← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K052702 # MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY (K052702) _Misonix, Inc. · GEI · Nov 21, 2005 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K052702 ## Device Facts - **Applicant:** Misonix, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Nov 21, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is indicated for use in bipolar procedures to grasp, manipulate, coagulate and/or transect tissues in the following specialities: Neurosurgery Plastic and Reconstructive Surgery General Surgery ## Device Story Passive electrosurgical accessory; tweezer-like design; metal electrodes (stainless steel or titanium) with titanium oxide coating to minimize tissue adhesion; nylon-insulated prongs; connects to standard bipolar electrosurgical generator. Used in OR by surgeons; provides mechanical spring action for grasping/manipulating tissue; delivers RF energy for coagulation/transection. Device does not alter generator output; provides safety via insulation. Benefits include reduced tissue adhesion and precise tissue management during surgery. ## Clinical Evidence Bench testing only. Included life tests, EMI/dielectric tests, patient leakage current measurements, and RF cautery output power tests. In vitro testing performed on animal tissue to evaluate bipolar effect and clinician feedback. ## Technological Characteristics Passive electrosurgical accessory; stainless steel or titanium electrodes; titanium oxide coating; nylon insulation; mechanical spring-action plastic assembly. Connects to standard bipolar electrosurgical generators. Complies with UL 2601-1, EN 60601-1, EN 60601-1-2, EN 60601-2-2, and FCC Part 18. ## Regulatory 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. ## Predicate Devices - Boston Surgical Products Inc. Disposable Bipolar Coagulating Forceps ([K942710](/device/K942710.md)) - Olsen Electrosurgical Inc. Teflon Coated Electrodes for Electrosurgical Handles ([K913108](/device/K913108.md)) - Guenter Bissinger Medizintechnik GmbH Claris Non Stick Bipolar Forceps ([K051429](/device/K051429.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K 052702 Page 1 of (4) # 510(k) SUMMARY - Misonix Inc. FS-1000-RF Bipolar Forceps Exhibit E Accessory This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92. #### 1. Submitter's Identification | Submitter's Name: | MISONIX INCORPORATED | |-------------------|-----------------------------------------| | Address: | 1938 New Highway, Farmingdale, NY 11735 | | Telephone Number: | 516-694-9555 | | Contact Person: | Ronald R. Manna | | Date Prepared: | August 22, 2005 | ### 2. Name of Device 一 | Proprietary Name: | Misonix Inc. FS-1000-RF Bipolar Forceps
Accessory | |--------------------|-------------------------------------------------------------------| | Common/Usual Name: | Electrosurgical cutting and coagulation
device and accessories | | Product Code: | GEI | | Classification: | Class II | ## 3. Predicate Device Information 4 | Predicate Devices | Boston Surgical Products Inc. Disposable Bipolar
Coagulating Forceps K942710
Olsen Electrosurgical Inc. Teflon Coated Electrodes
for Electrosurgical Handles K913108
Guenter Bissinger Medizintechnik GmbH Claris
Non Stick Bipolar Forceps K051429 | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Description | Metal and plastic construction that approximates a
tweezer assembly. Includes provision for
connection to the output of a standard bipolar
electrosurgical generator. Also includes provision
for mechanical attachment to an ultrasonic surgical | {1}------------------------------------------------ 052702 Page 2 of (4) aspirator. There is no energy interaction between the ultrasound unit and the electrosurgery unit. 5. Intended Use: The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is indicated for use in bipolar procedures to grasp, mampulate, coagulate and/or transect tissues in the following specialities: Neurosurgery Plastic and Reconstructive Surgery General Surgery #### 6. Comparison to Predicate Device FS-1000-RF Bipolar Forceps Accessory is similar in design, material and operating parameters to the Boston Surgical Products Inc. Disposable Bipolar Coaculpting Forceps, the Olsen Electrosurgical Inc. Teflon Coated Electrodes for Electrasurgical Handles and the Guenter Bissinger Medizintechnik GmbH Claris Non Stick Birgolar Forceps. All devices utilize two electrodes made of metal material, usually stainless steel or titanium. A coating of titanium oxide is used on the Misonix FS-1000-RF focce or accessory to minimize tissue adhesion. Predicates use other coatings such as Teflon to accomplish the same effect. The prongs of the forceps are held together at the proximal end by plastic assemblies which both provide a spring action to either hold the forceps open or closed without. operator intervention. Nylon coatings insulate the prongs so that the operator is not touching the RF energized metal, providing a measure of safety. # 7 Safety and Performance Data The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory have been designed and tested to pass the following Voluntary Standards: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . {2}------------------------------------------------ $$ \ltimes \circlearrowright \ltimes \ltimes \ltimes$$ Page 3 of (4) UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1-2:2001 Electromagnetic Compatibility EN 60601-2-2 Medical Electrical Equipment, Part 2: Particular Requirements for the safety of high frequency surgical equipment FCC Part 18 EMC Requirements - This device does not contain software. 7. Software Validation - 8. Sterilization Validations Validation statements are contained in Exhibit J. - Non-Clinical Tests Performed for Determination of Substantial Equivalence の are as follows: Note: Forceps are passive devices. Testing was done while attached to standard electrosurgical generator. Testing confirmed that forceps did not alter expected output characteristics of any generator tested. > Life Tests Input Power Measurements EMI Tests Dielectric Tests on Mains Circuits Patient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits RF Cautery Life Tests Dielectric Tests with RF Cautery Unit Attached RF Cautery Unit Ouput Power Tests Temperature testing with tips closed for prolonged period of time #### In Vitro Tests Performed 9. Testing of bipolar effect on animal tissue (bench top) Temperature testing of forceps during prolonged bench testing Surgeon assisted trial on animal tissue (bench top) for clinician feedback #### 10. Conclusions Based upon a review of the published literature and its internal testing. Misonix Inc. can state that the use of the FS-1000-RF Bipolar Forceps Accessory for grasping, manipulating, coagulation and transecting tissue is safe and efficacious. We can also state that the FS-1000-RF Bipolar Forceps Accessory is substantially equivalent in this regard to the Boston Surgical Products Inc. Disposable Bipolar Coagulating Forceps, the Olsen Electrosurgical {3}------------------------------------------------ KOS2702 Page 4 of (4) 科 Inc. Teflon Coated Electrodes for Electrosurgical Handles and the Guenter Bissinger Medizintechnik GmbH Claris Non Stick Bipolar Forceps. Based upon the engineering and in vitro testing experiences outlined herein, the device poses no new issues of safety or efficacy for coagulating and transecting tissue. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ and the controlled on the commend and commend of the comments of the comments of the comments of the comments of {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. NOV 2 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ronald R. Manna Vice President Regulatory Affairs Misonix, Inc. 1938 New Highway Farmingdale, New York 11735 Re: K052702 Trade/Device Name: Misonix Inc. FS-1000-RF Bipolar Forceps Accessory Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 23, 2005 Received: September 28, 2005 Dear Mr. Manna: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set 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. {5}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Barbara Buckins Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ 510(k) Number (if known): _KQ52 702 Device Name: Misonix Inc. FS-1000-RF Bipolar Forceps Accessory Indications for Use: The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is indicated for use in bipolar procedures to grasp, manipulate, coagulate and/or transect tissues in the following specialities: Neurosurgery Plastic and Reconstructive Surgery General Surgery Prescription Use ズ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Louare buchns (Division Sign-Off) Division of General, Restorative, and Neurological Devices Page 1 of 1 **510(k) Number** K052702 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K052702](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K052702) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com