The SURx TV System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence due to hypermobility in women not eligible for major corrective surgery.

Device Description

The SURx TV System consists of two components: the SURx TV Generator and the SURx TV Applicator. The SURx TV Applicator connects to the Generator. The Applicator also provides irrigation to the treatment site. The SURx TV Applicator is supplied sterile and intended for single use. The Applicator uses a bipolar design, which means that a return pad is not required for operation. The tip of the Applicator contains a thermistor to monitor temperature at the targeted area. The SURx TV Generator is a radiofrequency (RF) electronic instrument. Software is utilized in the operation of the SURx TV Generator.

AI/ML Overview

The provided text details the 510(k) summary for the SURx TV System, which is an electrosurgical system for treating stress urinary incontinence. While it states that "clinical evaluations were used to demonstrate that the SURx TV System functioned as clinically intended," the document does not provide the specific acceptance criteria or detailed results of a study that proves the device meets those criteria. The focus of this 510(k) summary is primarily on demonstrating substantial equivalence to a predicate device based on design, materials, and principle of operation, and on stating that clinical data supports its intended function without elaborating on the specifics of that data or how it addresses acceptance criteria.

Therefore, I cannot fulfill most of the requested information based on the provided text.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance:

Cannot be provided. The document does not specify any quantitative acceptance criteria or report specific performance metrics from a study against such criteria. It generally states that the device "performs as clinically intended" and "demonstrates that the SURx TV System functioned as clinically intended."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot be provided. The document mentions "clinical evaluations" and "clinical studies" but does not give any details about sample sizes, study design (retrospective/prospective), or data provenance.

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):

Cannot be provided. There is no mention of ground truth establishment, experts, or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Cannot be provided. There is no information regarding adjudication methods.

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:

Cannot be provided. The SURx TV System is an electrosurgical device, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI would not be relevant or performed for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is an electrosurgical system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Cannot be provided directly. While it implied "clinical performance data" for a device indicated for "shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence," the specific type of ground truth (e.g., objective measurement of shrinkage, patient-reported outcomes, physician assessment) is not detailed.

8. The sample size for the training set:

Not applicable. This is a physical electrosurgical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. As above, no training set.

Summary from the provided text:

The document states that:

"Results of clinical evaluations were used to demonstrate that the SURx TV System functioned as clinically intended."
"Sufficient data have been gathered from clinical studies to determine that the SURx TV System performs as clinically intended and that no new issues of safety and effectiveness are introduced."

However, these are general statements and do not provide the detailed evidence requested. The 510(k) summary explicitly focuses on substantial equivalence based on technological characteristics and indications for use compared to a predicate device, rather than detailed clinical performance metrics from de novo studies.

Summary

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SURx Women's Health First

Image /page/0/Picture/1 description: The image shows a handwritten text string that reads "K620126 1/2". The text is written in a cursive style with thick, dark strokes, suggesting it was written with a pen or marker. The numbers and letters are clearly legible, and the "1/2" is slightly separated from the main string.

MAR 1 5 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

Alan Curtis SURX 2675 Collier Canyon Road Livermore, CA 94550 (925) 398-4500 (phone) (925) 398-4509 (facsimile) acurtis@surx.com

NAME OF DEVICE

Trade Name:	SURx TV System
Common Name:	Electrosurgical System
Device Product Code:	GEI
Classification Name:	Electrosurgical Cutting and Coagulation Device andAccessories (21 CFR 878.4400)
Device Panel:	General Surgery/Restorative Devices
Device Classification:	Class II

PREDICATE DEVICES

. SURx LP System (K011190)

DEVICE DESCRIPTION

The SURx TV Generator is a radiofrequency (RF) electronic instrument.

Software is utilized in the operation of the SURx TV Generator.

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INDICATION FOR USE STATEMENT

SUBSTANTIAL EQUIVALENCE COMPARISON

Technological Characteristics

The technological characteristics of the SURx TV System are identical to those of the cited predicate electrosurgical device. This device is equivalent in terms of design, materials, principal of operation, and product specifications. The minor modification between the SURx TV System and the predicate device does not raise new issues regarding safety or effectiveness.

Indications for Use

Substantial equivalence is also supported for the SURx LP System by the predicate devices cleared for the treatment of female stress urinary incontinence.

Clinical Performance Data

Results of clinical evaluations were used to demonstrate that the SURx TV System functioned as clinically intended. Sufficient data have been gathered from clinical studies to determine that the SURx TV System performs as clinically intended and that no new issues of safety and effectiveness are introduced.

CONCLUSION

Based on the design, materials, function, intended use, and clinical evaluation, the SURx TV System is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. In addition, the SURx TV System raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) clearance.

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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 consists of a stylized depiction of a bird-like figure, often referred to as the "Human Services Insignia." The bird is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular fashion around the bird symbol.

4 2010 NUV

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Alan Curtis Vice President, Regulatory and Clinical Affairs SURx, Inc. 2675 Collier Canyon Road LIVERMORE CA 94550

Re: K020126

Trade/Device Name: SURx TV System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: MUK Dated: January 14, 2002 Received: January 15, 2002

Dear Mr. Curtis:

This letter corrects our substantially equivalent letter of March 15, 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 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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Page 2 - Mr. Alan Curtis

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" (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,
Hubert Lewis

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

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SURX Women's Health First Special 510(k): Device Modifications SURx TV System

SECTION 1.2

INDICATIONS FOR USE STATEMENT

510(k) Number:

KO20126

SURx TV System Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Muriam C. Provost

(Division Sign-Off) (Division of General, Restorative and Neurological Devices

020126 510(k) Number -

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.