(132 days)
Not Found
No
The document describes a standard electrosurgical generator and its components, focusing on energy delivery and safety standards. There is no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.
Yes
The device delivers energy for cutting, coagulation, and ablation, which are therapeutic interventions aimed at treating soft tissue.
No
The device is described as an electrosurgical generator intended for cutting, coagulation, and ablation of soft tissue, which are therapeutic rather than diagnostic functions.
No
The device is described as an electrosurgical generator, which is a hardware device that produces and delivers energy. While it incorporates software, it is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cutting, coagulation, and ablation of soft tissue" using RF and MW energy. This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description details an "Electrosurgical unit (ESU)" that generates energy for surgical procedures. This aligns with surgical devices, not IVDs.
- Lack of Diagnostic Language: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Focus on Energy Delivery: The core function described is the delivery of energy for tissue modification.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, NEY, KNS
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Electrical safety and electromagnetic compatibility (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.
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 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
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.
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
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.
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.
1
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
2
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
3
Indications for Use
510(k) Number (if known) K242983
Device Name
CROMA Electrosurgical Generator (PRD-EMR-050)
Indications for Use (Describe)
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.
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 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.
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 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.
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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.
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 | Subject
CROMA Electrosurgical Generator
PRD-EMR-050 | Primary Predicate
CROMA Electrosurgical Generator
7-EMR-050 (K230328) | Secondary Predicate
CROMA Electrosurgical Generator
7-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 For
Use CROMA
Electrosurgical
Generator: | 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 Generator
PRD-EMR-050 | CROMA Electrosurgical Generator
7-EMR-050 (K230328) | CROMA Electrosurgical Generator
7-EMR-050 (K223138) |
| | The Creo Medical Electrosurgical
System is not intended for use in
cardiac procedures. | Instrument, intended for
coagulation (hemostasis and
cauterization) of soft tissue. | Instrument, intended for
coagulation (hemostasis and
cauterization) of soft tissue. |
| | | The Electrosurgical Generator
provides microwave (MW) and
radiofrequency (RF) energy to
compatible Creo Medical
Speedboat Instruments, intended
for coagulation (hemostasis and
cauterization) and cutting soft
tissue. | The Electrosurgical Generator
provides microwave (MW) and
radiofrequency (RF) energy to
compatible Creo Medical
Speedboat Instruments, intended
for coagulation (hemostasis and
cauterization) and cutting soft
tissue. |
| | | The Electrosurgical System is not
intended for use in cardiac
procedures. | The Electrosurgical System is not
intended for use in cardiac
procedures. |
| Display: | Liquid Crystal display (LCD)
supporting Alphanumeric, Chinese
and Japanese characters. | Vacuum fluorescent display (VFD)
supporting Alphanumeric
characters. | Vacuum fluorescent display (VFD)
supporting Alphanumeric
characters. |
| Mains power
input: | Input Voltage: 100 V - 120 V / 220
V - 240 V. Maximum Input Power:
450 W.
Frequency: 50 / 60 Hz, Single phase. | SAME | SAME |
| Protective
class (IEC
60601-1): | Equipment is Class I
Requires a protective ground
connection. | SAME | SAME |
| Patient circuit,
as per IEC
60601-1: | Type CF | SAME | SAME |
| Degree of IP
protection: | IPOO | SAME | SAME |
| Energy output: | RF output: 400 Hz
MW output: 5.8 GHz | SAME | SAME |
| Maximum
voltage: | RF: 460 Vpeak
MW: 79 Vpeak (50 Ohm load) | SAME | SAME |
| RF output
modality: | Bipolar, single waveform | SAME | SAME |
| RF output
operating
frequency: | 396.7 kHz ± 2.0 kHz | SAME | SAME |
| Characteristic | Subject
CROMA Electrosurgical Generator
PRD-EMR-050 | Primary Predicate
CROMA Electrosurgical Generator
7-EMR-050 (K230328) | Secondary Predicate
CROMA Electrosurgical Generator
7-EMR-050 (K223138) |
| RF output
capability
(Biomed
mode): | 200 W maximum into a rated load
of 400 Ohm | SAME | SAME |
| RF output
capability
(treatment
mode): | 35 W (Max) into a rated load of 400 Ohm | SAME | SAME |
| RF output
adjustment: | 15 W to 35 W at the rated load of
400 Ohm. 10 s ON, 30 s OFF, 1 hour | SAME | SAME |
| MW output
modality: | Microwave, single waveform. | SAME | SAME |
| MW output
operating
frequency: | 5.8 GHz ± 1 MHz | SAME | SAME |
| MW output
capability
(treatment
mode): | 62 W maximum into a rated load of 50 Ohm | SAME | SAME |
| MW output
power: | AB1 – 27 W (for use with Interface
Cable 2m only) NP1 – 62 W | AB1 - 25W NP1 - SAME | AB1 - 25W NP1 - SAME |
| MW output
duration: | Defined in the generator IFU:
RS2 - 10 s ON, 1 s OFF x 3, then 268
s OFF HS1 – 10 s ON, 1 s OFF x 5,
then 246 s OFF SB1-L - 5 s ON, 1 s
OFF x 5, then 268 s OFF
AB1 – 180 s ON, 30 s OFF x 9, then
28 min 30 sec OFF NP1 - 120 s ON,
30 s OFF x 8, then 40 min OFF | Defined in the generator IFU: RS2 -
SAME
HS1 – SAME SB1-L – SAME AB1 –
SAME
NP1 – 120 s ON, 120 s OFF x 8, then
28 min OFF | Defined in the generator IFU: RS2 -
SAME
HS1 – SAME SB1-L – SAME AB1 –
SAME
NP1 – 120 s ON, 120 s OFF x 8, then
28 min OFF |
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7
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
8
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.