Who is the manufacturer of Titan Manufacturing Bipolar Forceps?

Titan Manufacturing, Inc. filed the 510(k) submission for Titan Manufacturing Bipolar Forceps (K213386).

What is the FDA product code for Titan Manufacturing Bipolar Forceps?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Titan Manufacturing Bipolar Forceps?

510(k) clearance (submission type: Special).

What are the predicate devices for Titan Manufacturing Bipolar Forceps?

Semkin Insulated Bipolar Forcep (K974593); Semkin Bipolar Forcep (K974594); Cushing Bayonet Insulated Bipolar Forcep (K974595).

Who can help prepare an FDA 510(k) submission like Titan Manufacturing Bipolar Forceps?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Titan Manufacturing Bipolar Forceps

K213386 · Titan Manufacturing, Inc. · GEI · Oct 25, 2021 · General, Plastic Surgery

Device Facts

Record ID	K213386
Device Name	Titan Manufacturing Bipolar Forceps
Applicant	Titan Manufacturing, Inc.
Product Code	GEI · General, Plastic Surgery
Decision Date	Oct 25, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic, 3rd-Party Reviewed

Intended Use

Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current.

Device Story

Bipolar forceps; reusable handpiece/active accessory for electrosurgical generator (ESU). Device connects to ESU via bipolar cable and footswitch (not included). Surgeon grasps and manipulates tissue; ESU delivers high-frequency electrical current to coagulate tissue. Used in general surgery; available in various styles (straight, bayonet, etc.), lengths (3.5 to 10.75 inches), and tip sizes (0.2mm to 2.0mm). Constructed of stainless steel or titanium; some models insulated or irrigating. Benefits include precise tissue coagulation and bleeding control. Device is non-sterile; requires cleaning and sterilization before use.

Clinical Evidence

No clinical data. Bench testing only. Testing included biocompatibility (ISO 10993-5, -10, -11, -4, USP Rabbit Pyrogen), electrical safety (IEC 60601-2-2), and performance validation (thermal spread, HiPot, continuity, durability).

Technological Characteristics

Reusable bipolar forceps; stainless steel or titanium construction; Kynar (PVDF) insulation coating; epoxy bonding. Dimensions: 3.5-10.75 inches; tip sizes 0.2-2.0mm. Connectivity: 4mm outlet/U.S. 2-pin plug. Sterilization: Pre-vacuum steam. No software/algorithm.

Indications for Use

Indicated for use in general surgical procedures for grasping, manipulating, and coagulating selected tissue in patients requiring electrosurgical intervention.

Regulatory Classification

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

Semkin Insulated Bipolar Forcep (K974593)
Semkin Bipolar Forcep (K974594)
Cushing Bayonet Insulated Bipolar Forcep (K974595)

Reference Devices

Synergetics Disposable Spetzler Malis Standard Bipolar Forceps (K121426)
Faulhaber Pinzetten OHG Single-Use Non-Stick Bipolar Forceps (K182773)

Related Devices

K083162 — STINGRAY ELECTROSURGICAL FORCEPS · Stingray Surgical Products, Inc. · Jan 12, 2009
K093108 — STRYKER BIPOLAR FORCEPS · Stryker Leibinger GmbH & Co KG · Jun 22, 2010
K123478 — STINGRAY BIPOLAR FORCEPS · Stingray Surgical Products · May 10, 2013
K101080 — NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX · Egon Faulhaber Surgical Instruments Pinzetten · Jun 21, 2010
K131058 — BIPOLAR FORCEPS · Boston Endo-Surgical Technologies, Inc. · Oct 25, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. October 25, 2021 Titan Manufacturing, Inc. % Prithul Bom Regulatory Technology Services, LLC 1000 Westgate Drive Suite #510k Saint Paul, Minnesota 55114 Re: K213386 Trade/Device Name: Titan Manufacturing Bipolar 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 12, 2021 Received: October 13, 2021 Dear Prithul Bom: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdth/cfdocs/cfpmn/pmn.cfm combination product submissions. 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. 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 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. {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Leam (https://www.fda.gov/training-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K213386 Device Name Titan Manufacturing Bipolar Forceps Indications for Use (Describe) Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| |X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Titan Manufacturing Inc. The logo features a stylized Spartan helmet on the left and the company name in bold, black letters on the right. Below the logo is the text "K213386" enclosed in a rectangular box. Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com # 510(k) Summary Device Name: Titan Manufacturing Bipolar Forceps | Submission Sponsor: | Titan Manufacturing, Inc. | | |---------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Contact Person: | Donald Seavey, President | | | Address/Phone#/Email: | Owner Operator: 1 Rapps Run Malvern, PA 19355 610-935-8203 don@titanmfg.com | Manufacturing Site: 818 Jefferson St Fall River, MA 02721 610-935-8203 don@titanmfg.com | | Owner Operator/Manufacturing Site Establishment Registration #s: | 9025545 | 3001452522 | | Submission Correspondent: | WolfKat Regulatory Consulting, LLC. | |---------------------------|-------------------------------------------------| | Contact Person: | Katrina Fiedler, Founder & Principal Consultant | | Address/Phone#/Email: | 44 Oxford Drive | | | East Windsor, NJ 08520 | | | 609-902-6162 | | | katrina@wolfkatreg.com | | Date of Preparation: | October 22, 2021 [REVISED] | |----------------------|----------------------------| |----------------------|----------------------------| | Type of Submission: | Traditional 510(k) Premarket Notification | |---------------------|-------------------------------------------| |---------------------|-------------------------------------------| | Device Identification | | |-------------------------|------------------------------------------------------| | Trade/Proprietary Name: | Titan Manufacturing Bipolar Forceps | | Common Name: | Bipolar Forceps | | Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories | | Regulation Number: | §878.4400 | | Product Code: | GEI | | Review Panel: | General & Plastic Surgery | | Predicate Devices 510(k) # | Product Name | Manufacturer | |-------------------------------|------------------------------------------|---------------------------| | K974593 | Semkin Insulated Bipolar Forcep | Titan Manufacturing, Inc. | | K974594 | Semkin Bipolar Forcep | Titan Manufacturing, Inc. | | K974595 | Cushing Bayonet Insulated Bipolar Forcep | Titan Manufacturing, Inc. | These predicates have not been subject to a design-related recall. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Titan Manufacturing Inc. The logo features a stylized helmet on the left and the company name on the right. Below the logo is the alphanumeric code K213386. Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com | Reference Device 510(k) # | Product Name | Manufacturer | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | K121426 | Synergetics Disposable Spetzler Malis Standard Bipolar Forceps | Synergetics | | K182773 | Faulhaber Pinzetten OHG Single-Use Non-Stick Bipolar Forceps sterile/non-sterile; Faulhaber Pinzetten OHG Single-Use Bipolar Irrigating forceps sterile/non-sterile | Faulhaber Pinzetten OHG | ### Indications For Use Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current. ### Device Description Titan Manufacturing Bipolar Forcep is a generic electrosurgical device (handpiece)/active accessory that is to be connected through a bipolar cable with the bipolar output of a standard, general electrosurgical generator unit (ESU) and footswitch. The bipolar cable, ESU and footswitch are not part of the subject device, therefore not included in this submission. The subject device is not an electrosurgical vessel sealer system. Titan Manufacturing Bipolar Forceps are indicated for use in general surgical procedures; designed to grasp, manipulate, and coagulate selected tissue. Titan Manufacturing Bipolar Forceps are to be connected through a suitable bipolar cable [not supplied by Titan Manufacturing, Inc.] with the bipolar output of a standard, general electrosurgical generator [not supplied by Titan Manufacturing, Inc.]. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch [not supplied by Titan Manufacturing, Inc.]. Titan Manufacturing, Inc., offers an extensive line of precision crafted reusable stainless steel and titanium bipolar forceps in a multitude of handle styles, lengths, and tip sizes. Titan Manufacturing Bipolar Forceps are available in styles such as but not limited to straight and bayonet styles, patterned designs such as but not limited to Semkin, Jewelers, Adson, Scoville-Greenwood, Ti Square Grip, Yargasil, Tenzel, McPherson, and Cozean, etc. Titan Manufacturing offers bipolar forceps in lengths from approximately 3 ½ inches to 10 ¾ inches ; titanium or stainless steel; insulated or non-insulated; irrigating or non-irrigating; straight, curved, angled or coaptation; and varying tip sizes from 0.2mm to 2.0mm. The product line is similar to those offered by other wellestablished bipolar forcep manufacturers [e.g., Codman, Kirwin, Faulhaber Pinzetten, Synergetics (a.k.a. Stryker), etc.]. Titan Manufacturing Bipolar Forceps are reusable medical devices, provided non-sterile and must be cleaned and sterilized prior to use. They are used with the bipolar output for standard, general electrosurgical generators (ESU). The Titan Manufacturing Bipolar Forceps are compatible with {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Titan Manufacturing Inc. The logo includes a stylized gray helmet on the left and the company name in black on the right. Below the company name, there is a box with the text "K213386" inside. Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com general electrosurgical generators with 4mm outlets; U.S. 2-pin plugs. Bipolar cables, ESU and footswitch are not part of the subject device. Titan Manufacturing Bipolar Forceps are available in four (4) general model types in stainless steel or titanium: Non-insulated; Insulated; Non-insulated/Irrigating; and Insulated/Irrigating. | Comparison [Subject Device vs. Predicate Devices] | | | | | Same or Different | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | | Subject Device | Predicate Device | Predicate Device | Predicate Device | | | 510(k) Number | K213386 | K974593 | K974594 | K974595 | -- | | Product Name | Titan Manufacturing Bipolar Forceps | Semkin Insulated Bipolar Forcep | Semkin Bipolar Forcep | Cushing Bayonet, Insulated Bipolar Forcep | -- | | Manufacturer | Titan Manufacturing, Inc. | Titan Manufacturing, Inc. | Titan Manufacturing, Inc. | Titan Manufacturing, Inc. | SAME | | Classification | Class II | Class II | Class II | Class II | SAME | | Subsequent Product Code | GEI | GEI | GEI | GEI | SAME | | Regulation | 878.4400 | 878.4400 | 878.4400 | 878.4400 | SAME | | Rx or OTC | Rx | Rx | Rx | Rx | SAME | | Intended Use | Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current. | Semkin Insulated Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current. | Semkin Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current. | Cushing Bayonet, Insulated Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current. | SAME | | Principles of Operation | Bipolar forceps are designed to grasp, manipulate, and coagulate selected tissue. They are to be connected through a bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit (ESU) and activated by a footswitch. | Bipolar forceps are designed to grasp, manipulate, and coagulate selected tissue. They are to be connected through a bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit (ESU) and activated by a footswitch. | Bipolar forceps are designed to grasp, manipulate, and coagulate selected tissue. They are to be connected through a bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit (ESU) and activated by a footswitch. | Bipolar forceps are designed to grasp, manipulate, and coagulate selected tissue. They are to be connected through a bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit (ESU) and activated by a footswitch. | SAME | | | Bipolar cables, ESU and footswitch are not part of the subject device. | Bipolar cables, ESU and footswitch are not part of the subject device. | Bipolar cables, ESU and footswitch are not part of the subject device. | Bipolar cables, ESU and footswitch are not part of the subject device. | | | Electrode Type | Bipolar | Bipolar | Bipolar | Bipolar | SAME | | Physical Dimensions Available | 3 ½ inches to 10 ¾ inches in length | 3 ½ inches to 10 ¾ inches in length | 3 ½ inches to 10 ¾ inches in length | 3 ½ inches to 10 ¾ inches in length | SAME | | Tip Sizes Available | 0.2mm to 2.0mm | 0.2mm to 2.0mm | 0.2mm to 2.0mm | 0.2mm to 2.0mm | SAME | ### Substantial Equivalence Discussion Comparison [Subiect Device vs. Predicate Devices] {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains a logo for Titan Manufacturing Inc. The logo features a stylized Spartan helmet on the left and the company name on the right. Below the logo is the alphanumeric code K213386. Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com # Substantial Equivalence Discussion Comparison [Subject Device vs. Predicate Devices] (cont'd) | | Subject Device | Predicate Device | Predicate Device | Predicate Device | Same or Different | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | | Materials | Stainless Steel or Titanium | Stainless Steel or Titanium | Stainless Steel or Titanium | Stainless Steel or Titanium | | | | Epoxy | Epoxy | Epoxy | Epoxy | | | Kynar Insulation Coating [Polyvinylidene Fluoride (PVDF)] | Kynar Insulation Coating [Polyvinylidene Fluoride (PVDF)] | Kynar Insulation Coating [Polyvinylidene Fluoride (PVDF)] | Kynar Insulation Coating [Polyvinylidene Fluoride (PVDF)] | | | Visual Appearance Insulated Bipolar Forceps | Lighter, semi-gloss, blue-colored insulating coating material | Dark, matte, blue- colored insulating coating material | Dark, matte, blue- colored insulating coating material | Dark, matte, blue-colored insulating coating material | SIMILAR - blue colorant, Kynar | | Sterilization Recommendations | Pre-Vacuum Steam | Pre-Vacuum Steam | Pre-Vacuum Steam | Pre-Vacuum Steam | SAME | | Re-usable | YES | YES | YES | YES | SAME | | Packaging | Bipolar forcep in a propionate clear hard plastic tube with foam insets at both ends packaged in an instrument sturdy box with packaging material to protect the instrument (bipolar forcep) | Bipolar forcep in a propionate clear hard plastic tube with foam insets at both ends packaged in an instrument sturdy box with packaging material to protect the instrument (bipolar forcep) | Bipolar forcep in a propionate clear hard plastic tube with foam insets at both ends packaged in an instrument sturdy box with packaging material to protect the instrument (bipolar forcep) | Bipolar forcep in a propionate clear hard plastic tube with foam insets at both ends packaged in an instrument sturdy box with packaging material to protect the instrument (bipolar forcep) | SAME | | Biocompatible | YES | YES | YES | YES | SAME | | Drop Test Cable Connector Type | YES Compatible with U.S. 2-pin round plugs | YES Compatible with U.S. 2-pin round plugs | YES Compatible with U.S. 2-pin round plugs | YES Compatible with U.S. 2- pin round plugs | SAME SAME | | Electrical Safety Features | HiPot & Continuity Test Dielectric strength insulation; insulated safety plug; Compatible with general electrosurgical generators with 4mm outlets | HiPot & Continuity Test Dielectric strength insulation; insulated safety plug: Compatible with general electrosurgical generators with 4mm outlets | HiPot & Continuity Test Dielectric strength insulation; insulated safety plug; Compatible with general electrosurgical generators with 4mm outlets | HiPot & Continuity Test Dielectric strength insulation; insulated safety plug; Compatible with general electrosurgical generators with 4mm outlets | SAME | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Titan Manufacturing Inc. The logo features a stylized helmet on the left, followed by the word "Titan" in a bold, sans-serif font with a green dot above the "i". Below "Titan" is the text "Manufacturing Inc." in a smaller font. There is also a box with the text "K212286". K213386 Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com # Comparison [Subject Device vs. Reference Devices] | | Subject Device | Reference Device #1 | Reference Device #2 | Same or Different | |----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K213386 | K121426 | K182773 | ------------------------- | | Product Name | Titan Manufacturing Bipolar Forceps | Synergetics Disposable Spetzler Malis Standard Bipolar Forceps | Faulhaber Pinzetten OHG Single- Use Non-Stick Bipolar Forceps sterile/non-sterile; Faulhaber Pinzetten OHG Single- Use Bipolar Irrigating forceps sterile/non-sterile | ------------------------- | | Manufacturer | Titan Manufacturing, Inc. | Synergetics | Faulhaber Pinzetten OHG | ------------------------- | | Classification | Class II | Class II | Class II | SAME | | Product Code | GEI | GEI | GEI | SAME | | Regulation | 878.4400 | 878.4400 | 878.4400 | SAME | | Rx or OTC | Rx | Rx | Rx | SAME | | Intended Use | Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current. | The Synergetics Disposable Spetzler-Malis Standard Bipolar Forceps are single use device sold sterile and are intended for use in electrosurgery for coagulation of tissue. | Faulhaber Single Use Non-Stick Bipolar Forceps sterile/non-sterile and Single-Use Non-Stick Bipolar Irrigating Forceps sterile/non-sterile are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general surgery. The bipolar forceps are used with the bipolar output for standard electrosurgical generators. The products are intended for single use and are provided sterile as well as non-sterile. Products supplied non-sterile must be cleaned, disinfected, and sterilized prior to their use by validated cleaning, disinfection, and sterilization process. The bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended are: -General surgery -Laryngeal coagulation -Orthopedic coagulation -Thoracic coagulation -Neurosurgical coagulation Gynecological coagulation (except for use in sterilization) -Urological coagulation -Ear, Noe, Throat coagulation. | SIMILAR – Intended use for subject device is general; Subject device is reusable and provided non-sterile. | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Titan Manufacturing Inc. The logo features a stylized helmet on the left and the company name on the right. Below the logo is the text "K213386" in a box. Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com # Comparison [Subject Device vs. Reference Devices] (cont'd) | | Subject Device | Reference Device #1 | Reference Device #2 | Same or Different | |----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Principles of Operation | Bipolar forceps are designed to grasp. manipulate, and coagulate selected tissue. They are to be connected through a bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit (ESU) and activated by a footswitch. Bipolar cables, ESU and footswitch are not part of the subject device. | Bipolar forceps are designed to grasp, manipulate, and coagulate selected tissue. They are to be connected through a bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit (ESU) and activated by a footswitch. Bipolar cables, ESU and footswitch are required for operation, but not provided. | Bipolar forceps are designed to grasp, manipulate, and coagulate selected tissue. They are to be connected through a bipolar cable with the bipolar output of an electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit (ESU) and activated by a footswitch. Bipolar cables, ESU and footswitch are required for operation, but not provided. | SAME | | Electrode Type | Bipolar | Bipolar | Bipolar | SAME | | Materials | Stainless Steel or Titanium Epoxy Kynar® Insulation Coating [Polyvinylidene Fluoride PVDF)] | Stainless Steel or Titanium Epoxy Insulation Coating [Polyvinylidene Fluoride (PVDF)] | Stainless Steel Epoxy Insulation Coating [Rilsan (Nylon)] | SIMILAR - Brand of PVDF not known for 1st cited reference device; Similar insulation coating material for 2nd cited reference device | | Biocompatible | YES | YES | YES | SAME | | Cable Connector Type | Compatible with U.S. 2-pin round plugs | Compatible with U.S. 2-pin round plugs | Compatible with U.S. 2-pin round plugs | SAME…