(20 days)
The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression, of disc material to treat symptomatic patients with contained herniated discs.
The Wands are bipolar, single use, high frequency electrosurgical devices.
This document is a 510(k) summary for modifications to an existing device, the ArthroCare® PercD™ SpineWand™. It is not a detailed study report that would typically contain specific acceptance criteria and performance data for a new device's efficacy.
Based on the provided text, the device is cleared based on demonstrating substantial equivalence to a predicate device (ArthroCare PercD SpineWand K020621). This means the submission argues that the modified device's performance is assumed to meet the same acceptance criteria as the predicate device because the changes are not substantial.
Therefore, many of the requested elements for a detailed study proving acceptance criteria are not present in this type of submission.
Here's a breakdown of what can be inferred or stated based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as such for this submission. The acceptance criterion for this 510(k) is demonstrating "substantial equivalence" to the predicate device. This implies that the modified device should perform comparably to the predicate device in terms of safety and efficacy.
- Reported Device Performance: No specific numerical performance data is presented in this summary for the modified device, as the submission focuses on asserting that "The proposed modification in dimensional specifications, materials, and labeling are not substantial changes or modifications, and do not significantly affect the safety or efficacy of the devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable/not provided. This submission is for modifications to an already cleared device, relying on the substantial equivalence principle rather than new performance testing data to establish initial safety and efficacy.
- Data Provenance: Not applicable/not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. As no new clinical study data is presented to assess performance against new acceptance criteria, there's no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new test set requiring adjudication is mentioned.
5. 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. This device is an electrosurgical tool, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (electrosurgical wand), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for this submission. The "ground truth" for this 510(k) is the established safety and efficacy of the predicate device (K020621). The modified device is asserted to be substantially equivalent to that.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
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ArthroCare
CORPORATION
APR 1 6 2003
510(k) Summary
ArthroCare Corporation ArthroCare® PercD™ SpineWand™
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: March 25, 2003 Device Description ArthroCare® PercD™ SpineWand™ Trade Name: Generic/Common Name: Electrosurgical Device and Accessories Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) Predicate Devices ArthroCare PercD SpineWand K020621
Product Description
The Wands are bipolar, single use, high frequency electrosurgical devices.
Intended Use
The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression, of disc material to treat symptomatic patients with contained herniated discs.
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Substantial Equivalence
This Special 510(k) proposes modifications in dimensional specifications, materials, and labeling for the ArthroCare PercD SpineWand, which were previously cleared under K020621 on March 28, 2002. The indications for use, technology, principle of operation, performance specifications, packaging, or sterilization parameters of the SpineWands remain the same as in the predicate cleared 510(k).
Summary of Safety and Effectiveness
The modified SpineWands, as described in this submission, are substantially equivalent to the predicate SpineWands. The proposed modification in dimensional specifications, 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/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the symbol in a circular fashion. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2003
Ms. Valerie Defiesta-Ng Director. Regulatory Affairs ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, California 94085-2936
Re: K030954
Trade/Device Name: ArthroCare® PercD™ SpineWandTM Regulation Number: 21 CFR 878.4400 Regulation Names: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Codes: GEI Dated: March 26, 2003 Received: March 27, 2003
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.
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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), 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) you may obtain. 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.
Miriam C. Provost
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
.
ArthroCare® Perc-D™ SpineWand™ Device Name:
K030954 510(k) Number:
Indications for use:
The Perc-D™ SpineWand™ is indicated for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs.
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K630954
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
OR
Over-the-Counter Use
(Per 21 CFR 801.109)
§ 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.