
Trade/Device Name: Atrium C-Qur'" Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 20, 2006 Received: March 22, 2006
Dear Mr. DePaolo:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
1
Page 2 - Mr. Joseph P. DePaolo
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product rainell allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated predicated on "ce results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Malkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K050311
Atrium C-QUR™ Mesh Device Name:
Indications For Use:
Atrium C-QUR™ Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material.
Prescription Use
(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)
(Division Sign-Off)
Division of General, Restorative. and Neurological Devices
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KO 56311 510(k) Number_