(77 days)
When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues, and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow and wrist) that utilize a conductive irrigant.
The arthroscopic wand electrode is bipolar electrosurgical probe comprised of a shaft with an electrode array at its distal end and a connector at its proximal end for coupling the electrode array to a high frequency power supply. The electrode array has at least one active electrode and at least one return electrode. Return electrodes are electrically insulated from the active ones and are spaced so as not to contact the tissue being treated. The spacing also ensures that the electrical circuit is always completed by a surrounding conductive fluid, and not simply arcing between electrodes. The electrode number and configuration can vary in number and spacing, electrode material, or angle of the distal tip. In use, the probe is positioned in close proximity to a target site within an electrically conducting liquid, such as an isotonic saline. The conducting liquid provides a current path between the active electrode(s) and the return electrode(s). When radio frequency voltage is applied between the active and return electrodes, high voltage gradients in the distal boundary of the active electrode(s) is sufficiently high to break down the tissue through molecular dissociation or disintegration. The ablative process can be precisely controlled to remove a layer of tissue as thin as a few cells. Formation of an ionized layer or plasma does not occur when the electrodes are activated with a lower voltage. In this case, electrical current passes through the tissue creating a thermal zone for coagulation of blood vessels and shrinkage of some collagenous tissues of the joints during arthroscopic surgery. Vanguard receives previously used arthroscopic wands from healthcare facilities; cleans, refurbishes (replaces shaft insulation), inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.
The provided text is a 510(k) Summary for a reprocessed medical device, the Vanguard Reprocessed Arthroscopic Wands. For such devices, the acceptance criteria and study focus on demonstrating substantial equivalence to the original predicate devices, primarily through performance, functional, and biocompatibility testing, rather than establishing de novo clinical efficacy or diagnostic accuracy.
Here's an analysis of the acceptance criteria and supporting study based on the provided document:
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for this reprocessed device is that it performs as intended and is safe and effective, essentially being "substantially equivalent" to legally marketed predicate devices. This is established by demonstrating that its technological characteristics are essentially identical and that it maintains performance after reprocessing.
| Acceptance Criterion | Reported Device Performance/Conclusion |
|---|---|
| Technological Characteristics Identical to OEM: No changes to original specifications (except insulation material). | The Vanguard reprocessed arthroscopic wands are "essentially identical to the currently marketed OEM wands. No changes are made to the currently marketed device's specifications (except for the insulation material) and they possess the same technological characteristics." |
| Biocompatibility: Safe for use in the body. | "Biocompatibility and performance/functional testing demonstrate that the devices are equivalent and continue to be safe and effective for their intended use." "Biocompatibility testing demonstrate that the reprocessed devices perform as intended and are safe and effective." |
| Performance/Functional: Performs as intended for resection, ablation, coagulation, hemostasis. | "Performance/functional testing demonstrate that the devices are equivalent and continue to be safe and effective for their intended use." "Functional/performance [...] testing demonstrate that the reprocessed devices perform as intended and are safe and effective." This implicitly means they meet the function of the predicate device for their stated indications. |
| Sterilization and Packaging Validation: Device maintains sterility until use and packaging is intact. | "Sterilization and packaging validations [...] demonstrate that the reprocessed devices perform as intended and are safe and effective." |
| Overall Safety and Effectiveness/Substantial Equivalence: | "Based on the information provided herein and the 510(k) 'Substantial Equivalence' Decision Making Process Chart, we conclude that the Vanguard reprocessed arthroscopic wands are substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act." |
Study Details
The document describes several types of tests conducted, but does not outline a clinical study with a "test set" in the traditional sense of evaluating diagnostic or treatment accuracy with patient data. Instead, the studies are engineering and laboratory tests to confirm the physical and biological integrity and function of the reprocessed devices.
-
Sample size used for the test set and the data provenance:
The document does not specify the sample size for each type of testing (sterilization, packaging, functional/performance, biocompatibility). It doesn't refer to a "test set" from a patient population, but rather laboratory samples of the reprocessed wands.
Data provenance is not explicitly stated in terms of country of origin, but it would be laboratory testing conducted by or for Vanguard Medical Concepts, Inc. The studies are not retrospective or prospective in the clinical trial sense, but rather pre-market engineering and pre-clinical evaluations. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the studies are technical validations (biocompatibility, performance, sterilization) of a reprocessed device, not clinical performance studies requiring expert interpretation of patient data to establish a ground truth. The "ground truth" here is the established specification and performance of the original OEM devices and relevant standards. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no clinical test set requiring adjudication by experts. Adjudication methods are typically used in clinical trials or diagnostic accuracy studies where there is ambiguity in individual expert assessments. -
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:
No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. This device is a reprocessed surgical tool, not an AI diagnostic or assistance system. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical, electrosurgical device, not a software algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a reprocessed device, the "ground truth" is largely established by:- Predicate device specifications and performance data: The original, legally marketed OEM devices serve as the benchmark for performance.
- Relevant industry standards: For sterilization, biocompatibility, and electrical safety.
- Engineering and functional tests: Demonstrating the reprocessed device meets the same functional output and safety parameters as the new OEM device without degradation.
-
The sample size for the training set:
Not applicable. This document describes the re-validation of a physical medical device, not the training of an AI algorithm. -
How the ground truth for the training set was established:
Not applicable. (See point 7).
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OCT 3 0 2001
510(k) Summary of Safety & Effectiveness KO12695
| Submitter | Vanguard Medical Concepts, Inc.5307 Great Oak DriveLakeland, FL 33815 |
|---|---|
| Contact | Mr. Mike Sammon, Ph.D.Director, Research and Development(863) 683-8680, extension 228(801) 327-3339 (facsimile)mikes@safe-reuse.com |
| Date | August 13, 2001 |
| Device | Trade Names: Vanguard Reprocessed Arthroscopic Wands⇒ ArthroCare® ArthroWand® Arthroscopic Wands/Electrodes⇒ Mitek® VAPR® Arthroscopic Wands/ElectrodesCommon Name: Arthroscopic wand or electrodeClassification: 21 CFR 878.4400 - Electrosurgical cutting and coagulation device and accessories – Class IIProduct Code GEI |
| PredicateDevices | Respective ArthroCare® ArthroWand®, and Mitek® VAPR® legallymarketed arthroscopic wands under various 510(k) premarket notifications. |
| Indications forUse | When coupled with a compatible electrosurgical unit, an arthroscopic wandelectrode is intended for resection, ablation and coagulation of soft tissues,and for hemostasis of blood vessels during arthroscopic procedures (of theknee, shoulder, ankle, elbow and wrist) that utilize a conductive irrigant. |
| Continued on next page |
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510(k) Summary of Safety & Effectiveness, Continued
| Contra-indications | Use of this device is contraindicated for:non-arthroscopic surgical procedures,arthroscopic procedures during which a conductive irrigant is not used,patients for whom arthroscopy is contraindicated, andpatients with pacemakers or other electronic device implants. |
|---|---|
| DeviceDescription | The arthroscopic wand electrode is bipolar electrosurgical probe comprised of a shaft with an electrode array at its distal end and a connector at its proximal end for coupling the electrode array to a high frequency power supply. The electrode array has at least one active electrode and at least one return electrode. Return electrodes are electrically insulated from the active ones and are spaced so as not to contact the tissue being treated. The spacing also ensures that the electrical circuit is always completed by a surrounding |
number and configuration can vary in number and spacing, electrode material, or angle of the distal tip. In use, the probe is positioned in close proximity to a target site within an electrically conducting liquid, such as an isotonic saline. The conducting liquid provides a current path between the active electrode(s) and the return electrode(s). When radio frequency voltage is applied between the active and return electrodes, high voltage gradients in the distal boundary of the active electrode(s) is sufficiently high to break down the tissue through molecular dissociation or disintegration. The ablative process can be precisely
conductive fluid, and not simply arcing between electrodes. The electrode
Formation of an ionized layer or plasma does not occur when the electrodes are activated with a lower voltage. In this case, electrical current passes through the tissue creating a thermal zone for coagulation of blood vessels and shrinkage of some collagenous tissues of the joints during arthroscopic surgery.
controlled to remove a layer of tissue as thin as a few cells.
Vanguard receives previously used arthroscopic wands from healthcare facilities; cleans, refurbishes (replaces shaft insulation), inspects, tests, repackages and sterilizes the devices; and returns them to the healthcare facility.
Continued on next page
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510(k) Summary of Safety & Effectiveness, Continued
i
| TechnologicalCharacteristics | The Vanguard reprocessed arthroscopic wands are essentially identical tothe currently marketed OEM wands. No changes are made to the currentlymarketed device's specifications (except for the insulation material) and theypossess the same technological characteristics. Biocompatibility andperformance/functional testing demonstrate that the devices are equivalentand continue to be safe and effective for their intended use. |
|---|---|
| Test Data | Sterilization and packaging validations, functional/performance, ndbiocompatibility testing demonstrate that the reprocessed devices perform asintended and are safe and effective. |
| Conclusion | Based on the information provided herein and the 510(k) "SubstantialEquivalence" Decision Making Process Chart, we conclude that the Vanguardreprocessed arthroscopic wands are substantially equivalent to the predicatedevices under the Federal Food, Drug and Cosmetic Act. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 0 2001
Mike Sammon, Ph.D. Director, Research and Development Vanguard Medical Concepts, Inc. 5307 Great Oak Drive Lakeland, Florida 33815
Re: K012695 Trade/Device Name: Vanguard Reprocessed Arthroscopic Wands Regulation Number: 878.4400, 888.1100 Regulation Name: Electrosurgical cutting and coagulation device and accessories Arthroscope Regulatory Class: II Product Code: GEI, HRX Dated: August 8, 2001 Received: August 14, 2001
Dear Dr. Sammon:
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 - Mike Sammon, Ph.D.
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,
Susan Walker, MS
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
510(k) Number: K 012 695
Device Name: Vanguard Reprocessed Arthroscopic Wands
Indications for Use:
When coupled with a compatible electrosurgical unit, an arthroscopic wand electrode is intended for resection, ablation and coagulation of soft tissues, and for hemostasis of blood vessels during arthroscopic procedures (of the knee, shoulder, ankle, elbow and wrist) that utilize a conductive irrigant.
(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)
m use w to m m m = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K012695
iv
§ 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.