Kronos Electrocautery Device

K232805 · Single Pass, Inc. · GEI · Apr 25, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K232805
• Device Name: Kronos Electrocautery Device
• Applicant: Single Pass, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 25, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kronos Electrocautery Device is indicated to be used as a tool to achieve hemostasis through coagulation for liver, kidney, and lung soft tissue.

Device Story

Single-use, battery-operated electrocautery device; used to control bleeding post-biopsy of solid organs (liver, kidney, lung). Device consists of handle with on/off switch/push button, and stainless steel distal probe with rounded heated tip. Operation: user presses button to complete circuit; two AA batteries power coiled wire to heat tip (75°C–100°C); thermistor controls temperature; thermal conductive epoxy distributes heat. Heated tip applied directly to surgical site; heat vaporizes water in blood/tissue to create clot. Used by clinicians in surgical/procedural settings. Output is thermal energy for coagulation; aids in hemostasis, potentially reducing hematoma formation and need for reintervention.

Clinical Evidence

Evidence includes bench testing, GLP animal studies (swine model), and two prospective, non-randomized feasibility studies (one US, one OUS). Animal studies evaluated usability and thermal effects (histopathology) in liver, lung, kidney, and skeletal muscle, showing no significant difference in thermal damage compared to predicate. Clinical studies (up to 30 participants each) assessed safety/performance via hematoma absence, blood loss categorization, and reintervention rates; all primary and secondary outcomes met acceptance criteria.

Technological Characteristics

Battery-powered (2x AA) thermal cautery. Probe: 304 stainless steel; Tip: 316 stainless steel. Handle: ABS. Tip temperature: 75°C–100°C controlled by thermistor. Dimensions: 0.040" outer diameter; 17cm (K10) or 22cm (K15) working length. Sterilization: 100% Ethylene Oxide (ISO 11135). Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1-2.

Indications for Use

Indicated for achieving hemostasis through coagulation in soft tissues including liver, kidney, lung, spleen, lymph nodes, and various soft tissue lesions.

Regulatory Classification

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.

Predicate Devices

• Bovie Cautery Device (K121441)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: | [e-mail] |
| 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 Evaluation<br>CDRH) |

# 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 DEVICE<br>K121441] | [SUBJECT DEVICE] |
| Product Code | GEI | Same |
| Regulatory Class | Class II | Same |
| Regulation Number | 21 CFR 878.4400 | Same |
| Classification Name | Electrosurgical, Cutting &<br>Coagulation & Accessories | Same |
| Generic Name | Battery Operated Cautery;<br>Cauterizer | Same |
| Indications for Use<br>Statement | Bovie Cautery Devices are used<br>for stopping small bleeders in<br>hemostasis and other similar uses. | The Kronos Electrocautery<br>Device is indicated to be used as<br>a tool to achieve hemostasis<br>through coagulation for soft<br>tissues such as liver, kidney,<br>spleen, lymph nodes and various<br>soft tissue lesions. |
| Intended Use | Used for stopping bleeding | Used for stopping bleeding |
| Sterility | Single Use; Sterilized by Ethylene<br>Oxide; Sterility Assurance Level<br>of 10-6 | Single Use; Sterilized by<br>Ethylene Oxide; Sterility<br>Assurance Level of 10-6 |
| Materials | Patient contacting tips constructed<br>of Nichrome 80 and Kanthal A-1.<br>Cautery handles constructed of<br>Acrylonitrile Butadiene Styrene<br>(ABS).<br>Cautery tip tubes are embedded in<br>the handle. | Patient contacting tip is made of<br>316 stainless steel.<br>Patient contacting probe is made<br>of 304 stainless steel.<br>The handle assembly is made of<br>ABS material. |
| Energy Source | Device is powered by one or two<br>1.5 volt alkaline batteries | Device is powered by two (2)<br>1.5 volt alkaline batteries |
| Feature | Bovie Cautery Device | Kronos Electrocautery Device |
| | [PREDICATE DEVICE<br>K121441] | [SUBJECT DEVICE] |
| Principle of Operation | The device is activated by pressing<br>the green button on the cautery<br>body. Once the button is pressed,<br>an internal circuit is completed that<br>directs power from an internal<br>battery to the cautery tip which in<br>turn heats. The heated tip is<br>introduced to the surgical site and<br>the heat vaporizes the water<br>component in blood/tissue, causing<br>a clot that halts the bleeding. | The principle of operation<br>involves heating of the device<br>probe tip by the use of an<br>electrical current. The heated<br>probe tip is applied directly to the<br>target tissue area of treatment to<br>control bleeding. |
| Method of Supply | Sterile, Single Use | Same |
| Configuration | Not Listed | KU10<br>KU15 |
| Probe Outer Diameter | Not Listed | 0.040" |
| Working Length | Not Listed | KU10: 17cm<br>KU15: 22cm |
| Guide Needle<br>Compatibility | Not Listed | K10: 10cm guide needle<br>K15: 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 <i>in vivo</i> performance of the device in an acute swine model.<br>All Usability Evaluation Ratings scored ≥3 (acceptable) for the following:<br>- Device Condition (Visual Inspection)<br>- Maneuverability to Target Tissue<br>- Device Performance (Blood Control)<br>- Compatibility with Guide Needle<br>Withdrawal Force were assessed. | All test samples passed testing. |
| Histopathological<br>Assessment | The thermal effects of the subject device<br>against the predicate device in porcine<br>tissue explants using histopathologic<br>analysis were performed. The subject<br>devices and the predicate device were tested<br>on four porcine tissue types including liver,<br>lung, kidney, and skeletal muscle. The<br>surface and depth (up to 1.6 cm deep into<br>tissues) of each tissue type was treated at<br>triplicated sites for 10 seconds. An<br>additional 10 seconds was added while<br>removing the active probe from deep<br>treatment sites. Control samples were<br>prepared by penetrating the tissues with the<br>inactive probe without cauterizing the<br>tissues. The treated tissues were evaluated<br>histopathologically via light microscopy,<br>and the dimension of the cauterized areas<br>were measured. | There were no significant<br>differences between the thermal<br>damage induced by subject<br>device as compared to the<br>predicate device.<br>The subject device is equivalent<br>in safety and efficacy of the<br>predicate device.<br>The intensity of the thermal<br>damage and structure of<br>cauterized areas were similar.<br>Mild cellular damage along<br>with tinctorial changes were<br>found at the site of treatments in<br>all tissues. There was no major<br>thermal damage beyond the<br>active tip of the probe. The<br>subject device induced a<br>stronger thermal injury on the<br>surface of the tissues with visible<br>burn margins separating the<br>treatment sites from the adjacent<br>healthy 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 assess<br>safety and performance<br>of the Kronos Electrocautery Device for<br>electrocautery procedures<br>following a biopsy procedure in the liver, lung,<br>kidney, etc. | All Test Samples Passed<br>Primary and Secondary<br>Outcomes |
| This was designed as a multicenter,<br>prospective, non-randomized feasibility study<br>designed to evaluate the performance of the<br>Kronos Electrocautery Device. It was planned<br>for up to 30 participants with the<br>involvement of each participant lasting up to<br>14 days. | | |
| Primary Study Outcomes: | | |
| - Absence of Hematoma formation | | |
| - Measure and categorize amount of<br>blood loss from biopsy access site | | |
| - Absence of the need for ultrasound<br>examination due to observation of<br>bleeding | | |

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| | Secondary Study Outcomes:<br>- Absence of secondary reintervention<br>- Time to hospital discharge | |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Performance OUS Clinical Study | | |
| OUS Clinical Study | The objective of this study was to verify<br>optimal withdrawal parameters in humans<br>to reduce and control bleeding following a<br>biopsy procedure in solid tissue organs and<br>to assess preliminary usability<br>evaluations of the Kronos Electrocautery<br>Device.<br><br>This was a single-center, prospective, non-<br>randomized feasibility study designed to<br>evaluate the performance of the Kronos<br>Electrocautery Device. It was designed for<br>up to 30 participants with the<br>involvement of each participant lasting upto 14 days.<br><br>Primary Study Outcomes:<br>- Absence of Hematoma formation<br>- Measure and categorize amount of<br>blood loss from biopsy access site<br>- Absence of the need for ultrasound<br>examination due to observation of<br>bleeding<br><br>Secondary Study Outcomes:<br>- Absence of secondary reintervention<br>- Time to hospital discharge | - All Test Samples Passed<br>Primary and Secondary<br>Outcomes |

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Electrocautery Device (Subject Device) is electromagnetically compatible (EMC) and electrically safe (ES) and compatible with common environments.

| Test | Results | Conclusion | |
|--------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------|
| Electromagnetically<br>Compatibility (EMC) | Test<br>Radiated Emissions | Result<br>Complies | electromagnetically<br>compatible |
| | AC Mains Conducted<br>Emissions | The EUT is battery operated.<br>Therefore, such test is not necessary | |
| | Harmonics | The EUT is battery operated.<br>Therefore, such test is not necessary | |
| | Flicker | The EUT is battery operated.<br>Therefore, such test is not necessary | |
| | Electro-Static Discharge<br>Immunity Test | Complies | |
| | Radiated, Radio Frequency,<br>Electromagnetic Immunity | Complies | |
| | Proximity Fields from RF<br>Wireless Communications<br>Equipment | Complies | |
| | Electrical Fast Transient/Burst<br>Immunity Test | The EUT is battery operated.<br>Therefore, such test is not necessary | |
| | Immunity to Surges | The EUT is battery operated.<br>Therefore, such test is not necessary | |
| | Conducted, Radio-Frequency,<br>Electromagnetic Immunity<br>Test | The EUT is battery operated.<br>Therefore, such test is not necessary | |
| | Power Frequency Magnetic<br>Field Immunity Test | Complies | |
| | Voltage Dips/Interruption<br>Immunity Test | The EUT is battery operated.<br>Therefore, such test is not necessary | |
| | Radiated fields in close<br>proximity - Immunity Test | Complies | |
| | IEC 60601-1-2 Clause 5<br>Worksheet | Complies | |
| | Electrical Safety (ES) | Test<br>Humidity Preconditions | |
| Accessible Parts | | Pass | |
| Leakage Current Test | | Pass | |
| Dielectric Strength Means | | Pass | |
| Ball Pressure Test | | Pass | |
| Creepage & Clearance<br>Measurements | | N/A | |
| Excessive Temperature | | Pass | |
| Push | | Pass | |
| Drop (Hand-held and Body-<br>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 site<br>24 or 48 hours after the challenge patch<br>removal for physiological sale (polar<br>extract) 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 test<br>article was 1.0 or less. | Non-irritant |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Acute Systemic Toxicity | No gross abnormalities were noted for any<br>of the animals when necropsied at the<br>conclusion of the 3-day observation period. | Non-cytotoxic |
| Systemic Toxicity -ISO<br>Materials Mediated Rabbit<br>Pyrogen | During the 3-hour observation period, none<br>of the rabbits administered with the test<br>article extract had a temperature rise ≥0.5℃<br>at the required observation time points. This<br>response did not exceed the USP limit and<br>meets the requirements for this test.<br>Therefore, these results indicate that the test<br>article 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 Sterilization<br>validation and Adoption | 100% EO is used to sterilize<br>the device to achieve a<br>minimum SAL of 10-6. The<br>validation was conducted in<br>accordance with ISO 11135.<br>The original validation of the<br>EO sterilization cycle of a<br>predicate device was<br>performed using one (1)<br>fractional exposure cycle,<br>three (3) half exposure cycles<br>and one (1) full exposure<br>cycle, an overkill approach<br>described in ISO 11135. The<br>subject device was adopted to<br>the original validated<br>sterilization cycle by<br>performing one (1) full cycle. | The validation study<br>demonstrated that the<br>sterilization process and<br>equipment are capable of<br>reliably and consistently<br>sterilizing the devices to a<br>minimum SAL of 10-6. The<br>BI results confirm the<br>acceptable lethality of the<br>sterilization cycle to achieve<br>the required SAL of 10-6.<br>Fractional cycles, half cycles,<br>and full cycles met the<br>acceptance criteria. The<br>subject device was<br>successfully adopted to the<br>original sterilization<br>validation. |
| EO and ECH Residuals | EO and ECH residuals were<br>measured per ISO 10993-7. | The residual traces of EO and<br>ECH for the subject device<br>are below the limits specified<br>in ISO 10993-7. |
| EO and<br>ECH Tolerable<br>Contact Limit (TCL) | EO and ECH TCL were<br>measured per ISO 10993-7. | The TCL of EO and ECH for<br>the subject device are below |

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| | | 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.