(224 days)
Not Found
No
The description focuses on the material composition and physical structure of a surgical mesh, with no mention of AI or ML capabilities.
Yes
The device is a surgical mesh primarily used to provide structural support and repair for vaginal vault prolapse, which directly addresses a health condition.
No
Explanation: The device is a surgical mesh used for treating vaginal vault prolapse, which is a therapeutic rather than a diagnostic application.
No
The device description clearly indicates it is a physical mesh product made of polypropylene and poliglecaprone-25, intended for surgical implantation. It is 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 surgical repair of vaginal vault prolapse by acting as a bridging material. This is a surgical procedure performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device is a surgical mesh designed to be implanted in the body. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
Therefore, the ARTISYN™ Y-Shaped Mesh is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparatomy or laparascopic approach) where surgical treatment for vaginal vault prolapse is warranted.
Product codes (comma separated list FDA assigned to the subject device)
OTO, FTL
Device Description
ARTISYN™ Y-Shaped Mesh consists of two pieces of partially absorbable mesh provided in a Y shape: a vaginal section with anterior/posterior flaps and a sacral section. The anterior and posterior flaps are for anterior and posterior vaginal attachment, and the sacral flap for attachment to the sacral promontory. The mesh consists of non-absorbable undyed and dyed polypropylene and absorbable undyed poliglecaprone-25 monofilament. The vaginal and sacral sections are sewn together using polypropylene monofilament. Blue polypropylene monofilaments have been incorporated in the mesh material to produce contrast striping. The vertical stripes on the sacral flap and the horizontal stripes on the anterior and posterior vaginal flaps help aid in positioning, trimming and suturing the mesh.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal vault, pelvic floor
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)
Non-clinical performance of the ARTISYN™ Y-Shaped Mesh was characterized in accordance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, March 22, 1999, to demonstrate substantial equivalence to the predicate devices. The mesh material used in the ARTISYN™ Y-Shaped Mesh device has been subjected to mechanical testing and is identical to the predicate, GYNECARE GYNEMESH M® Partially Absorbable Mesh, and substantially equivalent to the predicate, BARD ALYTE™ Y-Mesh Graft. The finished ARTISYN™ Y-Shaped Mesh device was subjected to mechanical testing and is substantially equivalent to the predicate devices, BARD ALYTE™ Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y. Bench testing was performed in accordance with the FDA guidance document Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, March 22, 1999. Results show that all four devices provide similar performance.
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.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
:
JUN 1 2 2012
| Sponsor: | ETHICON Women's Health and Urology
ETHICON, Inc.
P.O. Box 151
Route 22 West
Somerville, New Jersey 08876 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah McManus
ETHICON Women's Health and Urology
ETHICON, Inc.
P.O. Box 151
Route 22 West
Somerville, New Jersey 08876
Phone: 908-218-2954
Fax: 908-218-2595 |
| Date of Submission: | 13 January 2012 |
| Proprietary Name: | ARTISYN™ Y-Shaped Mesh |
| Common Name: | Surgical Mesh |
| Regulation: | 21 CFR878.3300 |
| Regulatory Class: | II |
| Product Codes: | OTO - Mesh, Surgical, Gynecologic, For Apical Vaginal Prolapse,
Transabdominally Placed.
FTL - Mesh, Surgical, Polymeric |
| Predicate Devices: | ALYTE™ Y-Mesh Graft, CR BARD, K101722
GYNECARE GYNEMESH M® Partially Absorbable Mesh , ETHICON Inc., K082216
RESTORELLE® Y, Mpathy Medical Devices, Ltd., K092207 |
| Device Description: | ARTISYN™ Y-Shaped Mesh consists of two pieces of partially absorbable mesh
provided in a Y shape: a vaginal section with anterior/posterior flaps and a
sacral section. The anterior and posterior flaps are for anterior and posterior
vaginal attachment, and the sacral flap for attachment to the sacral
promontory. The mesh consists of non-absorbable undyed and dyed
polypropylene and absorbable undyed poliglecaprone-25 monofilament. The |
1
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vaginal and sacral sections are sewn together using polypropylene monofilament. Blue polypropylene monofilaments have been incorporated in the mesh material to produce contrast striping. The vertical stripes on the sacral flap and the horizontal stripes on the anterior and posterior vaginal flaps help aid in positioning, trimming and suturing the mesh.
ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for Indications for Use sacrocolposuspension/sacrocolpopexy (laparatomy or laparascopic approach) where surgical treatment for vaginal vault prolapse is warranted.
ARTISYN™ Y-Shaped Mesh is composed of the same partially absorbable mesh Technological material used in the predicate device, GYNECARE GYNEMESH M® Partially Characteristics Absorbable Mesh. The design of the ARTISYN™ Y-Shaped Mesh is a Y Summary configuration with a similar shape and similar dimensions as the predicate devices, BARD ALYTE™ Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y.
Non-clinical performance of the ARTISYN™ Y-Shaped Mesh was characterized Performance Data in accordance with FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, March 22, 1999, to demonstrate substantial equivalence to the predicate devices. The mesh material used in the ARTISYN™ Y-Shaped Mesh device has been subjected to mechanical testing and is identical to the predicate, GYNECARE GYNEMESH M® Partially Absorbable Mesh, and substantially equivalent to the predicate, BARD ALYTE™ Y-Mesh Graft. The finished ARTISYN™ Y-Shaped Mesh device was subjected to mechanical testing and is substantially equivalent to the predicate devices, BARD ALYTE™ Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y.
Conclusions
The data provided in this premarket notification demonstrate that the ARTISYN™ Y-Shaped Mesh is substantially equivalent to the predicate devices. All four devices have the same intended use, fundamental technology and principle of operation.
ARTISYN™ Y-Shaped Mesh and the three predicate devices, BARD ALYTE® Y-Mesh Graft, GYNECARE GYNEMESH M® Partially Absorbable Mesh and Mpathy MEDICAL RESTORELLE® Y are surgical mesh intended to support organs in the pelvic floor to address pelvic organ prolapse. ARTISYN™ Y-Shaped Mesh, BARD ALYTE® Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y are the same shape and same approximate dimensions. ARTISYN™ Y-Shaped Mesh and GYNECARE GYNEMESH M® Partially Absorbable Mesh are made of the same mesh material.
Bench testing was performed in accordance with the FDA guidance document Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, March 22, 1999. Results show that all four devices provide similar performance.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 1 2012
Ms. Sarah McManus Manager, Regulatory Affairs ETHICON Women's Health and Urology ETHICON, Inc. P.O. Box 151. Route 22 West SOMERVILLE NJ 08876
K113205 Re:
. •
Trade/Device Name: ARTISYN™ Y-Shaped Mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: May 18, 2012 Received: May 21, 2012
Dear Ms. McManus:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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device-related adverse events) (21 CFR 803); 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.
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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Benjamin K. Kirk
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: ARTISYN™Y-Shaped Mesh
Indications for Use:
ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparatomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.
Prescription Use_ V 21 CFR Part 801 Subpart D
and/or
Over-the-Counter Use 21 CFR Part 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)
6/11/2012
Division of Reproductive, Gastro-Renal, and
Urological Devices K1/3205
510(k) Number.