(30 days)
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.
The Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications.
The provided document is a 510(k) summary for ArthroCare Electrosurgery Wands. It discusses a special 510(k) submission for modifications to a previously cleared device (K014222). The key aspect of this submission is that the modified specifications, materials, and labeling are not substantial and do not significantly affect the safety or efficacy of the devices, and thus the device is considered substantially equivalent to its predicate.
Crucially, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical data analysis, such as sensitivity, specificity, or accuracy metrics often associated with AI/ML devices.
This document is a regulatory submission for an electrosurgical device, not an AI/ML diagnostic tool. Therefore, the questions related to clinical study design for AI/ML devices (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to the information contained within this 510(k) summary.
The summary states: "The Electrosurgery System modified Wands, as described in this submission, are substantially equivalent to the predicate, unmodified Wands. The proposed modifications in dimensional and performance specifications, materials, and labeling are not substantial and do not significantly affect the safety or efficacy of the devices." This statement serves as the "proof" that the device meets acceptance criteria, implying that it continues to perform as safely and effectively as the predicate device because the changes are not substantial.
Therefore, I cannot populate the table or answer most of the questions as the document does not provide this type of information.
Here's what I can infer from the document regarding the general nature of this submission:
-
A table of acceptance criteria and the reported device performance:
The document asserts "substantial equivalence" to a predicate device (K014222) due to "modifications in dimensional and performance specifications, materials, and labeling [that] are not substantial and do not significantly affect the safety or efficacy of the devices." This implies that the 'acceptance criteria' are met by demonstrating that the modified device performs identically or insignificantly differently from the predicate device, whose performance would have been established during its original clearance. No specific quantitative performance metrics (e.g., in terms of cutting efficiency, coagulation time, tissue damage) or acceptance thresholds for these metrics are provided in this summary. -
Sample sizes used for the test set and the data provenance: Not applicable. This document does not describe a clinical study in the context of an AI/ML device to establish performance metrics against a test set.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
-
Adjudication method for the test set: Not applicable.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
-
The type of ground truth used: Not applicable.
-
The sample size for the training set: Not applicable.
-
How the ground truth for the training set was established: Not applicable.
In summary, the provided text is a regulatory clearance document for an electrosurgical device based on substantial equivalence, not a performance study report for an AI/ML medical device.
{0}------------------------------------------------
ArthroCare
CORPORATION
MAR 2 8 2002
.
510(k) Summary KO206222 ArthroCare Corporation Electrosurgery Wands
General Information
Submitters Name/Address:
ArthroCare, Corporation 680 Vaqueros Ave Sunnyvale, CA 94085-2936
Establishment Registration Number:
2951580
(408) 736-0224
February 25, 2002
Valerie Defiesta-Ng Director, Regulatory Affairs
Phone Number:
Contact Person:
Date Prepared:
Device Description
Trade Name:
Generic/Common Name:
Classification Name:
ArthroCare® Electrosurgery Wands
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices
ArthroCare Electrosurgery System Wands
K014222; cleared on January 18, 2002
Product Description
The Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications.
{1}------------------------------------------------
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 tisse and neinveral 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 a modification in dimensional and performance specifications, materials, and labeling for the Wands, which were previously cleared under K014222 on Janurary 18, 2002. The indications for use, technology, principle of operation, packaging, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k)s.
{2}------------------------------------------------
Summary of Safety and Effectiveness
The Electrosurgery System modified Wands, as described in this submission, are The Enchrosargery Dystent in the predicate, unmodified Wands. The proposed modification Substantially equivalent to the predications, materials, and labeling are not substantial n unficitsional and performance opet significantly affect the safety or efficacy of the devices.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles in a row, with a snake-like form intertwined. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ArthoCare Corporation Ms. "Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-2936
Re: K020622
Trade Name: ArthroCare® Electrosurgery Wands Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: II Product Code: GEI Dated: February 26, 2002 Received: February 26, 2002
Dear Ms. Defiesta-Ng:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bootion is soking is substantially equivalent (for the referenced above and we have acterinaure) to devices marketed in interstate commerce prior to indications for use success in the envice Medical Device Amendments, or to devices that have May 26, 1970, the charment date of the provisions of the Federal Food, Drug, and Cosmetic Act
been reclassified in accordance with the provisions of the Federal W becal recrassmed in accoration of a premarket approval application (PMA). You may, (Act) that do not require upprovated to the general controls provisions of the Act. The general therefore, marker the device, sabject to equirements for annual registration, listing of devices, Controls provisions or the free heating, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it ri your device is classified (600 a0010) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations af may be subject to such adaterial eculations, Title 21, Parts 800 to 898. In addition, FDA may of found in the Outs occements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i Tease of advised that I Drisonalise cour device complies with other requirements of the Act that I Dri has made a actor regulations administered by other Federal agencies. You must of any I cacal statuted und registents, including, but not limited to: registration and listing (21 comply with an the 11et 31equirements) 01); good manufacturing practice requirements as set Of It in the quality systems (21 CFR Part 820); and if applicable, the electronic form in and qualis) by selling (Sections 531-542 of the Act); 21 CFR 1000-1050.
{4}------------------------------------------------
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" (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,
Muriam C. Provost
Col 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
{5}------------------------------------------------
Indications for Use Statement
Device Name:
ArthroCare® Electrosurgery Wands
510(k) Number:
K 020622
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 (Per 21 CFR 801.109)
X
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020622
viii
§ 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.