(415 days)
No
The description focuses on the electrosurgical mechanism and materials, with no mention of AI or ML.
Yes
The device is described as being used to apply electrosurgical current to destroy spider veins, which is a therapeutic intervention.
No
The device is used to apply electrosurgical current to destroy spider veins, indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly describes a physical needle electrode made of Tungsten Carbide and Parylene-C insulation, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- Device Function: The Given Electrosurgical Needle directly applies electrosurgical current into a spider vein located within the skin. This is a therapeutic procedure performed on the body (in vivo), not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use is to destroy a spider vein, which is a treatment, not a diagnostic process.
Therefore, the Given Electrosurgical Needle is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
GEI
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 The needle is withdrawn and additional veins are then treated in a similar fashion.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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Court
Augusta, GA 30909
Tel: (706) 721-6945 Fax: (706) 721-6931 |
|----------------------------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Julie Stephens, President/Consultant
Regulatory 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 (21
CFR 878.4400) |
| Product Code: | GEI |
| Legally Marketed
Predicate 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.
1
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.
2
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
3
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
4
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
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