(80 days)
No
The document describes a standard electrosurgical device and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is used for resection, ablation, and coagulation of soft tissue, which are surgical procedures, not therapeutic treatments for a disease or condition. Its function is to perform surgical actions like cutting, removing, and sealing tissue and blood vessels.
No
The device is used for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly states the device is a "single use, disposable bipolar electrosurgical device," indicating it is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The ArthroCare Electrosurgery Wands are described as electrosurgical devices used for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels during surgical procedures. This involves direct interaction with the patient's body during surgery, not the analysis of samples taken from the body.
The device's function is to physically alter tissue and control bleeding during surgery, which is a therapeutic or surgical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Electrosurgery Wands arc indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures may include the following:
General Surgery
• cholecystectomy
• lysis of adhesions
• upper GI
• GI (other)
• splenectomy
• thyroidectomy
• herniorrhaphy
• breast biopsy
• bowel resection
• pelvic adhesiolysis
• removal of lesions
• removal of polyps
• tumor biopsy
Gynecological Surgery
• lysis of adhesions
• hysterectomy
• salpingo-oophorectomy
• burch colposuspension
• myomectomy
• endometriosis
• ovariohysterectomy
• removal of tumors
Product codes
GEI
Device Description
The ArthroCarc Electrosurgery Wands are single use, disposable bipolar electrosurgical devices designed to be used in conjunction with the ArthroCare Electrosurgery System (System 2000).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, blood vessels
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 testing has been completed to demonstrate the safe and effective use of the Electrosurgery Wands in the resection and ablation of soft tissue. The performance testing and device comparison demonstrated that the subject devices are substantially equivalent to the prodicate devices, and are safe and effective for their intended use.
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
OCT 2 5 2001
510(k) Summary of Safety and Effectiveness ArthroCare Corporation ArthroCare® Electrosurgery Wands
K012519 | ||
---|---|---|
General Information | ||
Manufacturer: | ArthroCare, Corporation | |
595 North Pastoria Avenue | ||
Sunnyvale, CA 94085-2936 | ||
Establishment Registration Number: | 2951580 | |
Contact Person: | Bruce Prothro | |
Vice President Regulatory Affairs, Quality | ||
Assurance, and Clinical Research | ||
Date Prepared: | August 3, 2001 | |
Device Description | ||
Classification Name: | Electrosurgical Cutting and Coagulation | |
Device and Accessorics (21 CFR 878.4400) | ||
Trade Name: | ArthroCare® Electrosurgery Wand | |
Generic/Common Name: | Electrosurgical Device and Accessories | |
Predicate Devices | ||
• ArthroCare Electrosurgery System | K001302 | |
• Ethicon PowerStar Bipolar Scissors | K981361 | |
• Coherent VersaPulse Select Single Wavelength (Ho:YAG) Dual |
- . Conerent Versuruise Sciect Single Wavelchigh |
Wavelcngth (Ho:YAG/Nd:YAG) Laser System ﺎ K990947
.
1
Intended Use
The Electrosurgery Wands arc indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures may include the following:
General Surgery |
---|
• cholecystectomy |
• lysis of adhesions |
• upper Gl |
• GI (other) |
• splenectomy |
• thyroidectomy |
• herniorrhaphy |
• breast biopsy |
• bowel resection |
• pelvic adhesiolysis |
• removal of lesions |
• removal of polyps |
• tumor biopsy |
Gynecological Surgery |
• lysis of adhesions |
• hysterectomy |
• salpingo-oophorectomy |
• burch colposuspension |
• myomectomy |
• endometriosis |
• ovariohysterectomy |
• removal of tumors |
Product Description
The ArthroCarc Electrosurgery Wands are single use, disposable bipolar electrosurgical devices designed to be used in conjunction with the ArthroCare Electrosurgery System (System 2000).
Substantial Equivalence
In establishing substantial equivalence to the prodicate devices, ArthroCare evaluated the indications for use, materials, technology, product specifications, and energy requirements of those systems. Additionally, performance testing has been completed to demonstrate the safe and effective use of the Electrosurgery Wands in the resection and ablation of soft tissue. The performance testing and device comparison demonstrated that the subject devices are substantially equivalent to the prodicate devices, and are safe and effective for their intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2001
Mr. Bruce Prothro Vice President Regulatory Affairs, Ouality Assurance and Clinical Research ArthroCare Corporation 595 North Pastoria Avenue Sunnyvale, California 94085
Re: K012519
Trade/Device Name: ArthroCare® Electrosurgery Wand Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 3, 2001 Received: August 6, 2001
Dear Mr. Prothro:
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 such 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 - Mr. Bruce Prothro
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 premaired predicated 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compination at (301) 594-4639 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entired, "Thison on your responsibilities under the Act may be obtained from the Oiner general mioninational 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,
Susan Walker, MD
Image /page/3/Picture/5 description: The image shows a close-up of a handwritten symbol or character. It features a curved line that resembles a loop or a stylized letter. The stroke is thick and dark, suggesting it was written with a pen or marker. The overall impression is abstract and calligraphic.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications Statement
Device Name: | ArthroCare® Electrosurgery Wands |
---|---|
510(k) Number: | K012519 |
Indications for use:
The ArthroCare Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures may include the following:
General Surgery | |
---|---|
• cholecystectomy | |
• lysis of adhesions | |
• upper GI | |
• GI (other) | |
• splenectomy | |
• thyroidectomy | |
• herniorrhaphy | |
• breast biopsy | |
• bowel resection | |
• pelvic adhesiolysis | |
• removal of lesions | |
• removal of polyps | |
• tumor biopsy | |
Gynecological Surgery | |
• lysis of adhesions | |
• hysterectomy | |
• salpingo-oophorectomy | |
• burch colposuspension | |
• myomectomy | |
• endometriosis | |
• ovariohysterectomy | |
• removal of tumors |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OD
Prescription Use (Per 21 CFR 801.109) OR
X
(Division Sign-Off)
Over-the-Counter Use
Division of ether, Restorative
and Neurological Devices
510(k) Number.