Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on basic electrical and thermal control mechanisms, with no mention of AI/ML algorithms for decision-making, image processing, or adaptive control.

Therapeutic

Yes
The device is used to achieve hemostasis through coagulation, which is a method of treating bleeding.

Diagnostic

No

The Kronos Electrocautery Device is described as a tool used to achieve hemostasis through coagulation (controlling bleeding, or treatment), not to identify or monitor medical conditions (diagnosis).

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components including a power supply (batteries), a stainless steel probe with a heated tip, a handle with switches, and internal components like a thermistor and coiled wire. The performance studies also focus on the physical and thermal characteristics of this hardware.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use of the Kronos Electrocautery Device is to achieve hemostasis (stop bleeding) through coagulation of soft tissue (liver, kidney, lung). This is a therapeutic or surgical function performed directly on the patient's tissue.
Device Description: The device description details a tool used for direct intervention on tissue via heat. It's a physical instrument for a medical procedure.
Lack of In Vitro Activity: An In Vitro Diagnostic device is used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The Kronos Electrocautery Device does not perform any analysis or testing on such specimens.
Performance Studies: The performance studies described focus on the device's ability to control bleeding in animal and human tissue in vivo (within a living organism), not on the analysis of in vitro samples.

The Kronos Electrocautery Device is a surgical or therapeutic device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

GEI

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

liver, kidney, and lung soft tissue.

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)

Performance Bench Testing:

Tests: Physical Attribute, Surface Contamination, Time-Temperature Characterization Study, Tensile Test.
Results: All test samples passed testing for all bench tests.

Performance Animal Testing:

Study Type: Animal Testing (GLP) in an acute swine model.
Method Summary: Evaluated in vivo performance. Usability Evaluation Ratings scored ≥3 (acceptable) for Device Condition (Visual Inspection), Maneuverability to Target Tissue, Device Performance (Blood Control), Compatibility with Guide Needle, Withdrawal Force.
Results: All test samples passed testing.
Study Type: Histopathological Assessment.
Method Summary: Compared thermal effects of subject device against predicate device in porcine tissue explants (liver, lung, kidney, skeletal muscle). Tissues treated at triplicated sites for 10 seconds, with an additional 10 seconds for probe removal from deep sites. Control samples involved penetrating tissues with an inactive probe. Evaluated histopathologically via light microscopy, and measured cauterized areas.
Results: No significant differences between thermal damage induced by subject device and predicate device. Intensity of thermal damage and structure of cauterized areas were similar. Mild cellular damage along with tinctorial changes were found at treatment sites in all tissues. No major thermal damage beyond the active tip of the probe. Subject device induced a stronger thermal injury on the surface of tissues with visible burn margins.

Performance US Clinical Study:

Study Type: Multicenter, prospective, non-randomized feasibility study.
Sample Size: Up to 30 participants.
Method Summary: Assessed safety and performance for electrocautery procedures following biopsy in liver, lung, kidney, etc. Participant involvement lasted up to 14 days.
Primary Study 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.
Secondary Study Outcomes: Absence of secondary reintervention, Time to hospital discharge.
Results: All Test Samples Passed Primary and Secondary Outcomes.

Performance OUS Clinical Study:

Study Type: Single-center, prospective, non-randomized feasibility study.
Sample Size: Up to 30 participants.
Method Summary: Verified optimal withdrawal parameters in humans to reduce and control bleeding following biopsy in solid tissue organs and assessed preliminary usability evaluations. Participant involvement lasted up to 14 days.
Primary Study 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.
Secondary Study Outcomes: Absence of secondary reintervention, Time to hospital discharge.
Results: All Test Samples Passed Primary and Secondary Outcomes.

Electromagnetically Compatibility (EMC) and Electrical Safety (ES):

EMC Tests: Radiated Emissions (Complies), AC Mains Conducted Emissions (Not necessary - battery operated), Harmonics (Not necessary - battery operated), Flicker (Not necessary - battery operated), Electro-Static Discharge Immunity Test (Complies), Radiated, Radio Frequency, Electromagnetic Immunity (Complies), Proximity Fields from RF Wireless Communications Equipment (Complies), Electrical Fast Transient/Burst Immunity Test (Not necessary - battery operated), Immunity to Surges (Not necessary - battery operated), Conducted, Radio-Frequency, Electromagnetic Immunity Test (Not necessary - battery operated), Power Frequency Magnetic Field Immunity Test (Complies), Voltage Dips/Interruption Immunity Test (Not necessary - battery operated), Radiated fields in close proximity - Immunity Test (Complies), IEC 60601-1-2 Clause 5 Worksheet (Complies).
ES Tests: Humidity Preconditions (Pass), Accessible Parts (Pass), Leakage Current Test (Pass), Dielectric Strength Means (Pass), Ball Pressure Test (Pass), Creepage & Clearance Measurements (N/A), Excessive Temperature (Pass), Push (Pass), Drop (Hand-held and Body-worn) (Pass), Molding Stress Relief (Pass).
Conclusion: Electromagnetically compatible and electrically safe.

Biocompatibility:

Tests: Sensitization, Irritation or Intracutaneous, Acute Systemic Toxicity, Systemic Toxicity -ISO Materials Mediated Rabbit Pyrogen.
Results: Non-sensitizer, Non-irritant, Non-cytotoxic, Non-pyrogenic. Subject device is biocompatible.

Shelf life:

Study Type: Accelerated shelf life testing (T=2 year accelerated aging).
Results: All acceptance criteria were met. No new questions of safety or effectiveness. Labeled for 2-year shelf life.

Packaging:

Study Type: Packaging validation (T=2 year accelerated aging).
Results: Acceptance criteria were met. Packaging provides adequate and effective protection and sterile barrier requirements.

Sterilization:

Method: 100% Ethylene Oxide (EtO) gas, in accordance with ISO 11135.
Test Description: Original Sterilization validation and Adoption, EO and ECH Residuals, EO and ECH Tolerable Contact Limit (TCL), Bacterial Endotoxin Levels.
Results: Sterilization process reliably achieves a minimum SAL of 10^-6. Subject device successfully adopted to original sterilization validation. Residuals of EO and ECH are below specified limits. Bacterial endotoxins were not present above the endotoxin limit.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K121441

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.

Summary

0

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).

1

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

2

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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3

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 Evaluation
CDRH)

PREDICATE DEVICE [807.92(a)(3)]

Bovie Cautery Device (K121441)

4

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).

5

Feature	Bovie Cautery Device	Kronos Electrocautery Device
	[PREDICATE DEVICE
K121441]	[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 Use
Statement	Bovie Cautery Devices are used
for stopping small bleeders in
hemostasis and other similar uses.	The Kronos Electrocautery
Device is indicated to be used as
a tool to achieve hemostasis
through coagulation for soft
tissues such as liver, kidney,
spleen, lymph nodes and various
soft tissue lesions.
Intended Use	Used for stopping bleeding	Used for stopping bleeding
Sterility	Single Use; Sterilized by Ethylene
Oxide; Sterility Assurance Level
of 10-6	Single Use; Sterilized by
Ethylene Oxide; Sterility
Assurance Level of 10-6
Materials	Patient contacting tips constructed
of Nichrome 80 and Kanthal A-1.
Cautery handles constructed of
Acrylonitrile Butadiene Styrene
(ABS).
Cautery tip tubes are embedded in
the handle.	Patient contacting tip is made of
316 stainless steel.
Patient contacting probe is made
of 304 stainless steel.
The handle assembly is made of
ABS material.
Energy Source	Device is powered by one or two
1.5 volt alkaline batteries	Device is powered by two (2)
1.5 volt alkaline batteries
Feature	Bovie Cautery Device	Kronos Electrocautery Device
	[PREDICATE DEVICE
K121441]	[SUBJECT DEVICE]
Principle of Operation	The device is activated by pressing
the green button on the cautery
body. Once the button is pressed,
an internal circuit is completed that
directs power from an internal
battery to the cautery tip which in
turn heats. The heated tip is
introduced to the surgical site and
the heat vaporizes the water
component in blood/tissue, causing
a clot that halts the bleeding.	The principle of operation
involves heating of the device
probe tip by the use of an
electrical current. The heated
probe tip is applied directly to the
target tissue area of treatment to
control bleeding.
Method of Supply	Sterile, Single Use	Same
Configuration	Not Listed	KU10
KU15
Probe Outer Diameter	Not Listed	0.040"
Working Length	Not Listed	KU10: 17cm
KU15: 22cm
Guide Needle
Compatibility	Not Listed	K10: 10cm guide needle
K15: 15cm guide needle

Table 4-1: Predicate Device vs. Subject Device Comparison Table

6

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.

7

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 Needle
Withdrawal Force were assessed. | All test samples passed testing. |
| Histopathological
Assessment | The thermal effects of the subject device
against the predicate device in porcine
tissue explants using histopathologic
analysis were performed. The subject
devices and the predicate device were tested
on four porcine tissue types including liver,
lung, kidney, and skeletal muscle. The
surface and depth (up to 1.6 cm deep into
tissues) of each tissue type was treated at
triplicated sites for 10 seconds. An
additional 10 seconds was added while
removing the active probe from deep
treatment sites. Control samples were
prepared by penetrating the tissues with the
inactive probe without cauterizing the
tissues. The treated tissues were evaluated
histopathologically via light microscopy,
and the dimension of the cauterized areas
were measured. | 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. |

Table 4-2: Performance Bench Testing and Animal Testing Summary

8

Performance US Clinical Study
US Clinical Study	The primary objective for this study is to assess
safety and performance
of the Kronos Electrocautery Device for
electrocautery procedures
following a biopsy procedure in the liver, lung,
kidney, etc.	All Test Samples Passed
Primary and Secondary
Outcomes
This was designed as a multicenter,
prospective, non-randomized feasibility study
designed to evaluate the performance of the
Kronos Electrocautery Device. It was planned
for up to 30 participants with the
involvement of each participant lasting up to
14 days.
Primary Study 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

9

| | 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 verify
optimal withdrawal parameters in humans
to reduce and control bleeding following a
biopsy procedure in solid tissue organs and
to assess preliminary usability
evaluations of the Kronos Electrocautery
Device.

This was a single-center, prospective, non-
randomized feasibility study designed to
evaluate the performance of the Kronos
Electrocautery Device. It was designed for
up to 30 participants with the
involvement of each participant lasting upto 14 days.

Primary Study 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

Secondary Study Outcomes:

Absence of secondary reintervention
Time to hospital discharge | - All Test Samples Passed
Primary and Secondary
Outcomes |

10

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

Test	Results	Conclusion
Electromagnetically
Compatibility (EMC)	Test
Radiated Emissions	Result
Complies	electromagnetically
compatible
	AC Mains Conducted
Emissions	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 Discharge
Immunity Test	Complies
	Radiated, Radio Frequency,
Electromagnetic Immunity	Complies
	Proximity Fields from RF
Wireless Communications
Equipment	Complies
	Electrical Fast Transient/Burst
Immunity 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 Immunity
Test	The EUT is battery operated.
Therefore, such test is not necessary
	Power Frequency Magnetic
Field Immunity Test	Complies
	Voltage Dips/Interruption
Immunity Test	The EUT is battery operated.
Therefore, such test is not necessary
	Radiated fields in close
proximity - Immunity Test	Complies
	IEC 60601-1-2 Clause 5
Worksheet	Complies
	Electrical Safety (ES)	Test
Humidity Preconditions
Accessible Parts		Pass
Leakage Current Test		Pass
Dielectric Strength Means		Pass
Ball Pressure Test		Pass
Creepage & Clearance
Measurements		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 site
24 or 48 hours after the challenge patch
removal for physiological sale (polar
extract) or sesame oil (non-polar extract).	Non-sensitizer

Table 4-4: Biocompatibility Test Summary

11

| Irritation or Intracutaneous | The primary irritation index (PII) of the test
article was 1.0 or less. | Non-irritant |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Acute Systemic Toxicity | No gross abnormalities were noted for any
of the animals when necropsied at the
conclusion of the 3-day observation period. | Non-cytotoxic |
| Systemic Toxicity -ISO
Materials Mediated Rabbit
Pyrogen | During the 3-hour observation period, none
of the rabbits administered with the test
article extract had a temperature rise ≥0.5℃
at the required observation time points. This
response did not exceed the USP limit and
meets the requirements for this test.
Therefore, these results indicate that the test
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.

12

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
validation and Adoption	100% EO is used to sterilize
the device to achieve a
minimum SAL of 10-6. The
validation was conducted in
accordance with ISO 11135.
The original validation of the
EO sterilization cycle of a
predicate device was
performed using one (1)
fractional exposure cycle,
three (3) half exposure cycles
and one (1) full exposure
cycle, an overkill approach
described in ISO 11135. The
subject device was adopted to
the original validated
sterilization cycle by
performing one (1) full cycle.	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	EO and ECH residuals were
measured per 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)	EO and ECH TCL were
measured per ISO 10993-7.	The TCL of EO and ECH for
the 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, 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, 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.