(12 days)
Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current.
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 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.
This document describes the premarket notification (510(k)) for the Titan Manufacturing Bipolar Forceps. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than proving novel safety or effectiveness claims through extensive clinical trials. Therefore, the acceptance criteria and study proving the device meets them will be based on non-clinical performance testing and comparison to legally marketed predicate devices.
Here's an breakdown of the information provided in the format you requested:
Acceptance Criteria and Device Performance for Titan Manufacturing Bipolar Forceps
The acceptance criteria for the Titan Manufacturing Bipolar Forceps were primarily based on demonstrating substantial equivalence to existing predicate devices (Titan Manufacturing's own Semkin Insulated Bipolar Forcep (K974593), Semkin Bipolar Forcep (K974594), and Cushing Bayonet Insulated Bipolar Forcep (K974595)) and meeting recognized standards for electrosurgical devices.
1. Table of Acceptance Criteria and Reported Device Performance
Note: Since this is a 510(k) submission for substantial equivalence based on non-clinical testing, the performance metrics are primarily functional, material, and electrical safety comparisons rather than large-scale clinical endpoints. The acceptance criteria are implicit in the comparison to the predicate devices and adherence to the listed standards.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (Titan Manufacturing Bipolar Forceps) | Reference/Justification |
|---|---|---|---|
| Intended Use | Intended to remove tissue and control bleeding by use of high frequency electrical current. | Same as predicate devices. | "Titan Manufacturing Bipolar Forceps are intended to remove tissue and control bleeding by use of high frequency electrical current." (Page 2, 4) |
| Technological Characteristics | Principles of Operation: Grasp, manipulate, coagulate tissue, connected to bipolar output of ESU via cable, coagulation via electrosurgical energy and footswitch. Bipolar cables, ESU, footswitch not part of device. | Same as predicate devices. | "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." (Page 5) |
| Electrode Type: Bipolar | Bipolar | "Electrode Type: Bipolar" (Page 5) | |
| Physical Dimensions Range: 3 ½ inches to 10 ¾ inches in length | Same range as predicate devices. | "Physical Dimensions Available: 3 ½ inches to 10 ¾ inches in length" (Page 5) | |
| Tip Sizes Available: 0.2mm to 2.0mm | Same range as predicate devices. | "Tip Sizes Available: 0.2mm to 2.0mm" (Page 5) | |
| Materials: Stainless Steel or Titanium; Epoxy; Kynar (PVDF) Insulation Coating | Same base materials as predicate devices. The Kynar insulation coating material is from a new supplier but showed equivalent performance. | "Materials: Stainless Steel or Titanium; Epoxy; Kynar Insulation Coating [Polyvinylidene Fluoride (PVDF)]" (Page 6). "Current vs. New Kynar Equivalency Tests [Validation - Change in Kynar Insulation Coating Material Supplier]: Sprayability, Durability (Stress) Drop, Finish/Appearance, Heat, Hipot, Continuity. The testing results demonstrated the Titan Manufacturing Bipolar Forceps performed equivalent to the predicate devices." (Page 9) | |
| Visual Appearance (Insulated Bipolar Forceps): Blue-colored insulating coating material. | Lighter, semi-gloss, blue-colored insulating coating material (slight difference from predicate's dark, matte blue, but considered SIMILAR as it's still blue Kynar). | "Visual Appearance Insulated Bipolar Forceps: Lighter, semi-gloss, blue-colored insulating coating material" vs. predicate's "Dark, matte, blue-colored insulating coating material". "SIMILAR - blue colorant, Kynar" (Page 6) | |
| Sterilization Recommendations: Pre-Vacuum Steam | Same as predicate devices. | "Sterilization Recommendations: Pre-Vacuum Steam" (Page 6) | |
| Re-usable: Yes | Yes | "Re-usable: YES" (Page 6) | |
| Cable Connector Type: Compatible with U.S. 2-pin round plugs. | Compatible with U.S. 2-pin round plugs. | "Cable Connector Type: Compatible with U.S. 2-pin round plugs" (Page 6) | |
| Performance Testing | Biocompatibility: Meets ISO 10993-5, 10993-10 (Skin Sensitization, Intracutaneous Reactivity), USP 151 (Pyrogenicity), ISO 10993-11 (Acute Systemic Toxicity), ISO 10993-4 (Interactions with Blood). | Testing performed in accordance with stated ISO standards; demonstrated compliance. | "Biocompatibility Testing performed in accordance with the following: ISO 10993-5:2009, ISO 10993-10:2010 (two parts), USP 151, ISO 10993-11, ISO 10993-4:2017." (Page 9) |
| Medical Electrical Equipment Safety: Meets IEC 60601-2-2 Ed. 6 (2017). | Testing performed in accordance with stated IEC standard; demonstrated compliance. | "Medical Electrical Equipment Safety Testing performed in accordance with the following: IEC 60601-2-2 Ed. 6 (2017)" (Page 9) | |
| Electrical Safety Features: HiPot & Continuity Test Dielectric strength insulation; insulated safety plug; compatible with general electrosurgical generators with 4mm outlets. | Same as predicate devices; testing demonstrated performance equivalent to predicates. | "Electrical Safety Features: HiPot & Continuity Test Dielectric strength insulation; insulated safety plug; Compatible with general electrosurgical generators with 4mm outlets" (Page 6). "Current vs. New Kynar Equivalency Tests... Hipot; and Continuity. The testing results demonstrated the Titan Manufacturing Bipolar Forceps performed equivalent to the predicate devices." (Page 9) | |
| Cleaning and Sterilization: Validation of Recommendations in Instructions for Use (IFU). | Validation performed. | "Cleaning and Sterilization Recommendations IFU Validation" (Page 9) | |
| Thermal Spread (Functional equivalence to predicates): Equivalent thermal spread under same conditions across different tissue types and power settings (minimum, default, maximum). | Demonstrated equivalent thermal spread under the same conditions across different tissue types and power settings compared to predicate devices. | "Electrical performance of the device was completed following FDA Guidance 'Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery', issued August 15, 2016. This required (thermal spread) testing on three (3) different tissue types at minimum, default, and maximum generator power to simulate thermal spread across different tissue types. The spread was then measured and recorded, compared to predicate devices. Results demonstrated an equivalent thermal spread under the same conditions across the different tissue types and power settings." (Pages 9-10) | |
| Biocompatibility | The device must be biocompatible. | The device is biocompatible. | "Biocompatible: YES" (Page 6). Confirmed by testing based on ISO 10993 series. (Page 9) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" in this context refers to the samples of the Titan Manufacturing Bipolar Forceps that underwent non-clinical performance and safety testing.
- Sample Size: The document does not specify exact quantitative sample sizes for each non-clinical test (e.g., how many forceps were used for biocompatibility testing, electrical safety, or thermal spread analysis). It broadly states "Nonclinical testing has been conducted to verify that the Titan Manufacturing Bipolar Forceps met all design specifications and are substantially equivalent to the predicate devices." (Page 9). Regulatory submissions often refer to standard numbers of units for these tests as per the respective test protocols and standards, but the specific numbers are not explicitly listed in this summary.
- Data Provenance: The testing was conducted internally or outsourced to accredited labs, as is typical for medical device manufacturers. The document does not specify the country of origin of the data beyond "Titan Manufacturing, Inc." The studies are prospective in the sense that the new device was manufactured and then tested to demonstrate its performance against established standards and predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- "Ground Truth" in this context: For a 510(k) submission based on substantial equivalence and non-clinical testing, "ground truth" is defined by the technical specifications and performance of the predicate device, as well as adherence to recognized national and international standards (e.g., ISO, IEC, FDA guidance documents).
- Number of Experts/Qualifications: The document does not explicitly mention external experts establishing "ground truth" for the test set in the way one would for a clinical study with image annotations or disease diagnoses. The "experts" implied are the engineers, scientists, and regulatory professionals who designed the device, conducted the tests, analyzed the data, and prepared the submission, ensuring compliance with relevant standards and comparison parameters derived from the predicate devices. These individuals would possess relevant engineering, materials science, electrical safety, and regulatory expertise.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of this 510(k) submission's non-clinical testing. Adjudication typically refers to resolving discrepancies in expert opinions, especially in clinical reads (e.g., radiology studies). Here, the comparison is objective (measurements, compliance with standards) rather than subjective interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. The document explicitly states: "There were no clinical trials performed on these devices." (Page 10). This means no MRMC study was conducted. MRMC studies are typically performed for diagnostic imaging devices where human reader performance is a critical endpoint. This device is an electrosurgical tool, which focuses on functional and safety performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device (bipolar forceps), not an algorithm or AI system. Its performance is inherent to its design, materials, and interaction with an electrosurgical generator and human user during surgery.
7. The Type of Ground Truth Used
- Type of Ground Truth:
- Predicate Device Specifications and Performance: The primary "ground truth" for substantial equivalence is the intended use, technological characteristics, and demonstrated performance of the legally marketed predicate devices. The new device must be shown to be as safe and effective as these predicates.
- Recognized Consensus Standards: Compliance with established international and national standards (e.g., ISO 10993 for biocompatibility, IEC 60601-2-2 for electrical safety) serves as another form of "ground truth" for safety and performance.
- FDA Guidance Documents: Adherence to FDA guidance (e.g., "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery") provides criteria for specific tests like thermal spread.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not applicable, as there is no training set for this type of device.
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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.
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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
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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)
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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 RunMalvern, PA 19355610-935-8203don@titanmfg.com | Manufacturing Site:818 Jefferson StFall River, MA 02721610-935-8203don@titanmfg.com |
| Owner Operator/ManufacturingSite 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 Devices510(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.
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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 Device510(k) # | Product Name | Manufacturer |
|---|---|---|
| K121426 | Synergetics Disposable Spetzler Malis StandardBipolar Forceps | Synergetics |
| K182773 | Faulhaber Pinzetten OHG Single-Use Non-Stick BipolarForceps sterile/non-sterile;Faulhaber Pinzetten OHG Single-Use Bipolar Irrigatingforceps 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
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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 orDifferent | ||||
|---|---|---|---|---|---|
| Subject Device | Predicate Device | Predicate Device | Predicate Device | ||
| 510(k) Number | K213386 | K974593 | K974594 | K974595 | -- |
| Product Name | Titan ManufacturingBipolar Forceps | Semkin InsulatedBipolar Forcep | Semkin Bipolar Forcep | Cushing Bayonet,Insulated Bipolar Forcep | -- |
| Manufacturer | TitanManufacturing, Inc. | TitanManufacturing, Inc. | TitanManufacturing, Inc. | TitanManufacturing, Inc. | SAME |
| Classification | Class II | Class II | Class II | Class II | SAME |
| Subsequent ProductCode | 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 ManufacturingBipolar Forceps areintended to removetissue and controlbleeding by use ofhigh frequencyelectrical current. | Semkin InsulatedBipolar Forceps areintended to removetissue and controlbleeding by use of highfrequency electricalcurrent. | Semkin BipolarForceps are intended toremove tissue andcontrol bleeding by useof high frequencyelectrical current. | Cushing Bayonet,Insulated Bipolar Forcepsare intended to removetissue and controlbleeding by use of highfrequency electricalcurrent. | SAME |
| PrinciplesofOperation | Bipolar forceps aredesigned to grasp,manipulate, andcoagulate selectedtissue. They are to beconnected through abipolar cable with thebipolar output of anelectrosurgicalgenerator.Coagulation is achievedusing electrosurgicalenergy generated by theelectrosurgical generatorunit (ESU) and activatedby a footswitch. | Bipolar forceps aredesigned to grasp,manipulate, andcoagulate selectedtissue. They are to beconnected through abipolar cable with thebipolar output of anelectrosurgicalgenerator. Coagulationis achieved usingelectrosurgical energygenerated by theelectrosurgicalgenerator unit (ESU)and activated by afootswitch. | Bipolar forceps aredesigned to grasp,manipulate, andcoagulate selectedtissue. They are to beconnected through abipolar cable with thebipolar output of anelectrosurgicalgenerator. Coagulationis achieved usingelectrosurgical energygenerated by theelectrosurgicalgenerator unit (ESU)and activated by afootswitch. | Bipolar forceps are designedto grasp, manipulate, andcoagulate selected tissue.They are to be connectedthrough a bipolar cable withthe bipolar output of anelectrosurgical generator.Coagulation is achievedusing electrosurgical energygenerated by theelectrosurgical generatorunit (ESU) and activated bya footswitch. | SAME |
| Bipolar cables, ESU andfootswitch are not partof the subjectdevice. | Bipolar cables, ESUand footswitch are notpart of the subjectdevice. | Bipolar cables, ESUand footswitch are notpart of the subjectdevice. | Bipolar cables, ESU andfootswitch are not part of thesubject device. | ||
| Electrode Type | Bipolar | Bipolar | Bipolar | Bipolar | SAME |
| Physical DimensionsAvailable | 3 ½ inches to10 ¾ inches in length | 3 ½ inches to10 ¾ inches in length | 3 ½ inches to10 ¾ inches in length | 3 ½ inches to10 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]
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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 orDifferent | |
|---|---|---|---|---|---|
| Materials | Stainless Steel orTitanium | Stainless Steel orTitanium | Stainless Steel orTitanium | Stainless Steel orTitanium | |
| Epoxy | Epoxy | Epoxy | Epoxy | ||
| KynarInsulation Coating[PolyvinylideneFluoride (PVDF)] | KynarInsulationCoating[PolyvinylideneFluoride (PVDF)] | KynarInsulationCoating[PolyvinylideneFluoride (PVDF)] | KynarInsulation Coating[Polyvinylidene Fluoride(PVDF)] | ||
| Visual AppearanceInsulated BipolarForceps | Lighter, semi-gloss,blue-coloredinsulating coatingmaterial | Dark, matte, blue-colored insulatingcoating material | Dark, matte, blue-colored insulatingcoating material | Dark, matte, blue-coloredinsulating coatingmaterial | SIMILAR -blue colorant,Kynar |
| SterilizationRecommendations | Pre-Vacuum Steam | Pre-Vacuum Steam | Pre-Vacuum Steam | Pre-Vacuum Steam | SAME |
| Re-usable | YES | YES | YES | YES | SAME |
| Packaging | Bipolar forcep in apropionate clear hardplastic tube with foaminsets at both endspackaged in aninstrument sturdy boxwith packagingmaterial to protect theinstrument (bipolarforcep) | Bipolar forcep in apropionate clear hardplastic tube with foaminsets at both endspackaged in aninstrument sturdy boxwith packagingmaterial to protect theinstrument (bipolarforcep) | Bipolar forcep in apropionate clear hardplastic tube with foaminsets at both endspackaged in aninstrument sturdy boxwith packagingmaterial to protect theinstrument (bipolarforcep) | Bipolar forcep in apropionate clear hardplastic tube with foaminsets at both endspackaged in aninstrument sturdy boxwith packaging materialto protect the instrument(bipolar forcep) | SAME |
| Biocompatible | YES | YES | YES | YES | SAME |
| Drop TestCable Connector Type | YESCompatible with U.S.2-pin round plugs | YESCompatible with U.S.2-pin round plugs | YESCompatible with U.S.2-pin round plugs | YESCompatible with U.S. 2-pin round plugs | SAMESAME |
| Electrical SafetyFeatures | HiPot & ContinuityTest Dielectricstrength insulation;insulated safety plug;Compatible withgeneralelectrosurgicalgenerators with 4mmoutlets | HiPot & ContinuityTest Dielectric strengthinsulation; insulatedsafety plug:Compatible withgeneral electrosurgicalgenerators with 4mmoutlets | HiPot & ContinuityTest Dielectric strengthinsulation; insulatedsafety plug;Compatible withgeneral electrosurgicalgenerators with 4mmoutlets | HiPot & Continuity TestDielectric strengthinsulation; insulatedsafety plug;Compatible with generalelectrosurgical generatorswith 4mm outlets | SAME |
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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".
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 ManufacturingBipolar Forceps | Synergetics Disposable SpetzlerMalis Standard Bipolar Forceps | Faulhaber Pinzetten OHG Single-Use Non-Stick Bipolar Forcepssterile/non-sterile;Faulhaber Pinzetten OHG Single-Use Bipolar Irrigating forcepssterile/non-sterile | ------------------------- |
| Manufacturer | TitanManufacturing, 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 ManufacturingBipolar Forceps areintended to removetissue and controlbleeding by use ofhigh frequencyelectrical current. | The Synergetics DisposableSpetzler-Malis Standard BipolarForceps are single use devicesold sterile and are intended foruse in electrosurgery forcoagulation of tissue. | Faulhaber Single Use Non-StickBipolar Forceps sterile/non-sterileand Single-Use Non-Stick BipolarIrrigating Forceps sterile/non-sterileare intended for use by a physicianfamiliar with electrosurgery forbipolar coagulation and irrigation oftissue for general surgery. Thebipolar forceps are used with thebipolar output for standardelectrosurgical generators.The products are intended for singleuse and are provided sterile as wellas non-sterile.Products supplied non-sterile mustbe cleaned, disinfected, andsterilized prior to their use byvalidated cleaning, disinfection, andsterilization process.The bipolar forceps have not beenshown to be effective for tubalsterilization or tubal coagulation forsterilization procedures and shouldnot be used for these procedures.The types of surgery intended are:-General surgery-Laryngeal coagulation-Orthopedic coagulation-Thoracic coagulation-Neurosurgical coagulationGynecological coagulation (exceptfor use in sterilization)-Urological coagulation-Ear, Noe, Throat coagulation. | SIMILAR – Intendeduse for subject deviceis general;Subject device isreusable and providednon-sterile. |
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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 ofOperation | Bipolar forceps aredesigned to grasp.manipulate, andcoagulate selectedtissue. They are to beconnected through abipolar cable withthe bipolar output ofan electrosurgicalgenerator.Coagulation isachieved usingelectrosurgicalenergy generated bythe electrosurgicalgenerator unit (ESU)and activated by afootswitch.Bipolar cables, ESUand footswitch arenot part of thesubject device. | Bipolar forceps are designed tograsp, manipulate, and coagulateselected tissue. They are to beconnected through a bipolarcable with the bipolar output ofan electrosurgical generator.Coagulation is achieved usingelectrosurgical energy generatedby the electrosurgical generatorunit (ESU) and activated by afootswitch.Bipolar cables, ESU andfootswitch are required foroperation, but not provided. | Bipolar forceps are designed tograsp, manipulate, and coagulateselected tissue. They are to beconnected through a bipolar cablewith the bipolar output of anelectrosurgical generator.Coagulation is achieved usingelectrosurgical energy generated bythe electrosurgical generator unit(ESU) and activated by a footswitch.Bipolar cables, ESU and footswitchare required for operation, but notprovided. | SAME |
| Electrode Type | Bipolar | Bipolar | Bipolar | SAME |
| Materials | Stainless Steel orTitaniumEpoxyKynar® InsulationCoating[PolyvinylideneFluoride PVDF)] | Stainless Steel or TitaniumEpoxyInsulation Coating[Polyvinylidene Fluoride(PVDF)] | Stainless SteelEpoxyInsulation Coating[Rilsan (Nylon)] | SIMILAR - Brand ofPVDF not known for1st cited referencedevice; Similarinsulation coatingmaterial for 2nd citedreference device |
| Biocompatible | YES | YES | YES | SAME |
| Cable Connector Type | Compatible withU.S. 2-pin roundplugs | Compatible with U.S. 2-pinround plugs | Compatible with U.S. 2-pin roundplugs | SAME |
| Safety Features | Dielectric strengthinsulated safety plug | Dielectric strength insulatedsafety plug | Dielectric strength insulated safetyplug | SAME |
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Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com
Non -Clinical Performance Testing
Nonclinical testing has been conducted to verify that the Titan Manufacturing Bipolar Forceps met all design specifications and are substantially equivalent to the predicate devices. Testing included the following:
- . Biocompatibility Testing performed in accordance with the following:
- ISO 10993-5:2009 "Biological Evaluation of Medical Devices Part 5: In Vitro o Cytotoxicity Test"
- ISO 10993-10:2010 "Biological Evaluation of Medical Devices Part 10: Skin O Sensitization Test"
- ISO 10993-10:2010 "Biological Evaluation of Medical Devices Part 10: Skin o Intracutaneous Reactivity Test"
- USP 151 Material Mediated Pyrogenicity Rabbit Pyrogen Test O
- ISO 10993-11: "Biological Evaluation of Medical Devices Part 11: Tests for Acute O Systemic Toxicity"
- ISO 10993-4:2017 "Biological Evaluation of Medical Devices Part 4, Selection of Tests O for Interactions with Blood"
- Medical Electrical Equipment Safety Testing performed in accordance with the following: ●
- o IEC 60601-2-2 Ed. 6 (2017)
- Cleaning and Sterilization Recommendations IFU Validation
In addition, Titan Manufacturing Bipolar Forceps have been compared to the predicate device through various performance studies designed to test visual/operational use, performance and electrical safety and effectiveness.
The testing results demonstrated the Titan Manufacturing Bipolar Forceps performed equivalent to the predicate devices.
- Current vs. New Kynar Equivalency Tests | Validation - Change in Kynar Insulation Coating Material Supplier]:
- 0 Sprayability;
- Durability (Stress) Drop; O
- Finish/Appearance; O
- Heat; O
- Hipot: and O
- Continuity. o
The testing results demonstrated the Titan Manufacturing Bipolar Forceps performed equivalent to the predicate devices.
Electrical performance of the device was completed following FDA Guidance "Premarket Notification [510(k) Submissions for Electrosurgical Devices for General Surgery", issued August 15, 2016. This required (thermal spread) testing on three (3) different tissue types at minimum, default, and maximum
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Image /page/10/Picture/0 description: The image shows the logo for Titan Manufacturing Inc. The logo features a stylized Spartan helmet on the left. Below the logo is the alphanumeric code K213386.
Ph: (610) 935-8203 Fx: (610)933-9771 www.titanmfg.com
generator power to simulate thermal spread across different tissue types. The spread was then measured and recorded, compared to predicate devices. Results demonstrated an equivalent thermal spread under the same conditions across the different tissue types and power settings.
Clinical Performance Testing
There were no clinical trials performed on these devices.
Statement of Substantial Equivalence
The subject device has the same intended use and technological characteristics as the cited predicate devices. The minor changes or differences presented do not affect the safety or performance of the subject device or raise new questions of safety or effectiveness. The non-clinical test results have demonstrated the subject device is as safe as the predicate devices.
Therefore, it is concluded that no new questions of safety and effectiveness were raised. We conclude that the subject device is substantially equivalent to the cited predicate devices.
§ 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.