(35 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology. The device description and intended use are purely focused on the physical device and its function with standard RF generators.
Yes
The device is described as being used for procedures like "resection, ablation, hemostasis, coagulation and excision" of various tissues, which are all therapeutic interventions.
No
The "Intended Use / Indications for Use" section describes the device's function for surgical procedures like resection, ablation, hemostasis, coagulation, and excision, which are therapeutic actions, not diagnostic ones. There is no mention of identifying or characterizing diseases.
No
The device description explicitly mentions "RF electrodes and Electrosurgical devices," which are hardware components. The intended use also describes procedures involving physical interaction with tissue using these devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue samples) outside of the body to provide information about a person's health.
- The description of this device clearly states it is used during endoscopic surgery within the body for procedures like tissue resection, ablation, hemostasis, coagulation, and excision. It interacts directly with tissue in situ.
Therefore, this device falls under the category of a surgical or electrosurgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TURBT - RF electrodes and electrosurgical devices are designed to be used with commercially available RF generators, Resectoscopes and suction / irrigation systems. These devices can be used in patients requiring endoscopic surgery for general urological soft tissue, including prostatic and bladder tissue resection, ablation, hemostatis, coagulation and excision procedures involving bladder turnors, bladder cancer, enlarged prostate, BPH, prostate & bladder biopsy, Transurethral resection of prostate, urethral stricture, bladder and vesical neck constriction, using cutting, coagulation and vaporization mode of RF energy.
Product codes
FAS
Device Description
TURBT - RF electrodes and electrosurgical devices are designed to be used with commercially available RF generators, Resectoscopes and suction / irrigation systems. These devices can be used in patients requiring endoscopic surgery for general urological soft tissue, including prostatic and bladder tissue resection, ablation, hemostatis, coagulation and excision procedures involving bladder turnors, bladder cancer, enlarged prostate, BPH, prostate & bladder biopsy, Transurethral resection of prostate, urethral stricture, bladder and vesical neck constriction, using cutting, coagulation and vaporization mode of RF energy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological soft tissue, including prostatic and bladder 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with three curved lines extending from its wing. The logo is black and white and appears to be a scan of a document.
APR - 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ashvin Desai Manager, Regulatory Affairs Prosurg, Inc. 2193 Trade Zone Blvd. SAN JOSE CA 95131
Re: K050488
Trade/Device Name: TURBT-RF electrodes and Electrosurgical devices Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS Dated: February 16, 2005 Received: March 1, 2005
Dear Mr. Desai:
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 application (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 (Premarket Approval), it may be subject to such 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); 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.
1
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow yourto begin manceang of your device of your device to a legally premarket nothleation: "The PDF midnig of our device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device to be on the regulation numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115 |
|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prease note the regulation onlined, "Association on your responsibilities under the Act from the 807.97). Tou may outlain other general missistance at its toll-free number (800)
Division of Small Manufacturers, International and Consumer Assistance at its toll-free num DIVISION of Sillan Manufactures, Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page
਼ (
510(k) NUMBER (IF KNOWN): KOSO488
TURBT- RF electrodes and Electrosurgical devices DEVICE NAME:
INDICATIONS FOR USE:
TURBT - RF electrodes and electrosurgical devices are designed to be used with commercially available RF generators, Resectoscopes and suction / irrigation systems. These devices can be used in patients requiring endoscopic surgery for general urological soft tissue, including prostatic and bladder tissue resection, ablation, hemostatis, coagulation and excision procedures involving bladder turnors, bladder cancer, enlarged prostate, BPH, prostate & bladder biopsy, Transurethral resection of prostate, urethral stricture, bladder and vesical neck constriction, using cutting, coagulation and vaporization mode of RF energy.
(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)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Nancy Broadon
(Division Sign-Off) ( (Division of Reproductive, Abdominal, Division ological Devices 510(k) Number