(29 days)
Not Found
No
The summary describes a standard electrosurgical system and does not mention any AI or ML components or functionalities.
Yes
The device is used for tissue resection, ablation, excision, and hemostasis in surgical procedures, which are therapeutic interventions.
No
The device is an electrosurgical system for resecting tissue and achieving hemostasis, which are therapeutic actions, not diagnostic ones. Its intended use is to perform surgical procedures, not to diagnose conditions.
No
The device description explicitly states it consists of a generator (Controller), disposable wands, and a reusable patient cable, which are all hardware components.
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 for surgical procedures on the human body (resecting urological tissue, prostate, bladder wall). IVDs are used to examine specimens from the human body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The description details an electrosurgical system with a generator, wands, and cables, all components used for direct surgical intervention.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on laboratory tests.
Therefore, the ArthroCare® Bipolar Loop Electrosurgery System is a surgical device, not an In Vitro Diagnostic device.
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 non-malignant 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 family of disposable, bipolar, single use Wands; 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)
Reference Device(s)
Not Found
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).
This Special 510(k) proposes a modification in the performance specifications, dimensional specifications, and labeling for the Bipolar Loop Electrosurgery System, which was previously cleared in K955531 on February 21, 1996 and K010568 on March 27, 2001. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare Bipolar Loop Electrosurgery System remain the same as in the predicate cleared 510(k).
§ 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
X022543
pg 1 of 2
AUG 3 0 2002
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: | Bruce Prothro
Vice President,
Operational Planning, Quality and
Regulatory Affairs |
| Date Prepared: | July 30, 2002 |
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 and K010568 |
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 family of disposable, bipolar, single use Wands; and a reusable Patient Cable.
1
Intended Uses
Kozz543 pro 20 f 2
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 non-malignant 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
This Special 510(k) proposes a modification in the performance specifications, dimensional specifications, and labeling for the Bipolar Loop Electrosurgery System, which was previously cleared in K955531 on February 21, 1996 and K010568 on March 27, 2001. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the ArthroCare Bipolar Loop Electrosurgery System remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The modified Bipolar Loop Electrosurgery System, as described in this Special 510(k), is substantially equivalent to the predicate device. The proposed modifications in performance specifications, dimensional specifications, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the System.
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 stylized eagle with three tail feathers, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2002
Re: K022543
Trade/Device Name: ArthroCare® Bipolar Loop Electrosurgery System Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II
Product Codes: 78 FAS and KNS Dated: July 30, 2002 Received: August 1, 2002
Dear Ms. Defiesta-Ng:
Ms. Valerie Defiesta-Ng
ArthroCare® Corporation
SUNNYVALE CA 94085
680 Vaqueros Avenue
Director, Regulatory Affairs
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 (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
Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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 Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
ArthroCare® Bipolar Loop Electrosurgery System Device Name
K022543 510(k) Number:
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 non-malignant turnors 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 | X | OR | Over-the-Counter Use |
|---|---|---|---|
| ------------------ | ---------- | ---- | ---------------------- |
(Per 21 CFR 801.109)
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K022543