(53 days)
The SiiS#1 Device is intended to be used as a pubourethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Indications (from labeling): The SiiS#1 device is intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The SiiS#1 Inserter, Sling Locater and Urethral Probe are available and intended to facilitate placement of the SiiS#1 device.
The SiiS#1 Bladder-Neck Suspension Device is a sterile, single-use device intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting form urethral hypermobility and/or intrinsic sphincter deficiency. The SiiS#1 Bladder-Neck Suspension Device Inserter, and Sling Locator are provided and are intended to facilitate the placement of the SiiS#1 Bladder-Neck Suspension Device.
The SiiS#1 Tissue Suspension Device is a sterile single use device, consisting of one piece of undyed polyester tubular mesh approximately 6 mm diameter x 305 mm long (.250 x 12 inches) with both ends terminating in toggle type tissue anchors. The anchors and part of the mesh are held within a long needle inserter. Attached to the mesh creating a secondary sling is a sliding mesh approximately 80 mm long connected to the longer mesh with sliding locks. The sliding locks are advanced with the sling locator to shorten the length of the sling until desired length is achieved. Polyester tubular mesh is constructed of knitted filaments of extruded polyester strands identical in composition to that used in polyester non-absorbable surgical suture. The material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.
The SiiS#1 Inserter is provided sterile and single use. The inserter is made of stainless steel with an anodized aluminum handle. The tip of the inserter is constructed to accept the toggle anchors and part of the tubular mesh. The inserter is intended to facilitate the passage of the toggle anchors through the rectus fascia below the abdominal skin.
The SiiS#1 Reusable Sling Locator is provided sterile and single use. The locator is made of polyacetal or equivalent and is intended to facilitate the position of the sliding sling on the longer suspender. It is connected and fixed to the longer suspender and interfaces with the sliding sling adjustment locks.
Acceptance Criteria and Device Performance for SiiS#1 Tissue Suspension System
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pull-out Force | Device has a pull-out force well over the predicate device. | "Cadaver testing has shown that the SiiS#1 has a pull-out force that is well over that of the predicate device." |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: Not explicitly stated in the provided document. However, the study was conducted using cadavers.
- Data Provenance: The study was conducted on cadavers. The country of origin of the data is not specified. It is a retrospective study since it uses cadaveric tissue.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable/Not specified. This study focuses on a biomechanical property (pull-out force) and does not involve expert image interpretation or clinical expert evaluation for ground truth.
4. Adjudication Method for the Test Set
- Not applicable. The "ground truth" for pull-out force in cadaver testing is a direct measurement, not subject to subjective expert interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. The study focuses on the physical performance of the device (pull-out force) on cadavers.
6. Standalone (Algorithm Only) Performance
- Not applicable. This is a medical device (surgical mesh), not an AI algorithm. Therefore, the concept of standalone performance for an algorithm does not apply.
7. Type of Ground Truth Used
- The ground truth used was direct biomechanical measurement of pull-out force, conducted on cadaveric tissue.
8. Sample Size for the Training Set
- Not applicable. Training sets are typically associated with machine learning or AI algorithms. This study involves physical testing of a medical device.
9. How Ground Truth for the Training Set was Established
- Not applicable. As mentioned above, this is not an AI/ML study requiring a training set.
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K020705 page 1 of 2
SUMMARY OF SAFETY AND EFFECTIVENESS
510(K) summary of Safety and Effectiveness
Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary in formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
| New Device Name: | SiiS#1 Tissue Suspension System |
|---|---|
| Predicate Device Name: | Tension Free Vaginal Tape (TVT)System |
The SiiS#1 Tissue Suspension Device is a sterile single use device, consisting of Device one piece of undyed polyester tubular mesh approximately 6 mm diameter x 305 Description mm long (.250 x 12 inches) with both ends terminating in toggle type tissue The anchors and part of the mesh are held within a long needle inserter. anchors. Attached to the mesh creating a secondary sling is a sliding mesh approximately 80 mm long connected to the longer mesh with sliding locks. The sliding locks are advanced with the sling locator to shorten the length of the sling until desired length is achieved. Polyester tubular mesh is constructed of knitted filaments of extruded polyester strands identical in composition to that used in polyester non-absorbable surgical suture. The material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.
The SiiS#1 Inserter is provided sterile and single use. The inserter is made of stainless steel with an anodized aluminum handle. The tip of the inserter is constructed to accept the toggle anchors and part of the tubular mesh. The inserter is intended to facilitate the passage of the toggle anchors through the rectus fascia below the abdominal skin.
The SiiS#1 Reusable Sling Locator is provided sterile and single use. The locator is made of polyacetal or equivalent and is intended to facilitate the position of the sliding sling on the longer suspender. It is connected and fixed to the longer suspender and interfaces with the sliding sling adjustment locks.
- The SiiS#1 Device is intended to be used as a pubourethral sling for treatment of Intended Use Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency,
Indications (from labeling): The SiiS#1 device is intended to be used as a Indications pubourethral sling for treatment of stress urinary incontinence (SUI), for female Statement urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The SiiS#1 Inserter, Sling Locater and Urethral Probe are available and intended to facilitate placement of the SiiS#1 device.
Technologically both the new device and predicate device are the same (i.e., both Technological are meshes that provide pubourethral support). Additionally, both devices utilize Characteristics accessories for use in the surgical procedure. Any differences between the devices do not raise new questions of safety and effectiveness.
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K020705 page 2 of 2
| PerformanceData | Cadaver testing has shown that the SiiS#1 has a pull-out force that is well over thatof the predicate device. Cadaver test data is provided in Attachment # 5. |
|---|---|
| Conclusions | Based on the 510(k) summaries and the 510(k) statements (21 CFR 807) and theinformation provided herein, we conclude that the modified device is substantiallyequivalent to the existing legally marketed device under the Federal Food, Drugand Cosmetic Act. |
| Contact | Dan Moor, Chief Engineer, T..A.G. Medical Products LTD, Kibbutz Gaaton 25130,Israel |
| Date | 02/01/02 |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle image. The logo is simple and recognizable, and it is often used on official documents and websites related to the department.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Dan Moor Chief Engineer T.A.G. Medical Products LTD. Kibbuts Gaaton ISRAEL 25130
SEP 2 8 2012
Re: K020705 Trade/Device Name: SiiS#1 Tissue Suspension System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: February 4, 2002 Received: March 4, 2002
Dear Mr. Moor:
This letter corrects our substantially equivalent letter of April 26, 2002.
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 (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 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
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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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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510(k) Number (if known): ____K020705
Device Name: SiiS#1 Tissue Suspension System
Indications for Use:
The SiiS#1 Bladder-Neck Suspension Device is a sterile, single-use device intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting form urethral hypermobility and/or intrinsic sphincter deficiency. The SiiS#1 Bladder-Neck Suspension Device Inserter, and Sling Locator are provided and are intended to facilitate the placement of the SiiS#1 Bladder-Neck Suspension Device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
× Prescription Use
or
Over-The- Counter Use
Miriam C. Provost
ision Sion-Off Division of General, Restorative and Neurological Devices
(Optional Format 1-2-96)
510(k) Number K020705
TRADITIONAL 510(k) SiiS#1
PAGE 19 of 19
§ 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.