(96 days)
MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System is an implant device that is intended for the treatment of Stress Urinary Incontinence (SUI ) resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the Urological, Gynecological, Uro-Gynecological or Gastroenterological anatomy. This includes but not limited to the following procedures: Pub urethral support, and Bladder support, Urethral and Vaginal Prolapse Repair, Colon and Rectal Prolapse Repair, Reconstruction of Pelvic floor and Sacral Colposuspension.
The MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Modular Anchor System is available with Single use, universal introducer device with notched tip design, compatible with Fixed, Adjustable and Snap-On modular self anchoring fixation ends of urethral sling and surgical mesh. The Introducer tip can be attached to slot in the fixation anchor for quick connect & disconnect for easy delivery of urethral sling and surgical mesh into target soft tissue. The position of Fixation anchors and sling can also be adjusted intra-operatively using introducer. The T anchors and Split anchors can be delivered in to soft tissue using, modified needle device with ease and minimum discomfort to the patient. The introducer device is available in straight, curved malleable and detachable configuration in various length and curvature to meet physician's preference, patient's anatomy & surgical procedure requirements.
The provided text details a 510(k) summary for the MiniSling™ device. It describes the device, its intended use, and compares its technological characteristics to predicate devices. However, the document does not contain a comprehensive study proving the device meets specific acceptance criteria in the format typically associated with a clinical trial or a detailed performance validation report. Instead, it relies on preclinical testing and comparison to legally marketed predicate devices for substantial equivalence.
Here's a breakdown of the information that can be extracted from the provided 510(k) summary, structured to address your request as much as possible, while also highlighting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Expected Performance) | Reported Device Performance |
|---|---|
| Device performs as intended when used according to instructions. | "Laboratory product testing has indicated that the urethral Sling and Surgical mesh devices has demonstrated satisfactory performance for its intended applications." |
| Tensile strength and breakage force are satisfactory for intended use. | "Mechanical testing of the devices also demonstrated that the tensile strength and breakage force are equal or more than the predicated devices and are satisfactory for its intended use." |
| Pull force of tissue fixation anchor. | "The average pull force of tissue fixation anchor is more than 4000 Gms, during initial implantation stage." |
Important Note: The provided document states that "Preclinical testing was performed," but it does not specify what the quantitative acceptance criteria for "satisfactory performance," "tensile strength," or "breakage force" were. It only states that the device met these unquantified criteria and that the tensile strength and breakage force were "equal or more than the predicated devices."
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the preclinical testing. Therefore, the data provenance (e.g., country of origin, retrospective/prospective) cannot be determined from this text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary. The preclinical testing described appears to be laboratory-based mechanical testing, not a study involving expert assessment or clinical ground truth establishment in the typical sense.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The testing described is preclinical mechanical testing, not a study requiring adjudication of expert interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document focuses on preclinical mechanical testing and comparison to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This is not applicable and not mentioned. The device is a physical surgical implant, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the preclinical testing described is based on predefined mechanical and performance parameters (e.g., tensile strength, breakage force, pull force) measured in a laboratory setting. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this safety and effectiveness summary.
8. Sample Size for the Training Set
This information is not applicable and not provided. As this is a physical device, not an algorithm or AI system, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, for the same reasons as above.
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510K Summary of Safety & Effectiveness
MiniSling™ - Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System
Company:
Contact:
Prosurg, Inc 2193 trade Zone blvd San Jose CA 95131
Ashvin Desai , Mgr Regulatory Affairs Tel: (408) 945 -4044
Date Preparaed: June 26, 2007
Device Name: MiniSling™ - Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System
Predicated Devices: BioSling - Bioabsorbable Sling & Surgical Mesh (Ref: K 010533) Zippere - bioabsorbable / Non-Absorbable Polymer Sling & Mesh (Ref: K 030631) AMS-Smart Sling System & pelvic Floor Repair System (Ref K 063713) Gynecare - TVT Secure System & Pelvic Floor Repair System ( K 052401)
Device Description:
The MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Modular Anchor System is available with Single use, universal introducer device with notched tip design, compatible with Fixed, Adjustable and Snap-On modular self anchoring fixation ends of urethral sling and surgical mesh. The Introducer tip can be attached to slot in the fixation anchor for quick connect & disconnect for easy delivery of urethral sling and surgical mesh into target soft tissue. The position of Fixation anchors and sling can also be adjusted intra-operatively using introducer. The T anchors and Split anchors can be delivered in to soft tissue using, modified needle device with ease and minimum discomfort to the patient. The introducer device is available in straight, curved malleable and detachable configuration in various length and curvature to meet physician's preference, patient's anatomy & surgical procedure requirements.
Indications for Use:
MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System is an implant device that is intended for the treatment of Stress Urinary Incontinence (SUI) resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the Urological, Gynecological, Uro-Gynecological or Gastroentrological anatomy. This includes but not limited to the following procedures: Pub urethral support, and Bladder support, Urethral and Vaginal Prolapse Repair, Colon and Rectal Prolapse Repair, Reconstruction of Pelvic floor and Sacral Colposuspension.
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Comparison of technological Characteristics:
The Mini-Sling - Adjustable Polymer Sling & Surgical Mesh with Self-anchoring System is a modification of the currently marketed BioSling and Zippere Urethral Sling and Surgical Mesh used for pelvic floor support. While it represents s a refinement to the predicate systems, the overall technology and the intended use of the both system are identical. Both predicate and proposed systems are designed for treatment of female Strees Urinary Incontinence (SUI) disorders and pelvic floor repair and reconstruction surgery. The materials, manufacturing methods, packaging and sterilization process used are also identical.
Performance Data:
Preclinical testing was performed to ensure that the Urethral Slings and Surgical mesh products performs as intended when used according to the instructions for use. Laboratory product testing has indicated that the urethral Sling and Surgical mesh devices has demonstrated satisfactory performance for its intended applications. Mechanical testing of the devices also demonstrated that the tensile strength and breakage force are equal or more than the predicated devices and are satisfactory for its intended use. The average pull force of tissue fixation anchor is more than 4000 Gms, during initial implantation stage.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Prosurg, Inc % Mr. Ashvin Desai Manager, Regulatory Affairs 2193 Trade Zone Boulevard San Jose, California 95131
JUL - 2 2007
Re: K070846
Trade/Device Name: MiniSling" Adjustable Polymer Sling & Surgical Mesh with Self Anchoring System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: May 31, 2007 Received: June 05, 2007
Dear Mr. Desai:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); good manufacturing practice requirements as set
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Page 2 - Mr. Ashvin Desai
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours. Mark N. Melkerson Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K070846
Device Name: MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System
Indications for Use:
MiniSling™- Adjustable Polymer Sling & Surgical Mesh with Self-Anchoring System is an implant device that is intended for the treatment of Stress Urinary Incontinence (SUI ) resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissue where weakness exists in the Urological, Gynecological, Uro-Gynecological or Gastroenterological anatomy. This includes but not limited to the following procedures: Pub urethral support, and Bladder support, Urethral and Vaginal Prolapse Repair, Colon and Rectal Prolapse Repair, Reconstruction of Pelvic floor and Sacral Colposuspension.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
Page 1 of 1
16070846
§ 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.