(78 days)
K 011251, K 974098, K010533
K 011251, K 974098, K010533
No
The device description and performance studies focus on the physical properties and biocompatibility of the implant, with no mention of AI or ML technology.
Yes
The device is described as treating stress urinary incontinence, indicating a therapeutic purpose.
No
The device is described as an implantable sling for the treatment of stress urinary incontinence, acting as a urethral support, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a permanent implant manufactured with biocompatible silicone elastomers and polypropylene, indicating it is a physical 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 to be "permanently implanted in women, for the treatment of stress urinary incontinence". This describes a surgical implant used to treat a medical condition within the body.
- Device Description: The description details a physical implant made of silicone and polypropylene, designed to provide structural support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is implanted inside the body for therapeutic purposes.
N/A
Intended Use / Indications for Use
Safyre Sling is to be permanently implanted in women, for the treatment of stress urinary incontinence grades II and III (due to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.
Product codes
OTN
Device Description
PROMEDON's Sling, SAFYRE, is manufactured with biocompatible silicone elastomers and polypropylene. It is a permanent implant and is offered as a single use sterile product. Safyre consists of a pierced polypropylene mesh between two silicone columns that are made of multiple cone-shaped soft tissue anchors. The e units are the basis of the self anchoring system. The polypropylene shilles on the mid-urethra and the interconnective tissue grows among me the perforations between the vaginal flap and the urethra, which leads to internation of the implant without a loss of vascularization between the bladder and the vagina. The two columns are fixed to the abdominal fascia. This self anchoring is enough to keep the sling in its place when there is an important muscular activity, such as coughing or other strains.
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)
Bench testing and biocompatibility testing was performed on the SAFYRE Sling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 011251, K 974098, K010533
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.
0
Promedon S.A.
SAFYRE Sling Premarket Notification
MAR 2 1 2002
510K Summary of Safety and Effectiveness
-
- Sponsor Name Corniche. L.L.C. Address: 7 Main St. Essex Junction, VT 05452 Telephone: 802 878 0900 Fax: 802 878 0425 Contact Individual: Stuart Smyth
-
- Device Name
| Proprietary Name: | SAFYRE Sling |
|---|---|
| Common/Usual Name: | Surgical Mesh |
| Classification Name: | Surgical Mesh |
-
- Identification of Predicate or Legally Marketed Device
- SPARC Sling System K 011251 manufactured by American O Medical Systems
- Tension Free Vaginal Tape (TVT) System K 974098 O manufactured by Ethicon (J&J)
- BioSling K010533 manufactured by InjectX Inc. o
- Device Description 4.
PROMEDON's Sling, SAFYRE, is manufactured with biocompatible silicone elastomers and polypropylene. It is a permanent implant and is offered as a single use sterile product.
Safyre consists of a pierced polypropylene mesh between two silicone columns that are made of multiple cone-shaped soft tissue anchors. The e units are the basis of the self anchoring system. The polypropylene shilles on the mid-urethra and the interconnective tissue grows among me the perforations between the vaginal flap and the urethra, which leads to internation of the implant without a loss of vascularization between the bladder and the vagina. The two columns are fixed to the abdominal fascia. This self anchoring is enough to keep the sling in its place when there is an important muscular activity, such as coughing or other strains.
.00362
1
ട. Intended Use
Safyre Sling is to be permanently implanted in women, for the treatment of stress urinary incontinence grades II and III (due to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.
6. Comparison of Technological Characteristics
All of the devices are indicated for permanent implantation for the treatment of stress urinary incontinence grades II and III acting as a urethral support. All of the devices are made of the same or similar materials and are supplied with reusable insertion components.
The SAFYRE Sling is substantially equivalent to the predicate devices. The intended use, technological characteristics of the device materials and design of the SAFYRE Sling support the concept of substantial equivalence.
7. Performance Testing
Bench testing and biocompatibility testing was performed on the SAFYRE Sling.
000263
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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 eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Promedon % Ms. Debbie Iampietro QRC Associates 7 Tiffany Trail HOPKINTON MA 01748
SEP 28 2012
Re: K020007 Trade/Device Name: Safyre Sling System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: December 30, 2001 Received: January 4, 2002
Dear Ms. Iampietro:
This letter corrects our substantially equivalent letter of March 21, 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 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/ReportalProblem/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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Statement of Indications for Use A.3.
Applicant: PROMEDON S.A.
510(k) Number (if known): K020007
¡ Device Name: SAFYRE - SLING FOR URINARY INCONTINENCE
Indications For Use:
.
Safyre Sling is to be permanently implanted in women, for the treatment of stress : Salyre Oling 13 to be pormanonay implex to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription.. X
(Per 21 CFR 801.109) OTC
(Optional Format 1-2-96)
Nissiam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020007
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