(188 days)
No
The device description and performance studies focus on mechanical components and material properties, with no mention of AI or ML.
Yes
The device is intended for the treatment of male stress urinary incontinence (SUI), which is a medical condition, making it a therapeutic device.
No
The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence by a suburethral sling placement, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is comprised of physical components including a permanently implanted mesh sling, needle passers, and a retraction system. There is no mention of software as a component of the device.
Based on the provided information, the AdVance™ XP Male Sling System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of male stress urinary incontinence by surgically implanting a suburethral sling. This is a therapeutic intervention performed in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a physical implant (mesh sling) and associated surgical tools (needle passers, retraction system). It does not involve the analysis of biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, analyzing, or interpreting biological samples (like blood, urine, tissue, etc.) for diagnostic information.
Therefore, the AdVance™ XP Male Sling System is a surgical implant system, not an in vitro diagnostic device.
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 Male Sling System is a sling system which treats male stress urinary incontinence by repositioning the urethra with a suburethral mesh. The AdVance XP Male Sling System is comprised of a permanently implanted monofilament polypropylene mesh sling, two needle passers used to implant the sling, and retraction system (retractor ring and stay hooks). The male sling is connected during the procedure to the needle passers through keved connectors at each end of the male sling which are removed after the male sling is positioned. The male sling repositions the bulbar urethra 2-4cms. The AdVance™ XP Male Sling System kit is composed of four primary components: Male Sling, Needle Passers, Retractor Ring, and Stay Hooks. The AdVance™ XP Male Sling and Needle Passers are the subject of this submission. The Retraction System (retractor ring and stay hooks) is purchased pre-sterilized off the shelf components and is cleared through K791665.
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
Healthcare facility/Hospital
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)
Performance testing was conducted on non-aged samples that were accelerated aged for the equivalent of 37 months, in order to support a 3-year shelf life. To demonstrate substantial equivalence of the AdVance™ XP Male Sling System to the predicate device (K182169), technological characteristics and performance criteria were evaluated using bench testing, sterilization evaluation, and shelf life testing. The following performance tests were completed:
- Design verification and validation
- Packaging tests
- Shelf life assessments
- Sterility assurance
The results of performance testing demonstrate that the technological characteristics and performance criteria of the AdVance™ XP Male Sling System are comparable to the predicate device (K182169) and functions as intended equivalent to 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.
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.
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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December 20, 2021
Boston Scientific Corporation Anuja Bhatt Senior Regulatory Affairs Specialist 300 Boston Scientific Way Marlborough, MA 01752
Re: K211847
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: November 19, 2021 Received: November 23, 2021
Dear Anuja Bhatt:
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. Although this letter refers to your product as a device, please be aware 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.
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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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K211847
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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 Urology and Pelvic Health Division 10700 Bren Road West Minnetonka, MN 55343 USA
Contact Person: Anuja Bhatt, Senior Regulatory Affairs Specialist Phone: 510-314-1862 Email: AnujaAshokkumar.Bhatt@bsci.com Date Prepared: June 14, 2021
DEVICE
Trade Name: AdVance™ XP Male Sling System Model Number: 720163-03 Regulatory Class: II Product Code: OTM Product Code Name: Mesh, Surgical, For Stress Urinary Incontinence, Male Common/Usual/Classification Name: Surgical Mesh Classification Number: 21 CFR 878.3300
PREDICATE DEVICE
Trade Name: AdVance™ XP Male Sling System, 510(k) K182169 (cleared November 27, 2018) Model Number: 720163-01 Regulatory Class: II Product Code: OTM Product Code Name: Mesh, Surgical, For Stress Urinary Incontinence, Male Common/Usual/Classification Name: Surgical Mesh Classification Number: 21 CFR 878.3300 Sponsor: Boston Scientific Corporation
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REFERENCE DEVICE
Trade Name: Obtryx™ II System, 510(k) K121754 (cleared October 10, 2012) Requlatory Class: II Product Code: OTN Product Code Name: Mesh, Synthetic, Urogynecologic, For Stress Urinary Incontinence. Retropubic Or Transobturator Common/Usual/Classification Name: Surgical Mesh Classification Number: 21 CFR 878.3300 Sponsor: Boston Scientific Corporation
ENVIRONMENT OF USE
Healthcare facility/Hospital
DEVICE DESCRIPTION
AdVance™ XP Male Sling System is a sling system which treats male stress urinary incontinence by repositioning the urethra with a suburethral mesh. The AdVance XP Male Sling System is comprised of a permanently implanted monofilament polypropylene mesh sling, two needle passers used to implant the sling, and retraction system (retractor ring and stay hooks). The male sling is connected during the procedure to the needle passers through keved connectors at each end of the male sling which are removed after the male sling is positioned. The male sling repositions the bulbar urethra 2-4cms. The AdVance™ XP Male Sling System kit is composed of four primary components: Male Sling, Needle Passers, Retractor Ring, and Stay Hooks. The AdVance™ XP Male Sling and Needle Passers are the subject of this submission. The Retraction System (retractor ring and stay hooks) is purchased pre-sterilized off the shelf components and is cleared through K791665.
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 (K182169).
Operating Principle
AdVance™ XP Male Sling System and the predicate device (K182169) achieve their mechanism of action by repositioning the bulbar urethra 2-4 cm.
Comparison of Technological Characteristics with the Predicate Device
AdVance™ XP Male Sling System and the predicate device (K182169) have the same intended use, device material, design, environment of use (healthcare facility/hospital), mesh material, pore size, sling arm width, sheath and connectors, sterilization method (Ethylene
5
Oxide), Needle Passers, placement route (transobturator), procedural steps, similar design and fundamental technology of mesh assemblies.
The primary differences between AdVance™ XP Male Sling System and the predicate device (K182169) are the Ethylene Oxide sterilization cvcle, sterilization sites, packaging configuration and materials, shelf life, and kitting location.
SUBSTANTIAL EQUIVALENCE
A direct comparison of key characteristics demonstrates that the AdVance™ XP Male Sling System is substantially equivalent to the predicate device (K182169) in terms of intended use, technological and performance characteristics.
STERILITY
The predicate device (K182169) and proposed AdVance™ XP Male Sling System utilize the same sterilization method (Ethylene Oxide) but different sterilization parameters and sterilization locations. The AdVance™ XP Male Sling System has been qualified to be used with the different sterilization parameters. Ethylene Oxide residual testing was successfully completed on the AdVance™ XP Male Sling System device. The device has met the ISO 10993-7:2008 requirements for the respective classification after 0 days, 0 hours of aeration following 1X and 2X exposures in the sterilization cycle. This device categorized as Limited Contact/Implantable meets the TCL limits as per ISO 10993-7:2008. The AdVance™ XP Male Sling System is sterilized to a Sterility Assurance Level (SAL) of 10-6.
BIOCOMPATIBILITY
A biological evaluation was performed within a risk management process using the framework established in ISO 10993-1: 2018 and Section III of the FDA quidance document. Use of International Standard ISO 10993-1, "Biological evaluation of medical device- Part 1: Evaluation and testing within a risk management process." to demonstrate the proposed AdVance™ XP Male Sling System is biocompatible for its intended use. This biological evaluation included the materials of the device, processing of the materials, manufacturing methods (inclusive of sterilization), and potential residuals from manufacturing processing aids. In assessing the changes to the AdVance™ XP Male Sling System and consideration of testing to mitigate potential biocompatibility risks, the clinical location, duration of exposure, and intended patient population were all taken into consideration. The packaging and sterilization modifications that are the subject of this submission did not affect the materials of the device or the fact that it is biocompatible for its intended use. Therefore. existing testing of the predicate device and reference device demonstrate the biological safety of the subject AdVance™ XP Male Sling System device.
PERFORMANCE DATA
Performance testing was conducted on non-aged samples that were accelerated aged for the equivalent of 37 months, in order to support a 3-year shelf life. To demonstrate substantial equivalence of the AdVance™ XP Male Sling System to the predicate device (K182169), technological characteristics and performance criteria were evaluated using bench testing, sterilization evaluation, and shelf life testing. The following performance tests were completed:
6
- Design verification and validation
- Packaging tests ●
- Shelf life assessments .
- Sterility assurance .
The results of performance testing demonstrate that the technological characteristics and performance criteria of the AdVance™ XP Male Sling System are comparable to the predicate device (K182169) and functions as intended equivalent to devices currently on the market for the same intended use.
Conclusion
Based on the indication for use, technological characteristics, and performance data it can be concluded that the AdVance™ XP Male Sling System is substantially equivalent to the predicate device (K182169) and is appropriate for the indications for use