(68 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical efficacy of a surgical mesh, with no mention of AI or ML components or functionalities.
Yes
The device is described as "intended for the treatment of female stress urinary incontinence (SUI)", which indicates a therapeutic purpose.
No
Explanation: The device is an "I-STOP Mid-Urethral Sling" intended for the treatment of female stress urinary incontinence. It is a surgical implant made of polypropylene mesh. There is no indication that it is used to diagnose a condition.
No
The device description clearly states it is comprised of physical components like polypropylene mesh, polyethylene clips, stainless steel needles, and polycarbonate handles, indicating it is a hardware 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 female stress urinary incontinence (SUI) by surgically implanting a sling. This is a therapeutic intervention performed on the patient's body.
- Device Description: The device is a surgical implant made of polypropylene mesh and associated tools for implantation. It is not designed to analyze biological samples (like blood, urine, or tissue) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Product codes
OTN
Device Description
The I-STOP Device is comprised of a non-resorbable polypropylene material woven into a mesh with each end attached to a polyethylene clip, two technique-dependant stainless steel implantation needles and two polycarbonate needle handles. The device is EtO sterilized and intended for single-use only.
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
Not Found
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)
Clinical experience with the I-STOP device has demonstrated that it successfully and safely functions as intended. Additional biocompatibility testing supports the safety profile of the I-STOP Sling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tension Free Vaginal Tape (TVT) System; Ethicon, Inc. (K974098)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Uroplasty, Inc. Premarket Notification [510(k)] Submission I-STOP™ Mid-Urethral Sling
OCT 1 7 2005
Page / of f
Section 8: 510(k) Summary
| Date Prepared | August 9, 2005 |
|---|---|
| New Device Name | I-STOP™ Mid-Urethral Sling |
| Predicate Device | Tension Free Vaginal Tape (TVT) System; Ethicon, Inc. (K974098) |
| Contact | Uroplasty, Inc. |
| 2718 Summer Street NE | |
| Minneapolis, MN 55413-2820 | |
| Telephone: (612) 378-1180, Facsimile: (612) 378-2027 | |
| info.usa@uroplasty.com |
Intended Use
The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence (SUI) due to urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Device Description
The I-STOP Device is comprised of a non-resorbable polypropylene material woven into a mesh with each end attached to a polyethylene clip, two technique-dependant stainless steel implantation needles and two polycarbonate needle handles. The device is EtO sterilized and intended for single-use only.
Indications Statement
The I-STOP Mid-Urethral Sling is intended for the treatment of female stress urinary incontinence due to urethral hypermobility and/or intrinsic sphincter deficiency. Four different I-STOP models allow for implantation of the I-STOP mesh via retropublic (transvaginal or suprapubic) or transobturator (outside-in or inside-out) approaches.
Technological Characteristics
The new and predicate devices are technologically the same; they are polypropylene meshes implanted with stainless steel needles to provide urethral support for females patients with SUI. The devices have similar implantation, sterilization, and storage requirements. In the few instances where the devices differ, no additional concerns about safety or effectiveness are raised.
Performance
Clinical experience with the I-STOP device has demonstrated that it successfully and safely functions as intended. Additional biocompatibility testing supports the safety profile of the I-STOP Sling.
Conclusion
The I-STOP Mid-Urethral Sling is substantially equivalent to the predicate device, the Tension Free Vaginal Tape (TVT) from Ethicon, Inc. (K974098).
CONFIDENTIAL
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Michael Morrell, RAC Director of Regulatory Affairs SEP 2 8 2012 Uroplasty, Inc. 2718 Summer Street NE MINNEAPOLIS MN 55413
Re: K052175 Trade/Device Name: I-STOPTM Mid-Urethral Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: August 9, 2005 Received: August 11, 2005
Dear Mr. Morrell:
This letter corrects our substantially equivalent letter of October 17, 2005.
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/CDRH0ffices/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.
Sincerely yours,
Benjamin R. Perkins
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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PREMARKET NOTIFICATION [510(k)] SUBMISSION I-STOP" MID-URETHRAL SLING
Indication for Usc Statement
| 510(k) Number: | K052175 |
|---|---|
| New Device Name: | I-STOP™ Mid-Urethral Sling |
| Indication for Use: | The I-STOP Mid-Urethral Sling is intended for the treatment of female |
| stress urinary incontinence (SUI) due to urethral hypermobility and/or | |
| intrinsic sphincter deficiency (ISD). |
X Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
(Please do not write below this line. Continue on another page if needed)
Concurrence of CDRH, Olfice of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052175