(109 days)
The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling.
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.
This is a 510(k) premarket notification for the AdVance™ XP Male Sling System, which is a surgical mesh used for treating male stress urinary incontinence (SUI). The document does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and sample sizes for AI model training/testing cannot be extracted from this document.
However, I can provide information about the general performance assessment conducted for this medical device, which is a non-AI product.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI device, there are no "acceptance criteria" for an algorithm's performance. Instead, the "performance criteria" refer to the physical and functional characteristics of the medical device. The document states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Technological Equivalence | The AdVance™ XP has the same mesh material, pore size, sling arm width, sheath, connectors, and transobturator surgical approach as the predicate device (AdVance™ Male Sling System, K053371). The technological differences are sling length, mesh weave, anchoring mechanism, and needle passer shape. Despite these differences, the device achieves its mechanism of action by repositioning the bulbar urethra 2-4 cm, which is the same as the predicate. |
| Safety and Effectiveness | Demonstrated through: - Bench testing: Evaluated technological characteristics and performance criteria. - Biocompatibility testing: Assessed the material's compatibility with the body. - Real-world complaint data: Reviewed existing data, likely from the predicate device or similar products. - Clinical literature searches: Reviewed published clinical studies. - Clinical evaluations: Specific details are not provided in this summary, but these would typically involve human use studies or literature reviews of previous human use. Conclusion: "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." And "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." |
The following information cannot be provided as the document describes a traditional medical device (surgical mesh), not an AI/Machine Learning diagnostic or assistive device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for a non-AI device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable for a non-AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a non-AI device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable for a non-AI device. There are no "human readers" or "AI assistance" involved in the direct assessment of this surgical mesh.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for a non-AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a traditional medical device like this, "ground truth" would be related to established safety and performance standards, clinical outcomes, and successful use in target patients, often from the predicate device's history and relevant clinical literature. The document mentions "clinical evaluations" and "clinical literature searches."
8. The sample size for the training set
Not applicable for a non-AI device.
9. How the ground truth for the training set was established
Not applicable for a non-AI device.
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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.
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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/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,
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See 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) |
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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 Corporation10700 Bren Road WestMinnetonka, MN 55343USA |
|---|---|
| Phone: 952-930-6000 | |
| Contact Person: Kaitlyn RainbowDate Prepared: November 26, 2018 | |
| Device: | Device Name: AdVance™ XP Male Sling SystemModel: 720163-01Common Name: Sub-Urethral Sling System; Surgical MeshClassification Name: Surgical MeshClassification Number: 21 CFR 878.3300Regulatory Class: IIProduct Code: OTMProduct Code Name: Mesh, Surgical, For Stress Urinary Incontinence, Male |
| Predicate Device | AdVance™ Male Sling System, K053371No reference devices were used for this submission |
| Device Description | AdVance™ XP is a sling system which treats male stress urinary incontinenceby repositioning the urethra with a suburethral mesh. The AdVance XPsystem is comprised of a permanently implanted monofilament polypropylenemesh sling, two needle passers used to implant the sling, SKW retractor andpercutaneous needle. The sling is connected during the procedure to theneedle passers through keyed connectors at each end of the sling which areremoved after the sling is positioned. The sling repositions the bulbar urethra2-4cms. |
| Indications for Use | The AdVance™ XP Male Sling System is intended for the treatment of malestress urinary incontinence (SUI) by the placement of a suburethral sling. |
| The indications for use of the AdVance™ XP Male Sling System are the sameas the predicate device. | |
| Comparison ofTechnologicalCharacteristics withthe Predicate Device | AdVance™ XP and the predicate device achieve their mechanism of actionby repositioning the bulbar urethra 2-4 cm. Both devices have the same meshmaterial, pore size, sling arm width, sheath and connectors, and transobturatorsurgical approach. |
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| The technological differences that exist between the two devices are slinglength, mesh weave, anchoring mechanism, and needle passer shape. | |
|---|---|
| Performance Data | To demonstrate substantial equivalence of the AdVance™ XP to the predicatedevice, technological characteristics and performance criteria were evaluatedusing 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 technologicalcharacteristics and performance criteria of the AdVance™ XP are comparableto the predicate device and can perform in a manner equivalent to the devicescurrently on the market for the same intended use. | |
| Conclusion | As the indications for use and fundamental scientific technology have notchanged, non-clinical and clinical performance data supports a determinationthat the subject device is substantially equivalent to the predicate device, andthat it is at least as safe and effective for its intended use. |
§ 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.