(269 days)
Not Found
No
The device description and testing focus on the electrosurgical function and electrical safety standards, with no mention of AI or ML.
No.
The device is an electrosurgical instrument used for cutting and coagulation during surgery, which are active interventions rather than therapeutic treatments in themselves.
No
Explanation: The device is described as an electrosurgical tool for cutting and coagulating tissue during surgery, which are therapeutic actions, not diagnostic ones. It does not mention any function for identifying or characterizing diseases or conditions.
No
The device description explicitly states it is a physical instrument made of stainless steel (forceps) that connects to an electrosurgical generator via a cable. It is a hardware device used for cutting and coagulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrosurgical cutting and coagulation... during surgery" and to "grasp, manipulate cut or coagulate selected soft tissue." This describes a surgical instrument used directly on a patient's tissue.
- Device Description: The description details a surgical instrument that connects to an electrosurgical generator to perform cutting and coagulation.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is therapeutic (cutting and coagulating tissue) rather than diagnostic.
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 does not fit that description.
N/A
Intended Use / Indications for Use
The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
OLSEN Medical® Electrosurgical Monopolar and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate, cut or coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (bipolar or monopolar) to the specified output terminal of an electrosurgical generator. The bipolar forceps are intended for use with a maximum voltage of 500 volts while the monopolar forceps have a maximum voltage of 2000 volts. The forceps are offered either as single (disposable) or multiple-use (reuseable).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
selected soft tissue
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 following testing was conducted with successful outcome to establish device safety and equivalence:
- IEC 60601-2-2 Medical Electrical Equipment/Part 2-2: Particular . Requirements for Safety of High Frequency Surgical Equipment
- . ANSI/AAMI/ISO 11137-2:2006: Sterilization of Health Care Products -Radiation - Part 2: Establishing the sterilization dose
- ISO 10993: Biological evaluation of medical devices Part 5: Tests for in . vitro cytotoxicity
- ANSI/AAMI HF18-1993 American National Standard for Electrosurgical . Devices
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.
K884656, K982705, K093108, K950877
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 3
510(k) Premarket Notification Olsen Medical Bipolar and Monopolar Forceps
510(k) Summary Pursuant to 21 CFR 807.92
General Company Information
| Company Name: | Olsen Medical® |
|---|---|
| Company Address: | 3230 Commerce Center Place |
| Louisville, Kentucky 40211 | |
| Company Telephone: | (502) 772-4280 |
| Contact: | Dalene T. Binkley |
| Contact Address: | 1927 N. Arthur Drive |
| Columbia City, Indiana 46725 | |
| (260) 244-4189 | |
| Date: | October 7, 2013 |
| DEC 0 6 2013 | |
| Device Trade Name: | Olsen Medical Bipolar and Monopolar Forceps |
| (Single and Multiple-Use) | |
| Common Name: | Single Use Bipolar and Monopolar Forceps; |
| Multiple-Use Bipolar and Monopolar Forceps | |
| Classification Name | |
| and Reference: | GEI – 878.4400, Electrosurgical cutting and |
| coagulation device and accessories | |
| Predicate Device: | Bipolar Forceps: |
| Dermacare (now Olsen Medical) Disposable | |
| Bipolar Cord and Bipolar Forcep, K884656, | |
| cleared November 25, 1988 | |
| Olsen Medical Midas Touch Bipolar Forceps, | |
| K982705, cleared September 8, 1998 | |
| Stryker Bipolar Forceps, K093108, cleared June | |
| 22, 2010 |
1
510(k) Premarket Notification Olsen Medical Bipolar and Monopolar Forceps
Page 2 of 3
Monopolar Forceps:
Boston Surgical Products Reusable Monopolar Forceps, K950877, cleared March 9, 1995
Device Description:
OLSEN Medical® Electrosurgical Monopolar and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate, cut or coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (bipolar or monopolar) to the specified output terminal of an electrosurgical generator. The bipolar forceps are intended for use with a maximum voltage of 500 volts while the monopolar forceps have a maximum voltage of 2000 volts. The forceps are offered either as single (disposable) or multiple-use (reuseable).
Intended Use:
The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue.
Comparison to Predicate Device:
The proposed Olsen Bipolar and Monopolar Forceps is similar in design as its predicates. The Olsen Forceps are sterilized using equivalent materials and processes as its predicates. The subject devices also have the same intended use and performance characteristics as their predicates. No new technological characteristics were introduced and as such, the proposed forceps do not raise new types of safety and effectiveness issues as compared to the predicates.
Testing and Technological Characteristics:
The Olsen Medical Bipolar and Monopolar Forceps are active electrosurgical devices that provide an electrical current that is fired through the tips of the forceps. The devices are hand-held and provided sterile for the single use forceps and non-sterile for the multiple use forceps. The forceps connect to a corresponding power cord (bipolar or monopolar).
2
510(k) Premarket Notification Olsen Medical Bipolar and Monopolar Forceps
The following testing was conducted with successful outcome to establish device safety and equivalence:
- IEC 60601-2-2 Medical Electrical Equipment/Part 2-2: Particular . Requirements for Safety of High Frequency Surgical Equipment
- . ANSI/AAMI/ISO 11137-2:2006: Sterilization of Health Care Products -Radiation - Part 2: Establishing the sterilization dose
- ISO 10993: Biological evaluation of medical devices Part 5: Tests for in . vitro cytotoxicity
- ANSI/AAMI HF18-1993 American National Standard for Electrosurgical . Devices
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Olsen Medical % Ms. Dalene T. Binkley FDC Services, LLC 1927 N. Arthur Drive Columbia City, Indiana 46725
December 6, 2013
Re: K130669
Trade/Device Name: Olsen Medical® Bipolar and Monopolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 7, 2013 Received: October 11, 2013
Dear Ms. Binkley:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nove 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 10 use sured in the enorse. 976, 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). and Cosinction room in the device, subject to the general controls provisions of the Act. The r ou may, merelory, manss of the Act include requirements for annual registration, listing of general ookies provision practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. 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 It may be subject to additions, 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 r lease of advised that I Dr 3 lesaants or our device complies with other requirements of the Act that I DA has Indo a dolorimians administered by other Federal agencies. You must or any I collares and regulances and regulations but not limited to: registration and listing (21 Comply will an the Fee 316quirements (1); medical device reporting (reporting of medical CrK Fall 807), labeling (21 OFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Dalene T. Binkley
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
ктзоева
510(k) Number (if Known):
Device Name: Device Name: Olsen Medical® Bipolar and Monopolar Forceps
Indications For Use: The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue.
Prescription Use: _ X
OR Over-The-Counter Use: (Part 21 CFR 807.109)
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-off) Division of Surgical Devices 510(k) Number: K130669 17