(79 days)
No
The summary describes a standard electrosurgical system with a generator, electrode, and cable. There is no mention of AI, ML, image processing, or any data-driven algorithms. The focus is on the electrosurgical mechanism and its application in urological procedures.
No
A therapeutic device is used to treat or cure a disease or condition. This device is an electrosurgical system used for tissue resection, ablation, excision, and hemostasis during surgical procedures, which are considered treatments. However, the system itself is performing the surgical actions, not actively treating a disease or condition on its own.
No
The device description and intended use clearly state that it is an electrosurgical device for tissue resection, ablation, and excision, and hemostasis. It is used during surgery, not for diagnosing conditions.
No
The device description explicitly states it consists of three hardware components: a generator, a disposable electrode, and a reusable patient cable.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a surgical procedure to resect, ablate, excise, and achieve hemostasis of tissue within the body. This is an in vivo application, meaning it's used on living tissue inside the patient.
- Device Description: The components (generator, electrode, cable) are consistent with an electrosurgical system used for surgical intervention, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) outside the body to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used directly on the patient's tissue during a procedure.
N/A
Intended Use / Indications for Use
The ArthroCare Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUIP), as well as tumors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution, Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.
Product codes
78 FAS, KNS
Device Description
The ArthroCare Bipolar Loop Electrosurgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a disposable, bipolar, single use Loop Electrode; and a reusable Patient Cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, bladder wall
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)
K955531, K010568, K020832, K022543
Reference Device(s)
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
§ 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
JUN 1 9 2003
510(k) Summary
ArthroCare Corporation ArthroCare® Bipolar Loop Electrosurgery System
General Information
| Submitter Name/Address: | ArthroCare Corporation
680 Vaqueros Avenue
Sunnyvale, CA 94085-2936 |
|-------------------------|---------------------------------------------------------------------------|
| Phone Number: | (408) 736-0224 |
| Contact Person: | Valerie Defiesta-Ng
Director, Regulatory Affairs |
| Date Prepared: | March 31, 2003 |
Device Description
| Trade Name: | ArthroCare Bipolar Loop Electrosurgery
System |
|----------------------|-------------------------------------------------------------------------------------|
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation
Device and Accessories (21 CFR 878.4400) |
Predicate Devices
| ArthroCare Bipolar Loop
| Electrosurgery System | K955531, K010568, K020832 and K022543 |
|---|---|
| PlasmaKinetic Endourology | |
| Generator | K003569 |
Product Description
The ArthroCare Bipolar Loop Electrosurgery System is a bipolar, high frequency electrosurgical system consisting of three components: an electrosurgical generator called the Controller; a disposable, bipolar, single use Loop Electrode; and a reusable Patient Cable.
1
Intended Uses
The ArthroCare Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUIP), as well as tumors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution. Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.
Substantial Equivalence
Based on the indications for use statement and technological characteristics to the predicate devices, the ArthroCare Bipolar Loop Electrosurgery System has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
Summary of Safety and Effectiveness
The Bipolar Loop Electrosurgery System, as described in this 510(k), is substantially equivalent to the predicate device with respect to the indications for use and technological characteristics. The modification of the indications for use statement does not raise any new issues of safety or efficacy. There are no changes or modifications being made to the technology, principle of operation, materials, packaging and sterilization parameters that were previously cleared 510(k)s.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Public Health Service
JUN 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Valerie Defiesta-Ng Director, Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue SUNNYVALE CA 94085-2936
Re: K031029
Trade/Device Name: ArthroCare Bipolar Electrosurgery System, Model TBD Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Codes: 78 FAS and KNS Dated: March 31, 2003 Received: May 13, 2003
Dear Ms. Defiesta-Ng:
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. Iisting 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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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
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Indications for Use Statement
ArthroCare® Bipolar Loop Electrosurgery System Device Name
510(k) Number: K 03/029
Indications for Use:
The ArthroCare Bipolar Loop Electrosurgery System is a bipolar electrosurgical device intended for use in patients requiring endoscopic surgery for general urological procedures. Urological tissue can be resected using this System, such as the prostate, in procedures including transurethral prostatectomy (TURP) and transurethral incisions in the prostate (TUIP), as well as tumors of the bladder wall. The System has been shown to be effective in tissue resection, ablation, and excision, as well as in hemostasis of blood vessels. It is intended for endoscopic procedures using saline solution, Ringer's lactate, or other conductive solutions as irrigants, under direct or video-assisted fiberoptic visualization.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
David R. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devi-
X
510(k) Number.
ix