The Creo Electrosurgical System is intended to provide microwave energy for coagulation (ablation) of soft tissue and is for use only with compatible Creo Medical instruments and accessories.

The System is not intended for use in cardiac procedures.

Device Description

The Creo Medical (Creo) AB1 soft tissue microwave ablation instrument (electrosurgical instrument, accessory or instrument, also referred to as AB1) is designed for use with the Creo electrosurgical system, previously cleared under K200298. No changes have been made to the Creo generator, footswitch, or interface cable with sterile sheaths that comprise the electrosurgical system, nor are any changes proposed to the AB1 instrument in this 510k.

AB1 is provided as a sterile, single-use instrument that is 0.95 m long with a 4.3 mm diameter shaft that terminates in a distal antenna that is 38 mm long and less than 2.00 mm in diameter (nominally, 1.9 mm) with a conical tip. The AB1 instrument is provided with a flexible, removable (distal) handle. The outer sheath of the flexible shaft may be removed.

This 510k provides instructions to the end user on how to remove the outer extrusion and distal handle to create a configuration that has an outer diameter less than 2.00 mm. The instrument may be used to access target tissue directly, e.q. in open surgical procedures, or, with the handle and outer sheath removed, through a compatible trocar in minimally invasive procedures. The antenna couples microwave energy to target tissue when AB1 is powered by the Creo Electrosurqical System. AB1 is only compatible for use with the Creo Electrosurgical System, and the Creo Electrosurgical System is only intended for use with compatible Creo instruments and accessories.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Creo Electrosurgical System with AB1 Instrument). It describes a change to the Indications For Use (IFU) of an already cleared device, specifically allowing the removal of an outer sheath and distal handle to enable use with a compatible trocar in minimally invasive procedures.

This document does not describe an AI/ML-based device or a study involving human readers and AI assistance for diagnostic purposes. Therefore, most of the requested information (such as acceptance criteria for AI performance, sample size for AI test sets, expert ground truth establishment, MRMC studies, standalone AI performance, etc.) is not applicable to this submission.

The document focuses on demonstrating the safety and effectiveness of a modified configuration of an electrosurgical instrument for soft tissue ablation, predominantly through bench testing and preclinical evaluation, ensuring it is equivalent to the predicate device.

However, I can extract the information related to the device performance data based on the context of the document, even though it's not an AI/ML study.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests conducted to address the change in labeling. It doesn't present a formal table of acceptance criteria with corresponding performance data, but rather a list of tests and a general conclusion.

Test Conducted	Purpose/Criterion (Inferred)	Reported Performance
Pull (tensile) test	To ensure the mechanical integrity and strength of the instrument in the modified configuration.	"meets all design specifications" (general statement)
Removal of outer extrusion test (effects on underlying cable, cosmetics, electrical performance)	To verify that the process of removing the outer sheath does not damage the instrument, affect its appearance, or compromise its electrical function.	"meets all design specifications" (general statement)
Insertion and retraction into and from an introducer test	To ensure the instrument can be safely and effectively inserted into and retracted from an introducer, as implied by the revised IFU.	"meets all design specifications" (general statement)
Shaft bending test	To assess the flexibility and durability of the instrument shaft in the modified configuration under potential bending stress.	"meets all design specifications" (general statement)
VNA (vector network analyzer) return loss test	To evaluate the electrical performance and impedance matching of the microwave antenna in the modified configuration, ensuring efficient energy delivery.	"meets all design specifications" (general statement)
Thermal profile with introducer test	To assess the thermal characteristics of the device when used with an introducer, ensuring safe operating temperatures and effective energy delivery.	"meets all design specifications" (general statement)
Comparison of dimensions of ablations created by new and predicate device in ex-vivo tissue	To demonstrate that the modified configuration produces comparable ablation zones (size and shape) to the original predicate device, ensuring equivalent therapeutic effect.	"meets all design specifications" (general statement)
Preclinical evaluation of safety and performance in a pig model	To assess the safety and efficacy of the device in a living biological system, simulating clinical use conditions.	"meets all design specifications" (general statement), also "results... demonstrate that the potential risks associated... have been reduced to low and acceptable levels."
Simulated use testing of deployment through introducers	To simulate the clinical use case of deploying the device through compatible introducers, verifying ease of use and functionality.	"meets all design specifications" (general statement)
Electrical safety testing	To ensure the device meets applicable electrical safety standards.	"meets all design specifications and applicable medical device standard requirements"
Usability engineering validation	To ensure the device (with the modified IFU) can be safely and effectively used by intended users, and to identify potential use errors. This is particularly relevant for instructions on modifying the device configuration.	"meets all design specifications" (general statement), and "no new or different questions of safety or effectiveness raised by the modification to the IFU"

Overall Conclusion on Performance: "The results of the tests conducted and leveraged demonstrate that the AB1 instrument in the proposed configuration with outer sheath and distal handle removed meets all design specifications and applicable medical device standard requirements, and that it is substantially equivalent to the predicate AB1 instrument with the handle and outer sheath in place."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for individual bench or preclinical tests. The document generically refers to "tests conducted". For the "Preclinical evaluation of safety and performance in a pig model", the sample size (number of pigs) is not provided.
Data Provenance: Not explicitly stated for each test. The sponsor, Creo Medical Ltd., is based in the United Kingdom, so some testing might have occurred there. The preclinical study type would be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This summary is for an electrosurgical instrument, not an AI/ML-based diagnostic device where expert ground truth for interpretation would be established. The "ground truth" for this device's performance would be engineering specifications, material properties, and biological effects (ablation size/shape, safety in animal models).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This refers to a process typically used in AI/ML performance evaluation where multiple human readers contribute to a consensus ground truth. The tests performed here are primarily objective engineering and preclinical evaluations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC study is not relevant to an electrosurgical cutting and coagulation device. This document is not describing an AI-assisted diagnostic or therapeutic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an algorithm-based device. The "performance" being evaluated is the physical and functional characteristics of the electrosurgical instrument itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests, the "ground truth" would be:
- Engineering Specifications: For mechanical tests (tensile, bending, insertion/retraction), and electrical tests (VNA, electrical safety).
- Defined Ablation Characteristics: For ex-vivo tissue comparisons (ablation dimensions).
- Physiological/Histopathological Observation: For the preclinical pig model, assessing safety (e.g., lack of unintended damage) and efficacy (e.g., successful ablation).
- Usability Standards: For usability engineering validation.

8. The sample size for the training set

Not applicable. This device is an electrosurgical instrument, not an AI/ML model. There is no training set in the AI/ML sense.

9. How the ground truth for the training set was established

Not applicable. As above, there is no AI/ML training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 26, 2023

Creo Medical Ltd. % Phil Triolo President and Senior Consultant Phil Triolo and Associates LC 86 Skvcrest Ln Salt Lake City, Utah 84108

Re: K223138

Trade/Device Name: AB1 Electrosurgical Instrument, Creo Electrosurgical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: NEY Dated: September 30, 2022 Received: May 26, 2023

Dear Phil Triolo:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,

Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2013.06.26
13:08:24 -04'00'

Mark Trumbore, 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) K223138

Device Name

Creo Electrosurgical System with AB1 Electrosurgical Instrument

Indications for Use (Describe)

The AB1 Instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.

The AB1 Instrument is not intended for use in cardiac procedures.

The Creo Electrosurgical System is intended to provide microwave energy for coagulation (ablation) of soft tissue and is for use only with compatible Creo Medical instruments and accessories.

The System is not intended for use in cardiac procedures.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Creo Electrosurqical System with AB1 Instrument

510(k) Summary

Date Prepared: June 23, 2023

1.SUBMITTER

510(k) Sponsor: Creo Medical Ltd Creo House, Unit 2, Beaufort Park Way Chepstow NP16 5UH United Kingdom
Contact Persons: Phil Triolo, PhD, RAC President and Senior Consultant Phil Triolo and Associates LC Phone: 801 699 9846 / Email: philt@philt.com

Tiffany Powell Global RA/QA Director, Creo Medical Ltd. Phone +44 (0) 7760 150775 / Email Tiffany.Powell@CreoMedical.com Fax +44 (0) 1291 606015

Phil Triolo and Associates, LC Prepared By: 86 Skycrest Lane SLC UT 84108 801 699 9846

2.DEVICE

Trade/Device Name:	Creo Electrosurgical System with AB1 Instrument
Common Name:	Electrosurgical System
Classification Name:	Electrosurgical cutting and coagulation device and accessories
Regulation number:	CFR 878.4400
Product Code:	NEY (Class II)

3.PREDICATE DEVICE

K200298 - Creo Electrosurgical System with AB1 Accessory

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Creo Electrosurqical System with AB1 Instrument

4.DEVICE DESCRIPTION

5.INDICATIONS FOR USE

The AB1 Instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue.

The AB1 Instrument is not intended for use in cardiac procedures.

The Creo Electrosurgical System is intended to provide microwave energy for coagulation (ablation) of soft tissue and is for use only with compatible Creo Medical instruments and accessories.

The System is not intended for use in cardiac procedures.

6.COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF THE AB1 WITH MODIFIED IFU WITH THE CLEARED INSTRUMENT

The only change addressed in this 510k is a change to the IFU that instructs the user how to remove the outer sheath and distal handle of the cleared AB1 instrument to create a configuration that has a diameter less than 2.00 mm which can be used with a compatible trocar in minimally invasive procedures. No other changes have been made to the design, materials, or processing of the cleared AB1 instrument.

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Creo Electrosurqical System with AB1 Instrument

Attribute	Subject Device	Predicate Device (K200298)
Instrument dimensions	Shaft (with outer sheath): 4.3 mm diameter x 0.95 m lengthShaft (without outer sheath): 1.9 mm diameter x 0.95 m lengthAntenna: 1.9 mm diameter x 38mm length	Shaft (with outer sheath): 4.3 mm diameter x 0.95 m lengthAntenna: 1.9 mm diameter x 38mm length
Patient contactingmaterials	Shaft: FEP (Fluorinated Ethylene Propylene)Handle: Silicone ElastomerSleeve tube: Pebax	Shaft: FEP (Fluorinated Ethylene Propylene)Handle: Silicone ElastomerSleeve tube: Pebax
Microwave energysupplied	25 W microwave power at 5.8 GHz	25 W microwave power at 5.8 GHz
Device life and sterility	Single-use, delivered in a sterile condition.Sterilized using Ethylene Oxide gas.	Single-use, delivered in a sterile condition.Sterilized using Ethylene Oxide gas.
Pyrogenicity	Non-pyrogenic	Non-pyrogenic

7.PERFORMANCE DATA

In order to address the change in labeling to the device, a risk assessment was conducted that identified that the following tests needed to be control any new, or increased risks and demonstrate substantially equivalent safety and effectiveness of the configuration created by the user following the revised labeling, to that of the predicate configuration.

Pull (tensile) test
. Removal of outer extrusion test (effects on underlying cable, cosmetics, electrical performance)
Insertion and retraction into and from an introducer test
Shaft bending test
VNA (vector network analyzer) return loss test
Thermal profile with introducer test
Comparison of dimensions of ablations created by new and predicate device in ex-vivo ● tissue
Preclinical evaluation of safety and performance in a pig model
Simulated use testing of deployment through introducers
. Electrical safety testing
. Usability engineering validation

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The results of the tests conducted and leveraged demonstrate that the AB1 instrument in the proposed configuration with outer sheath and distal handle removed meets all design specifications and applicable medical device standard requirements, and that it is substantially equivalent to the predicate AB1 instrument with the handle and outer sheath in place.

8.CONCLUSION

Results of the bench and preclinical tests conducted demonstrate that the potential risks associated with the configuration of the AB1 instrument created by following the change to the IFU have been reduced to low and acceptable levels. The results further demonstrate that there are no new or different questions of safety or effectiveness raised by the modification to the IFU, and the AB1 instrument in the configuration created following the revised labeling is as safe and effective as the predicate device. Consequently, The Creo Medical AB1 electrosurgical instrument (Accessory) in the configuration created by following the modified IFU is substantially equivalent to the predicate instrument.

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.