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.

AI/ML Overview

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).

Study Details

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.
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.
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).
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.
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.
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.
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."
How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no "training set" for this device.

Summary

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K091107

Food and Drug Administration 510(k) Notification - Model P8400 Hemostatix Thermal Scalpel System March 12, 2009

	510(k) SummaryPage 1 of 2
Trade Name:Common Name:Classification Name:	Model P8400 Hemostatix Thermal Scalpel SystemThermal ScalpelElectrosurgical cutting and coagulation device and accessories(§ 878.4400)
Official Contact:	Jeffrey W. CobbExecutive VPHemostatix Medical Technologies, LLC8400 Wolf Lake Drive, Ste 109Bartlett, TN 38133
Telephone:Telefax:	(901) 261-0012(901) 261-0017
Date Prepared:	March 12, 2009

Intended Use - 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.

Predicate Device - The Model P8400 Hemostatix Thermal Scalpel System is substantially equivalent to the Hemostatix Model 2400Z Thermal Scalpel System and any differences should not affect safety or effectiveness.

Statement of Similarities and Dissimilarities - 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.

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Food and Drug Administration 510(k) Notification - Model P8400 Hemostatix Thermal Scalpel System March 12, 2009

510(k) Summarv Page 2 of 2

Performance Testing - Performance testing of the Model P8400 Hemostatix Thermal Scalpel System was conducted and the results compared to the predicate device - the Model 2400Z Hemostatix Thermal Scalpel System. Results of the following performance tests demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.

1. VERIFICATION OF ACTUAL BLADE TEMPERATURES COMPARED WITH CONTROLLER SETPOINTS

To verify the design input requirements that the Model P8400 controller was capable of controlling blade temperatures to within ± 10° C of the controller's set points. temperature measurements using a thermocouple attached to a blade surface at controller set points over a range of 150° C and the maximum temperature of 300° C were taken in still air without load applied to the blades using both the Model P8400 controller and the Model 2400Z controller. The results indicated that the actual blade temperature using the Model P8400 controller correlated within 0° C to 5° C over the entire range of the controller's set points. Comparing the results of the Model P8400 controller to that of the Model 2400Z controller, it was concluded that the Model P8400 controller was more capable of matching actual blade temperature to controller set point temperature than the Model 2400Z controller.

2. VERIFICATION OF THE LEVEL OF HEMOSTASIS ACHIEVED

To compare the results of hemostasis achieved with the Model 8400 Hemostatix Thermal Scalpel System to the predicate device, the Model 2400Z Hemostatix Thermal Scalpel System, controlled animal testing was conducted. Results of this testing demonstrated that the P8400 system achieved an average level of hemostasis of 4.8 (as judged on a 0 to 5 scale with 5 representing the best) compared with the Model 2400Z system which achieved an average level of hemostasis of 4.56.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the bird.

Public Health Service

MAY - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hemostatix Medical Technologies, LLC % Underwriters Laboratories, Inc. Mr. Casey Conry 1285 Walt Whitman Road Melville, NY 11747

Re: K091107

Trade/Device Name: Model P8400 Hemostatix Thermal Scalpel System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI Dated: April 15, 2009 Received: April 16, 2009

Dear Mr. Conry:

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.

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); 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.

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Page 2 - Mr. Casey Conry

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Neil R. Ogden

Mark N. Melkerson of Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Food and Drug Administration 5 I 0(k) Notification - Model P8400 Hemostatix Thermal Scalpel System March 12, 2009

510(k) Number: Device Name:

Model P8400 Hemostatix Thermal Scalpel System

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE = CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neitme Gde for mxm

Civision Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K091107

Page 1 of 1

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Page 4

Regulation Number and Section

§ 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.