(97 days)
Not Found
Not Found
No
The device description and intended use focus on a physical mesh bag for organ support, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as providing temporary wound or solid organ support, which is a supportive function and not explicitly therapeutic in the sense of treating a disease or condition. Its purpose is to facilitate healing by providing structural support rather than directly curing or alleviating a medical condition.
No
The device, VICRYL Mesh Bag, is described as a surgical mesh for temporary wound or organ support, made of absorbable material. Its intended use is to provide physical support to organs like the kidney, liver, or spleen, not to diagnose any condition.
No
The device description clearly states it is a physical mesh bag made of polyglactin 910, a synthetic absorbable copolymer. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary wound or solid organ support (kidney, liver, spleen)". This describes a surgical device used in vivo (within the body) to provide physical support.
- Device Description: The description details a mesh bag made of a synthetic absorbable material (polyglactin 910) designed to be placed around organs. This is consistent with a surgical implant or support device.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of samples, analysis of biological markers, or diagnostic purposes.
Therefore, the VICRYL Mesh Bag is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VICRYL Mesh bag may be used wherever temporary wound or solid organ support is required (kidney, liver, spleen).
Product codes
FTL
Device Description
VICRYL Mesh Bag consists of a VICRYL Mesh adapted to the form and size of kidney, spleen, or liver and tied with VICRYL sutures (dyed and undyed).
The integrated strands of VICRYL sutures are threaded along the periphery of the mesh, which facilitates its use as organ support for the kidney, spleen, or liver. The VICRYL Mesh is prepared from polyglactin 910, a synthetic absorbable copolymer of glycolide and lactide, derived respectively from glycolic acid and lactic acids. The mesh is prepared from uncoated, undyed fiber identical in composition to that used in VICRYL (polyglactin 910) synthetic absorbable suture, which has been found to be inert, nonantigenic, and nonpyrogenic and to elicit only a milc tissue reaction during absorption.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, spleen, liver
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)
Prior data supporting the predicate device demonstrate that VICRYL Mesh Bag performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VICRYL Mesh
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
KOS1701
SEP 2 9 2005
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
NEW DEVICE NAME: VICRYL* Mesh Bag
PREDICATE DEVICES NAME: VICRYL Mesh
Device Description
VICRYL Mesh Bag consists of a VICRYL Mesh adapted to the form and size of kidney, spleen, or liver and tied with VICRYL sutures (dyed and undyed).
The integrated strands of VICRYL sutures are threaded along the periphery of the mesh, which facilitates its use as organ support for the kidney, spleen, or liver. The VICRYL Mesh is prepared from polyglactin 910, a synthetic absorbable copolymer of glycolide and lactide, derived respectively from glycolic acid and lactic acids. The mesh is prepared from uncoated, undyed fiber identical in composition to that used in VICRYL (polyglactin 910) synthetic absorbable suture, which has been found to be inert, nonantigenic, and nonpyrogenic and to elicit only a milc tissue reaction during absorption.
Intended Use
VICRYL Mesh bag may be used wherever temporary wound or solid organ support is required (kidney, liver, spleen).
Indications Statement
VICRYL Mesh bag may be used wherever temporary wound or solid organ support is required (kidney, liver, spleen).
1
Technological Characteristics
VICRYL Mesh Bag has similar technological characteristics as the predicate device. The VICRYL Mesh Bag is essentially VICRYL Mesh that has been preshaped to specific sizes to facilitate its application.
Performance Data
Prior data supporting the predicate device demonstrate that VICRYL Mesh Bag performs as intended.
Conclusions
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Devices under the Federal Food, Drug, and Cosmetic Act.
Contact
Jennifer Paine Manager, Regulatory Affairs ETHICON, Inc. Rt. #22, West Somerville, NJ 08876-0151 908-218-3323
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (DHHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The caduceus is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The text is written in capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 2005
Ms. Jennifer M. Paine, M.S. Manager, Regulatory Affairs Ethicon, Inc. Route 22 West Somerville, New Jersey 08876
Rc: K051701
Trade/Device Name: VICRYI Mesh Bag Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 26, 2005 Received: August 29, 2005
Dear Ms. Paine:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became of one device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the 28, 1976. the enactment date of the Medical Device Amendments, or to commerce pror co may 2011-11-11 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 1 ou may outrols 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 may be sabyeet to back at 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 I hat 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 or any I 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 form in the qualify by over provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Ms. Jennifer M. Paine, M.S.
This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier will anow you to begin manisting your device of your device to a legally premits tourneadon. The PIPA mainig of cation 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 If you desire specific advice for your do november 10 - 11 5. Also, please note the regulation entitled, Colliact the Office of Complance at (21 t ) stiffication" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response 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. Millersen
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KOS1701
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: VICRYL Mesh Bag
Indications for Use:
VICRYL Mesh bag may be used wherever temporary wound or solid organ support is required (kidney, liver, spleen).
AND/OR Over-The-Counter Use _ Prescription Use X . (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Melkman
(Division Sign-Off) (Division Signeral, Restorative, and Neurological Devices man 510(k) Number_ KOS1701