(384 days)
Not Found
No
The device description and intended use clearly define the device as a passive cable/adapter for transmitting electrical current. There is no mention of any computational or analytical functions that would involve AI/ML.
No.
The device is an accessory that transmits high-frequency current from an electrosurgical generator to instruments for cutting and coagulation, but it does not directly perform a therapeutic action itself.
No.
The device is described as an accessory for connecting electrosurgical instruments to a generator for energy transmission during cutting and coagulation, not for diagnostic purposes.
No
The device description explicitly states it is comprised of an insulated cord and fixed instrument and generator connectors, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument." This describes a device used during a surgical procedure on a patient, not for testing samples in vitro (outside the body).
- Device Description: The description reinforces this by explaining its function in conveying electrosurgical energy to instruments used for cutting and coagulation during surgery.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics of an IVD device.
Therefore, the Olsen Medical Electrosurgical Cables/Adapters is a surgical accessory used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Olsen Medical Electrosurgical Cables/Adapters is intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Olsen Medical Electrosurgical Cables/Adapters has been designed as an accessory to various electrosurgical instruments where monopolar/bipolar electrosurgical cutting and coagulation is desired during surgery. Examples of such instruments are; scissors, forceps, dissectors, lap electrodes and handles. The device connects to the high frequency generator on one end and the active instrument on the other end for cutting and coagulation. It is comprised of an insulated cord and a fixed instrument and generator connector on either end as the means of conveying high frequency electrosurgical energy from the generator to the standard electrosurqical instrument during surgery.
The adapter interfaces between the instrument cable and various model of electrosurgical generators to match a proper fit for ESU model output connection.
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
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)
The new device is technologically the same as the predicate device. Device qualification criteria meet or exceeds the minimum qualification criteria for the predicate device and conforms to applicable ASTM and ISO Standards for biocompatibility of materials. All tests will meet the applicable requirements of AAMI/ANSI/IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories. The Olsen Medical Electrosurgical Cables/Adapters provides safe connection by adapting the generator connectors with the recess sockets appropriately and insulating the exposed terminal to prevent unintended high frequency leakage current.
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.
K941908, K942194, K073450, K083528, K982667
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).
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
PAGE 1 OF 2
KI11262
MAY 2 3 2012
510 (k) Summary Olsen Medical Electrosurgical Cables/Adapters
Company Name and Address:
Olsen Medical 3230 Commerce Center Place Louisville, KY 40211 (502) 772-4280 Phone Fax (502) 772-4282
Date: April 19, 2011
Trade Name: Olsen Medical Electrosurgical Cable/Adapters Common Name: Monopolar/Bipolar Electrosurgical Cord and Accessory Classification Name: 21 CFR 878.4400 Electrosurgical Cutting and Coagulation Device and Accesories-Class II
Device Product Code and Panel Code: GEI
Contact Information:
Larry Potts President Olsen Medical 3230 Commerce Center Place Louisville, KY Telephone (502)772-4269 Facsimile (502)772-4282 Email larryp@olsenmedical.com
Device Description:
The Olsen Medical Electrosurgical Cables/Adapters has been designed as an accessory to various electrosurgical instruments where monopolar/bipolar electrosurgical cutting and coagulation is desired during surgery. Examples of such instruments are; scissors, forceps, dissectors, lap electrodes and handles. The device connects to the high frequency generator on one end and the active instrument on the other end for cutting and coagulation. It is comprised of an insulated cord and a fixed instrument and generator connector on either end as the means of conveying high frequency electrosurgical energy from the generator to the standard electrosurqical instrument during surgery.
The adapter interfaces between the instrument cable and various model of electrosurgical generators to match a proper fit for ESU model output connection.
Statement of Substantial Equivalence:
The Olsen Medical Olsen Medical Electrosurgical Cables/Adapters are substantially equivalent to legally marketed devices by Quantum
1
Instruments (K941908, K942194), Sutter Medizintechnik (K073450), Smith and Nephew (K083528) and Richard Wolf Medical Instruments (K982667) based on the device's similarity to the predicated device in intended use. materials, design, and technological characteristics.
Indications for Use:
The Olsen Medical Electrosurgical Cables/Adapters is intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
Technological Characteristic:
The Olsen Medical Electrosurgical Cables/Adapters is similar to Olsen Medical pre-amendment devices like the 900 series monopolar cable and adapters and the 800 series bipolar cables and adapters and are designed to withstand a high frequency voltage of 5,000 volts peak. They share similar indication for use and incorporate similar technological characteristic to most legally marketed electrosurgical devices by Quantum Instruments, Sutter Medizintechnik, Valleylab, Conmed, Kirwan, Bovie, Megadyne, Wolf Instruments, Stryker, Smith and Nephew, Codman, Sutter, Pilling Weck and Erbe.
Device Testing:
The new device is technologically the same as the predicate device. Device qualification criteria meet or exceeds the minimum qualification criteria for the predicate device and conforms to applicable ASTM and ISO Standards for biocompatibility of materials. All tests will meet the applicable requirements of AAMI/ANSI/IEC 60601-2-2:2009 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories. The Olsen Medical Electrosurgical Cables/Adapters provides safe connection by adapting the generator connectors with the recess sockets appropriately and insulating the exposed terminal to prevent unintended high frequency leakage current.
Conclusion:
Based on the evaluation, testing, dimensional information and intended use information provided, the Olsen Medical Electrosurqical Cables/Adapters is substantially equivalent to the predicate devices listed above. Testing demonstrate that these devices are safe, effective and perform as well as the legally marketed devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a bird or abstract human figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Olsen Medical % Nunie Tabermejo 3230 Commerce Center Place Louisville, Kentucky 40211
MAY 2 3 2012
Re: K111262
Trade/Device Name: Olsen Medical Electrosurgical Cables/Adapters Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 30, 2012 Received: May 7, 2012
Dear Nunie Tabermejo:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Nunie Tabermejo
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours;
Mark N. Melkerson
Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
4
Indications for Use
510(k) Number (if known): KIII262
Device Name: Olsen Medical Electrosurgical Cables/Adapters
Indications For Use:
The Olsen Medical Electrosurgical Cables/Adapters are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
1 AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C). (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Surgical, Ofthopedic, and Restorative Devices
510(k) Number K111262