(26 days)
ArthroCare System 2000: The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
ArthroCare Orthopedic Electrosurgery System: The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in in orthopedic, arthroscopic, and spinal procedures.
ArthroCare Bipolar Loop: The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.
The ArthroCare Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in neurosurgical, spinal, and urological procedures.
The provided 510(k) summary for the ArthroCare System 2000, ArthroCare Orthopedic Electrosurgery System, and ArthroCare Bipolar Loop does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document is a communication from ArthroCare Corporation to the FDA seeking substantial equivalence for modifications to existing devices (ArthroCare Wands). It primarily focuses on:
- Device Description and Intended Use: Outlining what the devices are and what procedures they are used for.
- Predicate Device: Identifying the previously cleared device (K011634) to which the current submission claims substantial equivalence.
- Modifications: Stating that the proposed modifications are in "materials and labeling" and do not affect the safety or efficacy, or the core technology, principle of operation, performance, or dimensional specifications.
- Substantial Equivalence Claim: Asserting that the modified Wands are substantially equivalent to the predicate devices.
- FDA Response: The FDA letter confirms the substantial equivalence determination based on the provided information.
There is no mention of:
- Acceptance Criteria Table: No such table is presented.
- Reported Device Performance: No specific performance metrics or data derived from testing are included.
- Sample Size/Data Provenance: No information about test sets, sample sizes, or data origin is provided.
- Ground Truth Experts/Qualification: No details about experts, their qualifications, or how ground truth was established.
- Adjudication Method: No adjudication process is described.
- MRMC Comparative Effectiveness Study: No such study is mentioned, nor any effect size.
- Standalone Performance: No algorithm-only performance is discussed, as this is a medical device, not an AI algorithm.
- Type of Ground Truth: No ground truth type is specified because no performance study is detailed.
- Training Set Sample Size: No training set is mentioned as this is not an AI/ML device.
- Training Set Ground Truth Establishment: Not applicable.
This document is a regulatory submission for device modifications based on a claim of substantial equivalence to a predicate device, not a performance study report with acceptance criteria. The claim is that the modifications do not significantly affect the safety or efficacy, implying that the performance assumed for the predicate device still holds without a new performance study being explicitly detailed in this document.
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ArthroCare
CORPORATION
510(k) Summary
ArthroCare Corporation ArthroCare® System 2000 ArthroCare® Orthopedic Electrosurgery System ArthroCare® Bipolar Loop
KO20832
2951580
Valerie Defiesta-Ng
March 13, 2002
General Information
Submitter Name/Address:
ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Director, Regulatory Affairs
APR = 9 2002
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Trade Name:
ArthroCare System 2000 ArthroCare Orthopedic Electrosurgery System ArthroCare Bipolar Loop
Generic/Common Name:
Classification Name:
Electrosurgical Device and Accessories
Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400)
Predicate Devices
ArthroCare System 2000, ArthroCare Orthopedic Electrosurgery System, and ArthroCare Bipolar Loop
Product Description
The ArthroCare Wands are bipolar, single use, high frequency electrosurgical devices designed for specific indications in neurosurgical, spinal, and urological procedures.
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Intended Use
ArthroCare System 2000
- The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of 프 soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
ArthroCare Orthopedic Electrosurgery System
- The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, II and coagulation of soft tissue and hemostasis of blood vessels in in orthopedic, arthroscopic, and spinal procedures.
ArthroCare Bipolar Loop
- The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as 비 well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.
Substantial Equivalence
This Special 510(k) proposes modifications in materials and labeling for the ArthroCare Wands, which were previously cleared under K011634 on June 19, 2001. The indications for use, technology, principle of operation, performance and dimensional specifications, packaging, and sterilization parameters of the Wands remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The modified Wands, as described in this submission, are substantially equivalent to the predicate Wands. The proposed modification in materials and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices.
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Image /page/2/Picture/0 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized eagle with three heads facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 .
APR = 9 2002
Ms. Valerie Defiesta-Ng Director Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale. California 94085
Re: K020832
Trade/Device Name: ArthroCare® System 2000, ArthroCare® Orthopedic Electrosurgery System and ArthroCare® Bipolar Loop Regulation Number: 878.440 and 888.1100 Regulation Name: Electrosurgical Device, Cutting & Coagulation & Accessories and Arthroscope and Accessories Regulatory Class: II Product Code: GEI and HRX Dated: January 4, 2002 Received: January 7, 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
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Page 2 -- Ms. Valerie Defiesta-Ng
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.
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.
R. Mark N. Milliken
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
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Indications for Use Statement
Device Name:
ArthroCare® System 2000 ArthroCare® Orthopedic Electrosurgery System ArthroCare® Bipolar Loop
K_020832 510(k) Number:
Indications for use:
ArthroCare System 2000
- The ArthroCare System 2000 is indicated for resection, ablation, and coagulation of 비 soft tissue and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
ArthroCare Orthopedic Electrosurgery System
- The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, .. and coagulation of soft tissue and hemostasis of blood vessels in in orthopedic, arthroscopic, and spinal procedures.
ArthroCare Bipolar Loop
- The ArthroCare Bipolar Loop is indicated for resection, ablation, and excision, as # well as hemostasis of blood vessels in patients requiring endoscopic surgery for general urological procedures including transurethral prostatectomy (TURP), transurethral incisions in the prostate (TUIP), and non-malignant tumors of the bladder wall.
(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 | |
|---|---|---|---|---|
| Mark N Millman (Division Sign-Off) Division of General, Restorativeand Neurological Devices | viii | |||
| 510(k) Number | K020833 |
§ 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.