(66 days)
"Not Found"
No
The device description focuses on radiofrequency technology and temperature monitoring, with no mention of AI or ML algorithms for analysis, decision-making, or image processing. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is indicated for "shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence due to hypermobility," which describes a therapeutic action.
No
The device description and intended use indicate that the SURx RF System is used for shrinkage and stabilization of tissue, which is a treatment, not a diagnostic
function. It doesn't collect or analyze data to identify a disease or condition.
No
The device description clearly outlines hardware components: a generator, applicators (LP and TV), and an optional sizer. These are physical devices, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic or monitoring purposes.
- SURx RF System Function: The SURx RF System is a therapeutic device. It uses radiofrequency energy to directly treat female pelvic tissue for stress urinary incontinence. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "shrinkage and stabilization of female pelvic tissue for treatment of stress urinary incontinence," which is a therapeutic action, not a diagnostic one.
- Device Description: The description details a generator and applicator that apply energy to tissue, not a system for analyzing biological samples.
Therefore, based on the provided information, the SURx RF System is a therapeutic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, MUK
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 SON blunt dissection is required prior to applying the SURx TV Applicator tip on the tissue to be treated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
female pelvic tissue
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 and |
| Accessories (21 CFR 878.4400) | |
| Device Panel: | General Surgery/Restorative Devices |
| Device Classification: | Class II |
PREDICATE DEVICES
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).
000004
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
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.
000005
2
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
3
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
4
SECTION 1.2
INDICATIONS FOR USE STATEMENT
510(k) Number:
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
OL
on of General. Restorative and Neurological Devices
510(k) Number K020952
0000003