(109 days)
No reference devices were used for this submission
No
The device description and performance studies focus on a physical sling system and its mechanical properties, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for the treatment of male stress urinary incontinence, which is a medical condition, making it a therapeutic device.
No
This device is a sling system intended for the treatment of male stress urinary incontinence by repositioning the urethra. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a "sling system which treats male stress urinary incontinence by repositioning the urethra with a suburethral mesh" and lists physical components like mesh, needle passers, retractor, and needle. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of male stress urinary incontinence by surgically implanting a sling. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a physical implant (mesh sling) and surgical tools used for its placement. It does not involve analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample collection, or analysis of biological markers.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The AdVance™ XP Male Sling System is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling.
Product codes (comma separated list FDA assigned to the subject device)
OTM
Device Description
AdVance™ XP is a sling system which treats male stress urinary incontinence by repositioning the urethra with a suburethral mesh. The AdVance XP system is comprised of a permanently implanted monofilament polypropylene mesh sling, two needle passers used to implant the sling, SKW retractor and percutaneous needle. The sling is connected during the procedure to the needle passers through keyed connectors at each end of the sling which are removed after the sling is positioned. The sling repositions the bulbar urethra 2-4cms.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bulbar urethra
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)
To demonstrate substantial equivalence of the AdVance™ XP to the predicate device, technological characteristics and performance criteria were evaluated using bench testing, biocompatibility testing, real world complaint data, clinical literature searches, and clinical evaluations. The results from this testing and other data demonstrate that the technological characteristics and performance criteria of the AdVance™ XP are comparable to the predicate device and can perform in a manner equivalent to the devices currently on the market for the same 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.
AdVance™ Male Sling System, K053371
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.
No reference devices were used for this submission
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
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November 27, 2018
Boston Scientific Corporation Kaitlyn Rainbow Senior Regulatory Affairs Specialist 10700 Bren Road West Minnetonka, MN 55343
Re: K182169
Trade/Device Name: AdVance™ XP Male Sling System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTM Dated: August 16, 2018 Received: August 17, 2018
Dear Kaitlyn Rainbow:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,
Image /page/1/Picture/7 description: The image shows the name "Glenn B. Bell -S" in a large, bold font. The text is black and is set against a white background. The letters are evenly spaced and easy to read.
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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K182169 |
| Device Name | AdVance™ XP Male Sling System |
| Indications for Use (Describe) | The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling. |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
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Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 508-683-4000 www.bostonscientific.com
510(k) Summary
| Submitter | Boston Scientific Corporation
10700 Bren Road West
Minnetonka, MN 55343
USA |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: 952-930-6000 |
| | Contact Person: Kaitlyn Rainbow
Date Prepared: November 26, 2018 |
| Device: | Device Name: AdVance™ XP Male Sling System
Model: 720163-01
Common Name: Sub-Urethral Sling System; Surgical Mesh
Classification Name: Surgical Mesh
Classification Number: 21 CFR 878.3300
Regulatory Class: II
Product Code: OTM
Product Code Name: Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Predicate Device | AdVance™ Male Sling System, K053371
No reference devices were used for this submission |
| Device Description | AdVance™ XP is a sling system which treats male stress urinary incontinence
by repositioning the urethra with a suburethral mesh. The AdVance XP
system is comprised of a permanently implanted monofilament polypropylene
mesh sling, two needle passers used to implant the sling, SKW retractor and
percutaneous needle. The sling is connected during the procedure to the
needle passers through keyed connectors at each end of the sling which are
removed after the sling is positioned. The sling repositions the bulbar urethra
2-4cms. |
| Indications for Use | The AdVance™ XP Male Sling System is intended for the treatment of male
stress urinary incontinence (SUI) by the placement of a suburethral sling. |
| | The indications for use of the AdVance™ XP Male Sling System are the same
as the predicate device. |
| Comparison of
Technological
Characteristics with
the Predicate Device | AdVance™ XP and the predicate device achieve their mechanism of action
by repositioning the bulbar urethra 2-4 cm. Both devices have the same mesh
material, pore size, sling arm width, sheath and connectors, and transobturator
surgical approach. |
4
| | The technological differences that exist between the two devices are sling
length, mesh weave, anchoring mechanism, and needle passer shape. |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | To demonstrate substantial equivalence of the AdVance™ XP to the predicate
device, technological characteristics and performance criteria were evaluated
using bench testing, biocompatibility testing, real world complaint data,
clinical literature searches, and clinical evaluations. |
| | The results from this testing and other data demonstrate that the technological
characteristics and performance criteria of the AdVance™ XP are comparable
to the predicate device and can perform in a manner equivalent to the devices
currently on the market for the same intended use. |
| Conclusion | As the indications for use and fundamental scientific technology have not
changed, non-clinical and clinical performance data supports a determination
that the subject device is substantially equivalent to the predicate device, and
that it is at least as safe and effective for its intended use. |