(117 days)
Not Found
No
The device description and intended use focus on mechanical delivery systems for surgical mesh and do not mention any computational or analytical capabilities that would suggest the use of AI/ML. The performance studies listed are standard tests for medical device safety and efficacy, not AI/ML model validation.
No.
The device is a delivery system intended to aid in the insertion, placement, fixation, and anchoring of surgical mesh; it does not directly provide a therapeutic effect.
No
The device is described as an aid in insertion, placement, fixation, and anchoring of surgical mesh. Its function is to facilitate the passage of mesh through bodily tissues for surgical placement, which is a therapeutic rather than diagnostic purpose.
No
The device description explicitly details physical components like handles, needles, shafts, and deployment mechanisms, indicating it is a hardware device used for surgical procedures.
Based on the provided information, these devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly states that these devices are "an aid in insertion, placement, fixation, and anchoring of surgical mesh during urogynaecological procedures." This describes a surgical tool used in vivo (within the body) to facilitate a surgical procedure.
- Device Description: The device descriptions detail physical components like handles, needles, shafts, and deployment mechanisms designed for manipulating and placing surgical mesh within the body. This aligns with surgical instruments, not devices used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. These devices do not fit that description. They are surgical instruments used during a procedure.
N/A
Intended Use / Indications for Use
The Advantage System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage surgical mesh during urogynaecological procedures.
The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures.
The Lynx System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Lynx surgical mesh during urogynaecological procedures.
The Solyx SIS Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Solyx SIS surgical mesh during urogynaecological procedures.
The Obtryx (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.
The Obtryx (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.
The Obtryx II (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.
The Obtryx II (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.
Product codes
PWJ
Device Description
The subject devices are not sold individually and are only offered packaged as part of a surgical mesh system. Device descriptions specific to each delivery device are italicized below within each existing system description.
Advantage™ System and Advantage Fit™ System
The Advantage System and the Advantage Fit System are sterile, single use systems, consisting of one delivery device and one mesh assembly. Each mesh assembly is comprised of a polypropylene knitted mesh protected by a disposable plastic sleeve. At the distal ends of the mesh assembly are two dilators designed to be placed over the needle end of the delivery device. The disposable delivery device consists of a handle with a curved needle, and a pusher component. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for transvaginal placement.
Lynx™ System
The Lynx System is a sterile, single use system consisting of two (2) delivery devices and one (1) mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by a disposable plastic sleeve. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of the delivery device. The disposable delivery device consists of a handle with a curved needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.
Solyx™ SIS System
The Solyx SIS (Single Incision Sling) System is a sterile single use system consisting of one (1) delivery device and one (1) mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh with polypropylene carriers at each end of the distal mesh. The carrier is designed to be placed on the tip of the delivery device. The disposable delivery device consists of a handle, a stainless steel shaft and a deployment mechanism. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for placement into the obturator internus muscle.
Obtryx™ System (Curved & Halo)
The Obtryx Sling Systems (Curved or Halo) are sterile, single use system consisting of two (2) delivery devices and one (1) mesh assembly. Each mesh assembly is comprised of a polypropylene knitted mesh protected by a disposable plastic sleeve. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of the delivery devices. The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.
Obtryx™ II System (Curved & Halo)
The Obtryx II Systems (Curved or Halo) are sterile, single use system consisting of two (2) delivery devices and one (1) mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh with dilator legs and a center tab. At the distal ends of the dilator legs there are association loops designed to be placed in the needle slot of the distal end of the delivery devices. The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The following tests were performed to demonstrate that the proposed subject devices met the applicable design and performance requirements and support a determination of substantial equivalence under the specified testing parameters. These tests include:
- Sterilization Validation
- Package integrity testing following real-time aging
- Dye Penetration O
- Seal Strength o
- Visual Inspection O
- Dimensional Tests
- . Functional Tests
- Distribution Challenge of Packaging
- . Biocompatibility
- Cytotoxicity O
- O Sensitization
- Irritation or Intracutaneous Reactivity O
- Acute systemic toxicity O
- Shelf-life Testing ●
The results of performance testing demonstrate the subject devices are biocompatible, have sufficient mechanical performance for its intended use, and support a three-year shelf life.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4910 Specialized surgical instrumentation for use with urogynecologic surgical mesh.
(a)
Identification. Specialized surgical instrumentation for use with urogynecologic surgical mesh is a prescription device specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures. These procedures include transvaginal pelvic organ prolapse repair, sacrocolpopexy (transabdominal pelvic organ prolapse repair), and treatment of female stress urinary incontinence. Examples of specialized surgical instrumentation include needle passers and trocars, needle guides, fixation tools, and tissue anchors. This device is not a manual gastroenterology-urology surgical instrument and accessories (§ 876.4730) or a manual surgical instrument for general use (§ 878.4800).(b)
Classification. Class II (special controls). The special controls for specialized surgical instrumentation for use with urogynecologic surgical mesh are:(1) The device must be demonstrated to be biocompatible;
(2) The device must be demonstrated to be sterile and, if reusable, it must be demonstrated that the device can be adequately reprocessed;
(3) Performance data must support the shelf life of the device by demonstrating package integrity and device functionality over the requested shelf life;
(4) Non-clinical performance testing must demonstrate that the device meets all design specifications and performance requirements, and that the device performs as intended under anticipated conditions of use; and
(5) Labeling must include:
(i) Information regarding the mesh design that may be used with the device;
(ii) Detailed summary of the clinical evaluations pertinent to use of the device;
(iii) Expiration date; and
(iv) Where components are intended to be sterilized by the user prior to initial use and/or are reusable, validated methods and instructions for sterilization and/or reprocessing of any reusable components.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2017
Anand Patel Regulatory Affairs Specialist II 100 Boston Scientific Way Marlborough, MA 01752
Re: K172565
Trade/Device Name: Advantage™ System Delivery Device, Advantage Fit™ System Delivery Device. Lynx™ System Delivery Device. Solyx™ SIS Delivery Device. Obtryx™ (Curved) Delivery Device, Obtryx™ (Halo) Delivery Device, Obtryx™ II (Curved) Delivery Device, Obtryx™ II (Halo) Delivery Device Regulation Number: 21 CFR§ 884.4910 Regulation Name: Specialized Surgical Instrumentation for use with Urogynecologic Surgical Mesh Regulatory Class: II Product Code: PWJ Dated: November 17, 2017 Received: November 20, 2017
Dear Anand Patel:
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.
1
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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Charles Viviano -S
For 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
2
Indications for Use
510(k) Number (if known) K172565
Device Name
Advantage™ System Delivery Device, Advantage Fif™ System Delivery Device, Lynx™ System Delivery Device, Solyx™ SIS Delivery Device, Obtryx™ (Curved) Delivery Device, Obtryx™ (Halo) Delivery Device, Obtryx™ II (Curved) Delivery Device, Obtryx™ II (Halo) Delivery Device
Indications for Use (Describe)
The Advantage System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage surgical mesh during urogynaecological procedures.
The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures.
The Lynx System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Lynx surgical mesh during urogynaecological procedures.
The Solyx SIS Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Solyx SIS surgical mesh during urogynaecological procedures.
The Obtryx (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.
The Obtryx (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx surgical mesh during urogynaecological procedures.
The Obtryx II (Curved) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.
The Obtryx II (Halo) Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Obtryx II surgical mesh during urogynaecological procedures.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K172565
A. Date Prepared
December 20, 2017
B. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01752
C. Contact
Anand Patel Regulatory Affairs Specialist II 508-683-5320 anand.patel@bsci.com
Or
Lauren Russo Regulatory Affairs Manager 508-683-4707 lauren.russo@@bsci.com
D. Device Name(s)
Trade name: Advantage™ System Delivery Device Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
Trade name: Advantage™ Fit System Delivery Device Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
4
Trade name: Lynx™ System Delivery Device Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
Trade name: SolyxTM SIS Delivery Device
Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
Trade name: Obtryx™ (Curved) Delivery Device)
Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
Trade name: ObtryxTM (Halo) Delivery Device
Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
Trade name: Obtryx™ II (Curved) Delivery Device Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
5
Trade name: Obtryx™ II (Halo) Delivery Device Common/usual name: Delivery Devices Regulation Number: 21 CFR 884.4910 Regulation Name: Specialized Surgical Instrumentation for Use with Urogynecologic Surgical Mesh Classification: Class II Product Code: PWJ (instrumentation, surgical mesh, urogynecologic, stress urinary incontinence)
E. Predicate Device(s)
Trade name: Advantage™ System, Advantage Fit™ System, Lynx™ System Common/usual name: Surgical Mesh Regulation Number: 21 CFR 878.3300 Classification: Class II Product Code: OTN Premarket Notification: Boston Scientific, K020110
Trade name: Solyx™ SIS System Common/usual name: Surgical Mesh Regulation Number: 21 CFR 878.3300 Classification: Class II Product Code: PAH Premarket Notification: Boston Scientific, K081275
Trade name: Obtryx™ II System (Curved & Halo) Common/usual name: Surgical Mesh Regulation Number: 21 CFR 878.3300 Classification: Class II Product Code: OTN Premarket Notification: Boston Scientific, K121754
The predicate devices have not been subject to a design-related recall.
F. Device Description
The subject devices are not sold individually and are only offered packaged as part of a surgical mesh system. Device descriptions specific to each delivery device are italicized below within each existing system description.
Advantage™ System and Advantage Fit™ System
The Advantage System and the Advantage Fit System are sterile, single use systems,
consisting of one delivery device and one mesh assembly. Each mesh assembly is comprised of a polypropylene knitted mesh protected by a disposable plastic sleeve. At the distal ends of the mesh assembly are two dilators designed to be placed over the needle end of the delivery device. The disposable delivery device consists of a handle with a curved needle, and a pusher component. The delivery device is designed to facilitate the passage of the mesh
6
assembly through bodily tissues for transvaginal placement.
Lynx™ System
The Lynx System is a sterile, single use system consisting of two (2) delivery devices and one (1) mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh protected by a disposable plastic sleeve. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of the delivery device. The disposable delivery device consists of a handle with a curved needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for suprapubic placement.
Solyx™ SIS System
The Solyx SIS (Single Incision Sling) System is a sterile single use system consisting of one (1) delivery device and one (1) mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh with polypropylene carriers at each end of the distal mesh. The carrier is designed to be placed on the tip of the delivery device. The disposable delivery device consists of a handle, a stainless steel shaft and a deployment mechanism. The delivery device is designed to facilitate the passage of the mesh assembly through bodily tissues for placement into the obturator internus muscle.
Obtryx™ System (Curved & Halo)
The Obtryx Sling Systems (Curved or Halo) are sterile, single use system consisting of two (2) delivery devices and one (1) mesh assembly. Each mesh assembly is comprised of a polypropylene knitted mesh protected by a disposable plastic sleeve. At the distal ends of the mesh assembly there are association loops designed to be placed in the needle slot of the distal end of the delivery devices. The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.
Obtryx™ II System (Curved & Halo)
The Obtryx II Systems (Curved or Halo) are sterile, single use system consisting of two (2) delivery devices and one (1) mesh assembly. The mesh assembly is comprised of a polypropylene knitted mesh with dilator legs and a center tab. At the distal ends of the dilator legs there are association loops designed to be placed in the needle slot of the distal end of the delivery devices. The disposable delivery devices consist of a handle with a stainless steel needle. The needle is designed to facilitate the passage of the mesh assembly through bodily tissues for placement through the obturator foramen.
7
| Advantage™ Delivery Device | ||
|---|---|---|
| Indication for | ||
| Use | K172565 (Subject Device) | K020110 (Predicate Device) |
| The Advantage System Delivery | ||
| Device is intended for use as an | ||
| aid in insertion, placement, | ||
| fixation, and anchoring of | ||
| Advantage surgical mesh during | ||
| urogynaecological procedures. | The mesh implant is intended as | |
| a suburethral sling for the | ||
| treatment of stress urinary | ||
| incontinence resulting from | ||
| urethral hypermobility and/or | ||
| intrinsic sphincter deficiency. |
G. Comparison of Indications for Use with Predicate Devices
| Advantage™ Fit Delivery Device | ||
|---|---|---|
| Indication for Use | K172565 (Subject Device) | K020110 (Predicate Device) |
| The Advantage Fit System Delivery Device is intended for use as an aid in insertion, placement, fixation, and anchoring of Advantage Fit surgical mesh during urogynaecological procedures. | The mesh implant is intended as a suburethral sling for the treatment of stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. |
| LynxTM Delivery Device | ||
|---|---|---|
| Indication for Use | K172565 (Subject Device) | K020110 (Predicate Device) |
| The Lynx System Delivery | ||
| Device is intended for use as an | ||
| aid in insertion, placement, | ||
| fixation, and anchoring of Lynx | ||
| surgical mesh during | ||
| urogynaecological procedures. | The mesh implant is intended as | |
| a suburethral sling for the | ||
| treatment of stress urinary | ||
| incontinence resulting from | ||
| urethral hypermobility and/or | ||
| intrinsic sphincter deficiency. |
| Solyx™ SIS Delivery Device | ||
|---|---|---|
| Indication for Use | K172565 (Subject Device) | K081275 (Predicate Device) |
| The Solyx SIS Delivery Device is | ||
| intended for use as an aid in | ||
| insertion, placement, fixation, | ||
| and anchoring of Solyx SIS | ||
| surgical mesh during | ||
| urogynaecological procedures. | The mesh implant is intended as | |
| a suburethral sling for the | ||
| treatment of stress urinary | ||
| incontinence resulting from | ||
| urethral hypermobility and/or | ||
| intrinsic sphincter deficiency. |
8
| Obtryx™ & Obtryx™ II Delivery Device | ||
|---|---|---|
| Indication for | ||
| Use | K172565 (Subject Device) | K121754 (Predicate Device) |
| The Obtryx (Curved) Delivery | ||
| Device is intended for use as an | ||
| aid in insertion, placement, | ||
| fixation, and anchoring of Obtryx | ||
| surgical mesh during | ||
| urogynaecological procedures. |
The Obtryx (Halo) Delivery
Device is intended for use as an
aid in insertion, placement,
fixation, and anchoring of Obtryx
surgical mesh during
urogynaecological procedures.
The Obtryx II (Curved) Delivery
Device is intended for use as an
aid in insertion, placement,
fixation, and anchoring of Obtryx
II surgical mesh during
urogynaecological procedures.
The Obtryx II (Halo) Delivery
Device is intended for use as an
aid in insertion, placement,
fixation, and anchoring of Obtryx
II surgical mesh during
urogynaecological procedures. | The mesh implant is intended as
a suburethral sling for the
treatment of stress urinary
incontinence resulting from
urethral hypermobility and/or
intrinsic sphincter deficiency. |
The indications for use statements for subject devices and the predicate devices are not identical, as the predicate devices are surgical mesh systems for treatment of stress urinary incontinence. The intended use of the subject and predicate devices is the same, as the subject devices are an accessory to a surgical mesh.
9
| Device(s) | Subject Device | Predicate Device |
|---|---|---|
| K172565 | K020110 | |
| K081275 | ||
| K121754 | ||
| General Device Characteristics | ||
| Patient contact |