(217 days)
Not Found
No
The summary describes a physical electrosurgery electrode and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an electrosurgery electrode for cutting, dissecting, and cauterizing soft tissue, which are surgical procedures, not therapeutic treatments in the medical sense.
No
Explanation: The device is described as an "electrosurgery electrode" intended for "cutting, dissecting, and cauterizing of soft tissue," which are treatment functions, not diagnostic ones.
No
The device description clearly states it is a physical electrosurgical electrode constructed of a tungsten tip and stainless shaft, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "cutting, dissecting, and cauterizing of soft tissue." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical electrode used with electrosurgical handpieces. This is a surgical instrument.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of specimens.
The Porex Electrosurgery Needle is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Porex Surgical, Inc. Electrosurgery Needle is an electrosurgical electrode used for cutting, dissecting and cauterizing soft tissue by use of high-frequency electrical current.
The Porex Electrosurgery Needle is an electrosurgery clectrode for use in monopolar electrosurgical handpieces. It is a single-use device intended for cutting, dissecting, and cauterizing of soft tissue.
Product codes
GEI, JOS
Device Description
The Porex Surgical, Inc. Electrosurgery Needle is an electrosurgical electrode for use with monopolar electrosurgical accessories (cautery handpieces). It is constructed of a tungsten tip held by a gold plated stainless shaft/sleeve. The electrode shaft has two layers of insulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Colorado MicroDissection Needle (K000348), Megadyne Electrode, Electrosurgery (K903302), Valleylab Coated Electrodes (K962044)
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
MAR 2 8 2006
03/23/06
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SUMMARY 510(k) NUMBER: K052297
POREX SURGICAL ELECTROSURGICAL NEEDLE
SUBMITTER
Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265-1017 Tel: (678) 479-1610, Fax: (678)423-1435
CONTACT CONTACT CONTACT
Eric V. Hohenstein Vice President, Special Developmental Projects Tel: (678) 479-1610 / (323) 876-3767 Fax: (678) 423-1435 / (323) 876-5592 /
PROPRIETARY NAME: Porex Electrosurgery Needle
COMMON NAME: Microdissection Needle, Electrosurgical Needle
| DEVICE CLASSIFICATION | |||
|---|---|---|---|
| DEVICE NAME | CLASS NO. | CLASS | REG NO. |
| Device, Electrosurgical, cutting & | JOS | 2 | 878.4400 |
ત્ coagulation & accessories
IDENTIFICATION OF EQUIVALENT DEVICE___________________________________________________________________________________________________________________________________________
Porex Surgical, Inc. Electrosurgery Needles are substantially equivalent to the following predicate devices in their intended use, material, design, and surgical procedure:
Colorado MicroDissection Needle (K000348)
Megadyne Electrode, Electrosurgery (K903302)
Valleylab Coated Electrodes (K962044)
1
05297
DESCRIPTION
The Porex Surgical, Inc. Electrosurgery Needle is an electrosurgical electrode for use with monopolar electrosurgical accessories (cautery handpieces). It is constructed of a tungsten tip held by a gold plated stainless shaft/sleeve. The electrode shaft has two layers of insulation.
INTENDED USE
The Porex Surgical, Inc. Electrosurgery Needle is an electrosurgical electrode used for cutting, dissecting and cauterizing soft tissue by use of high-frequency electrical current.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA." The text is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2006
Porex Surgical Inc. c/o Mr. Eric V. Hohenstein V.P., Special Developmental Projects 15 Dart Road Newnan, Georgia 30265-1017
Re: K052297
Trade/Device Name: Porex Electrosurgery Needle Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, JOS Dated: March 6, 2006 Received: March 8, 2006
Dear Mr. Hohenstein:
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 I·DA'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
3
Page 2 -- Mr. Eric V. Hohenstein
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), please contact the Office of Compliance at (240) 276-0115. 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 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,
Hubert Lehman
r / Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
052297
510(k) Number (if known):
Device Name: Porex Electrosurgery Needle
Indications For Use:
The Porex Electrosurgery Needle is an electrosurgery clectrode for use in monopolar electrosurgical handpieces. It is a single-use device intended for cutting, dissecting, and cauterizing of soft tissue.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IS NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Julin Lemer
Division Sign-Off
Division of General, Restorative, and Neurological Devices
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510(k) Number