(51 days)
No
The summary describes a physical implantable device (a sling system) and its components. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a "Male Sling System intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling," which indicates it is used for treatment.
No
The device is described as a "Male Sling System intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling," which indicates it is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components like a sling, needle passers, retractor ring, and stay hooks, indicating it is a hardware-based 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 "for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling." This describes a surgical procedure and the implantation of a device within the body.
- Device Description: The device is a "Male Sling System" composed of physical components like a mesh sling, tissue anchors, needle passers, and a retractor ring. These are all physical instruments and implants used in a surgical setting.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
The device is a surgical implant and associated instruments, not a diagnostic tool used in vitro (outside the body).
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
The AdVance XP Male Sling System is provided as a sterile, single-pack kit composed of the following primary components: Male Sling, Needle Passers (2), Retractor Ring, and Stay Hooks. The subject of this premarket notification is around the Male Sling component of the AdVance XP Male Sling System, specifically the implantable portion of the Male Sling assembly, which is the mesh sling and the tissue anchors. There are no modifications to the Needle Passers, or Retractor Ring and Stay Hooks (which form the Retraction System) as a part of this submission. Note that the Retraction System are comprised of purchased, off-the-shelf components 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 (T=0) samples and samples that were accelerated aged for 37 months (in order to support the 3 year device shelf life). 37 month real-time aging is ongoing. To demonstrate substantial equivalence of the AdVance XP Male Sling System to the predicate device (K211847), technological characteristics and performance criteria were evaluated using design verification bench testing. The FDA Guidance for the Preparation of Premarket Notification Application for a Surgical Mesh (issued on 02Mar1999) was utilized for preclinical mesh attribute evaluations. Mesh product characteristics such as mesh thickness, mesh weave characteristics, pore size, mesh density, tensile strength, and burst strength were evaluated through mesh material specification controls. Additional evaluations were performed through design testing on the final product assembly using internally developed product design specifications. The results of the performance testing demonstrate that the technological characteristics and performance criteria of the proposed AdVance XP Male Sling System are comparable to the predicate device (K211847) and functions as intended, equivalent to a device currently on the market for the same indications for 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.
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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.
November 15, 2024
Boston Scientific Corporation Natalie Asprey Senior Regulatory Affairs Specialist 100 Boston Scientific Wav Marlborough, Massachusetts 01752
Re: K242960
Trade/Device Name: AdVance™ XP Male Sling System (720163-03) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: OTM Dated: September 25, 2024 Received: September 25, 2024
Dear Natalie Asprey:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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 -S
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
Submission Number (if known)
Device Name
AdVance™ XP Male Sling System (720163-03)
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)
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Urology 100 Boston Scientific Way Marlborough, MA 01752
510(k) Summary
Submitter
Boston Scientific Corporation Urology Division 100 Boston Scientific Way Marlborough, MA 01752 USA
Primary Contact: Natalie Asprey Senior Regulatory Affairs Specialist Email: Natalie.Asprey@bsci.com Date Prepared: 25 September 2024
Alternate Contact: Kristine Higgins Regulatory Affairs Director Email: Kristine.Higgins@bsci.com Telephone: 952-930-6475
Proposed Device K242960
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 K211847
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 Manufacturer: Boston Scientific Corporation
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Device Description
The AdVance XP Male Sling System is provided as a sterile, single-pack kit composed of the following primary components: Male Sling, Needle Passers (2), Retractor Ring, and Stay Hooks. The subject of this premarket notification is around the Male Sling component of the AdVance XP Male Sling System, specifically the implantable portion of the Male Sling assembly, which is the mesh sling and the tissue anchors. There are no modifications to the Needle Passers, or Retractor Ring and Stay Hooks (which form the Retraction System) as a part of this submission. Note that the Retraction System are comprised of purchased, off-the-shelf components cleared through K791665.
Environment of Use
Healthcare facility/Hospital
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.
Operating Principle
The AdVance XP Male Sling is a suburethral mesh implant designed to treat male incontinence by repositioning the urethra. AdVance XP needle passers assist in the placement of the male sling. AdVance XP Male Sling System is an implanted, surgical device that penetrates inside the body. Its intended purpose is for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling.
Comparison of Technological Characteristics with the Predicate Device
The proposed AdVance XP Male Sling System and the predicate device (K211847) have identical indications for use, operating principle, finished good device dimensions and features, environment of use, sterilization method, shelf life, Needle Passers, and Retraction System.
The primary differences between the proposed AdVance XP Male Sling System and the predicate device (K211847) are the material composition and the material wash process (including processing aids).
Substantial Equivalence
The direct comparison of key characteristics, along with data presented in this premarket notification, demonstrates that the proposed AdVance XP Male Sling System is substantially equivalent to the predicate AdVance XP Male Sling System device, which was cleared by the FDA under premarket notification K211847.
Sterility
There were no changes in the sterilization process used for the AdVance XP Male Sling System, however an ethylene oxide (EO) sterilization qualification was performed to confirm that the proposed device continues to meet a SAL of 10-6 or better and in accordance with global BSC procedures and ISO 11135. Additionally, a microbiology evaluation was performed in accordance
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with global BSC procedures, ISO 11737-1, and ANSI AAMI ST72 to ensure the proposed device continues to meet bioburden and endotoxin requirements.
Biocompatibility
A biological evaluation was performed per ISO 10993-1 Biological Evaluation of Medical Devices – Part 1 and FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" to demonstrate that the proposed AdVance XP Male Sling System device is biocompatible for its intended use. This biological evaluation included assessment of the materials of construction (including processing of the materials and processing aids), toxicological risk assessment, and biological testing.
Results of the material characterization, toxicological risk assessment, and biological testing support the biocompatibility of the device. The biological evaluation conducted in accordance with ISO 10993-1 and FDA Guidance (2023) confirms that the AdVance XP Male Sling System is biocompatible for its intended use per its ISO 10993-1 categorization as a Implant, Tissue/Bone, Permanent (> 30 day) contact device. The results of the biological evaluation of the device modifications support the proposed AdVance XP Male Sling System is substantially equivalent to the predicate (K211847).
Performance Data
Performance testing was conducted on non-aged (T=0) samples and samples that were accelerated aged for 37 months (in order to support the 3 year device shelf life). 37 month real-time aging is ongoing. To demonstrate substantial equivalence of the AdVance XP Male Sling System to the predicate device (K211847), technological characteristics and performance criteria were evaluated using design verification bench testing. The FDA Guidance for the Preparation of Premarket Notification Application for a Surgical Mesh (issued on 02Mar1999) was utilized for preclinical mesh attribute evaluations. Mesh product characteristics such as mesh thickness, mesh weave characteristics, pore size, mesh density, tensile strength, and burst strength were evaluated through mesh material specification controls. Additional evaluations were performed through design testing on the final product assembly using internally developed product design specifications. The results of the performance testing demonstrate that the technological characteristics and performance criteria of the proposed AdVance XP Male Sling System are comparable to the predicate device (K211847) and functions as intended, equivalent to a device currently on the market for the same indications for use.
Conclusion
Based on the indication for use, technological characteristics, and performance data it can be concluded that the proposed AdVance XP Male Sling System is substantially equivalent to the predicate device AdVance XP Male Sling System (K211847) and is appropriate for the indications for use.