(97 days)
Not Found
No
The summary describes a physical mesh device and its performance testing, with no mention of AI or ML technology.
Yes.
The device is a mesh intended for surgical treatment of vaginal vault prolapse, which is a therapeutic intervention.
No
The device is described as a "bridging material" for surgical treatment of vaginal vault prolapse, which indicates it is a therapeutic device, not a diagnostic one. Its function is to support tissue, not to identify or characterize medical conditions.
No
The device description clearly states it is a "preformed Y shaped lightweight polypropylene mesh," indicating it is a physical hardware 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 clearly states it's for surgical treatment of vaginal vault prolapse as a bridging material. This is a surgical implant used in the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a physical mesh implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Upsylon Y mesh is intended for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Product codes (comma separated list FDA assigned to the subject device)
OTO
Device Description
Upsylon Mesh is a preformed Y shaped lightweight polypropylene mesh consisting of two vaginal mesh arms and one sacral mesh arm. The Upsylon mesh is blue in color with a non-colored centering line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal vault
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)
Boston Scientific has conducted a user evaluation in cadavers which evaluated placement of the mesh. Performance testing was completed with samples aged at T=0 and T=7 months accelerated aging in support of the Upsylon Y mesh configuration. The following testing was completed: - Y mesh leg tensile . - Y mosh leg elongation t - . Y mesh attachment strength Performance data for biocompatibility and mesh characterization provided in K 103426 for the LITE Pelvic Floor Repair Kits supports the Upsylon Y mesh. The results of the performance testing demonstrate equivalence of the Upsylon Y mesh to the predicate meshes.
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.
0
K122794
Upsylon Y mcsh Traditional 510(k)
SECTION 5
Page 1 of 2
DEC 1 8 2012
Boston Scientific
510K SUMMARY
510(k) Summary for Upsylon Y mesh
A. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
Lauren Anderson Senior Specialist, Regulatory Affairs 508-683-4707 lauren.anderson@bsci.com
or
Donna Gardner Director, Regulatory Affairs 508-683-4398 gardnerd@bsci.com
C. Device Name
Upsylon Y mesh Trade name: Common/usual name: Surgical Mesh Classification Name: OTO- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal and Uterine Prolapsc, Transabdominally Placed 21 CFR 878.3300, Class II
D. Predicate Device
LITE Pelvic Floor Repair Kits Trade name: Common/usual name: Surgical Mesh Classification Name: OTP- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed 21 CFR 878.3300, Class II
Premarket Notification: Boston Scientific, K103426
Restorelle Y Trade namc: Common/usual náme: Surgical mesh Classification Name: OTO- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal and Uterine Prolapse, Transabdominally Placed 21 CFR 878.3300, Class II
Premarket Notification: Coloplast, K112322
Proprietary and Confidential Information of Boston Scientific Corporation
1
Upsylon Y mesh Traditional 510(k)
SECTION 5
Boston Scientific
510K SUMMARY
E. Device Description
Upsylon Mesh is a preformed Y shaped lightweight polypropylene mesh consisting of two vaginal mesh arms and one sacral mesh arm. The Upsylon mesh is blue in color with a non-colored centering line.
F. Intended Use
Intended for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
G. Technological Characteristics
The Upsylon Y mesh is a preconfigured, lightweight polypropylene mcsh and has the same technological characteristics and fundamental Y mesh design as the predicate Restorelle Y.
H. Substantial Equivalence
A direct comparison of key characteristics demonstrates that the proposed Y mesh is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics. The Upsylon Y mesh is as safe, as effective, and performs as well as the predicate devices.
I. Performance Testing (Bench and User Evaluation)
Boston Scientific has conducted a user evaluation in cadavers which evaluated placement of the mesh. Performance testing was completed with samples aged at T=0 and T=7 months accelerated aging in support of the Upsylon Y mesh configuration. The following testing was completed:
- Y mesh leg tensile .
- Y mosh leg elongation t
- . Y mesh attachment strength
Performance data for biocompatibility and mesh characterization provided in K 103426 for the LITE Pelvic Floor Repair Kits supports the Upsylon Y mesh. The results of the performance testing demonstrate equivalence of the Upsylon Y mesh to the predicate meshes.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2012
Boston Scientific Corporation Urology/Women's Health % Ms. Lauren B. Anderson, RAC Senior Specialist, Regulatory Affairs 100 Boston Scientific Way MARLBOROUGH MA 01752
Re: K122794
Trade/Device Name: Upsylon Y mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: November 28, 2012 Received: November 29, 2012
Dear Ms. Anderson:
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.
3
Page 2 - Ms. Lauren B. Anderson, RAC
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 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,
Benjamin R. Fisher -S
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
Upsylon Y mesh Traditional 510(k) Boston Scientific
INDICATIONS FOR USE SECTION 4
Indications for Use Statement
510(k) -Fo-be-determined: K122794 Number
Device Name Upsylon Y mesh
Indications For Use
The Upsylon Y mesh is intended for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin R. Fisher -S 2012.12.19 14:38:38 -05'00'
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number _ K122794
Proprietary and Confidential Information of Boston Scientific Corporation