SAFYRE VS and SAFYRE T are 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.

Device Description

PROMEDON's Slings, SAFYRE VS and SAFYRE T, are manufactured with biocompatible silicone elastomers and polypropylene. Each sling is a permanent implant and is offered as a single use sterile product. Safyre consists of a monofilament polypropylene mesh between two silicone columns that are made of multiple coneshaped soft tissue anchors. These units are the basis of the self anchoring system. The polypropylene mesh lies on the mid-urethra and the interconnective tissue grows among its pores, between the vaginal flap and the urethra, which leads to integration of the implant without a loss of vascularization between the bladder and the vagina. The two columns are fixed to the abdominal fascia or the obturator muscle. This self . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . enough to keep the sling in its place when there is an important muscular activity, such as coughing or other strains.

SAFYRE VS consists of a sling and a pair of single-use surgical instruments to facilitate its vaginal or suprapubic implantation ; while SAFYRE T is made up of the same sling, only varying in length with respect to the model VS, and a needle intended for the transobturator technique. Both are supplied with the surgical instruments to aid implantation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SAFYRE Sling System (SAFYRE VS and SAFYRE T) and not a study that proves the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity.

510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies with detailed measures like those outlined in the prompt. The "performance testing" mentioned in the document refers to bench testing and biocompatibility testing, which are fundamental safety and efficacy tests for medical devices, but not the type of clinical performance study with AI-specific metrics that the prompt is asking for.

Therefore, most of the information requested in the prompt cannot be extracted from the provided text because it describes a different type of regulatory submission.

Here's an analysis based on the information available in the text:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as performance metrics (e.g., accuracy, sensitivity). The "acceptance criteria" for a 510(k) are typically focused on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety/efficacy.
- Reported Device Performance: The document states "Bench testing and biocompatibility testing was performed on the SAFYRE VS and SAFYRE T." However, no specific performance results (e.g., tensile strength values, biocompatibility study results) are provided in this summary.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable/Not mentioned. The document refers to "bench testing" and "biocompatibility testing," which are not typically associated with clinical test sets in the way implied by the prompt (i.e., for evaluating diagnostic accuracy).
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):
- Not applicable/Not mentioned. This information would be relevant for a clinical performance study involving expert assessment, which is not described here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned.
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:
- Not applicable/Not mentioned. This device (surgical mesh) is not an AI-powered diagnostic tool, so such a study would not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not mentioned in the context of clinical performance evaluation. For bench testing, the "ground truth" would be engineering specifications or scientific standards.
The sample size for the training set:
- Not applicable/Not mentioned. This device is not an AI model requiring a training set in the sense implied.
How the ground truth for the training set was established:
- Not applicable/Not mentioned.

Summary from the provided text:

The document is a 510(k) summary for SAFYRE VS and SAFYRE T surgical mesh, demonstrating substantial equivalence to a predicate device (SAFYRE Sling System - K020007). The performance testing mentioned is "Bench testing and biocompatibility testing," aimed at ensuring the device's safety and fundamental functional properties, rather than clinical efficacy or diagnostic accuracy as might be evaluated for an AI medical device. No specific clinical study or performance data fitting the prompt's criteria (e.g., accuracy, sensitivity, expert review, AI integration) is present.

Summary

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Promedon S.A.

033691

SAFYRE VS and SAFYRE T Premarket Notification

DEC 1 9 2003

Appendix 6

page 1 of 2

510(k) Summary of Safety and Effectiveness November 22, 2003

GENERAL INFORMATION A.

Company Name and Address:

Sponsor/Manufacturer:	Promedon S.A.
Address:	Av. Hipolito Yrigoyen 388-PB
	X5000JHQ -- Cordoba
	Cordoba, Argentina
Telephone:	011-54-351-424 6026
Fax:	011-54-351-424 6025
Contact Individual:	Marcelo Olmedo

Device Name Proprietary Name: Common/Usual Name: Classification Name:

SAFYRE VS and SAFYRE T Surgical Mesh Surgical Mesh

Establishment Registration Number

Manufacturing Site: Promedon S.A. Hipolito Yrigoyen 388 - PB X5000JHO Cordoba Argentina Establishment Registration Number - 9680698

B. Identification of Predicate or Legally Marketed Device

0 SAFYRE Sling System - K020007

Device Description C.

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· Promedon S.A.

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enough to keep the sling in its place when there is an important muscular activity, such as coughing or other strains.

D. Intended Use

Safyre Slings are 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.

E. 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 insertion instruments.

The SAFYRE VS and SAFYRE T are substantially equivalent to the predicate device. The intended use, technological characteristics of the device materials and design of the SAFYRE VS and SAFYRE T support the concept of substantial equivalence.

F. Performance Testing

Bench testing and biocompatibility testing was performed on the SAFYRE VS and SAFYRE T.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 28 2012

Promedon S.A. % Ms. Debbie Iampietro QRC Consulting 7 Tiffany Trail HOPKINTON MA 01748

Re: K033691 Trade/Device Name: SAFYRE - Sling for Urinary Incontinence Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTN Dated: November 22, 2003 Received: December 1, 2003

Dear Ms. Iampietro:

This letter corrects our substantially equivalent letter of December 19, 2003.

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/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. Weeks

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

510(k) Number (if known):	K03369/
---------------------------	---------

SAFYRE - SLING FOR URINARY INCONTINENCE Device Name:

Indications For Use:

SAFYRE VS and SAFYRE T are to be permanently implanted in women, for the OH TRE VO and OXF TRE To ace or ace grades II and III (due to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.

X Prescription Use (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW TIJIS I.INE. CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Mulker

Gen. al, Restorative

ological Devices

K033691

Page 1 of __

Regulation Number and Section

§ 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.