(66 days)
Not Found
No
The summary describes a standard electrosurgical device and does not mention any AI or ML components or capabilities.
No.
The device is used for surgical procedures like resection, ablation, coagulation, and hemostasis, which are interventional rather than therapeutic in the sense of treating a disease or condition directly through physiological means. It functions as a surgical tool.
No
Explanation: The device is described as an electrosurgical device for resection, ablation, coagulation, and hemostasis of soft tissue and blood vessels. Its function is to perform surgical procedures, not to diagnose a condition or disease.
No
The device description explicitly states "The Wands are bipolar, single use, high frequency electrosurgical device," indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states that the Electrosurgery Wands are used for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels" during surgical procedures. This is a direct intervention on the body, not a test performed on a sample.
- Intended Use: The intended use describes surgical procedures performed on the patient, not diagnostic tests performed on samples from the patient.
Therefore, based on the provided information, the Electrosurgery Wands are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 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 include the following:
| General Surgery | Gynecological Surgery |
|---|---|
| cholecystectomy | lysis of adhesions |
| lysis of adhesions | hysterectomy |
| upper GI | salpingo-oophorectomy |
| GI (other) | burch colposuspension |
| splenectomy | myomectomy |
| thyroidectomy | endometriosis |
| herniorrhaphy | ovariohysterectomy |
| breast biopsy | removal of tumors |
| bowel resection | |
| pelvic adhesiolysis | |
| removal of lesions | |
| removal of polyps | |
| tumor biopsy |
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Wands are bipolar, single use, high frequency electrosurgical device designed for specific indications.
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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
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
ArthroCare
CORPORATION
Image /page/0/Picture/1 description: The image shows handwritten text. The text at the top reads 'K022475'. Below that, the text reads 'page 1 of 2'. The handwriting appears to be casual and the text is slightly slanted.
OCT 0 3 2002
510(k) Summary
ArthroCare Corporation ArthroCare® Electrosurgery Wands
General Information
| Submitter Name/Address: | ArthroCare Corporation
680 Vaqueros Avenue
Sunnyvale, CA 94085-2936 |
|------------------------------------|----------------------------------------------------------------------------------------|
| Establishment Registration Number: | 2951580 |
| Contact Person: | Valerie Defiesta-Ng
Director, Regulatory Affairs |
| Date Prepared: | July 26, 2002 |
| Device Description | |
| Trade Name | ArthroCare Electrosurgery Wands |
| Generic/Common Name: | Electrosurgical Device and Accessories |
| Classification Name: | Electrosurgical Cutting and Coagulation
Device and Accessories (21 CFR
878.4400) |
Predicate Devices ArthroCare Electrosurgery Wands
K020622; cleared on March 28, 2002
Product Description
The Wands are bipolar, single use, high frequency electrosurgical device designed for specific indications.
1
K022475
page 2 of 2
Intended Use
The 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 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 |
Substantial Equivalence
This Special 510(k) proposes modification in material for the Electrosurgery Wands, which were previously cleared under K020662, on March 28, 2002. The indications for use, technology, principle of operation, design, performance and dimensional specifications, labeling, packaging, and sterilization parameters of the ArthroCare Electrosurgery Wands remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The modified Electrosurgery Wands, as described in this submission, are substantially equivalent to the predicate Electrosurgery Wands. The proposed modification in material is not a substantial change or modification, and does not significantly affect the safety or efficacy of the devices.
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 features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 03 2002
Arthocare Corporation Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085
Re: K022475
Trade/Device Name: Modification to Arthrocare Controller (System 2000 and 8000) Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 11, 2002 Received: September 12, 2002
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, 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 – Ms. Valerie Defiesta-Ng
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 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 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.
sincerely yours,
elia 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 for Use Statement
Indications for Use Statement
ArthroCare® Electrosurgery Wands Device Name:
510(k) Number:
K (22475
Indications for use:
The 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 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 (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) | |
| Over-the-Counter | |
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K022475 |