(82 days)
Not Found
No
The device description and summary of performance studies focus on the physical properties and surgical placement of a mesh sling and associated tools. There is no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is a surgical sling used to treat urinary stress incontinence, which is a medical condition, making it a therapeutic device.
No
The device is a surgical mesh used for the treatment of urinary incontinence, not for diagnosing conditions.
No
The device description explicitly states it is a surgical mesh and includes ancillary tools for placement, indicating it is a physical medical device, not software.
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 surgical treatment of a medical condition (female urinary stress incontinence). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a surgical mesh and associated tools used for implantation within the body. IVD devices are typically reagents, instruments, or systems used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- No mention of in vitro testing: The description mentions "in-vitro and in-vivo testing" for performance, but this refers to testing the device itself, not using the device to test patient samples.
In summary, the Minitape® Urethral Sling is a surgical implant used for treatment, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Minitape® Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Product codes (comma separated list FDA assigned to the subject device)
PAH
Device Description
The subject device is a surgical mesh. The proprietary mesh is supplied along with ancillary tools for placement of the device (convenience kit). The kit consists of: Minitape Urethral Sling (mesh) intended to be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency; Disposable needle introducers, optionally used to aid in placement of the Minitape mesh; Polydioxanone absorbable sutures (CP Medical; Portland, OR), used to secure the mesh in place; Polypropylene suture bolsters (Ethicon Inc.; Sommerville, NJ), optionally used to aid in tightening ("snugging") the mesh following surgical placement.
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)
The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical 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.
K073646, K020007, K033310, K011251, K013355, K021263, K020663, K052401, K073703
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.
Not Found
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.
0
pg. 1 of 2
·
17. 510(k) SUMMARY OF SAFETY & EFFECTIVENESS
:
| SUBMITTER | Ms Melissa Peloquin
Director of Office Administration
Mpathy Medical Devices Inc.
175 Paramount Drive
Raynham, MA 02767 | JUL 1 4 2009 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| CONTACT PERSON | Dr Caroline Stretton
Quality & Regulatory Affairs Director
Mpathy Medical Devices, Ltd.
208 Wright Business Centre
Lonmay Road
Glasgow G33 4EL (United Kingdom) | |
| DATE PREPARED | 15 April 2009 | |
| CLASSIFICATION | Surgical Mesh; ref. 21 CFR 878.3300
Product Code PAH
Class II | |
| COMMON NAME | Surgical mesh | |
| PROPRIETARY
NAME | Minitape® Urethral Sling | |
| PREDICATE DEVICE | K073646 - Modified Minitape Urethral Sling (Mpathy
Medical Devices)
K020007 - SAFYRE Sling (Corniche, LLC)
K033310 - Remeex System (Remeex)
K011251, K013355, K021263 & K020663 - SPARC
Sling System (American Medical Systems)
K052401 - TVT® Secur (Gynecare)
K073703 - MiniArc® (American Medical Systems). | |
| DEVICE
DESCRIPTION | The subject device is a surgical mesh. The
proprietary mesh is supplied along with ancillary tools
for placement of the device (convenience kit). The kit
consists of: Minitape Urethral Sling (mesh) intended
to be used as a pubourethral sling for the treatment
of female urinary incontinence resulting from urethral
hypermobility and/or intrinsic sphincter deficiency;
Disposable needle introducers, optionally used to aid
in placement of the Minitape mesh; Polydioxanone
absorbable sutures (CP Medical; Portland, OR), used
to secure the mesh in place; Polypropylene suture
bolsters (Ethicon Inc.; Sommerville, NJ), optionally
used to aid in tightening ("snugging") the mesh
following surgical placement. | |
1
K091180
pg. 2 of 2
Minitape® Urethral Sling is indicated for the surgical INDICATIONS treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Minitape® Urethral Sling has the same intended use, TECHNOLOGICAL general design, material and fundamental scientific CHARACTERISTICS
technology as the predicate Modified Minitape Urethral Sling device, with the exception of a shorter overall sling length.
TESTING
The device has been subjected to in-vitro and in-vivo testing which demonstrate the ability of the device to adequately restrain urethral tissue under conditions in excess of those encountered during normal clinical use.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MPathy Medical Devices, Ltd. % Dr. Caroline Stretton Quality & Regulatory Affairs Director 208 Wright Business Centre Lonmay Road Glasgow G33 4EL United Kingdom
SEP 2 8 2012
Re: K091180
Trade/Device Name: Minitape Urethral Sling Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: PAH Dated: July 1, 2009 Received: July 8, 2009
Dear Dr. Stretton:
This letter corrects our substantially equivalent letter of July 14, 2009.
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
3
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); 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. Rooks
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
4
MPATHY MEDICAL DEVICES, LTD. MINITAPE URETHSAL SLING SPECIAL 510(K) NOTIFICATION
- STATEMENT FOR INDICATIONS FOR USE
510(k) Number:
Device Name: Minitape Urethral Sling
Indications for Use: Minitape Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Prescription Use: Yes
DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
Daniel Kramer for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091180
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