The Creo Electrosurgical Generator is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, and is for use only with compatible Creo Medical instruments and accessories.

The HS1 Hemostasis Accessory is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:

· Peptic Ulcers
· Dieulafoy Lesions
· Mallory-Weiss Tears
· Bleeding Polyp Stalks
· Arteriovenous Malformations (AVMs)
· Angiomata

The HS1 also has irrigation capability. Any other use is not recommended.

Device Description

The Creo Medical Electrosurgical System with HS1 hemostasis accessory comprises of the following:

. HS1 hemostasis surgical accessory
. Electrosurgical Generator
Footswitch
Interface Cable

The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave (MW) energy for the purpose of cutting and coagulating tissue. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cut: the other pedal activates the MW energy output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.

The Interface Cable connects electrosurgical instruments to the Electrosurgical Generator and is for single-use and is supplied with a sterile sheath that is fitted over its distal end during connection to the surgical accessory.

HS1 is an electrosurgical hemostasis accessory for use with the Creo Medical Electrosurgical Generator only. HS1 is for endoscopic use and provides coagulation and injection of fluids incorporated in a single device. HS1 is for single-use only and provided sterile.

AI/ML Overview

This submission describes the Creo Electrosurgical System with HS1 Hemostasis Accessory. The device is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, primarily for endoscopic electrohemostasis in the gastrointestinal tract.

Here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail format typical for AI/ML device submissions. Instead, it details performance testing to demonstrate substantial equivalence to predicate devices. The performance aspects tested are related to the device's functional characteristics.

Acceptance Criteria (Implied)	Reported Device Performance
Coagulation Energy Equivalence (penetration and spread of thermal effects)	Bench testing showed substantial equivalence with the predicate device (Boston Scientific Injection Gold Probe) regarding the penetration and spread of thermal effects in gastrointestinal tissue, despite using different energy types (MW vs. bipolar RF).
Distal Tip Design Equivalence (penetration and spread of thermal effects)	Bench testing showed substantial equivalence with the predicate device concerning the penetration and spread of thermal effects in gastrointestinal tissue, despite differences in distal tip design (blade vs. dome-shaped).
Shaft and Distal Tip Materials Biocompatibility	Meets all relevant requirements of FDA guidance and ISO 10993 (biocompatibility). Bench testing showed substantial equivalence with the predicate devices regarding penetration and spread of thermal effects.
Needle and Injection Performance (flowrate, durability, sharpness, tensile strength)	Bench testing showed acceptable levels of performance for injection flowrate, insertion and retraction durability (throughout lifetime use and in worst-case endoscope positions), needle point sharpness (throughout lifetime use), and needle to hypotube and ferrule tensile strength.
Needle and Injection Materials Biocompatibility	Meets all relevant requirements of FDA guidance and ISO 10993 (biocompatibility).
General Design Specifications & Standards Compliance	The system meets all design specifications, design-risk analysis, and medical device standards for electrical safety and FDA recognized versions of EMC (IEC 60601), electrical safety (IEC 60601), biocompatibility (ISO 10993), and sterility (ISO 11135).
Mechanical, Coagulation, and Injection Performance (in ex-vivo/in-vivo)	Meets the design specification and shows substantial equivalence to the predicate devices.

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

The document does not specify the exact sample sizes for each type of bench, ex-vivo, or in-vivo test.

Data Provenance: The studies include "bench testing," "ex-vivo," and "in-vivo" tests. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though in-vivo studies are typically prospective.

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

This information is not provided in the document. For a electrosurgical device, "ground truth" might refer to histological analysis of tissue effects or clinical outcomes. The document does not mention the use of experts for establishing ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method, such as 2+1 or 3+1, which is typically relevant for studies involving human interpretation or subjective assessments. For objective performance metrics like thermal spread or mechanical durability, such methods are not usually applicable.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is an electrosurgical system, not an AI-assisted diagnostic or interpretive tool that would typically involve human readers. Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device incorporates "proprietary software developed by Creo Medical for generating and controlling the two energies delivered," the submission focuses on the performance of the integrated electrosurgical system (hardware + software). There is no mention of a standalone algorithm performance study independent of the physical device or a human operator. The system itself is the "standalone" entity whose performance is being evaluated.

7. The Type of Ground Truth Used

The "ground truth" implicitly used for evaluation involved:

Physical Measurements/Observations: For bench testing of coagulation (penetration and spread of thermal effects), injection flowrate, durability, sharpness, and tensile strength.
Standard Compliance: Adherence to electrical safety (IEC 60601), EMC (IEC 60601), biocompatibility (ISO 10993), and sterility (ISO 11135) standards.
Clinical/Biological Equivalence: Demonstrated through ex-vivo and in-vivo tests (though specific metrics for "ground truth" here are not detailed, they would likely involve histological analysis or observable clinical effects in tissue).

8. The Sample Size for the Training Set

This information is not applicable/not provided in the context of this device submission. This is a medical device (electrosurgical system), not an AI/ML diagnostic or predictive algorithm that typically undergoes a training phase with a distinct training set of data. The "proprietary software" controls energy delivery but isn't described as a machine learning model trained on a dataset.

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

As there is no mention of a specific "training set" for an AI/ML algorithm in this submission, this information is not applicable. The "ground truth" for the device's design and engineering would have been established through established physics, electrical engineering principles, surgical practice, and regulatory standards.

Summary

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March 19, 2020

Creo Medical Ltd. % Leif Geoghegan Senior Design and Development Engineer Phil Triolo and Associates LC Creo House, Unit 2, Beaufort Park Way Chepstow, NP16 5 UH United Kingdom

Re: K192905

Trade/Device Name: Creo Electrosurgical System with HS1 Hemostasis Accessory Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: KNS Dated: February 18, 2020 Received: February 19, 2020

Dear Leif Geoghegan:

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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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

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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 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 (QS) 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 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-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,

for

Shani P. Haugen, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology 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) K192905

Device Name

Creo Electrosurgical System with HS1 Hemostasis Accessory

Indications for Use (Describe)

· Peptic Ulcers
· Dieulafoy Lesions
· Mallory-Weiss Tears
· Bleeding Polyp Stalks
· Arteriovenous Malformations (AVMs)
· Angiomata

The HS1 also has irrigation capability. Any other use is not recommended.

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)
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Creo Electrosurgical System with HS1 Hemostasis

Accessory

Page 1

510(k) Summary

Date Prepared: October 11, 2019

1.GENERAL

510(k) Sponsor:	Creo Medical LtdCreo House, Unit 2, Beaufort Park WayChepstowNP16 5UHUnited Kingdom
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Contact Person: Leif Geoghegan Senior Design and Development Engineer Phone: +44 (0) 1291 606005 Fax: +44 (0) 1291 606015

Prepared By: Phil Triolo and Associates, LC

2.DEVICE

Trade/Device Name:	Creo Electrosurgical System with HS1 Hemostasis Accessory
Common Name:	Electrosurgical System
Classification Name:	Endoscopic electrosurgical unit and accessories /Electrosurgical cutting and coagulation device and accessories
Regulation number:	21 CFR 876.4300
Product Code:	KNS

3.PREDICATE DEVICES

Boston Scientific Injection Gold Probe, bipolar electrohemostasis catheter (K133933) ERBE VIO 300 D electrosurgical generator (K083452) Creo Electrosurgical System including Speedboat RS2 surgical accessory (RS2) (K171983)

4.ASSOCIATED FDA DOCUMENT NUMBER

Q182299

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The Creo Medical Electrosurgical System with HS1 hemostasis accessory comprises of the following:

. HS1 hemostasis surgical accessory
. Electrosurgical Generator
Footswitch
Interface Cable

6.INDICATIONS FOR USE

· Peptic Ulcers
· Dieulafoy Lesions
· Mallory-Weiss Tears
· Bleeding Polyp Stalks
· Arteriovenous Malformations (AVMs)
· Angiomata

The HS1 also has irrigation capability. Any other use is not recommended.

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7.TCHNOLOGICAL CHARACTERISTICS

The Electrosurgical Generator comprises two distinct energy sources for the independent generation of bipolar RF current at 400 kHz and MW current at 5.8 GHz. Both energy sources are delivered through the same output coaxial connector. These generator outputs are controlled in terms of voltage, power, current, duty cycle, and duration by means of widely used and long-established design and engineering techniques. Via these controls and system design, only one energy source can be delivered to the output coaxial connector at any one time.

The HS1 surgical accessory is 1.75m long and used through the working channel of a compatible endoscope. The distal tip of the device comprised of:

. Stainless-steel bipolar electrodes that are separated by a PEEK dielectric for delivering coagulation energies.
. A parylene coating for provided a lubricious 'non-stick' coating
An extendable and retractable needle for delivery and injection of fluids that is useroperated by a slider control located on the proximal handle of the instrument

The proximal handle of the HS1 incorporates a Luer-lock port for connection of a user-supplied syringe containing injection solution and a coaxial connector for connection to the Interface Cable.

The Interface Cable has push-fit latching connectors on each end designed to deliver energy at both RF and MW frequencies.

Difference	Performance Testing
Coagulation: EnergyThe predicate device (GoldProbe) uses bipolar RF energy at350 kHz while the subject deviceuses MW energy at 5.8 GHz	Bench testing:Comparison with the predicate device for the penetrationand spread of thermal effects in gastrointestinal tissue.The bench testing showed substantial equivalence with thepredicate device.The difference in coagulation energy raises no newquestions regarding safety and efficacy.
Coagulation: Design distal tipThe predicate device (GoldProbe) has a dome shaped gold-metallized ceramic distal tip whilethe subject device has a bladeshaped gold-metallized ceramictip with a metal hull	Bench testing:Comparison with the predicate device for the penetrationand spread of thermal effects in gastrointestinal tissue.The bench testing showed substantial equivalence with thepredicate device.The difference in the design of the distal tip raises no newquestions regarding safety and efficacy.
Shaft and distal tip materialsThe materials used in the distaltip and shaft of the subject device	Bench testing:Comparison with the predicate devices for the penetrationand spread of thermal effects in gastrointestinal tissue.The bench testing showed substantial equivalence with thepredicate device.

8.DIFFERENCES BETWEEN SUBJECT AND PREDICATE DEVICES

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Creo Electrosurgical System with HS1 Hemostasis Accessory

Difference	Performance Testing
are similar but not identical to thepredicate devices	Biocompatibility:Meets all relevant requirements of FDA guidance and ISO10993.The difference in the shaft and distal tip materials raise nonew questions regarding safety and efficacy.
Needle and Injectionconfiguration and materialsThe materials used in the needleand the internal lumen of thepredicate device are similar butnot identical to the predicatedevices (Gold probe)	Bench Testing:Performance testing of injection flowrate.Performance testing of the insertion and retraction durabilitythe needle can extend and retract throughout lifetime use.The needle continues to perform to specification in a worst-case endoscope position.Performance testing of the needle point sharpnessthroughout the lifetime use of the device.Performance testing needle to hypotube and ferrule tensilestrength.All bench testing showed an acceptable level ofperformance.Biocompatibility:Meets all relevant requirements of FDA guidance and ISO10993.The difference in the needle configuration and materialsraise no new questions regarding safety and efficacy.

Difference

Performance Testing

are similar but not identical to thepredicate devices

Biocompatibility:Meets all relevant requirements of FDA guidance and ISO10993.The difference in the shaft and distal tip materials raise nonew questions regarding safety and efficacy.

Needle and Injectionconfiguration and materialsThe materials used in the needleand the internal lumen of thepredicate device are similar butnot identical to the predicatedevices (Gold probe)

Bench Testing:Performance testing of injection flowrate.Performance testing of the insertion and retraction durabilitythe needle can extend and retract throughout lifetime use.The needle continues to perform to specification in a worst-case endoscope position.Performance testing of the needle point sharpnessthroughout the lifetime use of the device.Performance testing needle to hypotube and ferrule tensilestrength.All bench testing showed an acceptable level ofperformance.Biocompatibility:Meets all relevant requirements of FDA guidance and ISO10993.The difference in the needle configuration and materialsraise no new questions regarding safety and efficacy.

9.PERFORMANCE DATA

The system meets all design specifications, design-risk analysis, and medical device standards for electrical safety and FDA recognized versions of EMC (IEC 60601), electrical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The mechanical, coagulation and injection performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicate devices.

10.CONCLUSION

The Creo Medical Electrosurgical System with HS1 surgical accessories is substantially equivalent to the Boston Scientific Injection Gold Probe, bipolar electrohemostasis catheter (K133933) and the ERBE VIO 300 D electrosurgical generator (K083452).

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).