(168 days)
Not Found
Not Found
No
The summary describes a physical implantable device for hernia repair and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as a repair device to reinforce soft tissues, specifically for hernia or body wall defects, which indicates it is a structural implant rather than a device that delivers therapy (e.g., electrical, heat, light, drug).
No
The device description states it is "intended to be implanted to reinforce soft tissues" for "repair of a hernia or body wall defect," which describes a therapeutic or reconstructive function, not a diagnostic one.
No
The device description clearly states it is an "implanted" device and is "supplied sterile," indicating it is a physical, hardware-based medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the SIS Hernia Repair Device is "intended to be implanted to reinforce soft tissues where weakness exists." It is a physical implant used for surgical repair.
- Lack of Diagnostic Activity: The device does not perform any tests on bodily samples to provide diagnostic information. Its function is purely structural and therapeutic.
Therefore, based on the provided information, the SIS Hernia Repair Device falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect. The device is intended for one-time use.
Product codes
FTL
Device Description
The SIS Hernia Repair Device is intended to be used for reconstructing and supporting soft tissues such as fo the repair of a hernia or body wall defect. The device is supplied sterile and is intended for one-time use. The material comprising the device has undergone appropriate biocompatibility and performance testing that provides reasonable assurance of safety and efficacy for its intended use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, hernia, body wall
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
510(k) Premarket Notification SIS Hernia Repair Device MAY 20 1998
510(K) SUMMARY I.
Submitted By:
Robert J. Morff, Ph.D., P.E. Associate Director, Medical Technology Sentron Medical, Incorporated 4445 Lake Forest Drive, Suite 600 Cincinnati, Ohio 45242 (513) 563-3254 November 26, 1997
Device:
Trade Name Common/Usual Name: Proposed Classification:
SIS Hernia Repair Device Hernia Patch, Tissue Patch, Surgical Mesh Surgical Mesh 21 CFR Part 878.3300 (uoFTL) Class II
Predicate Devices:
The SIS Hernia Repair Device is similar to predicate surgical meshes in terms of indications for use, and technological characteristics.
Device Description:
The SIS Hernia Repair Device is intended to be used for reconstructing and supporting soft tissues such as fo the repair of a hernia or body wall defect. The device is supplied sterile and is intended for one-time use. The material comprising the device has undergone appropriate biocompatibility and performance testing that provides reasonable assurance of safety and efficacy for its intended use.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a Quality Assurance Program. The device will be packaged and sterilized using validated sterilization procedures. This device is similar with respect to indications for use and technology to predicate devices in terms of section 510(k) substantial equivalency.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Robert J. Morff, Ph.D., P.E. ·Associate Director, Medical Technology Senmed Medical Ventures Sentron Medical, Incorporated 4445 Lake Forest Drive, Suite 600 Cincinnati, Ohio 45242
K974540 Re : SIS Hernia Repair Device Trade Name: Regulatory Class: II Product Code: FTL Dated: April 2, 1998 Received: April 3, 1998
Dear Dr. Morff:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Dr. Morff
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: SIS Hernia Repair Device
Indications For Use:
The SIS Hernia Repair Device is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect. The device is intended for one-time use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of General Resionative Devices 510(k) Number
Image /page/3/Picture/8 description: The image shows the words "Prescription Use" with a check mark next to it. Below that, it says "(Per 21 CFR 801.109)". The text is in black and white.
Over-The-Counter Use_ (Optional Format 1-2-96)