(226 days)
The Kronos Electrocautery Device is indicated to be used as a tool to achieve hemostasis through coagulation for liver, kidney, and lung soft tissue.
The Kronos Electrocautery Device is a single-use, disposable and battery-operated electrocautery device utilized to control bleeding post-biopsy procedure of solid organs (i.e., liver, kidney, lungs, etc.). The Kronos electrosurgical device consists of:
- a power supply: Two AA batteries
- a Stainless Steel (SS) distal probe with a rounded heated tip that is connected to the handle to cauterize targeted areas of tissue. The tip is heated (75 °C - 100 °C) via electrical current through a coiled wire. The temperature of the distal tip is controlled with a thermistor while the temperature of the tip is distributed with a thermal conductive epoxy.
- The ergonomic handle includes an on/off switch and a push button to activate the heated tip.
Kronos Electrocautery Device is available in two models, K10 and K15. K10 model is compatible with 10cm guide needle whereas K15 is compatible with 15cm guide needle.
The provided text describes the Kronos Electrocautery Device, a device for achieving hemostasis through coagulation, and its substantial equivalence to a predicate device (Bovie Cautery Device). It outlines various performance tests and their results.
Here's an analysis of the provided information based on your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Physical Attributes | Device dimensions meet specifications (distal tip, working length, outer diameter). | All test samples passed testing. |
| Surface Contamination | Absence of particulates on device surface. | All test samples passed testing. |
| Time-Temperature Characterization | Device temperature when submerged under water, while turned on, meets specified range (75 °C - 100 °C, as per device description). | All test samples passed testing. |
| Tensile Test (Distal Tip) | Distal tip tensile force meets specified requirements. | All test samples passed testing. |
| Animal Testing (Usability) | All Usability Evaluation Ratings for Device Condition (Visual Inspection), Maneuverability to Target Tissue, Device Performance (Blood Control), and Compatibility with Guide Needle Withdrawal Force scored ≥3 (acceptable). | All test samples passed testing. |
| Histopathological Assessment | No significant differences in thermal damage compared to the predicate device in porcine tissue explants (liver, lung, kidney, skeletal muscle). Similar intensity of thermal damage, structure of cauterized areas, mild cellular damage, and no major thermal damage beyond the active tip. | There were no significant differences between the thermal damage induced by subject device as compared to the predicate device. The subject device is equivalent in safety and efficacy of the predicate device. The intensity of the thermal damage and structure of cauterized areas were similar. Mild cellular damage along with tinctorial changes were found at the site of treatments in all tissues. There was no major thermal damage beyond the active tip of the probe. The subject device induced a stronger thermal injury on the surface of the tissues with visible burn margins separating the treatment sites from the adjacent healthy tissues. |
| US Clinical Study (Primary Outcomes) | Absence of Hematoma formation; measure and categorize amount of blood loss from biopsy access site; absence of the need for ultrasound examination due to observation of bleeding. | All Test Samples Passed Primary and Secondary Outcomes. |
| US Clinical Study (Secondary Outcomes) | Absence of secondary reintervention; time to hospital discharge. | All Test Samples Passed Primary and Secondary Outcomes. |
| OUS Clinical Study (Primary Outcomes) | Absence of Hematoma formation; measure and categorize amount of blood loss from biopsy access site; absence of the need for ultrasound examination due to observation of bleeding. | All Test Samples Passed Primary and Secondary Outcomes. |
| OUS Clinical Study (Secondary Outcomes) | Absence of secondary reintervention; time to hospital discharge. | All Test Samples Passed Primary and Secondary Outcomes. |
| Electromagnetic Compatibility (EMC) | Complies with relevant EMC standards (e.g., Radiated Emissions, Electro-Static Discharge Immunity, Radiated, Radio Frequency, Electromagnetic Immunity, Proximity Fields from RF Wireless Communications Equipment, Power Frequency Magnetic Field Immunity Test, Radiated fields in close proximity - Immunity Test, IEC 60601-1-2 Clause 5 Worksheet). | Complies (for all applicable tests based on battery operation). |
| Electrical Safety (ES) | Complies with relevant ES standards (e.g., Humidity Preconditions, Accessible Parts, Leakage Current Test, Dielectric Strength Means, Ball Pressure Test, Excessive Temperature, Push, Drop (Hand-held and Body-worn), Molding Stress Relief). | Pass (for all applicable tests). |
| Biocompatibility (Sensitization) | No irritation noted at any test site 24 or 48 hours after challenge patch removal (physiological saline or sesame oil extract). | Non-sensitizer. |
| Biocompatibility (Irritation) | Primary irritation index (PII) of the test article was 1.0 or less. | Non-irritant. |
| Biocompatibility (Acute Systemic Toxicity) | No gross abnormalities noted for any animals when necropsied at the conclusion of the 3-day observation period. | Non-cytotoxic. |
| Biocompatibility (Systemic Toxicity - ISO Materials Mediated Rabbit Pyrogen) | No rabbit administered with the test article extract had a temperature rise ≥0.5℃ at required observation time points during the 3-hour observation period, meeting USP limits. | Non-pyrogenic. |
| Shelf Life | All acceptance criteria met after 2-year accelerated aging. Device performs as intended to Design Specification. | All acceptance criteria were met. Device will perform as intended. Labeled for 2-year shelf life. |
| Packaging Validation | Acceptance criteria met for adequate and effective protection and sterile barrier requirements after 2-year accelerated aging. | Acceptance criteria were met. Packaging will provide adequate and effective protection and sterile barrier. |
| Sterilization Validation | Sterilization process achieves a minimum Sterility Assurance Level (SAL) of 10^-6, with BI results confirming acceptable lethality for fractional, half, and full cycles; subject device successfully adopted to original sterilization validation. | The validation study demonstrated that the sterilization process and equipment are capable of reliably and consistently sterilizing the devices to a minimum SAL of 10-6. The BI results confirm the acceptable lethality of the sterilization cycle to achieve the required SAL of 10-6. Fractional cycles, half cycles, and full cycles met the acceptance criteria. The subject device was successfully adopted to the original sterilization validation. |
| EO and ECH Residuals | Residual traces of Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) are below limits specified in ISO 10993-7. | The residual traces of EO and ECH for the subject device are below the limits specified in ISO 10993-7. |
| EO and ECH Tolerable Contact Limit (TCL) | TCL of EO and ECH are below limits specified in ISO 10993-7. | The TCL of EO and ECH for the subject device are below the limits specified in ISO 10993-7. |
| Bacterial Endotoxin Levels | Bacterial endotoxins are not present above the endotoxin limit specified in FDA guidance document (June 2012), USP<85>, and European Pharmacopeia BET 2.6.14. | The test results demonstrated that the bacterial endotoxins were not present above the endotoxin limit specified in FDA guidance document (June 2012), USP<85>, and European Pharmacopeia BET 2.6.14. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Physical, Surface Contamination, Time-Temperature, Tensile Tests: The document states "All test samples passed testing," but the specific number of samples for each bench test is not provided.
- Animal Testing (Usability & Histopathology): "an acute swine model" (number of animals not specified). "four porcine tissue types" (liver, lung, kidney, skeletal muscle) with "triplicated sites" for histopathology.
- US Clinical Study: Up to 30 participants. Prospective, non-randomized feasibility study. Data provenance is US (United States).
- OUS Clinical Study: Up to 30 participants. Prospective, non-randomized feasibility study. Data provenance is OUS (Outside United States), specific country not mentioned.
- EMC, ES, Biocompatibility, Shelf Life, Packaging, Sterilization, Residuals, Endotoxin Tests: "All test samples passed" or "results confirmed," but specific sample sizes for these tests are generally not detailed in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Bench Tests (Physical, etc.): No information about experts or their qualifications is provided; these tests rely on objective measurements.
- Animal Testing (Usability): Mentions "All Usability Evaluation Ratings scored ≥3 (acceptable)" but does not specify the number or qualifications of evaluators/experts.
- Animal Testing (Histopathological Assessment): Implies evaluation by qualified personnel for histopathological analysis, but the number and specific qualifications are not stated.
- Clinical Studies (US & OUS): Clinical outcomes (hematoma formation, blood loss, need for ultrasound, reintervention, hospital discharge) would be assessed by medical professionals, likely physicians. However, the number and specific qualifications of these "experts" (e.g., attending physicians, surgeons, radiologists) who evaluated the outcomes or contributed to the ground truth are not specified in this document.
4. Adjudication Method for the Test Set
- No specific adjudication method (e.g., 2+1, 3+1, none) is mentioned for any of the studies or tests. The clinical studies evaluated "Primary Study Outcomes" and "Secondary Study Outcomes" which would imply clinical assessment by treating physicians.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The studies performed (bench, animal, clinical) primarily focused on demonstrating the safety and performance of the Kronos Electrocautery Device itself, and its substantial equivalence to a predicate device, rather than comparing human reader performance with and without AI assistance. The device in question is an electrocautery tool, not an AI software.
6. Standalone (Algorithm Only) Performance Study
- Not applicable/Not done. This device is a physical electrocautery tool, not an AI algorithm, so a standalone algorithm-only performance study would not be relevant.
7. Type of Ground Truth Used
- Physical/Bench Tests: Objective measurements against pre-defined specifications.
- Animal Testing: In vivo performance in swine model, and histopathological analysis of porcine tissue. This is a form of objective test data and expert histological assessment.
- Clinical Studies (US & OUS): Clinical observations and outcomes data (e.g., absence of hematoma, amount of blood loss, need for ultrasound, reintervention, time to hospital discharge). This is a form of clinical outcome data and physician assessment.
8. Sample Size for the Training Set
- Not applicable/Not mentioned. This device is hardware for electrocautery, not a software or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As a non-AI device, there is no training set or ground truth establishment method for a training set.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 25, 2024
Single Pass, Inc. Bill Colone CEO 105 North Pointe Drive Suite B Lake Forest, California 92630
Re: K232805
Trade/Device Name: Kronos Electrocautery Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: September 5, 2023 Received: March 17, 2024
Dear Bill Colone:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.04.25 09:23:25 -04'00' Mark Trumbore, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232805
Device Name Kronos Electrocautery Device
Indications for Use (Describe)
The Kronos Electrocautery Device is indicated to be used as a tool to achieve hemostasis through coagulation for liver. kidney, and lung soft tissue.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Kronos Electrocautery Device 510(k) Summary
This 510(k) summary for Kronos Electrocautery Device is submitted in accordance with the requirements of 21 CFR 807.87(h) and 807.92 and following the recommendation outlined in FDA Guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)], dated 28 July, 2014.
SUBMITTER [807.92(a)(1)]
Single Pass, Inc. 105 North Pointe Drive, Suite B Lake Forest, CA 92630
| Contact Person: | Bill Colone |
|---|---|
| 105 North Pointe Drive, Suite B | |
| Lake Forest, CA 92630 | |
| United States | |
| Telephone: | 602-618-3377 |
| E-mail: | bcolone@singlepass.co |
| Date prepared: | September 05, 2023 (revised February 29, 2024) |
DEVICE [807.92(a)(2)]
| Name of Device: | Kronos Electrocautery Device |
|---|---|
| Common or Usual Name: | Unit, Cautery, Thermal, Battery-Powered |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Product Code: | GEI |
| Regulatory Class: | Class II |
| Submission Type: | Traditional 510(k) |
| Regulation Number: | 21 C.F.R. 878.4400 |
| Reviewing Product Branch: | General and Plastic Surgery Device (Office of Device EvaluationCDRH) |
PREDICATE DEVICE [807.92(a)(3)]
Bovie Cautery Device (K121441)
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DEVICE DESCRIPTION [807.92(a)(4)]
The Kronos Electrocautery Device is a single-use, disposable and battery-operated electrocautery device utilized to control bleeding post-biopsy procedure of solid organs (i.e., liver, kidney, lungs, etc.). The Kronos electrosurgical device consists of:
-
a power supply: Two AA batteries
-
a Stainless Steel (SS) distal probe with a rounded heated tip that is connected to the handle to cauterize targeted areas of tissue. The tip is heated (75 °C - 100 °C) via electrical current through a coiled wire. The temperature of the distal tip is controlled with a thermistor while the temperature of the tip is distributed with a thermal conductive epoxy.
-
The ergonomic handle includes an on/off switch and a push button to activate the heated tip.
Kronos Electrocautery Device is available in two models, K10 and K15. K10 model is compatible with 10cm guide needle whereas K15 is compatible with 15cm guide needle.
INDICATIONS FOR USE [807.92(a)(5)]
The Kronos Electrocautery Device is indicated to be used as a tool to achieve hemostasis through coagulation for liver, kidney, and lung soft tissue.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
The technological characteristics of the Kronos Electrocautery Device are substantial equivalent to the technological characteristics of the Bovie Cautery Device previously cleared (K121441). Substantial equivalence is determined based on the following similarities:
- Same intended use
- Similar principles of operation ●
- Similar design, materials of construction, fundamental scientific technology ●
Table 4-1 comprises the comparison between Kronos Electrocautery Device (Subject Device) and Bovie Cautery Device (Predicate Device, K121441).
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| Feature | Bovie Cautery Device | Kronos Electrocautery Device |
|---|---|---|
| [PREDICATE DEVICEK121441] | [SUBJECT DEVICE] | |
| Product Code | GEI | Same |
| Regulatory Class | Class II | Same |
| Regulation Number | 21 CFR 878.4400 | Same |
| Classification Name | Electrosurgical, Cutting &Coagulation & Accessories | Same |
| Generic Name | Battery Operated Cautery;Cauterizer | Same |
| Indications for UseStatement | Bovie Cautery Devices are usedfor stopping small bleeders inhemostasis and other similar uses. | The Kronos ElectrocauteryDevice is indicated to be used asa tool to achieve hemostasisthrough coagulation for softtissues such as liver, kidney,spleen, lymph nodes and varioussoft tissue lesions. |
| Intended Use | Used for stopping bleeding | Used for stopping bleeding |
| Sterility | Single Use; Sterilized by EthyleneOxide; Sterility Assurance Levelof 10-6 | Single Use; Sterilized byEthylene Oxide; SterilityAssurance Level of 10-6 |
| Materials | Patient contacting tips constructedof Nichrome 80 and Kanthal A-1.Cautery handles constructed ofAcrylonitrile Butadiene Styrene(ABS).Cautery tip tubes are embedded inthe handle. | Patient contacting tip is made of316 stainless steel.Patient contacting probe is madeof 304 stainless steel.The handle assembly is made ofABS material. |
| Energy Source | Device is powered by one or two1.5 volt alkaline batteries | Device is powered by two (2)1.5 volt alkaline batteries |
| Feature | Bovie Cautery Device | Kronos Electrocautery Device |
| [PREDICATE DEVICEK121441] | [SUBJECT DEVICE] | |
| Principle of Operation | The device is activated by pressingthe green button on the cauterybody. Once the button is pressed,an internal circuit is completed thatdirects power from an internalbattery to the cautery tip which inturn heats. The heated tip isintroduced to the surgical site andthe heat vaporizes the watercomponent in blood/tissue, causinga clot that halts the bleeding. | The principle of operationinvolves heating of the deviceprobe tip by the use of anelectrical current. The heatedprobe tip is applied directly to thetarget tissue area of treatment tocontrol bleeding. |
| Method of Supply | Sterile, Single Use | Same |
| Configuration | Not Listed | KU10KU15 |
| Probe Outer Diameter | Not Listed | 0.040" |
| Working Length | Not Listed | KU10: 17cmKU15: 22cm |
| Guide NeedleCompatibility | Not Listed | K10: 10cm guide needleK15: 15cm guide needle |
Table 4-1: Predicate Device vs. Subject Device Comparison Table
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PERFORMANCE DATA [807.92(b)]
Performance Bench Testing, Animal Testing, US and OUS Clinical Studies: Results of the performance bench testing, animal testing (usability evaluation and thermal effects histology), US Clinical Studies and OUS Clinical Studies (Table 4-2) indicate that Kronos Electrocautery Device (Subject Device) meets established performance requirements and is substantially equivalent for its intended use.
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| Performance Bench Testing | ||
|---|---|---|
| Tests | Test Method Summary | Results |
| Physical Attribute | Inspected dimensions for distal tip, working length, outer diameter. | All test samples passed testing. |
| Surface Contamination | A microscope was used to inspect the device surface for the presence of particulates. | All test samples passed testing. |
| Time-Temperature Characterization Study | A calibrated thermometer was used to measure the temperature of device while the device was turned on and submerged under water. | All test samples passed testing. |
| Tensile Test | Measured the distal tip tensile force using an Instron tensile tester. | All test samples passed testing. |
| Performance Animal Testing | ||
| Animal Testing (GLP) | Animal testing is to evaluate the in vivo performance of the device in an acute swine model.All Usability Evaluation Ratings scored ≥3 (acceptable) for the following:- Device Condition (Visual Inspection)- Maneuverability to Target Tissue- Device Performance (Blood Control)- Compatibility with Guide NeedleWithdrawal Force were assessed. | All test samples passed testing. |
| HistopathologicalAssessment | The thermal effects of the subject deviceagainst the predicate device in porcinetissue explants using histopathologicanalysis were performed. The subjectdevices and the predicate device were testedon four porcine tissue types including liver,lung, kidney, and skeletal muscle. Thesurface and depth (up to 1.6 cm deep intotissues) of each tissue type was treated attriplicated sites for 10 seconds. Anadditional 10 seconds was added whileremoving the active probe from deeptreatment sites. Control samples wereprepared by penetrating the tissues with theinactive probe without cauterizing thetissues. The treated tissues were evaluatedhistopathologically via light microscopy,and the dimension of the cauterized areaswere measured. | There were no significantdifferences between the thermaldamage induced by subjectdevice as compared to thepredicate device.The subject device is equivalentin safety and efficacy of thepredicate device.The intensity of the thermaldamage and structure ofcauterized areas were similar.Mild cellular damage alongwith tinctorial changes werefound at the site of treatments inall tissues. There was no majorthermal damage beyond theactive tip of the probe. Thesubject device induced astronger thermal injury on thesurface of the tissues with visibleburn margins separating thetreatment sites from the adjacenthealthy tissues. |
Table 4-2: Performance Bench Testing and Animal Testing Summary
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| Performance US Clinical Study | ||
|---|---|---|
| US Clinical Study | The primary objective for this study is to assesssafety and performanceof the Kronos Electrocautery Device forelectrocautery proceduresfollowing a biopsy procedure in the liver, lung,kidney, etc. | All Test Samples PassedPrimary and SecondaryOutcomes |
| This was designed as a multicenter,prospective, non-randomized feasibility studydesigned to evaluate the performance of theKronos Electrocautery Device. It was plannedfor up to 30 participants with theinvolvement of each participant lasting up to14 days. | ||
| Primary Study Outcomes: | ||
| - Absence of Hematoma formation | ||
| - Measure and categorize amount ofblood loss from biopsy access site | ||
| - Absence of the need for ultrasoundexamination due to observation ofbleeding |
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| Secondary Study Outcomes:- Absence of secondary reintervention- Time to hospital discharge | ||
|---|---|---|
| Performance OUS Clinical Study | ||
| OUS Clinical Study | The objective of this study was to verifyoptimal withdrawal parameters in humansto reduce and control bleeding following abiopsy procedure in solid tissue organs andto assess preliminary usabilityevaluations of the Kronos ElectrocauteryDevice.This was a single-center, prospective, non-randomized feasibility study designed toevaluate the performance of the KronosElectrocautery Device. It was designed forup to 30 participants with theinvolvement of each participant lasting upto 14 days.Primary Study Outcomes:- Absence of Hematoma formation- Measure and categorize amount ofblood loss from biopsy access site- Absence of the need for ultrasoundexamination due to observation ofbleedingSecondary Study Outcomes:- Absence of secondary reintervention- Time to hospital discharge | - All Test Samples PassedPrimary and SecondaryOutcomes |
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Electrocautery Device (Subject Device) is electromagnetically compatible (EMC) and electrically safe (ES) and compatible with common environments.
| Test | Results | Conclusion | |
|---|---|---|---|
| ElectromagneticallyCompatibility (EMC) | TestRadiated Emissions | ResultComplies | electromagneticallycompatible |
| AC Mains ConductedEmissions | The EUT is battery operated.Therefore, such test is not necessary | ||
| Harmonics | The EUT is battery operated.Therefore, such test is not necessary | ||
| Flicker | The EUT is battery operated.Therefore, such test is not necessary | ||
| Electro-Static DischargeImmunity Test | Complies | ||
| Radiated, Radio Frequency,Electromagnetic Immunity | Complies | ||
| Proximity Fields from RFWireless CommunicationsEquipment | Complies | ||
| Electrical Fast Transient/BurstImmunity Test | The EUT is battery operated.Therefore, such test is not necessary | ||
| Immunity to Surges | The EUT is battery operated.Therefore, such test is not necessary | ||
| Conducted, Radio-Frequency,Electromagnetic ImmunityTest | The EUT is battery operated.Therefore, such test is not necessary | ||
| Power Frequency MagneticField Immunity Test | Complies | ||
| Voltage Dips/InterruptionImmunity Test | The EUT is battery operated.Therefore, such test is not necessary | ||
| Radiated fields in closeproximity - Immunity Test | Complies | ||
| IEC 60601-1-2 Clause 5Worksheet | Complies | ||
| Electrical Safety (ES) | TestHumidity Preconditions | ||
| Accessible Parts | Pass | ||
| Leakage Current Test | Pass | ||
| Dielectric Strength Means | Pass | ||
| Ball Pressure Test | Pass | ||
| Creepage & ClearanceMeasurements | N/A | ||
| Excessive Temperature | Pass | ||
| Push | Pass | ||
| Drop (Hand-held and Body-worn) | Pass | ||
| Molding Stress Relief | Pass |
Table 4-3: Safety Standards Test Summary
Biocompatibility: Results of the biocompatibility testing (Table 4-4) indicate that the Kronos Electrocautery Device (Subject Device) is biocompatible and is substantially equivalent for its intended use.
| Test | Results | Conclusion |
|---|---|---|
| Sensitization | There was no irritation noted at any test site24 or 48 hours after the challenge patchremoval for physiological sale (polarextract) or sesame oil (non-polar extract). | Non-sensitizer |
Table 4-4: Biocompatibility Test Summary
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| Irritation or Intracutaneous | The primary irritation index (PII) of the testarticle was 1.0 or less. | Non-irritant |
|---|---|---|
| Acute Systemic Toxicity | No gross abnormalities were noted for anyof the animals when necropsied at theconclusion of the 3-day observation period. | Non-cytotoxic |
| Systemic Toxicity -ISOMaterials Mediated RabbitPyrogen | During the 3-hour observation period, noneof the rabbits administered with the testarticle extract had a temperature rise ≥0.5℃at the required observation time points. Thisresponse did not exceed the USP limit andmeets the requirements for this test.Therefore, these results indicate that the testarticle was determined to be non-pyrogenic. | Non-pyrogenic |
Shelf life: The accelerated shelf life testing for Kronos Electrocautery Device has been conducted (T=2 year accelerated aging) with test results confirmed that all acceptance criteria were met. No new questions of safety or effectiveness are raised. Based on the results, we can conclude that Kronos Electrocautery Device will perform as intended to the Design Specification. Kronos Electrocautery Device will be labeled for 2-year shelf life.
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Packaging: The packaging validation, T=2 year accelerated aging was performed on the Kronos Electrocautery Device. The results from packaging testing conducted on Kronos Electrocautery Device showed that the acceptance criteria were met. Therefore, we can conclude the Kronos Electrocautery Device packaging will provide the adequate and effective protection and sterile barrier requirements.
Sterilization: Kronos Electrocautery Device is sterilized using 100% Ethylene Oxide (EtO) gas in the same manner as FDA cleared predicate device, Bovie Cautery Device (K121441). Kronos Electrocautery Device is supplied sterile, for single use and single patient only. The sterilization validation was performed and is documented. The sterilization results showed that the sterilization dose and routine sterilization process was validated to achieve an SAL of 10° for the Kronos Electrocautery Device.
| Test Description | Test Summary | Results |
|---|---|---|
| Original Sterilizationvalidation and Adoption | 100% EO is used to sterilizethe device to achieve aminimum SAL of 10-6. Thevalidation was conducted inaccordance with ISO 11135.The original validation of theEO sterilization cycle of apredicate device wasperformed using one (1)fractional exposure cycle,three (3) half exposure cyclesand one (1) full exposurecycle, an overkill approachdescribed in ISO 11135. Thesubject device was adopted tothe original validatedsterilization cycle byperforming one (1) full cycle. | The validation studydemonstrated that thesterilization process andequipment are capable ofreliably and consistentlysterilizing the devices to aminimum SAL of 10-6. TheBI results confirm theacceptable lethality of thesterilization cycle to achievethe required SAL of 10-6.Fractional cycles, half cycles,and full cycles met theacceptance criteria. Thesubject device wassuccessfully adopted to theoriginal sterilizationvalidation. |
| EO and ECH Residuals | EO and ECH residuals weremeasured per ISO 10993-7. | The residual traces of EO andECH for the subject deviceare below the limits specifiedin ISO 10993-7. |
| EO andECH TolerableContact Limit (TCL) | EO and ECH TCL weremeasured per ISO 10993-7. | The TCL of EO and ECH forthe subject device are below |
{13}------------------------------------------------
| the limits specified in ISO 10993-7. | ||
|---|---|---|
| Bacterial Endotoxin Levels | LAL testing was conducted in accordance with FDA guidance document (June 2012), USP<85>, and European Pharmacopeia BET 2.6.14 | The test results demonstrated that the bacterial endotoxins were not present above the endotoxin limit specified in FDA guidance document (June 2012), USP<85>, and European Pharmacopeia BET 2.6.14 |
CONCLUSIONS
We conclude from the indications for use, technological characteristics, and performance testing data and evidence that the subject device, the Kronos Electrocautery Device, is substantially equivalent to and as safe and effective as the predicate device, Bovie Cautery 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.