(106 days)
The ArthroCare Monopolar Loop is indicated in patients requiring endoscopic soft tissue ablation and resection in general urological surgical procedures.
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.
Acceptance Criteria and Study for ArthroCare Urologic Monopolar Electrosurgery Loop
This document describes the acceptance criteria and the supporting information for the ArthroCare Urologic Monopolar Electrosurgery Loop (K970526).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not specify quantitative acceptance criteria or detailed performance metrics from a formal study for the ArthroCare Urologic Monopolar Electrosurgery Loop. Instead, the device's clearance is based on its substantial equivalence to predicate devices already on the market. The implied acceptance criteria revolve around exhibiting similar functionality and safety profiles to these existing devices.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functionality | Resect soft tissue | "intended for use in general urological surgery to resect soft tissue" |
| Provide hemostasis | "provide hemostasis" | |
| Safety | Utilize safe materials | "materials used...are virtually identical to those used in the ArthroCare Arthroscopic Electrosurgery System (K943450)" |
| Materials comparable to predicate devices | "Predicate devices use either stainless, tungsten or titanium for the wire material of their electrosurgical electrodes" | |
| Equivalence | Substantially equivalent to existing devices | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a specific test set or a formal study with a defined sample size for the ArthroCare Urologic Monopolar Electrosurgery Loop. The clearance is based on substantial equivalence to existing predicate devices. Therefore, there is no direct information on sample size for a test set or data provenance (country of origin, retrospective/prospective) for a study of this specific device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there was no specific test set described for this device, there is no information provided on the number or qualifications of experts used to establish ground truth. The "ground truth" implicitly relies on the established safety and effectiveness of the predicate devices based on their prior marketing and regulatory clearances.
4. Adjudication Method for the Test Set
Since no specific test set or study is described, there is no information on an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed, or at least not reported in the provided documents. The clearance is based on substantial equivalence, not a comparative effectiveness study against other devices or human performance.
6. Standalone (Algorithm Only) Performance Study
As this is a physical electrosurgical device and not an AI/algorithm-based product, a standalone (algorithm only) performance study was not applicable and therefore not performed/reported.
7. Type of Ground Truth Used
The "ground truth" for the clearance of this device is based on the established safety and effectiveness of predicate electrosurgical devices that have been marketed since the 1950s. This includes historical clinical use and regulatory clearances of devices manufactured by companies like Circon ACMI and Karl Storz, as well as more recent 510(k) clearances for monopolar loops and rollerball/barrel electrodes from manufacturers like ProSurge and Karl Storz-America, Inc.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI/machine learning model, the concept of a "training set" with a sample size is not applicable.
9. How the Ground Truth for the Training Set Was Established
Similarly, as there is no "training set," the concept of establishing ground truth for it is not applicable. The device's safety and effectiveness are established through demonstrating substantial equivalence to predicate devices, which gained their market clearance based on their own safety and effectiveness data (likely clinical experience and performance testing) at the time of their regulatory review.
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ArthroCare Corporation Sunnyvale, California Premarket Notification February 7, 1997
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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.
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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
§ 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).