(23 days)
Not Found
No
The document does not mention AI, ML, or related concepts, and the device description focuses on standard electrosurgical components.
Yes
The device is described as an "Electrosurgery System" intended for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels," among other surgical procedures, which are therapeutic interventions.
No
The device description states its intended use is 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 it consists of three hardware components: a generator, disposable wands, and a reusable patient cable. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside of the body (in vitro).
- Electrosurgery System Function: The description clearly states the Electrosurgery System is used for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels" during surgical procedures. This is a therapeutic and surgical tool used on the patient's body, not for testing specimens taken from the body.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, diagnostic testing, or providing diagnostic information based on laboratory results.
The device is a surgical tool used for manipulating tissue and controlling bleeding during surgery.
N/A
Intended Use / Indications for Use
The Electrosurgery System is intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general tissue 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 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
General 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)
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
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
'JAN 1 8 2002
ArthroCare
CORPORATION
510(k) Summary KO14222 ArthroCare Corporation Electrosurgery System
General Information
Submitter Name/Address:
Phone Number:
Contact Person:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
(408) 736-0224
December 20, 2001
Bruce Prothro Vice President, Regulatory Affairs, Quality Assurance, and Clinical Research
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
ArthroCare® Electrosurgery System
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices
K012519 ArthroCare® Electrosurgery Wands
Product Description
The 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
The Electrosurgery System is intended for resection, and coagulation of soft The Elouroburgery By clean is vessels in open, laparoscopic, and endoscopic general tissue 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 |
Substantial Equivalence
This Special 510(k) proposes a modification in the performance specifications, I imensional specifications, and labeling for the Electrosurgery System, which was previously cleared in K012519 on October 25, 2001. The indications for use, technology, principle of operation, materials, packaging, and sterilization parameters of the Electrosurgery System remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The modified 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2002
Mr. Bruce Prothro Vice President, Regulatory Affairs, Ouality Assurance, and Clinical Research ArthroCare Corporation 595 North Pastoria Avenue Sunnyvale, California 94085
Re: K014222 Trade/Device Name: ArthroCare® Electrosurgery System Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 20, 2001 Received: December 26, 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 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" (21CFR 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,
Ro. Merle N. Wilkinson
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 for Use Statement
Electrosurgery System Device Name
K_014 222 510(k) Number:
Indications for Use:
The Electrosurgery System is intended for resection, ablation, and coagulation of soft I he Electrosurgery System is included for readers, accopic, and endoscopic, and endoscopic general tissue and nemostasis of blood vessels in open, tapares 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 (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | X | OR Over-the-Counter Use | |
|---|---|---|---|
| ------------------------------------------ | --- | ------------------------- | -- |
for Mark N Millison
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number: | K014222 |
|---|---|
| ---------------- | --------- |
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