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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.

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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.

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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