(26 days)
The Hemostatix Thermal Scalpel System Handles and Blades are a surgical instrument designed to retain the precise. clean cutting characteristics of a traditional stainless 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 Hemostatix Thermal Scalpel System (HTSS) 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 system utilizes a razor-sharp blade coated with proprietary thick-film inks which when used with the Hemostatix handle and controller heat the blade to precisely controlled temperature levels to achieve the desired levels of hemostasis during surgery. The temperature of the HTSS's blade can be adjusted from 70°C to 300°C at the touch of button on the handle or the controller.
HTSS is intended to provide hemostasis as the surgeon incises. The sharpness of the steel blade and scalpel pressure provides the incising action. The steel blade is covered with a black non-stick coating. Below the non-stick coating surface and a layer of insulation is temperature-controlled micro- circuitry which transfers heat uniformly to the entire blade.
The HTSS consists of the following main components:
a) Controller An electronic power supply/controller that energizes the blade and provides various automatic calibration, sensing, and control functions. It has user controls with visual and audible indications of instrument status. The controller includes software installed on EPROM on the control PCBA. The software monitors the resistance of the blade which it uses to calculate the amount of power needed to be applied to the blade to maintain the temperature setting on the controller.
b) Footswitch An optional footswitch is available for use with the Model P8400 Controller which allows the user to increase/decrease the blade temperature and to switch from CUT and COAG modes.
c) Handle A disposable scalpel handle, connected to the controller with a lightweight, flexible electrical cable for use with disposable blades.
d) Blades Various sizes of sterile disposable scalpel blades similar in size, shape and sharpness to conventional #10, #12, and #15 scalpel blades.
Here's a breakdown of the acceptance criteria and study information for the Hemostatix Thermal Scalpel System Handles and Blades, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Comply with IEC 60601-1 Ed. 3.1 and IEC 60601-1-2 Ed. 4.0 b:2014 | The subject and predicate devices comply with both IEC 60601-1 Ed. 3.1 and IEC 60601-1-2 Ed. 4.0 b:2014. |
| Patient Contacting Material | Blades with new coating and blade hub must pass biocompatibility tests (ISO Guinea Pig Maximization, ISO Acute Systemic Injection, ISO Intracutaneous Irritation, ISO Materials Mediated Pyrogen, ISO MEM Elution) | All listed biocompatibility tests were passed. Toxicological Risk Assessment concluded acceptable risks. |
| Actual Blade Temp vs. Controller Set-point | Blade temperature must be within +10°, -20° C of the controller set-point. | Temperatures at 100°, 200°, and 300° C were found to be within the previously established acceptance criteria (+10°, -20° C temperature range). |
| Non-stick Performance (Egg Yolk) | Newly modified blades with ShieldSys coating must perform as well as or better than the original (Krytox) coating (graded on a 1-10 scale). | Krytox coated blades: 3.8 at 210°C, 7.6 at 300°C. ShieldSys coated blades: 9.9 at 210°C, 10 at 300°C. Met acceptance criteria. |
| Cutting Performance (Flank Steak) | Newly modified blades with ShieldSys coating must perform as well as or better than the original (Krytox) coating (graded on a 1-10 scale). | Krytox coated blades: 7.2 at 210°C, 7.7 at 300°C. ShieldSys coated blades: 10 at 210°C, 9.7 at 300°C. Met acceptance criteria. |
2. Sample Sizes and Data Provenance
- Electrical Safety & Patient Contacting Material Identification: No specific sample sizes are mentioned for these tests, implying they were likely type tests or extensive material characterization rather than statistical sampling of many devices. The data provenance is internal testing by the manufacturer.
- Actual Blade Temp vs. Controller Set-point: Not explicitly stated, but the phrase "original and newly modified blades" suggests at least two distinct units were tested. The data provenance is internal testing by the manufacturer.
- Non-stick Performance (Egg Yolk): 10 samples of Krytox coated blades and an unstated number (likely 10) of ShieldSys coated blades. Data provenance is internal testing by the manufacturer.
- Cutting Performance (Flank Steak): 10 samples of Krytox coated blades and an unstated number (likely 10) of ShieldSys coated blades. Data provenance is internal testing by the manufacturer.
- Country of Origin: Not explicitly stated, but given the US FDA submission, it's presumed to be from within the US or compliant with US standards. The study appears to be entirely prospective as it involves direct testing of the modified device components.
3. Number of Experts and Qualifications for Ground Truth
- None stated. The performance tests described (electrical safety, biocompatibility, temperature accuracy, non-stick, and cutting performance using egg yolk and flank steak) are objective, quantitative, or qualitative assessments that do not rely on expert interpretation for establishing ground truth in the way medical imaging or clinical diagnoses would.
4. Adjudication Method
- None. The described tests are based on objective measurements or qualitative assessments with clear grading criteria (e.g., 1-10 scale), not on expert consensus or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is not applicable to the device being described. The Hemostatix Thermal Scalpel System is a surgical instrument for cutting and hemostasis, not a diagnostic imaging device or an AI algorithm that assists human readers. Therefore, there's no "human readers improve with AI vs without AI assistance" effect size to report.
6. Standalone (Algorithm Only) Performance Study
- No. This device is a physical surgical instrument; it is not an algorithm, and thus, a standalone algorithm performance study is not relevant or applicable.
7. Type of Ground Truth Used
- The ground truth for the performance tests was based on:
- Objective Measurement/Standard Compliance: For Electrical Safety and Actual Blade Temperature, adherence to specified international standards and a defined temperature range.
- Laboratory Testing: For Biocompatibility, standard ISO tests and an elemental extraction study/toxicological risk assessment.
- Empirical Performance Metrics: For Non-stick Performance and Cutting Performance, a comparative evaluation against a predicate device using a defined grading scale for specific test materials (egg yolk, flank steak).
8. Sample Size for Training Set
- Not Applicable. This is a hardware device undergoing performance testing, not a machine learning model requiring a training set.
9. How Ground Truth for Training Set was Established
- Not Applicable. As there is no training set, there is no ground truth for it.
§ 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.