Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the electrical and mechanical aspects of electrocoagulation and hemostasis, with no mention of AI or ML capabilities.

Therapeutic

Yes
The device is described as causing coagulation of cellular tissue using heat and is intended for dermatologic and general surgical procedures for electro coagulation and hemostasis, which are therapeutic interventions.

Diagnostic

No

The device description clearly states its purpose is for "electro coagulation and hemostasis," which are therapeutic or surgical procedures, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a main frame, active electrodes, handpiece, foot switch, and power cable. It also describes the physical principle of operation involving electrical current and heat generation, which is characteristic of a hardware-based device.

IVD (In Vitro Diagnostic)

Based on the provided information, the INTRAgen device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is for "dermatologic and general surgical procedures for electro coagulation and hemostasis." This describes a procedure performed directly on a patient's tissue, not on samples taken from the body.
Device Description: The device description details how it uses high-frequency current to heat and coagulate tissue. This is a physical interaction with the body, not an analysis of biological samples.
Mechanism of Action: The principle of operation is based on the heat generated by electrical resistance in the tissue, leading to coagulation. This is a therapeutic/surgical action, not a diagnostic test performed on a sample.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue biopsies, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.

In summary, the INTRAgen is a surgical device used for tissue treatment (coagulation and hemostasis) and does not fit the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

INTRAgen is intended for dermatologic and general surgical procedures for electro coagulation and hemostasis.

Product codes (comma separated list FDA assigned to the subject device)

OUH, GEI

Device Description

The INTRAgen uses the principle that coagulation of cellular tissue is caused using the heat generated by the load or contact resistance by carrying high frequency current to the body.

Active electrodes of INTRAgen have 2 types according to effective area: model KT-07 (7 mm x 7 mm) and model KT-15 (15 mm x 15 mm). Electrical current flows through the tip of the electrode, through the target tissue and to the patient plate. The active electrodes are for single use. Patient contacting materials are PCB (Polychlorinated Biphenyl) and ABS (Acrylonitrile-Butadiene-Styrene Copolymer).

The INTRAgen consists of the following components:

INTRAgen (Main Frame)
Active Accessory : Active Electrode(KT-07 (7 mm x 7 mm), KT-15 (15 mm x 15 mm)), Handpiece Hanger and Hand-piece
Miscellaneous Accessories : Foot Switch and Power Cable

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Electrical Safety and Electromagnetic Compatibility: The tests were performed on the INTRAgen to confirm electrical safety and electromagnetic compatibility in accordance with IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2. The results were acceptable.
Biocompatibility: The patient contacting part of the INTRAgen is the active electrode and it is made of PCB (Polychlorinated Biphenyl) and ABS (Acrylonitrile-Butadiene-Stvrene Copolymer). Biocompatibility test has been conducted according to the ISO 10993-1 standards, and the test results support that it is biocompatible.
Bench Data: Bench tests were performed to evaluate the dimensional accuracy, the accuracy of measurement for impedance, the accuracy of the active electrode output and output waveform. The test results were acceptable. An additional bench test was performed to demonstrate that the temperature of the skin surface does not go up to the point where it can cause damage to the skin tissue even when the cooling system is not used. The results demonstrated that the temperature of the skin surface did not go up to the point where it could cause damage to the skin tissue.
Pre-Clinical: A pre-clinical trial was performed to evaluate performance of the subject device. The test was performed on a porcine tissue model using different joule energy levels and active electrodes.
- Study purpose: The study was designed to evaluate the effects of the novel grid fractional RF treatment on skin structure and collagen in vivo.
- Follow up periods/days: The wound healing response was evaluated histologically and by RT-PCR up to 10 weeks post-RF treatment.
- Animal type: Porcine
- Treatment applied: The INTRAgen RF device was used to deliver RF energy to skin.
- Histology evaluation: The study results showed that vigorous wound healing response was initiated post-treatment with progressive increase in inflammatory cell infiltration from day 2 through 10 weeks. Furthermore, through both immune histochemical and PCR studies, it was found that profound neocollagenesis and neoelastogenesis following RF treatment of micropigskin occurred.
- In conclusion, the test results of the pre-clinical study demonstrated that the subject device is substantially equivalent to the predicate device.
Sterilization: The active electrodes (KT-07 and KT-15) are sterilized in its final packaging using 20% Ethylene Oxide (EtO) and 80% CO2. The EtO sterilization process has been validated in accordance with ISO 11135-1:2007.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K023365

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized image of three human profiles facing right, with a design that resembles a bird or flowing fabric above them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 4, 2015

Jeisys Medical Incorporated % Ms. Priscilla Chung LK Consulting Group USA Incorporated 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831

Re: K142833

Trade/Device Name: INTRAgen Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: OUH GEI Dated: April 28, 2015 Received: April 30, 2015

Dear Ms. Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K142833

Device Name

INTRAgen

Indications for Use (Describe)

INTRAgen is intended for dermatologic and general surgical procedures for electro coagulation and hemostasis.

Type of Use (Select one or both, as applicable)

| > Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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3

510(k) Summary

[As required by 21 CRF 807.92] (K142833)

1. Date Prepared

June 3, 2015

2. Submitter's Information

Name of 510K Applicant / Manufacturer:
Jeisys Medical Inc.

307, Daeryung Techno Town 8th, 481-11, Gasan-dong, Geumcheon-gu, Seoul, 153-775, Korea,

Contact Name: KyungWon Hwang (Mr.) / RA Manager .
- -Telephone No. : +82 2 2603 6417
- -Fax No. :

●

+82 2 2603 6447 Email Address : lhs1436@jeisys.com
Registration Number: 3006985163 .

Trade Name, Common Name, and Classification 3.

. Trade Name: INTRAgen
Common Name: Electrosurgical Unit .
Classification Name: Electrosurgical cutting and . coagulation device and accessories.
- Classification Panel: General & Plastic Surgery
Classification Regulation: 21 CFR 878.4400 •
Primary Product Code: ойн • Secondary Product Code: GEI

4

. Device Class: ll

4. Identification of Predicate Device(s)

The identified predicate devices within this submission are shown as follow;

510(k) Number: K023365 .
Applicant: ●
Common Name: .

Thermage Inc. Electrosurgical Unit

Device Name:
Thermage ThermaCool System

5. Description of the Device

The INTRAgen uses the principle that coagulation of cellular tissue is caused using the heat generated by the load or contact resistance by carrying high frequency current to the body.

Active electrodes of INTRAgen have 2 types according to effective area: model KT-07 (7 mm x 7 mm) and model KT-15 (15 mm x 15 mm). Electrical current flows through the tip of the electrode, through the target tissue and to the patient plate. The active electrodes are for single use. Patient contacting materials are PCB (Polychlorinated Biphenyl) and ABS (Acrylonitrile-Butadiene-Styrene Copolymer).

The INTRAgen consists of the following components:

INTRAgen (Main Frame) .
. Active Accessory : Active Electrode(KT-07 (7 mm x 7 mm), KT-15 (15 mm x 15 mm)), Handpiece Hanger and Hand-piece
. Miscellaneous Accessories

: Foot Switch and Power Cable

6. Intended Use

The INTRAgen is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

5

7. Technological Characteristics

Based on a technical feature comparison, the subject device was found to have the same output frequency as the predicate devices. The design and the components of the INTRAgen including the RF generator and the handpiece applicator are similar to the predicate.

However, the subject device has a different power output, tip energy and electrode size from the predicate device. The power output of the subject device is 5 W - 136 W while that of the predicate device is 330 W. The tip energy of the subject device is 10 J – 136 J while that of the predicate device is 52 J - 220 J. The subject device has two types of tip size (7 mm x 7 mm and 15 mm x 15 mm) whereas the predicate device has three types of tip size (25 mm x 25 mm, 15 mm x 15 mm and 30 mm x 30 mm).The differences are insignificant and do not influence the safety or efficacy of the device as shown in the performance tests provided in section 9.

Description	INTRAgen
510(K) Number	K142833
Indications for Use	Dermatologic and general surgical procedures for electro coagulation and hemostasis.
Electrosurgical Unit	Major Functions	1. Monopolar
		2. Impedance monitor
	Performance Specifications	Output Frequency
		Power Output

		Tip Energy

		Fluence

Physical Specifications	1. Dimensions: 365.0 * 454.8 * 795.5 ( mm)
	2. Weight: 28 kg

The detailed information on INTRAgen's specifications is shown in the following table:

6

Active Accessory	Monopolar or Bipolar	Monopolar
	Physical
Dimensions and
Design	KT-07:
31 * 30.4 * 30.3 (mm)
(width * length * height)
KT-15:
31 * 30.4 * 29.4 (mm)
(width * length *height)
	Effective Area	KT-07: 7 * 7 (mm)
		KT-15: 15 * 15 (mm)
	Materials(Patient contact)	PCB
(polychlorinated biphenyl)
ABS (Acrylonitrile-Butadiene-
Styrene Copolymer)
	Foot Pedal	Physical Specification	1) Dimensions: 130 * 150 * 134.6 (mm) (width * length *height)

Cable length: 2 (m)
Weight: 1 kg | | | | | | | | | | | | | | | | | |
| Power adjustment increment | Level Joules (J) T 5 1 45 2 60 3 75 4 91 5 105 6 134 7 136 | | | | | | | | | | | | | | | | | | | |
| On/Off Time | KT-07 On: 2 sec
Off: 0 sec KT-15 On: 1 sec
Off: 0 sec | | | | | | | | | | | | | | | | | | | |
| | Use or Non-use of Coupling gels | | Use | | | | | | | | | | | | | | | | | |
| Skin Cooling Methods | | Not use | | | | | | | | | | | | | | | | | | |
| Ointment and/or Drug Product Use | | Not use | | | | | | | | | | | | | | | | | | |

7

8. Substantial Equivalence

Substantial equivalence to the following predicate devices is claimed:

| Description | | Proposed
[INTRAgen] | Predicate
[Thermage
ThermaCool
System] | Remark | |
|----------------------------------|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------------|
| 510(K) Number | | K142833 | K053365 | - | |
| Indications for Use | | The INTRAgen is
indicated for use in
dermatologic and
general surgical
procedures for
electrocoagulation
and hemostasis. | The Thermage
ThermaCool System
is indicated for use in
Dermatologic and
General Surgical
procedures for
electrocoagulation
and hemostasis". | Same | |
| Electr
osurgi
cal
Unit | Major Functions | 1. Monopolar
2. Impedance
monitor | 1. Monopolar
2. Impedance
monitor
3. Temperature
monitor | Performance
Testing | |
| | Performance
Specifications | Output
Frequency | 6 MHz | 6 MHz | Same |
| | | Power
Output | KT-07:
5 W - 35 W
KT-15:
5 W - 136 W | 330 W | Electrical
Safety
Testing
(IEC
60601-2-
2) and
Animal
Study |
| | | Tip Energy | KT-07:
10 J - 70 J
KT-15:
20 J - 136 J | 52 J - 220 J | Performa-
nce
Testing
and |
| | | | | | Animal
Study |
| | | Fluence | KT-07:
20 – 144 J/cm²
KT-15:
2 – 60 J/cm² | 225 J/cm² | Performa-
nce
Testing
and
Animal
Study |
| | Physical Specifications | | 1. Dimensions:
365.0 * 454.8 *
795.5 (mm)
2. Weight: 28 kg | Not known | - |
| Active
Accessory | Monopolar or Bipolar | | Monopolar | Monopolar | Same |
| | Physical
Dimensions
and Design | Dimensions | KT-07:
31 * 30.4 * 30.3
(mm)
(width * length *
height)
KT-15:
31 * 30.4 * 29.4
(mm)
(width * length *
height) | 2.5 * 2.5 (mm),
15 * 15 (mm),
30 * 30 (mm) | Performa-
nce
Testing |
| | | Effective
Area | KT-07: 7 * 7 (mm)
KT-15: 15 * 15
(mm) | 15 * 15 (mm),
2.5 * 2.5 (mm),
30 * 30 (mm) | |
| | | Materials(Patient contact) | PCB
(polychlorinated
biphenyl)
ABS (Acrylonitrile-
Butadiene-Styrene
Copolymer) | Polymid film | Biocompatibility
Testing |
| Foot
Pedal | Physical Specification | | 1) Dimensions:
130 * 150 *
134.6 (mm)
(width * length *
height)
2) Cable length: 2
(m)
3) Weight: 1 kg | Not known | - |
| Power adjustment increment | Level | Joules (J) | Level | Joules (J) | Performa- |
| | T | 5 | 10.5 | 52 | nce
Testing
and
Animal
Study |
| | 1 | 45 | 11.0 | 58 | |
| | 2 | 60 | 11.5 | 65 | |
| | 3 | 75 | 12.0 | 72 | |
| | 4 | 91 | 12.5 | 79 | |
| | 5 | 105 | 13.0 | 87 | |
| | 6 | 134 | 13.5 | 95 | |
| | 7 | 136 | 14.0 | 103 | |
| | | | 14.5 | 112 | |
| | | | 15.0 | 121 | |
| | | | 15.5 | 131 | |
| | | | 16.0 | 140 | |
| | | | 16.5 | 151 | |
| | | | 17.0 | 161 | |
| | | | 17.5 | 172 | |
| | | | 18.0 | 184 | |
| | | | 18.5 | 195 | |
| | | | 19.0 | 207 | |
| | | | 19.5 | 220 | |
| On/Off Time | KT-07 | On: 2 sec
Off: 0 sec | Not Known | | Performa-
nce
Testing
and
Animal
Study |
| | KT-15 | On: 1 sec
Off: 0 sec | | | |
| Use or Non-use of Coupling gels | Use | | Use | | Same |
| Skin Cooling Methods | Not use | | Uses a bio-safe
cryogen
Tetrafluoroethane | | Performa-
nce
Testing |
| Ointment and/or Drug Product Use | Not use | | Not known | | |

8

9

The indications for use and technological characteristics of the INTRAgen device are substantially equivalent to theThermageThermaCool System. The key technological characteristics of the INTRAgen, such as energy type and operating principle, are equivalent to the predicate device.The design and components in the INTRAgen device, including the RF generator and the hand piece applicator are also similar to the design and components found in the predicate ThermageThermaCool System.

The major differences between the subject device and the predicate device are power output, tip energy and electrode size from the predicate device. However, the preclinical study using the porcine model demonstrated the subject device would perform as well as the predicate devices in the market. The INTRAgen device also underwent performance testing, including software validation testing (provided in Section 4) and electrical and mechanical safety testing according to IEC 60601-1 and

10

electromagnetic compatibility testing according to IEC 60601-1-2 (provided in Section 10) and bench tests (provided in Section 9). These performance tests demonstrated that the differences in the device specifications meet the system requirements and do not raise new safety or effectiveness concerns.

Consequently, it can be concluded that the INTRAgen is substantially equivalent to the predicate ThermageThermaCool System, cleared under 510(k) K053365.

9. Summary of Non-Clinical Performance Data

. Electrical Safety and Electromagnetic Compatibility
The tests were performed on the INTRAgen to confirm electrical safety and electromagnetic compatibility in accordance with IEC 60601-1, IEC 60601-2-2, and IEC 60601-1-2. The results were acceptable.
Biocompatibility .
The patient contacting part of the INTRAgen is the active electrode and it is made of PCB (Polychlorinated Biphenyl) and ABS (Acrylonitrile-Butadiene-Stvrene Copolymer). Biocompatibility test has been conducted according to the ISO 10993-1 standards, and the test results support that it is biocompatible.
. Bench Data
Bench tests were performed to evaluate the dimensional accuracy, the accuracy of measurement for impedance, the accuracy of the active electrode output and output waveform. The test results were acceptable. An additional bench test was performed to demonstrate that the temperature of the skin surface does not go up to the point where it can cause damage to the skin tissue even when the cooling system is not used. The results demonstrated that the temperature of the skin surface did not go up to the point where it could cause damage to the skin tissue.
. Pre-Clinical
A pre-clinical trial was performed to evaluate performance of the subject device. The test was performed on a porcine tissue model using different joule energy levels and active electrodes.
Study purpose: The study was designed to evaluate the effects of the novel grid fractional RF treatment on skin structure and collagen in vivo.

11

Follow up periods/days: The wound healing response was evaluated histologically and by RT-PCR up to 10 weeks post-RF treatment. - Animal type: Porcine
Treatment applied: The INTRAgen RF device was used to deliver RF energy to skin.
Histology evaluation: The study results showed that vigorous wound healing response was initiated post-treatment with progressive increase in inflammatory cell infiltration from day 2 through 10 weeks. Furthermore, through both immune histochemical and PCR studies, it was found that profound neocollagenesis and neoelastogenesis following RF treatment of micropigskin occurred.

In conclusion, the test results of the pre-clinical study demonstrated that the subject device is substantially equivalent to the predicate device.

· Sterilization
The active electrodes (KT-07 and KT-15) are sterilized in its final packaging using 20% Ethylene Oxide (EtO) and 80% CO2. The EtO sterilization process has been validated in accordance with ISO 11135-1:2007.

· INTRAgen complies with the following recognized standards. The following table lists the non-clinical testing performed.

Testing Type	Test Description	Test Result
Electrical Safety and
Electromagnetic
Compatibility Testing	• IEC 60601-1:2012
• IEC 60601-2-2:2009
• IEC 60601-1-2:2007	The INTRAgen met all
The acceptance
criteria in accordance
with IEC 60601
1:2009, IEC 60601-2-
2:2009 and IEC
60601-1-2:2007.
Biocompatibility
Testing	• Cytotoxicity
• Sensitization
• Intracutaneous Reactivity
• Acute Systemic Toxicity
• Pyrogen	The active electrodes
are biocompatible.
Performance Testing	• Dimensional Inspection
• Accuracy of Measurement
• Energy Output
• Current Density
• On/off time
• Output Waveform
• Skin Temperature	The INTRAgen met all
the acceptance
criteria.

12

| Pre-clinical Trial | • Tissue Analysis
• Total RNA isolation and
real-time RT-PCR
· Statistical analysis | The test results
demonstrated that the
subject device is
substantially equivalent
to the predicate device. |
|--------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Sterilization | • ISO 11135-1:2007 | The INTRAgen met all
the acceptance
criteria in accordance
with ISO 11135-
1:2007. |

10. Summary of Clinical Test

No clinical studies were considered necessary and performed.

11. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR part 807, FDA's "Premarket Notification [510(k)] Submissions for Electrosurgical Devices for General Surgery" and based on the information provided in this premarket notification, Jeisys Medical Inc. concludes that INTRAgen is safe, effective and substantially equivalent to predicate devices for dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

Jennifer R. Stevenson -S

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

510(k) Summary

1. Date Prepared

2. Submitter's Information

Trade Name, Common Name, and Classification 3.

Classification Name: Electrosurgical cutting and . coagulation device and accessories.

4. Identification of Predicate Device(s)

5. Description of the Device

6. Intended Use

7. Technological Characteristics

8. Substantial Equivalence

9. Summary of Non-Clinical Performance Data

10. Summary of Clinical Test

11. Conclusion