(151 days)
Not Found
No
The device description focuses on mechanical and electrical components for tissue transection and does not mention any software, algorithms, or data processing related to AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used for tissue transection in the urological tract for histopathologic examination, which is a medical procedure to diagnose or treat a condition, thus making it a therapeutic device.
No
The device is described as a snare for tissue transection for "histopathologic examination," meaning it is used to obtain tissue for diagnosis, not to perform diagnosis itself. It is a surgical tool.
No
The device description clearly outlines physical components such as a catheter, handle, stainless steel wire, and a connection for an electrosurgical generator, indicating it is a hardware device.
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 the diagnosis, treatment, or prevention of disease. This examination is performed outside of the body (in vitro).
- Device Function: The Urology Monopolar Snare is a surgical instrument used within the body (in vivo) to physically transect (cut) tissue in the urological tract.
- Intended Use: The intended use is for tissue transection for histopathologic examination, but the device itself is performing the tissue collection, not the examination or analysis of the specimen.
The device is used to obtain a sample, which is then sent for histopathologic examination (which is an in vitro process), but the snare itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.
Product codes
FDI
Device Description
The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.
The Urology Monopolar Snare is a sterile device and consists of single lumen catheter attached to a 3-ring handle at the proximal end. The Urological Snare incorporates a braided stainless steel wire in a loop or hexagonal configuration that is attached to a stainless steel drive-wire and is extendable and retractable with respect to the catheter distal tip. The Urological snare is a Monopolar radio frequency device. The handle contains an active cord connection to make the connection to an electrosurgical generator.
The Urology Monopolar Snare is intended for single patient use only. The packaging consists of a peel pouch technology to preserve the sterile condition prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological tract
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)
Performance Data: The performance data found in this submission shows that the US Endoscopy Urology Monopolar Snare performs as intended.
Conclusion: The data presented in this submission shows that the US Endoscopy Urology Monopolar Snare performs as intended and in a manner that is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
- 9 2011 -
Image /page/0/Picture/1 description: The image shows the logo for US Endoscopy. The logo consists of the letters "us" in bold, followed by the word "endoscopy" in a smaller, non-bold font. A curved line extends over the word "endoscopy", and another curved line extends below the word. Below the logo is the phrase "listening...and delivering solutions" in a small font.
510(K) EXECUTIVE SUMMARY FOR UNITED STATES ENDOSCOPY GROUP, INC'S UROLOGY MONOPOLAR SNARE
Device Description:
The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.
The Urology Monopolar Snare is a sterile device and consists of single lumen catheter attached to a 3-ring handle at the proximal end. The Urological Snare incorporates a braided stainless steel wire in a loop or hexagonal configuration that is attached to a stainless steel drive-wire and is extendable and retractable with respect to the catheter distal tip. The Urological snare is a Monopolar radio frequency device. The handle contains an active cord connection to make the connection to an electrosurgical generator.
The Urology Monopolar Snare is intended for single patient use only. The packaging consists of a peel pouch technology to preserve the sterile condition prior to use.
Functional Technology:
The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.
The only assembly required is the attachment of the radio frequency current cord to the device and to an appropriate electrosurgical generator.
When tissue transection in the urological tract is desired, the snare is used to entrap the tissue and applies radio frequency current to resect the targeted tissue and provide hemostasis. The tissue specimen is then removed per standard fluid & specimen evacuation or grasping techniques.
Intended Use:
The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.
Substantial Equivalence:
The device that is substantially equivalent to US Endoscopy's Urology Monopolar Snare is US Endoscopy Flexible Snare, cleared on 11-24-1992 under 510(k) Accession number K924105 and the Cook Urological Endosnare cleared on 6-07-1993 under 510(k) Accession number K923031.
1
| Device Comparison Table
Features | Proposed
Urology Monopolar
Snare | Flexible Snare
US Endoscopy
510(k) K924105 | Cook Medical
Endosnare
510(k) 923031 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Urology
Monopolar Snare for
tissue transection is
intended to be used
in the urological
tract for tissue
transection for
histopathologic
examination. | The snare is used in
flexible endoscopy to
grasp, dissect and transect
tissue during endoscopic
procedures for
histopathologic
examination. | This device is
intended to remove
bladder tumors and
coagulate the area in
which the tumor was
removed for patients
with superficial
papillary tumors of the
urinary bladder. |
| Mode of
Operation | Stainless steel cable
transection via
Monopolar current and
mechanical means | Stainless steel cable
transection via Monopolar
current and mechanical
means | Stainless steel wire
transection via
Monopolar current and
mechanical means. |
| Sterile | Yes | Yes | Yes |
| Where used | Urology | Gastroenterology | Urology |
| Usage | Single Patient | Single Patient | Single Patient |
| Energy used/
delivered | Monopolar Radio
Frequency current | Monopolar Radio Frequency
current | Monopolar Radio
Frequency current |
The US Endoscopy Urology Monopolar Snare is comparable to the US Endoscopy Flexible Snare device and the Cook Urological Endosnare in intended use and mode of operation.
Technological Characteristics: The US Endoscopy Monopolar Snare operates comparably to the listed predicate device and raises no new issues of safety or effectiveness.
Performance Standards: Although no performance standards or special controls have been developed under Section 514 of the FDC Act for this device, US Endoscopy has elected to test the Urology Monopolar Snare against the standards referenced in this submission.
Performance Data: The performance data found in this submission shows that the US Endoscopy Urology Monopolar Snare performs as intended.
Conclusion: The data presented in this submission shows that the US Endoscopy Urology Monopolar Snare performs as intended and in a manner that is substantially equivalent to the predicate devices.
Device Comparison Table
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The logo is simple, using only black and white, and is designed to be easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002
Mr. Carroll L. Martin Regulatory Manager US Endoscopy Group, Inc. 5976 Heisley Road MENTOR OH 44060
MAY - 9 2011
- Re: K103611
Trade/Device Name: Urology Monopolar Snare Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FDI Dated: April 14, 2011 Received: April 15, 2011
Dear Mr. Martin:
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. Please note: CDRH does not evaluate information related to contract liability w warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 of medical device-related
3
Page 2
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.
Herbert Remmer MD
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
Enclosure
4
CONFIDENTIAL United States Endoscopy Group, Inc. 510(k) Premiarket Notification: Traditional Urology Monopolar Snare for tissue transection
Page _ of
INDICATIONS FOR USE
510(k) Number (if known): _
Device Name: Urology Monopolar Snare
Indications for Use:
The Urology Monopolar Snare for tissue transection is intended to be used in the urological tract for tissue transection for histopathologic examination.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 Prescription Use _ (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Hela Roun
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