The SURx RF System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence due to hypermobility.

Device Description

The SURx RF System consists of two components: the SURx Radiofrequency (RF) Generator and the SURx Applicator. The SURx Applicator connects to the Generator. The SURx Applicator is supplied sterile and intended for single use. The Applicator uses a bipolar design, such that no return pad is required for operation. The tip of the Applicator contains a thermistor to monitor temperature at the targeted area. Two applicators are available: one for use when performing this procedure using a laparoscopic approach (LP Applicator), the other applicator is used during a transvaginal approach (TV Applicator). The SURx Transvaginal (TV) Sizer is an optional accessory for use with the SURx TV Applicator. The SURx TV Sizer confirms the exposed area for treatment is adequate to Applicator. The SON blunt dissection is required prior to applying the SURx TV Applicator tip on the tissue to treated.

AI/ML Overview

This submission is a 510(k) premarket notification for a labeling change to the SURx RF System. The original 510(k) for the device (K011190) cleared the SURx LP System, and K020126 cleared the SURx TV System. This document specifically discusses the SURx RF System and its associated applicators (LP and TV).

Acceptance Criteria and Study for Device Performance:

The provided document describes a labeling change and primarily focuses on demonstrating substantial equivalence to predicate devices. It does not present acceptance criteria or a detailed study plan with specific metrics to "prove the device meets acceptance criteria" in the way typically seen for a new device's performance evaluation. Instead, it justifies the expanded indication for use based on existing clinical data and comparison to predicate devices.

Therefore, many of the requested elements for a detailed study on device performance cannot be answered from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Explicitly Stated)	Reported Device Performance (Summary)
Not explicitly defined for this submission's purpose of a labeling change.	The SURx RF System "performs as clinically intended and that no new issues of safety and effectiveness are introduced" based on "sufficient data gathered from clinical studies" and a "literature review."
	The system is substantially equivalent to predicate devices based on design, materials, function, intended use, and clinical evaluation.

Explanation: The document's purpose is to support a change in the "Indications for Use" statement for an already cleared device. It asserts that the device already performs as intended and that the changes do not introduce new safety or effectiveness concerns. It does not set new performance acceptance criteria to pass, but rather reviews existing evidence to support a broader claim.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not specified. The document refers to "clinical studies" but does not provide details on their design, sample sizes, or methodology for a "test set" in the context of this submission.
Data Provenance: "Sufficient data have been gathered from clinical studies." These studies are not further detailed (e.g., country of origin, retrospective or prospective nature). The document also mentions a "Literature Review" on devices cleared for the treatment of female urinary incontinence as "additional supporting documentation."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable/Not specified. This document is not describing a study where expert-established ground truth was generated for a new device performance evaluation. It refers to existing clinical data.

4. Adjudication Method for the Test Set:

Not applicable/Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not done. The document does not describe any MRMC study or comparison of human readers with and without AI assistance. This is a medical device (electrosurgical system) and not an AI-based diagnostic tool.

6. Standalone Performance Study (Algorithm Only):

Not applicable. The SURx RF System is an electrosurgical cutting and coagulation device, not an algorithm or AI model. Therefore, a standalone (algorithm only) performance study would not be relevant.

7. Type of Ground Truth Used:

The implicit "ground truth" for the device's original clearance and this labeling change is likely clinical outcomes data from the "clinical studies" mentioned. These studies would have assessed the effectiveness of the device in treating stress urinary incontinence and tracked any adverse events. The submission asserts that the device "performs as clinically intended."

8. Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that would require a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. (See #8)

Summary

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MAY 3 0 2002

SURx Women's Health First 1/2 Premarket Notification: SURx RF System, Labeling Change

SECTION 1.3

Ko20952

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 RF 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)
SURx TV System (K020126) ●

DEVICE DESCRIPTION

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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The SURx Transvaginal (TV) Sizer is an optional accessory for use with the SURx TV I ho Botor The SURx TV Sizer confirms the exposed area for treatment is adequate to Applicator. The SON blunt dissection is required prior to applying the SURx TV Applicator tip on the tissue to treated.

INDICATION FOR USE STATEMENT

The SURx RF System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence due to hypermobility.

SUBSTANTIAL EQUIVALENCE COMPARISON

Technological Characteristics

There has been no change to the generator or applicators. The system is identical to that cleared in the referenced 510(k)s.

Indications for Use

Substantial equivalence for the SURx RF System is supported by the predicate devices, which has an identical indication statement.

Clinical Performance Data

The SURx RF System has been cleared for the treatment of female stress urinary incontinence. Clinical analysis was conducted to support the change in the language in the indications for use statement. Sufficient data have been gathered from clinical studies to determine that the SURx RF System performs as clinically intended and that no new issues of safety and effectiveness are introduced.

Literature Review

Published literature was reviewed on devices cleared for the treatment of female urinary incontinence as additional supporting documentation to support the modified indication for use.

CONCLUSION

Based on the design, materials, function, intended use, and clinical evaluation, the SURx RF System is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing, abstract design connecting them.

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

NOV 4 2010

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

Re: K020952

Trade/Device Name: SURx RF System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: MUK Dated: March 22, 2002 Received: March 25, 2002

Dear Mr. Curtis:

This letter corrects our substantially equivalent letter of May 30, 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,

[signature]

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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SECTION 1.2

INDICATIONS FOR USE STATEMENT

510(k) Number:

K020952

SURx RF System Device Name:

Indications for Use:

The SURx RF System is indicated for shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence due to hypermobility.

(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

on of General. Restorative and Neurological Devices

510(k) Number K020952

0000003

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.