(415 days)
The Given Electrosurgical Needle is used to apply electrosurgical current directly into a spider vein located within the skin. The electrosurgical current destroys the spider vein.
The Given Electrosurgical Needle is a single patient use needle electrode for use in monopolar electrosurgical handpieces. The skin which is usually anesthetized with a topical and/or injectable anesthetic. The monopolar generator is set at the cutting mode to 1.5 to 1.75 Watts. The needle is introduced into the vein located within the skin. The current is then applied with destruction of the vein while the insulation protects the surrounding tissue. The needle is withdrawn and additional veins are then treated in a similar fashion. The needle is made of Tungsten Carbide and the insulation is Parylene-C which are both biocompatible materials that have been used extensively in electrosurgical electrodes.
This document describes a 510(k) premarket notification for the "Given Electrosurgical Needle." The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study with explicit performance metrics.
Therefore, many of the requested sections (acceptance criteria, specific study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not present in the provided text. The document is primarily a regulatory filing for market clearance based on substantial equivalence.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The provided document is a 510(k) summary, which establishes substantial equivalence to predicate devices rather than defining and demonstrating performance against specific quantitative acceptance criteria in the manner of a clinical efficacy study. The "performance" mentioned indirectly relates to safety and efficacy through similarity to predicates.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No specific test set or clinical study with a defined sample size and data provenance is described for demonstrating device performance against acceptance criteria. The submission relies on the established safety and efficacy of predicate devices and the biocompatibility of materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No "ground truth" establishment process for a test set is described in the context of performance criteria.
4. Adjudication Method for the Test Set
Not applicable. As no test set for performance evaluation is described, no adjudication method 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 needle, not an AI-based diagnostic tool that would typically involve human readers or MRMC studies for AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an electrosurgical needle, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. No specific ground truth is described as being used to evaluate the performance of the device against acceptance criteria. The basis for safety and effectiveness is largely technological equivalence and material biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This device is an electrosurgical needle, not a machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set or ground truth establishment for it is relevant to this type of device submission.
Summary of Information Provided Related to the Device and its Review:
- Device Name: Given Electrosurgical Needle
- Intended Use: To apply electrosurgical current directly into a spider vein located within the skin to destroy the spider vein.
- Technology: Monopolar electrosurgical needle made of Tungsten Carbide with Parylene-C insulation.
- Predicate Devices: Stryker Leibinger Colorado MicroDissection Needle® (K033232; K000348; K881763)
- Basis for Clearance: Substantial equivalence to predicate devices in "basic technology characteristics," "principles of operation," and "technological characteristics." The materials are known biocompatible materials used in electrosurgical electrodes.
- Review Outcome: FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
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Kenna S. Given, M.D./Tripps Court Enterprises, Inc. K082584 - Given Electrosurgical Needle
CONFIDENTIAL Response to Additional Information
Attachment 2 Revised - October 5, 2009
Page 1 of 2
510(k) Summarv
| Owner's Information: | Kenna S. Given, M.D.748 Tripps CourtAugusta, GA 30909Tel: (706) 721-6945 Fax: (706) 721-6931 |
|---|---|
| Contact Person: | Julie Stephens, President/ConsultantRegulatory Resources Group, Inc. |
| 510(k) Number: | K082584 OCT 2 8 2009 |
| Trade/Proprietary Name: | Given Electrosurgical Needle |
| Common Name: | Electrosurgical Instrument |
| Classification Name: | Electrosurgical Cutting & Coagulation Device and Accessories (21CFR 878.4400) |
| Product Code: | GEI |
| Legally MarketedPredicate Devices: | Stryker Leibinger Colorado MicroDissection Needle®510(k) #s: K033232; K000348; K881763 |
Device Description:
The Given Electrosurgical Needle is a single patient use needle electrode for use in monopolar electrosurgical handpieces. The skin which is usually anesthetized with a topical and/or injectable anesthetic. The monopolar generator is set at the cutting mode to 1.5 to 1.75 Watts. The needle is introduced into the vein located within the skin. The current is then applied with destruction of the vein while the insulation protects the surrounding tissue. The needle is withdrawn and additional veins are then treated in a similar fashion. The needle is made of Tungsten Carbide and the insulation is Parylene-C which are both biocompatible materials that have been used extensively in electrosurgical electrodes.
Intended Use:
The Given Electrosurgical Needle is used to apply electrosurgical current directly into a spider vein located within the skin. The electrosurgical current destroys the spider vein.
Similarities and Differences of the Proposed Devices to the Predicate Devices:
Similarities
The Given Electrosurqical Needle has the same basic technology characteristics for an electrosurgical electrode for use in monopolar electrosurgical handpieces. It is intended for precision cutting and cauterizing of soft tissue as the predicate devices, and the indications for use are the same except for the specific additions as noted below.
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Kenna S. Given, M.D./Tripps Court Enterprises, Inc. K082584 - Given Electrosurgical Needle
Response to Additional Information
Attachment 2 Revised - October 5, 2009
510(k) Summary
Differences
The Given Electrosurgical Needle utilizes some of the exact materials as the predicate devices; however, all materials are known biocompatible materials that have been used in electrosurgical electrodes or electrosurgical instruments.
Conclusion:
The Given Electrosurgical Needle has the same principles of operation, and technological characteristics as the predicate device. The Given Electrosurgical Needle has determined a specific intended use from results of testing as presented in the submission.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized manner.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
OCT 2 8 2009
Tripps Court Enterprises, Inc. % Regulatory Resources Group, Inc. Ms. Julie Stephens 111 Laurel Ridge Drive Alpharetta, Georgia 30004
Re: K082584
Trade/Device Name: Given Electrosurgical Needle Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 5, 2009 Received: October 6, 2009
Dear Ms. Stephens:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Julie Stephens
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082584
Device Name: Given Electrosurgical Needle
Indications For Use:
The Given Electrosurgical Needle is used to apply electrosurgical current directly into a spider vein located within the skin. The electrosurgical current destroys the spider vein.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nilkeal for mkm
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K082584
Page 1 of 1
§ 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.