(61 days)
Not Found
No
The description focuses on the electrosurgical pencil's mechanical and electrical functions (activating cut/coagulate modes, cable, plug, electrodes, holster) and does not mention any computational or data-driven capabilities indicative of AI/ML.
Yes.
This device is used to cut and coagulate tissue during surgical procedures, which directly treats a condition or disease.
No
This device is described as an electrosurgical pencil used to cut and coagulate tissue during surgical procedures, not to diagnose a condition.
No
The device description clearly details physical components such as a molded plastic housing, buttons/rocker switch, cable, plug, electrodes (PTFE coated and uncoated), and an optional holster. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The described device is an electrosurgical pencil used to deliver energy directly to tissue within the body during surgical procedures. It is used for cutting and coagulating tissue in vivo.
- Intended Use: The intended use clearly states it's for conducting energy to tissue to be cut and/or coagulated during surgical procedures. This is a therapeutic/surgical function, not a diagnostic one performed on specimens.
Therefore, this device falls under the category of a surgical instrument or electrosurgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use for this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU), to an electrosurgical electrode consequently to the intended tissue to be cut and/or coagulated.
Indications: General, urologic, thoracic, plastic/reconstructive, gynecologic, laparoscopic and arthroscopic surgical procedures.
Product codes
GEI
Device Description
This device is used to activate the CUT and COAGULATE modes of an electrosurgical generator in order to cut soft tissue via a handheld push button or rocker switch controlled electrosurgical pencil. The body of the device has a molded plastic housing with either two buttons (one for cut and one for coagulate) or a rocker switch located at the distal end of the pencil. A ten foot cable exiting the housing features a universal three prong plug allowing the pencil to be connected to the monopolar side of a standard electrosurgical generator. A PTFE coated electrode or an uncoated stainless steel electrode will be packaged with this device with the option of including an insulated holster.
The Holster serves as an insulated container to store the pencil while it is inactive in order to avoid accidental activation when not in use. The holster conveniently attaches to a surgical drape.
The uncoated stainless steel electrode is used to cut and coagulate soft tissue. The PTFE coated electrode is a stainless steel electrode coated with a non-stick material (PTFE), which is also used to cut and coagulate soft tissue. The PTFE coating reduces the build up of eschar on the electrode during use; thus, eliminates the need to clean or "scrape" the electrode on an abrasive surface to remove the eschar buildup.
This device is a single use, disposable device which will be sold sterile and bulk nonsterile to be sterilized by the customer. Electrode tips are also single use, disposable devices which may be sold individually sterile or bulk non-sterile to be sterilized by the customer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
AUG 1 2 2008
510(k) Summary
KOJ1647
510(k) Owner: Xodus Medical, Inc. Westmoreland Business & Research Park 702 Prominence Drive New Kensington, PA 15068 Phone: 724-337-5500 Fax: 724-337-0555 Contact: Brenda Niel (Quality Assurance Manager)
Establishment Registration Number: 2530138
Date Prepared: 6/10/08
Device Information
Trade/Device Name: Electrosurgical Pencil with PTFE Coated & Uncoated Electrode Tips Common Name: ES Pencil Classification Name: Electrosurgical, Cutting & Coagulation Device & Accessories Regulation Number: 21 CFR 878.4400 Product Code: GEI Regulatory Class: II
Predicate Device
Device Name: Electrosurgical Pencil with PTFE Coated & Uncoated Electrode Tips Common Name: ES Pencil 510 (k) Number: K965054 510 (k) Owner: MegaDyne Medical Products, Inc. Classification Name: Electrosurgical, Cutting & Coagulation Device & Accessories _ Regulation Number: 21 CFR 878.4400 Product Code: GEI Regulatory Class: II
1
510(k) Summary
Device Description
This device is used to activate the CUT and COAGULATE modes of an electrosurgical generator in order to cut soft tissue via a handheld push button or rocker switch controlled electrosurgical pencil. The body of the device has a molded plastic housing with either two buttons (one for cut and one for coagulate) or a rocker switch located at the distal end of the pencil. A ten foot cable exiting the housing features a universal three prong plug allowing the pencil to be connected to the monopolar side of a standard electrosurgical generator. A PTFE coated electrode or an uncoated stainless steel electrode will be packaged with this device with the option of including an insulated holster.
The Holster serves as an insulated container to store the pencil while it is inactive in order to avoid accidental activation when not in use. The holster conveniently attaches to a surgical drape.
The uncoated stainless steel electrode is used to cut and coagulate soft tissue. The PTFE coated electrode is a stainless steel electrode coated with a non-stick material (PTFE), which is also used to cut and coagulate soft tissue. The PTFE coating reduces the build up of eschar on the electrode during use; thus, eliminates the need to clean or "scrape" the electrode on an abrasive surface to remove the eschar buildup.
This device is a single use, disposable device which will be sold sterile and bulk nonsterile to be sterilized by the customer. Electrode tips are also single use, disposable devices which may be sold individually sterile or bulk non-sterile to be sterilized by the customer.
Intended Use
The intended use for this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU), to an electrosurgical electrode consequently to the intended tissue to be cut and/or coagulated.
Indications: General, urologic, thoracic, plastic/reconstructive, gynecologic, laparoscopic and arthroscopic surgical procedures.
Technological Characteristics Comparison
The Xodus Medical disposable Electrosurgical Pencil is substantially equivalent in material and operation to other electrosurgical pencils already on the market. All materials used to manufacture the Electrosurgical Pencils and Electrodes are non-toxic and are currently being utilized by our competitor's in previously marketed devices. There are no new technological characteristics associated with this device; thus, no new questions of safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
od and Drug Administration 00 Corporate Boulevard ckville MD 20850
Kodus Medical, Inc. % Ms. Brenda Niel Quality Assurance Manager Westmoreland Business & Research Park 702 Prominence Drive New Kensington, Pennsylvania 15068
AUG 12 2008
Re: K081647
Trade/Device Name: Electrosurgical Pencil with PTFE Coated & Uncoated Electrode Tins Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 10, 2008 Received: June 12, 2008
Dear Ms. Neil:
We have reviewed your Section 510(k) premarket notification of intent to market the device eferenced 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. Comment of Comments of Comments of ..............................................................................................................................................................................
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.
lease be advised that FDA's issuance of a substantial equivalence determination does not mean hat 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. Brenda Neil
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, perceits 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Milburn
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
510(k) Number (if known):_ KO 8 (647
Device Name: Electrosurgical Pencil with PTFE Coated & Uncoated Electrode Tips
Indications for Use:
The intended use for this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU), to an electrosurgical electrode consequently to the intended tissue to be cut and/or coagulated.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-The Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
MP. Phumm
(Division Sign-Off) Division of General, Restorative, Page 2and Neurological Devices
510(k) Number lic 81647