(59 days)
Not Found
No
The description mentions software but provides no indication of AI/ML functionality, image processing, or data-driven decision making.
Yes
The "Intended Use / Indications for Use" states the device is "indicated for shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence," which describes a therapeutic purpose.
No
The device is described as treating stress urinary incontinence by shrinking and stabilizing tissue, and it monitors temperature at the treatment site, indicating a therapeutic rather than diagnostic function.
No
The device description clearly states that the system consists of a Generator and an Applicator, which are hardware components. While software is used in the operation of the Generator, the system is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "shrinkage and stabilization of female pelvic tissue for treatment of Type II stress urinary incontinence". This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a radiofrequency (RF) system with an applicator that delivers energy to the tissue. This is consistent with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SURx TV System's function is to directly treat a condition within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, MUK
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.
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)
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.
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
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 and |
| Accessories (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 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.
1
INDICATION FOR USE STATEMENT
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.
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.
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 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
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,
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
4
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:
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.
(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
or
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
020126 510(k) Number -