(45 days)
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No
The summary describes a surgical mesh for reinforcement, with no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is indicated for use in hernia repair, chest wall reconstruction, and other surgical intervention procedures, which are therapeutic applications.
No
The device, Atrium ProLite Ultra S Mesh, is indicated for repair and reinforcement procedures (e.g., hernia repair, chest wall reconstruction), which are treatment-oriented surgical interventions, not diagnostic activities.
No
The intended use describes a mesh material for surgical procedures, which is a physical implant, not software.
Based on the provided information, the Atrium ProLite Ultra S 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 chest wall reconstruction. IVDs are used in vitro (outside the body) to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue), detecting markers, or providing diagnostic information based on laboratory tests.
Therefore, the Atrium ProLite Ultra S Mesh is a surgical mesh intended for implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Atrium ProLite Ultra S 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
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting three abstract shapes, possibly representing health, well-being, or services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 8 2007
Atrium Medical Corporation % Mr. Joseph P. De Paolo Vice President, Regulatory and Clinical Affairs 5 Wentworth Drive Hudson, New Hampshire 03051
Re: K070192
Trade/Device Name: Atrium Prolite Ultra S Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: February 5, 2007 Received: February 6, 2007
Dear Mr. De Paolo:
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 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.
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Page 2 - Mr. Joseph P. De Paolo
This letter will 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 marketed predicate device 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 prematket 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1 510(k) Number (if known): Device Name: Atrium ProLite Ultra S Mesh Indications for Use:
Atrium ProLite Ultra S 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 (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Melkerson
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K070192
Atrium Medical Corporation
CONFIDENTIAL