(83 days)
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Not Found
No
The summary describes a standard electrosurgical device for cutting and coagulation, with no mention of AI, ML, image processing, or data-driven features.
Yes
The device is described as an electrosurgical device used for cutting and coagulation of soft body tissue in arthroscopic procedures, which falls under the definition of a therapeutic device as it treats a medical condition.
No
The device is described as an electrosurgical device for cutting and coagulation of soft body tissue during arthroscopic procedures, which are therapeutic functions, not diagnostic.
No
The device description explicitly states it is an "electrosurgical device" and a "probe," which are hardware components used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting and coagulation of soft body tissue" during "Arthroscopic procedures." This is a surgical procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
This device is used inside the body during surgery, which is the opposite of an IVD.
N/A
Intended Use / Indications for Use
The Bipolar Arthroscopic Probe is an electrosurgical device designed to be used in Arthroscopic procedures involving cutting and coagulation of soft body tissue. The Bipolar Arthroscopic Probe is indicated for use in patients requiring arthroscopic surgery of the joint i.e., wrist, knee, shoulder, ankle, and elbow.
Product codes
GEI
Device Description
The Bipolar Arthroscopic Probe is an electrosurgical device designed to be used in Arthroscopic procedures involving cutting and coagulation of soft body tissue.
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
Joints (wrist, knee, shoulder, ankle, and elbow)
Indicated Patient Age Range
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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 and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jane Johnson Regulatory Affairs & Quality Assurance Manager Electroscope, Incorporated 4828 Sterling Drive Boulder, Colorado 80301
DEC 1 8 1997
Re: K973682
Trade Name: Bipolar Arthroscopic Probe, Straight/Angled, with Suction/ Irrigation Capabilities Regulatory Class: II Product Code: GEI Dated: September 22, 1997 Received: September 26, 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
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Page 2 - Ms. Johnson
not affect any obligation you might have under sections 531 through 542 of the Act for 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.
focall
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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P. 2
Page 1 of 1
510(k) Number (if known): K973682
Device Name:__________________________________________________________________________________________________________________________________________________________________ capabilities.
Indications For Usc:
The Bipolar Arthroscopic Probe is an electrosurgical device designed to be used in Arthroscopic procedures involving cutting and coagulation of soft body tissue. The Bipolar Arthroscopic Probe is indicated for use in patients requiring ine bipolar neurossoppf the joint i.e., wrist, knee, shoulder, ankle, and elbow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sian-Off)
Division of General Restorative Devices K973682
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Forust 1-2-96)