(449 days)
Ophira™ Mini Sling System is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Ophira™ Mini Sling System consists of a sterile polypropylene sling and a sterile retractable insertion guide for sling placement. The sling is composed of monofilament polypropylene mesh between two polypropylene fixation arms; the fixation arms have multiple fixation points along the arms, which is the basis of the autofixing system, i.e., the two fixation arms are self anchored to the internus transobturator muscle and, therefore, the sling needs no sutures. An easily identifiable mark in the center of the mesh sling helps to achieve a symmetrically centered location for the proper placement of the sling. The sling has a suture inserted onto each fixation arm to provide the ability to adjust tension, if necessary, during the procedure for optimum suburethral support. These sutures are removed once the implantation procedure is completed.
This document is a 510(k) summary for the Ophira™ Mini Sling System, a medical device for treating female stress urinary incontinence. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves acceptance criteria for the new device. Therefore, the information requested regarding acceptance criteria and performance studies is not fully present in the provided text.
However, based on the information provided, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a study for the Ophira™ Mini Sling System itself. Instead, it relies on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (Reference) |
|---|---|
| Bio-compatibility | "Sling is composed of monofilament polypropylene mesh" (implied bio-compatible as per predicate and common use for surgical mesh) |
| Mechanical Properties (e.g., tensile strength, pore size, material degradation) | Not explicitly stated, but assumed to be comparable to the predicate device, MiniArc Precise™ Single-Incision Sling (K100807), which has presumably met such criteria. |
| Functionality and Ease of Use | Described as having a "sterile retractable insertion guide," "autofixing system" with fixation points, and "suture inserted onto each fixation arm to provide the ability to adjust tension." Implied to function similarly to predicate. |
| Sterility | "Consists of a sterile polypropylene sling and a sterile retractable insertion guide" |
| Intended Use | "Treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD)." This matches the intended use of comparable devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The provided text does not contain information about a test set sample size or data provenance for a performance study of the Ophira™ Mini Sling System. The 510(k) summary focuses on substantial equivalence based on material, design, and intended use comparison to a predicate device, rather than patient performance data for the new 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):
This information is not provided in the document as there is no described clinical performance study or test set with ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided in the document as there is no described clinical performance study requiring adjudication.
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:
This is not applicable. The device is a surgical sling, not an AI-assisted diagnostic tool or a device where "human readers" would be involved in interpreting results.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
As no performance study with a test set is described, no ground truth is mentioned for the Ophira™ Mini Sling System. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the legally marketed predicate device, the MiniArc Precise™ Single-Incision Sling (K100807), and the demonstration that the new device is substantially equivalent in its characteristics.
8. The sample size for the training set:
This is not applicable. The device is a physical surgical implant and not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for a machine learning model.
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K11ø42ø
PAGE 1/2
MAY - 8 2012
510(K) SUMMARY
Ophira™ Mini Sling System
Submitter's name and address:
Promedon S.A.
Av Gral Manuel Savio s/n
Lote 3 - Manzana 3 - Parque Industrial Ferreyra
- X5925XAD
Cordoba, Argentina
Contact person and telephone number:
Sofia Olivero
Quality Assurance and Regulatory Affairs Manager Telephone: 54-351-4502100 Fax: 54-351-4502101
Date Summary was prepared:
February 11, 2011
Name of the device:
Proprietary Name: Common Name: Classification Name: Product Code:
OphiraTM Mini Sling System Mesh, Surgical (21 CFR 878.3300) OTN
Substantial Equivalence:
Ophira™ Mini Sling System is substantially equivalent in function and intended use to MiniArc Precise™ Single-Incision Sling, which has been cleared under K100807.
Device Description:
Ophira™ Mini Sling System consists of a sterile polypropylene sling and a sterile retractable insertion guide for sling placement. The sling is composed of monofilament polypropylene mesh between two polypropylene fixation arms; the fixation arms have multiple fixation points along the arms, which is the basis of the autofixing system, i.e., the two fixation arms are self anchored to the internus transobturator muscle and, therefore, the sling needs no sutures. An easily identifiable mark in the center of the mesh sling helps to achieve a symmetrically centered location for the proper placement of the sling. The sling has a suture inserted onto each fixation arm to provide the ability to adjust tension, if necessary, during the procedure for optimum suburethral support. These sutures are removed once the implantation procedure is completed.
Intended Use:
Ophira™ Mini Sling is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Promedon S.A. % Ms. Stephanie D. Rais Consultant SDRS LLC 221 Ellis Parkway PISCATAWAY NJ 08854
MAY - 8 2012
Re: K110420
Trade/Device Name: Ophira™ Mini Sling System Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: April 25, 2012 Received: April 26, 2012
Dear Ms. Rais:
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. 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. 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 (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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" (21CFR 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.
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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Indications for Use Form
Indications for Use
510(k) Number (if known): Jaknown
Device Name:
Ophira™ Mini Sling System
Indications for Use:
Ophira™ Mini Sling System is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
thomashwhan
Page 1 of
(Division 'Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110420
§ 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.