(224 days)
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.
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.
The document you provided is a 510(k) summary for a surgical mesh device, ARTISYN™ Y-Shaped Mesh. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific clinical performance acceptance criteria through a study with defined endpoints like sensitivity and specificity.
Therefore, many of the requested categories are not applicable or cannot be extracted from this specific document, as it focuses on demonstrating material and design equivalence rather than performance equivalence in the way a diagnostic AI device would.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) like those found for diagnostic or AI devices. The "acceptance criteria" here are implicitly related to demonstrating substantial equivalence in material properties and mechanical performance compared to predicate surgical meshes.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence | - ARTISYN™ Y-Shaped Mesh is composed of the same partially absorbable mesh material used in the predicate device, GYNECARE GYNEMESH M® Partially Absorbable Mesh.- The mesh material has been subjected to mechanical testing and is identical to GYNECARE GYNEMESH M® Partially Absorbable Mesh and substantially equivalent to BARD ALYTE™ Y-Mesh Graft. |
| Design/Configuration Equivalence | - The design is a Y-configuration with a similar shape and similar dimensions as the predicate devices, BARD ALYTE™ Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y.- ARTISYN™ Y-Shaped Mesh, BARD ALYTE® Y-Mesh Graft and Mpathy MEDICAL RESTORELLE® Y are the same shape and same approximate dimensions. |
| Mechanical Performance Equivalence | - 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 "FDA 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. |
| Intended Use Equivalence | - The device has the same intended use as the predicate devices (bridging material for sacrocolposuspension/sacrocolpopexy where surgical treatment for vaginal vault prolapse is warranted).- All four devices have the same intended use, fundamental technology, and principle of operation. They are surgical mesh intended to support organs in the pelvic floor to address pelvic organ prolapse. |
2. Sample size used for the test set and the data provenance
Not Applicable. The study described is bench testing (mechanical testing) of the mesh material and the finished device, and a comparison to predicate devices, not a clinical study on a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is a bench testing and equivalence study, not a study involving expert assessment of images or patient data to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable. This is a bench testing and equivalence study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This is a surgical mesh device, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is a surgical mesh device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" would be the measured physical and mechanical properties of the mesh materials and finished devices as determined by standardized laboratory tests and comparison to established specifications or the properties of the predicate devices.
8. The sample size for the training set
Not Applicable. There is no "training set" as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
Not Applicable. There is no "training set" or "ground truth" in the context of an algorithm for this type of device.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
:
JUN 1 2 2012
| Sponsor: | ETHICON Women's Health and UrologyETHICON, Inc.P.O. Box 151Route 22 WestSomerville, New Jersey 08876 |
|---|---|
| Contact: | Sarah McManusETHICON Women's Health and UrologyETHICON, Inc.P.O. Box 151Route 22 WestSomerville, New Jersey 08876Phone: 908-218-2954Fax: 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, K101722GYNECARE GYNEMESH M® Partially Absorbable Mesh , ETHICON Inc., K082216RESTORELLE® Y, Mpathy Medical Devices, Ltd., K092207 |
| Device Description: | ARTISYN™ Y-Shaped Mesh consists of two pieces of partially absorbable meshprovided in a Y shape: a vaginal section with anterior/posterior flaps and asacral section. The anterior and posterior flaps are for anterior and posteriorvaginal attachment, and the sacral flap for attachment to the sacralpromontory. The mesh consists of non-absorbable undyed and dyedpolypropylene and absorbable undyed poliglecaprone-25 monofilament. The |
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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.
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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
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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
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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.
§ 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.