(191 days)
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Not Found
No
The summary describes a standard electrosurgical pencil for cutting and coagulation, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is used for cutting and coagulation of soft body tissue, which is a therapeutic intervention.
No
The device is described as an electrosurgical pencil used for cutting and coagulation of soft body tissue, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "Bipolar Electrosurgical Pencil," which is a physical hardware device used for cutting and coagulation of tissue. It is not described as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and coagulation of the soft body tissue" during surgical procedures. This is a direct intervention on the body, not a test performed on samples taken from the body.
- Device Description: The description reinforces its use in surgical procedures on soft body tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely different, involving direct surgical manipulation of tissue.
N/A
Intended Use / Indications for Use
The Bipolar Electrosurgical Pencil is a device designed to be used in procedures involving cutting and coagulation of the soft body tissue.
Product codes
GEI
Device Description
The Electroscope, Inc. Bipolar Electrosurgical Pencil is designed as a "Disposable" product. The Bipolar Electrosurgical Pencil is a delicate surgical instrument.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft body tissue
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its head turned to the right. The eagle is composed of three lines that create the shape of the bird's head and neck. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jane Johnson Regulatory Affairs & Quality Assurance Manger Electroscope, Incorporated 4828 Sterling Drive Boulder, Colorado 80301
JAN 16 1998
K972562 Re:
Trade Name: Bipolar Electrosurgical Pencil, Straight and Angled Regulatory Class: II Product Code: GEI Dated: October 21, 1997 Received: October 27, 1997
Dear Ms. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for
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Page 2 - Ms. Johnson
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
ia M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ADDITIONAL INFORMATION----- K972562
Date: October 13, 1997
Food and Drug Administration Center foe Devices & Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, Md. 20856
Ref: "INDICATIONS FOR USE" for the following:
510(k) Premarket Submission, K972562 Bipolar Electrosurgical Pencil-Straight, Catalog No. AE-8000 Bipolar Electrosurgical Pencil-Angled, Catalog No. AE-8001
The Electroscope, Inc. Bipolar Electrosurgical Pencil is designed as a "Disposable" product.
The Bipolar Electrosurgical Pencil is a device designed to be used in procedures involving cutting and coagulation of the soft body tissue.
Electroscope, Inc.'s Bipolar Electrosurgical Pencil is a delicate surgical instrument. Any use of the instrument for tasks other than for which it is intended may result in a damaged or broken instrument.
Prescription Use
(Per 21 CFR 801.109)
P. Alejo