(26 days)
Not Found
No
The device description details a system that uses temperature control based on resistance measurements and user input. There is no mention of AI or ML algorithms for decision-making, image analysis, or adaptive learning. The control functions described are standard electronic feedback loops.
No
The device is a surgical instrument designed for cutting and minimizing blood loss during surgery, not primarily for therapeutic treatment.
No
The device is a surgical instrument designed to cut and simultaneously seal blood vessels, which are therapeutic actions, not diagnostic ones.
No
The device is a surgical instrument system that includes hardware components such as a handle, blades, and a controller, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly states that the device is 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...". This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description details a system for cutting and sealing tissue using heat. It involves a scalpel blade, handle, and controller. This is consistent with a surgical instrument.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of biological samples or diagnostic purposes.
The device is a surgical instrument used for cutting and providing hemostasis during surgery, which is a direct intervention on the patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
Device Description
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.
. REF 7013-8400 – Model P400 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.
. REF 7013-8410 – Model P400 Footswitch
c) Handle A disposable scalpel handle, connected to the controller with a lightweight, flexible electrical cable for use with disposable blades.
REF 7013-9050 – Disposable Handle for the Model P8400 Controller – Qty 1
REF 7023-9050 Disposable Handle for the Model P8400 Controller Qty 6 0
d) Blades Various sizes of sterile disposable scalpel blades similar in size, shape and sharpness to conventional #10, #12, and #15 scalpel blades.
0 REF 7013-5810 - #10 Scalpel Blade for the Model P8400 Controller – Qty 24
O REF 7023-5810 - #10 Scalpel Blade for the Model P8400 Controller – Qty 10
REF 7013-5815 - #15 Scalpel Blade for the Model P8400 Controller – Qty 24
REF 7023-5815 - #15 Scalpel Blade for the Model P8400 Controller - Qty 10
REF 7023-5812 - #12 Scalpel Blade for the Model P8400 Controller – Qty 10
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Electrical Safety: The device complies with IEC 60601-1 Ed. 3.1 and IEC 60601-1-2 Ed. 4.0 b:2014 standards.
- Patient Contacting Material Identification: Modified blades are coated with Miller Stephenson ShieldSys SB Coating. Blade hub made of medical grade ULTEM HU1000 thermoplastic. Biocompatibility tests (ISO Guinea Pig Maximization Test, ISO Acute Systemic Injection Test, ISO Intracutaneous Irritation Test, ISO Materials Mediated Pyrogen Test, ISO MEM Elution using L-929 Mouse Fibroblast Cells) were performed and all passed. A Toxicological Risk Assessment concluded acceptable health risks.
- Actual Blade Temp vs Controller Set-point: Measured blade temperature at 100°, 200°, and 300° C were within the acceptance criteria of +10°, -20° C.
- Non-stick Performance (Egg Yolk): Comparison between original (Krytox) and new (ShieldSys) coatings using egg yolk adhesion. At 210° C, Krytox yielded 3.8 and ShieldSys yielded 9.9. At 300° C, Krytox yielded 7.6 and ShieldSys yielded 10. The ShieldSys coating performed as well as or better than Krytox.
- Cutting Performance (Flank Steak): Comparison between original (Krytox) and new (ShieldSys) coatings in flank steak cutting tests. At 210° C, Krytox yielded 7.2 and ShieldSys yielded 10. At 300° C, Krytox yielded 7.7 and ShieldSys yielded 9.7. The ShieldSys coating performed as well as or better than Krytox.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 26, 2018
Hemostatix Medical Technologies, LLC Mr. Jeff Cobb Executive VP & COO 8400 Wolf Lake Drive, STE 109 Bartlett, Tennessee 38133
Re: K183009
Trade/Device Name: Hemostatix Thermal Scalpel System Handle and Blades Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: October 29, 2018 Received: October 31, 2018
Dear Mr. Cobb:
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/cdrh/cfdocs/cfpmn/pmn.cfm identifies 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.
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
1
801); medical device 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/6 description: The image shows the text "Long H. Chen -S" in a large, sans-serif font. The text is arranged vertically, with "Long H." on the top line, "Chen" on the second line, and "-S" on the third line. The letters are dark gray, and the background is white.
Digitally signed by Long H. Chen -S
Date: 2018.11.26 15:16:57 -05'00'
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K183009
Device Name
HEMOSTATIX THERMAL SCALPEL SYSTEM HANDLES AND BLADES
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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3
Page 1 of 5
l. SUBMITTER
Hemostatix Medical Technologies, LLC 8400 Wolf Lake Drive, Ste 109 Bartlett, TN 38133
Submitted by: Jeffrey Cobb, Executive VP & COO Phone: 901-261-0012 Fax: 901-261-0017
Contact Person: Jeffrey Cobb, Executive VP & COO Hemostatix Medical Technologies, LLC 8400 Wolf Lake Drive, Ste 109 Bartlett, TN 38133 Phone: 901-261-0012 Fax: 901-261-0017 Email: jcobb@hemostatix.com
Date Prepared: November 26, 2018
II. DEVICE
Name of Device: Hemostatix Thermal Scalpel System Handles and Blades Common or Usual Name: Thermal Scalpel Regulatory Class: II Product Code: GEI
III. PREDIČATE DEVIČE
- a) Hemostatix Thermal Scalpel System Handles Original 510(k) K091107, Hemostatix Thermal Scalpel System, May 1, 2009.
- b) Hemostatix Thermal Scalpel System Blades Original 510(k) K002021, Hemostatix Thermal Scalpel System, August 24, 2000.
These predicate devices have not been subject to a design-related recall.
IV. DEVICE DESCTRIPTION
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
4
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.
- . REF 7013-8400 – Model P400 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.
- . REF 7013-8410 – Model P400 Footswitch
- c) Handle A disposable scalpel handle, connected to the controller with a lightweight, flexible electrical cable for use with disposable blades.
- REF 7013-9050 – Disposable Handle for the Model P8400 Controller – Qty 1
- REF 7023-9050 Disposable Handle for the Model P8400 Controller Qty 6 0
- d) Blades Various sizes of sterile disposable scalpel blades similar in size, shape and sharpness to conventional #10, #12, and #15 scalpel blades.
- 0 REF 7013-5810 - #10 Scalpel Blade for the Model P8400 Controller – Qty 24
- O REF 7023-5810 - #10 Scalpel Blade for the Model P8400 Controller – Qty 10
- REF 7013-5815 - #15 Scalpel Blade for the Model P8400 Controller – Qty 24
- REF 7023-5815 - #15 Scalpel Blade for the Model P8400 Controller - Qty 10
- REF 7023-5812 - #12 Scalpel Blade for the Model P8400 Controller – Qty 10
V. INDICATIONS FOR USE
5
The Hemostatix Thermal Scalpel System Handles and Blades are surgical instruments 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.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Clean cutting characteristics of a traditional steel scalpel and heat thermally conducted to the tissue from an elevated-temperature blade to minimize blood loss by simultaneously sealing blood vessels as they are cut with minimal tissue damage and virtually no muscle stimulation are the technological principles for both the subject and predicate devices.
The subject and predicate devices are based on the following same technological elements:
- o Same form - Scalpel blades are provided in the shape of #10, #12, and #15 blades.
- . Same function – Scalpel blades contain a thick-film circuit to distribute heat to the blade for hemostasis covered with a non-stick coating to minimize tissue coagulation on the blade's surface.
- . Same temperature range – Blade temperature is controlled in 10° C increments from 70° C to 300° C.
The following technological differences exist between the subject and predicate devices:
- o Disposable Handles – The predicate device is a handle that can be reprocessed up to 10 times, whereas the subject handle is disposable.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
1. Electrical Safety
The subject and predicate devices comply with the following:
- IEC 60601-1 Ed. 3.1 – Medical electrical equipment - Part 1: General requirements for basic safety and essential performance CONSOLIDATED EDITION.
- IEC 60601-1-2 Ed. 4.0 b:2014 – Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
6
2. Patient Contacting Material Identification
The patient contacting materials used for the Modified Handle and Blades are as follows:
-
a) Non-stick Coating: Modified blades are coated with Miller Stephenson ShieldSys SB Coating.
According to ISO 10993-1, the blades are considered as: -
i. Category: External Communicating Device
-
ii. Contact: Tissue, Bone, Dentin
-
iii. Contact Duration: ≤ 24 hours
-
b) Blade hub: The blade hub is made of medical grade ULTEM HU1000 thermoplastic.
Blades with this coating and blade hub were tested to the biocompatibility tests identified in Table 1:
| Table 1 | ||
|---|---|---|
| Test | Result | |
| 1. | ISO Guinea Pig Maximization Test | 1. Passed |
| 2. | ISO Acute Systemic Injection Test | 2. Passed |
| 3. | ISO Intracutaneous Irritation Test | 3. Passed |
| 4. | ISO Materials Mediated Pyrogen Test | 4. Passed |
| 5. | ISO MEM Elution using L-929 Mouse Fibroblast Cells | 5. Passed |
- c) An elemental extraction study and Toxicological Risk Assessment were conducted. The Toxicological Risk Assessment concluded that "Based on the review of the available toxicity data for the identified extractable elements extracted under exaggerated conditions, as well as the exposure estimates, the safety margins, and results of biocompatibility testing on the REF 7023-5810 - #10 Hemostatix Thermal Scalpel Blades, the likelihood of the Hemostatix Thermal Scalpel producing unacceptable carcinogenic or non-carcinogenic health risks in adults or children under the proposed conditions and duration of clinical use (limited) is acceptable."
3. Actual Blade Temp vs Controller Set-point
Actual blade temperature as compared to controller set-point was measured with original and newly modified blades. Temperatures were evaluated at controller setpoint temperatures of 100°, 200°, and 300° C and were found to be within the previously established acceptance criteria of +10°, -20° C temperature range. Therefore, the acceptance criteria for this test were met.
7
4. Non-stick Performance (Egg Yolk)
The efficacy of the non-stick properties of the original (Krytox) coating was evaluated vs the newly modified blades with the ShieldSys coating to evaluate how well proteins adheres to the surface of each blade. Acceptance criteria was that the newly modified blades with the ShieldSys coating performed as well as or better than the original (Krytox) coating.
The two coating evaluation tests were performed at temperatures of 210° C and 300° C. Each blade was then dipped into egg yolk and evaluated how well the protein cleans from the blade. The grading criteria is a 1-10 scale with 1 being poor and 10 being optimal. The 10 samples of Krytox coated blades yielded ratings of 3.8 at 210° C and 7.6 at 300° C versus 9.9 at 210° C and 10 at 300° C for the ShieldSys coated blades. Therefore, the acceptance criteria for this test were met.
5. Cutting Performance (Flank Steak)
The efficacy of the non-stick properties of the original (Krytox) coating was evaluated vs the newly modified blades with the ShieldSys coating to evaluate how each performs mechanically in actual cutting tests. Acceptance criteria was that the newly modified blades with the ShieldSys coating performed as well as or better than the original (Krytox) coating.
At temperatures of 210C and 300C, perform 10 cuts in flank steak and evaluate the performance using the same 1-10 scale with 1 being poor and 10 being optimal. In the flank steak cutting testing, the 10 samples of Krytox coated blades yielded ratings of 7.2 at 210° C and 7.7 at 300° C versus 10 at 210° C and 9.7 at 300° C for the ShieldSys coated blades. Therefore, the acceptance criteria for this test were met.
VIII. CONCLUSIONS
Based upon the information submitted herein and the results of performance testing, we conclude that the subject devices are substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.