(15 days)
The Model P8400 Hemostatix Thermal Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
The Model P8400 Hemostatix Thermal Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of a traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade. The Model P8400 Hemostatix Thermal Scalpel System has the same intended use; the same technological characteristics; power modality; mode of operation: utilizes the same scalpel blades; has many of the same audible sounds and alarms; handles that are sterilized the same way (EO gas); same operating temperature ranges (70° C to 300° C), and, utilizes the same blades as the predicate device, the Hemostatix Model 2400Z Thermal Scalpel System cleared via 510(k) No .: K033089. The Model P8400 Hemostatix Thermal Scalpel System differs from the predicate device in that the Model P8400 Hemostatix Thermal Scalpel System features an aluminum enclosure vs. a thermoplastic enclosure for the Hemostatix Model 2400Z Thermal Scalpel System; requires a different handle with a unique plug-in connector which is not compatible with the Hemostatix Model 2400Z Thermal Scalpel System; will accommodate an optional footswitch to control the functions of the handle and blade; will mount on an IV pole unlike the Hemostatix Model 2400Z Thermal Scalpel System; has one multi-color 4.6 in x 3.4 in TFT display vs. two displays (1.5 in x 3 in - three color and 0.5 in x 3 in monochromatic message center); and is designed to be UL 60601-1 Type BF versus a Type B for the Hemostatix Model 2400Z Thermal Scalpel System.
Here's a breakdown of the acceptance criteria and study information for the K091107 Thermal Scalpel System, based on the provided documents:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Blade Temperature Control (Verification of Actual Blade Temperatures Compared with Controller Setpoints) | The Model P8400 controller should be capable of controlling blade temperatures to within ± 10° C of the controller's set points. |
| Hemostasis Achievement (Verification of the Level of Hemostasis Achieved) | To demonstrate that the Model P8400 system is at least as effective as the predicate device (Model 2400Z Hemostatix Thermal Scalpel System) in achieving hemostasis. (Implicit criterion is to meet or exceed the predicate's performance). |
| The predicate device (Model 2400Z system) achieved an average level of hemostasis of 4.56. |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Blade Temperature Test: Not explicitly stated as a "sample size" in terms of number of devices or blades, but measurements were taken over a range of set points (150°C and 300°C) with a thermocouple. The test was conducted in "still air without load applied to the blades," implying a controlled laboratory setting.
- Hemostasis Test: Involved "controlled animal testing." The specific number of animals or trials is not provided.
- Data Provenance: The tests were conducted internally by Hemostatix Medical Technologies, LLC, likely in a laboratory or preclinical setting. No information on country of origin for the data is provided beyond the company's location in Bartlett, TN, USA. The studies appear to be prospective for the purpose of demonstrating substantial equivalence.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Blade Temperature Test: Ground truth was established through direct temperature measurements using a thermocouple. No human experts were involved in establishing this ground truth directly for the test.
- Hemostasis Test: Hemostasis was "judged on a 0 to 5 scale." The number and qualifications of the individuals who performed this judgment (i.e., established the ground truth) are not specified in the provided summary.
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Adjudication Method for the Test Set:
- Blade Temperature Test: Not applicable (direct instrumental measurement).
- Hemostasis Test: The summary states hemostasis was "judged," but it does not describe an adjudication method (e.g., whether multiple graders were used, if there was a consensus process, or a tie-breaking rule).
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was reported. This device is a thermal scalpel, not an AI/software device that assists human readers.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device; it's not an algorithm or AI. The performance studies describe the device's inherent functional capabilities.
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The Type of Ground Truth Used:
- Blade Temperature Test: Instrumental measurements (thermocouple readings) served as the ground truth.
- Hemostasis Test: Expert judgment on a 0-5 scale, based on controlled animal testing.
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The Sample Size for the Training Set:
- Not applicable. This device is a thermal scalpel, not a machine learning model. There is no "training set."
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How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no "training set" for this device.
§ 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.