(106 days)
Not Found
No
The summary describes a standard electrosurgical device for tissue resection and hemostasis, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is described as an electrosurgical device used to resect soft tissue and provide hemostasis in urological surgery, which are therapeutic actions.
No
The device description and intended use indicate it is an electrosurgical device for tissue resection and hemostasis, which are treatment functions, not diagnostic ones.
No
The device description explicitly states it is a "high frequency electrosurgical device" and a "Loop," indicating a physical hardware component used for resection and hemostasis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states "endoscopic soft tissue ablation and resection in general urological surgical procedures." This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from a patient outside the body.
- Device Description: The description reinforces this by stating it's a "high frequency electrosurgical device intended for use in general urological surgery to resect soft tissue and provide hemostasis." This is a surgical tool.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used for treatment.
N/A
Intended Use / Indications for Use
The ArthroCare Urologic Monopolar Electrosurgery Loop is a high frequency electrosurgical device intended for use in general urological surgery to resect soft tissue and provide hemostasis.
The ArthroCare Monopolar Loop is indicated in patients requiring endoscopic soft tissue ablation and resection in general urological surgical procedures.
Product codes
78 FAS
Device Description
The ArthroCare Urologic Monopolar Electrosurgery Loop is a high frequency electrosurgical device intended for use in general urological surgery to resect soft tissue and provide hemostasis. The materials used in the ArthroCare Urologic Monopolar Electrosurgery Loop are virtually identical to those used in the ArthroCare Arthroscopic Electrosurgery System (K943450). Predicate devices use either stainless, tungsten or titanium for the wire material of their electrosurgical electrodes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general urological surgery
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)
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
ArthroCare Corporation Sunnyvale, California Premarket Notification February 7, 1997
1
ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ
MAY 2 8 1997
X. Summary of Safety and Effectiveness
The ArthroCare Urologic Monopolar Electrosurgery Loop is a high frequency electrosurgical device intended for use in general urological surgery to resect soft tissue and provide hemostasis. Predicate electrode products and electrosurgical generators have been marketed since the 1950's by several different manufacturers such as Circon ACMI and Karl Storz. Other monopolar loops and rollerball/barrel electrodes have been cleared for market via 510(k)'s, such as the rollerballs manufactured by ProSurge and Karl Storz-America, Inc. These products have been demonstrated to be safe and effective in resecting soft tissue during urological surgical procedures.
The materials used in the ArthroCare Urologic Monopolar Electrosurgery Loop are virtually identical to those used in the ArthroCare Arthroscopic Electrosurgery System (K943450). Predicate devices use either stainless, tungsten or titanium for the wire material of their electrosurgical electrodes.
By virtue of design, materials and function, the ArthroCare Urologic Monopolar Electrosurgery Loop is substantially equivalent to the predicate devices currently marketed in the United States.
013
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Image /page/1/Picture/0 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized bird or a wing-like shape. The symbol is composed of several curved lines that create a sense of movement and flow.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1997
Mr. Cheryl L. Shea Director - Regulatory Affairs/Quality Assurance ArthroCare, Corporation 595 North Pastoria Avenue Sunnyvale, California 94086
Re: K970526
ArthroCare Urologic Monopolar Electrosurgery Loop .... . Dated: April 15, 1997 Received: April 17, 1997 Regulatory class: II 21 CFR §876.4300/Product code: 78 FAS
Dear Mr. Shea:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your 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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K9700526 510(k) Number: ArthroCare Monopolar Loop Device Name:
Indications for Use:
The ArthroCare Monopolar Loop is indicated in patients requiring endoscopic soft tissue ablation and resection in general urological surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satterberg/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 970526 510(k) Number
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use