(118 days)
Not Found
No
The device description and performance studies focus on the physical properties and delivery mechanism of a mesh implant, with no mention of AI or ML.
Yes
The device is described as a suburethral sling for treating stress urinary incontinence, which is a medical condition, making it a therapeutic device.
No
Explanation: The device description clearly states it is a "mesh implant" for the treatment of stress urinary incontinence, and the explanation of its components and delivery mechanism indicates it is a therapeutic device (a sling) rather than one for diagnosing a condition.
No
The device description clearly outlines a physical mesh implant and delivery devices made of polymer and stainless steel, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is a "suburethral sling for the treatment of stress urinary incontinence." This describes a surgical implant used to physically support anatomical structures.
- Device Description: The device is a "synthetic mesh sling assembly" with delivery devices. This is a physical implant and surgical tool.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs are used to diagnose, monitor, or screen for diseases or conditions by analyzing these types of samples.
The device described is a surgical implant used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.
Product codes (comma separated list FDA assigned to the subject device)
OTN
Device Description
The proposed sling is a sterile, single use device, consisting of a synthetic mesh sling assembly and packaged with a delivery device. The mesh assembly consists of a blue knitted polypropylene monofilament fiber mesh body implant, association loops, dilator legs, sleeves, leader loops, center tab and lead.
The proposed sling is packaged with (2) delivery devices (Halo or Curved) which are used in conjunction with the mesh assembly to place the mesh implant. Each of the delivery devices consist of a polymer handle and a stainless steel needle which extends from the handle. The tip of the needle has a slot which is used to attach the association loop of the mesh assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
suburethral
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-Clinicial Testing:
Material testing was performed to demostrate that the material properites are suitable for the intended use.
Bench testing was performed to demostrate that the device as manufactured meets performance specifications. Test results demostrate that the device meets the predetermine specifications and is acceptable for clinical use.
Biocompatiblity testing was performed in accordance to standard EN ISO 10993-1 for each of the patient contacting materials, and results demonstrate that the device is biocompatible for its intended use.
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
K121754
PAGE 1 OF 2
510(k) Summary for Blue SUI Sling
A. Sponsor
Boston Scientific Corporation Urology and Gynecology Division 100 Boston Scientific Way Marlborough, MA 01756
B. Contact
Janet A. McGrath Principal Specialist Global Regulatory Affairs 508-683-4726 or Donna Gardner
Director, Regulatory Affairs 508-683-4398
C. Device Name
Obtryx II System Tradename: Common/usual name: Surgical Mesh Classification Name: OTN - Mesh, Surgical, Synthetic, Urogynecologic, for Stress Urinary Incontinence, Female, Multi-Incision 21 CFR 878.3300, Class II
D. Predicate Device(s)
| Tradename: | Advantage , Advantage Fit & Lynx Systems
Obtryx, Prefyx Systems |
|-------------------------|--------------------------------------------------------------------|
| Common/usual name: | Surgical Mesh |
| Classification Name: | FTL- Mesh, Surgical, Polymeric
21 CFR 878.3300, Class II |
| Premarket Notification: | Boston Scientific Corporation,
■ K020110
■ K040787 |
E. Device Description
The proposed sling is a sterile, single use device, consisting of a synthetic mesh sling assembly and packaged with a delivery device. The mesh assembly consists of a blue knitted polypropylene monofilament fiber mesh body implant, association loops, dilator legs, sleeves, leader loops, center tab and lead.
Traditional 510(k) Obtryx II System
OCT 10 2012
1
K121754
PAGE 2 OF 2
Image /page/1/Picture/2 description: The image shows a black and white picture with some dark spots. The spots are scattered across the image, with some appearing larger and more defined than others. The background is a plain white, which makes the dark spots stand out. The image is simple and lacks any complex details.
The proposed sling is packaged with (2) delivery devices (Halo or Curved) which are used in conjunction with the mesh assembly to place the mesh implant. Each of the delivery devices consist of a polymer handle and a stainless steel needle which extends from the handle. The tip of the needle has a slot which is used to attach the association loop of the mesh assembly.
F. Intended Use
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.
G. Technological Characteristics
The proposed sling has the same and/or equivalent technological characteristics (i.e. mesh design and mesh material) as the predicates K020110 & K040787.
H. Substantial Equivalence
Utilizing FDA's Guidance for Industry and FDA Staff "Format for Traditional and Abbreviated 510(k)s" and "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh", a direct comparison of key characteristics demonstrates that the proposed sling is substantially equivalent to the predicate sling in terms of intended use, technological characteristics, and performance characteristics tested. The proposed sling is as safe, as effective, and performs as well as the predicate devices.
I . Non-Clinicial Testing
Material testing was performed to demostrate that the material properites are suitable for the intended use.
Bench testing was performed to demostrate that the device as manufactured meets performance specifications. Test results demostrate that the device meets the predetermine specifications and is acceptable for clinical use.
Biocompatiblity testing was performed in accordance to standard EN ISO 10993-1 for each of the patient contacting materials, and results demonstrate that the device is biocompatible for its intended use.
Conclusion:
Based on material, biocompatiblity, bench testing, and the proposed device labeling, the Obtryx II System is substantially equivalent to the identified predicate devices in terms of intended, use , safety and effectiveness.
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 features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 10 2012
Ms. Janet A. McGrath Principal Specialist Global Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way, M21 MARLBOROUGH MA 01752
Re: K121754
Trade/Device Name: Obtryx II System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: September 19, 2012 Received: September 20, 2012
Dear Ms. McGrath:
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
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. Evanko
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
Boston Scientific Corporation
Indications for Use Statement
510(k) Number (if Known): _KlZ|75L
Device Name: Obtryx II System
Indications For Use:
The mesh implant is intended for use as a suburethral sling for the treatment of stress urinary incontinence resulting from hypermobility and/or intrinsic sphincter deficiency.
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)
(Division Sign-Off)
09 Oct 2012
oductive, Gastro-Renal, and
Traditional 510(k) Obtryx II System