The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.

The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.

The Reusable Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave (MW) energy for the cutting, coagulation and ablation of tissue via endoscopic access.

Device Description

The CROMA Electrosurgical Generator is an Electrosurgical unit (ESU) to be used with compatible electrosurgical instruments and accessories.

The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered ESU. It comprises two distinct energy sources for the independent generation of bipolar radiofrequency (RF) and microwave (MW) energies, intended to supply electrosurgical power for cutting, and ablation of soft tissues, when connected to compatible instruments via the interface cable.

The CROMA Electrosurgical Generator incorporates proprietary software developed by Creo Medical Ltd.

The CROMA Electrosurgical Generator subject of this submission incorporates a new front panel, which has been updated from a Vacuum Fluorescent Display (VFD) in the predicate device to a Liquid Crystal Display (LCD) screen in the subject device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CROMA Electrosurgical Generator. This document is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific acceptance criteria in the context of an AI-powered diagnostic. Therefore, many of the requested sections are not applicable.

Here's the information that can be extracted or derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a diagnostic device's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate electrosurgical generator by comparing technological characteristics and compliance with electrical safety and software standards.

Characteristic / Test	Acceptance Criteria (Implied)	Reported Device Performance
Electrical Safety	Compliance with IEC 60601-1 Ed. 3.2, IEC 60601-2-2 Ed. 6.0, IEC 60601-2-6 Ed. 2.1	Device complies with standards
EMC	Compliance with IEC 60601-1-2:2014	Device complies with standards
Software V&V	Compliance with IEC 62304 Ed. 1.1	Software developed, verified, and validated with IEC 62304 Ed. 1.1
Mechanical & Usability Testing	Satisfactory performance in power on/off, initialization, standby, timeout, settings, language, accessory selection, connection/reconnection	Tests performed, usability assessment of UI changes
Indications for Use	Same as predicate (with rewording for clarity)	Stated Indications for Use are substantially equivalent to predicate
Technological Characteristics	Substantially equivalent to predicate in terms of energy inputs/outputs, principles of operation, control console functionalities	Device has same energy inputs/outputs, principles of operation, and functionalities with minor differences in display (LCD vs VFD) and associated software

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This device is an electrosurgical generator, not an AI-powered diagnostic or a device that uses a "test set" of patient data in the way implied by the question. The testing described is primarily engineering and software verification/validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. As noted above, this device is not an AI-powered diagnostic, and therefore, the concept of "ground truth" established by experts for a test set of data does not apply in this context.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "Animal & Clinical Studies: Not Applicable." An MRMC study would fall under clinical studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, an electrosurgical generator does not have a "standalone algorithm" in the context of AI performance. The software mentioned is for controlling the device's functions and user interface.

7. The Type of Ground Truth Used

Not applicable. The ground truth concept, as it pertains to diagnostic accuracy, is not relevant here. The "truth" for this device relates to its adherence to engineering specifications, safety standards, and functional performance.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI that would require a "training set" of data in the common sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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February 5, 2025

Creo Medical Ltd Diane Davis RAQA Product Lead Unit 2 Beaufort Park Beaufort Park Way Chepstow, NP16 5UH United Kingdom

Re: K242983

Trade/Device Name: CROMA Electrosurgical Generator (PRD-EMR-050) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, NEY, KNS Dated: January 6, 2025 Received: January 6, 2025

Dear Diane Davis:

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.

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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).

Your device is also subject to, among other requirements, the Quality System (OS) 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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/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 James James H. Jang H. Jang H. Jang -S Date: 2025.02.05 13:05:38 -2 -05'00'

For Long Chen, Ph.D. 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

Enclosure

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Indications for Use

510(k) Number (if known) K242983

Device Name

CROMA Electrosurgical Generator (PRD-EMR-050)

Indications for Use (Describe)

The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K242983 510(k) Summary

CROMA Electrosurgical Generator

Date Prepared: February 4, 2025

CONTACT DETAILS

Applicant Name:	Creo Medical Ltd.
Applicant Address:	Unit 2 Beaufort Park, Beaufort Park Way, Chepstow NP16 5UH, UK
Applicant Contact Telephone:	+44 7899 306000
Applicant Contact:	Diane Davis
Applicant Contact Email:	diane.davis@creomedical.com

DEVICE NAME

Device Trade Name	CROMA Electrosurgical Generator (PRD-EMR-050)
Common Name	Electrosurgical cutting and coagulation device and accessories
Classification Name	Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number	878.4400
Product Code(s)	GEI, NEY, KNS

LEGALLY MARKETED PREDICATE DEVICES

K230328 Speedboat Flush SB1 Instrument with Croma Electrosurgical Generator, Product Code KNS

K223138 AB1 Electrosurgical Instrument, Creo Electrosurgical System, Product Code NEY

DEVICE DESCRIPTION SUMMARY

The CROMA Electrosurgical Generator is an Electrosurgical unit (ESU) to be used with compatible electrosurgical instruments and accessories.

The CROMA Electrosurgical Generator incorporates proprietary software developed by Creo Medical Ltd.

The subject and predicate devices have identical principles of operations:

Supply suitable Creo Medical instruments with appropriate power for their surgical uses at a MW frequency of 5.8 GHz for the purpose of coagulation, cauterisation and/or ablation.
. Supply suitable Creo Medical instruments with appropriate power for their surgical uses at a nominal RF of 400 kHz for the purpose of cutting.

INDICATIONS FOR USE STATEMENT

The Creo Medical Electrosurgical System is not intended for use in cardiac procedures.

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INDICATIONS FOR USE COMPARISON

The subject device has the same Indications for Use as the predicate for use statement for the subject device has been reworded for readability and clarity by removing the specific reference of the compatible instruments. Instead, compatible instruments are provided in a table form in the Instructions for Use, right under the Intended Use Statement.

Therefore, this formatting change does not raise concerns of safety and effectiveness.

TECHNOLOGICAL COMPARISON

The subject and predicate devices have the following same technological characteristics:

. Energy inputs
Energy outputs
Principles of operations
. Functionalities of the control console (front panel), including push buttons, output sockets for interface cable connection, symbols, LED lights and audio tones in compliance with IEC 60601 requirements.

The subject device has been modified to modernise the visual of the user interface and upgrade the screen from a Vacuum Fluorescent Display (VFD) to a Liquid Crystal Display (LCD). As a result, the following technological differences exist between the subject and predicate devices:

. Front panel screen changed from VFD to LCD
Front panel keypad membrane updated (aesthetics, features location)
. Software changed to support the new LCD screen, as well as include other minor software updates

The differences in the subject device technological characteristics do not raise concerns of safety and effectiveness.

Characteristic	SubjectCROMA Electrosurgical GeneratorPRD-EMR-050	Primary PredicateCROMA Electrosurgical Generator7-EMR-050 (K230328)	Secondary PredicateCROMA Electrosurgical Generator7-EMR-050 (K223138)
Classification:	Class II	SAME	SAME
Regulation:	21 CFR 878.4400	21 CFR 876.4300	SAME
Product Code:	GEI – Electrosurgical, Cutting & Coagulation & Accessories	& KNS – Unit, Electrosurgical, Endoscopic	NEY – System, Ablation, Microwave And Accessories
Intended Use /Indications ForUse CROMAElectrosurgicalGenerator:	The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and Microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories.	The Electrosurgical Generator provides microwave (MW) energy to compatible Creo Medical instruments AB1 MicroBlate Flex and NP1 MicroBlate Fine instruments, intended for coagulation (ablation) of soft tissue	The Electrosurgical Generator provides microwave (MW) energy to compatible Creo Medical instruments AB1 MicroBlate Flex and NP1 MicroBlate Fine instruments, intended for coagulation (ablation) of soft tissue
		The Electrosurgical Generator provides microwave (MW) energy to compatible Creo Medical instruments HS1 SlypSeal	The Electrosurgical Generator provides microwave (MW) energy to compatible Creo Medical instruments HS1 SlypSeal
Characteristic	Subject	Primary Predicate	Secondary Predicate
	CROMA Electrosurgical GeneratorPRD-EMR-050	CROMA Electrosurgical Generator7-EMR-050 (K230328)	CROMA Electrosurgical Generator7-EMR-050 (K223138)
	The Creo Medical ElectrosurgicalSystem is not intended for use incardiac procedures.	Instrument, intended forcoagulation (hemostasis andcauterization) of soft tissue.	Instrument, intended forcoagulation (hemostasis andcauterization) of soft tissue.
		The Electrosurgical Generatorprovides microwave (MW) andradiofrequency (RF) energy tocompatible Creo MedicalSpeedboat Instruments, intendedfor coagulation (hemostasis andcauterization) and cutting softtissue.	The Electrosurgical Generatorprovides microwave (MW) andradiofrequency (RF) energy tocompatible Creo MedicalSpeedboat Instruments, intendedfor coagulation (hemostasis andcauterization) and cutting softtissue.
		The Electrosurgical System is notintended for use in cardiacprocedures.	The Electrosurgical System is notintended for use in cardiacprocedures.
Display:	Liquid Crystal display (LCD)supporting Alphanumeric, Chineseand Japanese characters.	Vacuum fluorescent display (VFD)supporting Alphanumericcharacters.	Vacuum fluorescent display (VFD)supporting Alphanumericcharacters.
Mains powerinput:	Input Voltage: 100 V - 120 V / 220V - 240 V. Maximum Input Power:450 W.Frequency: 50 / 60 Hz, Single phase.	SAME	SAME
Protectiveclass (IEC60601-1):	Equipment is Class IRequires a protective groundconnection.	SAME	SAME
Patient circuit,as per IEC60601-1:	Type CF	SAME	SAME
Degree of IPprotection:	IPOO	SAME	SAME
Energy output:	RF output: 400 HzMW output: 5.8 GHz	SAME	SAME
Maximumvoltage:	RF: 460 VpeakMW: 79 Vpeak (50 Ohm load)	SAME	SAME
RF outputmodality:	Bipolar, single waveform	SAME	SAME
RF outputoperatingfrequency:	396.7 kHz ± 2.0 kHz	SAME	SAME
Characteristic	SubjectCROMA Electrosurgical GeneratorPRD-EMR-050	Primary PredicateCROMA Electrosurgical Generator7-EMR-050 (K230328)	Secondary PredicateCROMA Electrosurgical Generator7-EMR-050 (K223138)
RF outputcapability(Biomedmode):	200 W maximum into a rated loadof 400 Ohm	SAME	SAME
RF outputcapability(treatmentmode):	35 W (Max) into a rated load of 400 Ohm	SAME	SAME
RF outputadjustment:	15 W to 35 W at the rated load of400 Ohm. 10 s ON, 30 s OFF, 1 hour	SAME	SAME
MW outputmodality:	Microwave, single waveform.	SAME	SAME
MW outputoperatingfrequency:	5.8 GHz ± 1 MHz	SAME	SAME
MW outputcapability(treatmentmode):	62 W maximum into a rated load of 50 Ohm	SAME	SAME
MW outputpower:	AB1 – 27 W (for use with InterfaceCable 2m only) NP1 – 62 W	AB1 - 25W NP1 - SAME	AB1 - 25W NP1 - SAME
MW outputduration:	Defined in the generator IFU:RS2 - 10 s ON, 1 s OFF x 3, then 268s OFF HS1 – 10 s ON, 1 s OFF x 5,then 246 s OFF SB1-L - 5 s ON, 1 sOFF x 5, then 268 s OFFAB1 – 180 s ON, 30 s OFF x 9, then28 min 30 sec OFF NP1 - 120 s ON,30 s OFF x 8, then 40 min OFF	Defined in the generator IFU: RS2 -SAMEHS1 – SAME SB1-L – SAME AB1 –SAMENP1 – 120 s ON, 120 s OFF x 8, then28 min OFF	Defined in the generator IFU: RS2 -SAMEHS1 – SAME SB1-L – SAME AB1 –SAMENP1 – 120 s ON, 120 s OFF x 8, then28 min OFF

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NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing was conducted on the subject device as part of the Creo Medical System. The system complies with IEC 60601-1 Ed. 3.2, IEC 60601-2-2 Ed. 6.0, IEC 60601-2-6 Ed. 2.1, and IEC 60601-1-2:2014.

Software verification and validation testing

The software for this device was developed, verified and validated in with IEC 62304 Ed. 1.1. The software for this device requires an enhanced documentation level, as a failure or flaw of the software could present a hazardous situation with a probable risk of death or serious injury to the patient or user of the device.

Mechanical and Usability testing

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At a high level, the following mechanical and usability testing have been performed on the subject device:

. Device power on/off, initialisation, standby, timeout testing
. Settings, language, and accessory selection testing
. Accessory connection / reconnection testing
. Usability assessment of the changes to the user interface

Animal & Clinical Studies

Not Applicable.

CONCLUSION

Technological differences between subject and predicate devices do not raise new questions of safety or effectiveness. Based on the comparison of the indications for use, technological characteristics, and performance test results to the same of the predicate predicate, the subject CROMA Electrosurgical Generator has been shown to be substantially equivalent to the predicate devices for the requested indications for use.

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.