(69 days)
K94586, K964736
Not Found
No
The summary describes a standard electrosurgery generator with different power modes and does not mention any AI/ML terms or functionalities.
Yes
The device is described as an electrosurgery generator, which creates an RF signal for electrosurgical handpieces used on soft body tissues. Electrosurgery is a medical procedure, indicating a therapeutic application.
No
Explanation: The device is described as an electrosurgery generator that supplies an RF signal to handpieces for surgical procedures (cutting and coagulation). It does not mention any function for diagnosing conditions or processing medical data for diagnostic purposes.
No
The device description clearly states it is a "solid state generator" and describes hardware components like "monopolar electrosurgery generator" and "bipolar electrosurgery generator" with specific power outputs. This indicates a physical hardware device, not software only.
Based on the provided information, the Bergen Model 500 Generator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to supply an RF signal to electrosurgical handpieces for use on soft body tissues. This is a therapeutic/surgical application, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details an electrosurgery generator, which is a device used for cutting and coagulating tissue during surgery. This is a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Bergen Model 500 Generator's function is to perform surgical procedures.
N/A
Intended Use / Indications for Use
The Bergen Model 500 Generator is a general purpose solid state generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
Product codes
GEI
Device Description
An isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator. The monopolar generator has continuously adjustable 0-150 watts in three cut modes of cut, blend 2 and two coagulation modes 0-75 watts. The bipolar generator is continuously adjustable 0-50. Outputs of both generators are independently controlled and RF isolated from each other.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft body tissues
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): 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.
K94586, K964736
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
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.
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U.S. Food and Drug Administration 510K Document Mail Center HFZ-401 Center for Medical Devices 1390 Piccard Drive Rockville, Maryland 20850
AUG 27 199
To: Document Control Clerk
This summary of 510K safety and effectiveness for the Bergen Model 500 electrosurgery generator is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
An isolated output monopolar electrosurgery generator with independent bipolar electrosurgery generator. The monopolar generator has continuously adjustable 0-150 watts in three cut modes of cut, blend 2 and two coagulation modes 0-75 watts. The bipolar generator is continuously adjustable 0-50. Outputs of both generators are independently controlled and RF isolated from each other.
The monopolar electrosurgery generator is similar to the Bergen Model 710 K94586 I but without displays and calibrated to higher power levels. The bipolar generator is similar to the Bergen Model 610 K964736 but without digital power setting display and current monitor.
Each generator handswitch system is powered by independent low voltage (7 Vdc) isolated power supplies.
Audio and Visual monitors are in accord with IEC 601-1-2 and ANSI HF-18 guidelines.
Date
RF and Low Frequency leakages are well within IEC 601-1-2 and ANSI HF-18 safety guide lines for isolated (body floating) bipolar coagulators.
This device is similar to existing approved devices each as independent generators and in combination.
Sincerely,
Rogs Costen
Roger Oosten President Bergen Mfg. 9345 Rookery Road New Port Richey, Florida 34654
6/12/97
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AUG 27 1997
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Roger Oosten President Bergen Manufacturing ........ 9345 Rookery Road New Port Richey, Florida 34654
Re: K972299 Trade Name: Bergen Model 500 Electrosurgery Generator Regulatory Class: II Product Code: GEI Dated: June 12, 1997 Received: June 19, 1997
Dear Mr. Oosten:
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 (OS) 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 - Mr. Roger Oosten
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,
tosedalz
ia M. Witten, Ph.D., M.D. Ce Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K972299
Device Name: BERGEN MODEL, 500 ELECTROSURGERY GENERATOR
Indications for use: REVISED 7/30/97
The Bergen Model 500 Generator is a general purpose solid state generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tccello
of General Restorative D 510(k) Numbe
Prescription Use
(Per 21 CFR 801.109)
業
OR
Over The Counter Use
(Optional Format 1-2-96)
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