(38 days)
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No
The device description focuses on standard electrosurgical generator technology (RF signals, power MOSFETs, different output modes) and does not mention any AI/ML components or functionalities. The performance studies are based on meeting industry standards, not AI/ML performance metrics.
No
The device is an electrosurgical generator that supplies RF signals to handpieces for electrosurgical procedures, such as cutting and coagulation of soft tissues. While these procedures are part of medical treatment, the device itself is a tool used in a medical procedure, not a therapeutic device that directly treats a condition or restores health through its own mechanism of action. It generates energy, which is then applied by a separate handpiece to perform a surgical action.
No
The O.R. Pro 300 Electrosurgical Generator is used for surgical procedures (cutting and coagulation of soft tissues) by supplying RF signals to electrosurgical handpieces, not for diagnosing conditions.
No
The device description clearly outlines hardware components such as a solid state generator, RF amplifier, power MOSFETs, and input/output jacks, indicating it is a physical medical device, not software-only.
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 used to supply RF signals to electrosurgical handpieces for use on "soft tissues." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a generator that produces RF energy for surgical cutting and coagulation. This aligns with the function of an electrosurgical device used in surgery, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
Therefore, the O. R. Pro 300™ Electrosurgical Generator is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The O. R. Pro 300™ Electrosurgical Generator is a general purpose solid state generator used to supply the RF signals to electrosurgical handpieces used on soft tissues where a wide range of tissue types, patient conditions and load impedances are encountered.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The OR Pro 300™ is a full powered electrosurgical generator with separate monopolar and bipolar sections. The monopolar section is designed for cutting and coagulation outputs, is intended for use with a patient return electrode, and is a floating, isolated output. The bipolar section incorporates a separate output from the monopolar output and has independently controlled power. The Bipolar section is a floating isolated output and is intended to be used with bipolar instruments.
AC power mains is applied to the generator from a detachable line cord. This power mains voltage is converted to a DC voltage and applied to a single RF amplifier. An RF amplifier utilizes power MOSFETs to convert the DC voltage into a RF energy that is suitable for electrosurgical procedures. The generator is activated by either handswitching or footswitching active accessories. Three different types of CUTTING, Pure, Blend 1 and Blend 2, can be selected by the push buttons on the front panel. Two different types of COAG, Pinpoint and Spray, can also be selected on the front panel. In addition, BIPOLAR COAG is provided through the bipolar output jacks.
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 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
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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)
The O.R.Pro has been tested to all applicable requirements of AAMI HF18-R-10/93 - American National Standard for Electrosurgical Devices. The O.R.Pro300 met all the applicable requirements of the Standard. The requirements of the Standard that were not applied to the O.R. Pro were those associated with the electrosurgical pencil and return pad. These devices were cleared for marketing by separate submissions listed under Accessories.
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.
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.
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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
JUN 22 1998
SAFETY AND EFFECTIVENESS SUMMARY Medtrex O.R.Pro 300™ Electrosurgical Generator
Name and address of Device Manufacturer submitting 510(k) Notification:
Medtrex Incorporated 14 Inverness Drive East, Building B, Suites 116-120 Englewood, Colorado 80112
Regulatory Correspondent of Device Manufacturer:
William J. Bowers Medtrex Incorporated 14 Inverness Drive East Building B Suites 116-120 Englewood. Colorado 80112 Phone: (303)790-2032 FAX: (303)790-0302
Date Summary was prepared:
May 11, 1998
Name of the device:
Classification:
Indications for Use:
Description of the device:
O.R.Pro 300™ Electrosurgical Generator
Electrosurgical cutting and coagulation device and accessories. Class II per 21CFR 878.4400
The O. R. Pro 300™ Electrosurgical Generator is a general purpose solid state generator used to supply the RF signals to electrosurgical handpieces used on soft tissues where a wide range of tissue types, patient conditions and load impedances are encountered.
The OR Pro 300™ is a full powered electrosurgical generator with separate monopolar and bipolar sections. The monopolar section is designed for cutting and coagulation outputs, is intended for use with a patient return electrode, and is a floating, isolated output. The bipolar section incorporates a separate output from the monopolar output and has independently controlled power. The Bipolar section
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is a floating isolated output and is intended to be used with bipolar instruments.
AC power mains is applied to the generator from a detachable line cord. This power mains voltage is converted to a DC voltage and applied to a single RF amplifier. An RF amplifier utilizes power MOSFETs to convert the DC voltage into a RF energy that is suitable for electrosurgical procedures. The generator is activated by either handswitching or footswitching active accessories. Three different types of CUTTING, Pure, Blend 1 and Blend 2, can be selected by the push buttons on the front panel. Two different types of COAG, Pinpoint and Spray, can also be selected on the front panel. In addition, BIPOLAR COAG is provided through the bipolar output jacks.
The Medtrex O.R. Pro 300 Electrosurgical Generator is substantially equivalent to the following two legally marketed electrosurgical generators:
Valley Laboratories Inc. Boulder, Colorado 80301 Force FX™ Electrosurgical Generator 510(k) K944602, cleared 6/5/95
Aspen Surgical Systems Div of ConMed /Corporation 311 Broad Street Utica, NY 13501 ExcaliburPlus Electrosurgical Generator 510(k) K953007 Cleared 8/21/95
The O.R.Pro has been tested to all applicable requirements of AAMI HF18-R-10/93 - American National Standard for Electrosurgical Devices. The O.R.Pro300 met all the applicable requirements of the Standard. The requirements of the Standard that were not applied to the O.R. Pro were those associated with the electrosurgical pencil and return pad. These devices were cleared for marketing by separate submissions listed under Accessories.
Substantial Equivalence:
Safety and Efficacy:
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an emblem of an eagle with three stylized lines representing its wings. The text "DEPARTMENT OF HEALTH & HUM. SERVICES - USA" is arranged around the emblem in a circular fashion. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 1998
Medtrex Incorporated c/o Mr. William E. McKay President RCMDI 9712 South Altamont Drive Sandy, Utah 84092
Re: K981724 O.R. Pro 300™ Electrosurgical Generator Trade Name: Regulatory Class: II Product Code: GEI Dated: May 13, 1998 Received: May 15, 1998
Dear Mr. McKay:
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, Druq, 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 aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. William E. McKay
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,
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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510(k) Number (if known): Not-yet-assigned
Device Name: _ O. R. Pro 300™ Electrosurgical Generator
Indications For Use:
The O. R. Pro 300™ Electrosurgical Generator is a general purpose solid state generator used to supply the RF signals to electrosurgical handpieces used on soft 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 if Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Division of General Restorative Devic 510(k) Number