(14 days)
Not Found
No
The summary describes a physical surgical mesh and its intended use, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is a surgical mesh used in hernia repair, chest wall reconstruction, and other surgical procedures, which are therapeutic interventions.
No
The device is described as a surgical mesh used for reinforcement during surgical intervention procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a "surgical mesh" and describes its physical construction (two layers of mesh stitched together), indicating it is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Atrium C-Qur TM OVT Mesh is a surgical mesh that is implanted inside the body during surgical procedures. It is a physical material used for reinforcement.
- Intended Use: The intended use is for surgical procedures like hernia repair and chest wall reconstruction, which are performed on the body, not on samples taken from the body.
The description clearly indicates a surgically implanted device, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Atrium C-Qur OVT 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 non-absorbable supportive material.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The Atrium C-Qur" OVT Mesh is a surgical mesh used during surgical procedures. The mesh contains two layers of mesh stitched together. The second layer is cut into flaps. The intent of the addition of a second layer with flaps is to allow the surgeon to more easily position and attach the mesh to the surgical site.
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)
Results of verification testing indicate that the product meets the established performance requirements.
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.
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
K10076
JAN 2 6 2010
K.
510K-Summary
For
Atrium C-Qur" Device Modification
1. SPONSOR
Name and Address
ATRIUM MEDICAL CORP. 5 Wentworth Dr. Hudson, NH 03051, USA
Establishment Registration Number
1219977
DEVICE NAME 2.
Proprietary Name: Common/Usual Name: Classification Name:
Atrium C-Qur" OVT Mesh Surgical Mesh Mesh, surgical, polymeric
3. DEVICE CLASS
Regulation Number: Regulation Name: Regulatory Class: Product Code
21 CFR 878.3300 Surgical mesh ll FTL
PREDICATE DEVICES 4.
Concurrence Product Name Filing # Date 03/31/2006 Atrium C-Qur" Surgical Mesh K050311
DEVICE DESCRIPTION 5.
The Atrium C-Qur" OVT Mesh is a surgical mesh used during surgical procedures. The mesh contains two layers of mesh stitched together. The second layer is cut into flaps. The intent of the addition of a second layer with flaps is to allow the surgeon to more easily position and attach the mesh to the surgical site.
1
INTENDED USE 6.
The Atrium C-Qur" OVT 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 non-absorbable supportive material.
TECHNOLOGICAL CHARACTERISTICS 7.
C-Qur OVT Mesh's intended use and its material composition are identical to that of its predicate device and it is therefore substantially equivalent to its legally marketed predicate devices.
PERFORMANCE DATA 8.
Results of verification testing indicate that the product meets the established performance requirements.
CONCLUSION 9.
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the Predicate Devices under the Federal Food, Drug, and Cosmetic Act.
Contact Person
Jacqueline E.M. Emery, BS Engineering
Sr. Regulatory Affairs Specialist Telephone: 603-880-1433 X5366
Email: jemery@atriummed.com
Date
January 8, 2010
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 2 6 2010
Atrium Medical Corporation % Ms. Jacqueline E.M. Emery Senior Regulatory Affairs Specialist 5 Wentworth Drive Hudson, New Hampshire 03051
Re: K100076
Trade/Device Name: Atrium C-Qur™ OVT Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: January 08, 2010 Received: January 21, 2010
Dear Ms. Emery:
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 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); medical device reporting (reporting of medical
3
Page 2 - Ms. Jacqueline E.M. Emery
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
I.
Statement of Indications for Use
Indications for Use Statement
| 510(k) Number (if known) | To be Assigned |
|---|---|
| Device Name | Atrium C-Qur TM OVT Mesh |
| Indications for Use | The Atrium C-Qur TM OVT Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other |
fascial surgical intervention procedures requiring reinforcement
Prescription Use (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)
with a non-absorbable supportive material
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Keene for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100076