Intended for use in the cutting of soft tissue using radiofrequency current, the coagulation (hemostasis, cauterization) of soft tissue using microwave energy, and the delivery and injection of solutions for endoscopic surgical procedures within the gastrointestinal tract.

Device Description

The Creo Medical Electrosurgical System with Speedboat surgical instrument comprises:

Electrosurgical Generator (7-EMR-050)
Footswitch (2-EMR-032)
Interface Cable Procedure Pack (cable with sterile sheath) (7-RS2-210)
Speedboat RS2 instrument (7-RS2-001)
Speedboat RS2 8 Fr instrument (7-RS2-003)
Speedboat SB1 instrument (7-RS2-001)

The Electrosurgical Generator is deliver bipolar radiofrequency (RF) energy and microwave 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 microwave 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.

Speedboat is an electrosurgical instrument for use with the Creo Medical Electrosurgical Generator only. Speedboat instrument is for endoscopic use and provides cutting, coagulation and injection of fluids incorporated in a single device. Speedboat Instrument is for single-use only and is provided sterile via EO sterilization.

Speedboat SB1 instrument is a line addition to the system, designed to be used in endoscopes with a minimum working channel of 2.8 mm.

AI/ML Overview

The provided document is a 510(k) summary for the Creo Medical Speedboat Flush SB1 Instrument. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific acceptance criteria in a clinical setting with human subjects.

Therefore, the requested information, particularly regarding specific performance metrics with acceptance criteria, sample sizes for test sets (including data provenance, expert involvement, and adjudication methods), MRMC studies, standalone algorithm performance, and training set details, is not available in the provided text.

The document primarily covers bench testing to demonstrate that design changes (fluid injection, shaft diameter, distal tip dimensions, handle design) do not negatively impact device performance compared to the predicate device.

However, I can extract the general "acceptance criteria" through the lens of device validation and the types of performance testing mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) summary, the acceptance criteria are implicitly met by "passing" the various bench tests and demonstrating substantial equivalence. Explicit numerical targets are not provided within this document.

Acceptance Criteria Category	Reported Device Performance (as per bench tests)
Fluid Injection Functionality	Ability to produce a jet (constant stream) of saline from the device tip at minimum pressure, determined to be equivalent to the needle injection of the predicate.
Shaft Diameter/Compatibility	Performances evaluated via bench tests and determined to be substantially equivalent to the predicate device, despite smaller diameter.
Distal Tip Dimensions/Performance	Lifetime cut and coagulation performance evaluated and demonstrated to be substantially equivalent to the predicate device.
Handle Design Functionality	Function of the handle unchanged; incorporates same connections (QMA, luer lock). Evaluated via bench tests and determined to be substantially equivalent.
Overall Design Specifications	Meets all design specifications, risk mitigation requirements, and applicable medical device standard requirements.
Sterilization Assurance Level (SAL)	10⁻⁶ (as per ISO 11135:2014 and AAMI TIR28:2016).
Shelf-life	1 year (12 months).
Biocompatibility	Meets all required biological endpoints (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute systemic toxicity, Hemocompatibility) as per ISO 10993-1.
Electrical Safety, Microwave Safety, EMC	Complies with IEC 60601-1, IEC 60601-2-2, IEC 60601-2-6 (safety) and IEC 60601-1-2 (EMC).
Software Verification & Validation	Conducted and documented as per FDA guidance; "major" level of concern addressed.
Lifetime Cut & Coagulation	Passed acceptance criteria (implicitly, by demonstrating substantial equivalence).
Connection Latch & Retention	Passed acceptance criteria.
Minimum Bend Radius	Passed acceptance criteria.
Connector Rotation	Passed acceptance criteria.
Device Rotation	Passed acceptance criteria.
Device & Injection Fluid Temperature	Passed acceptance criteria.
Endoscope Insertion & Withdrawals	Passed acceptance criteria.
Vector Network Analysis (VNA)	Passed acceptance criteria.
Hot Tissue Damage	Passed acceptance criteria.
Cutting Speed & Thermal Margin	Passed acceptance criteria.
Distal Tip Shear Force	Passed acceptance criteria.
Components & Sub-assemblies Strength	Passed acceptance criteria.

2. Sample size used for the test set and the data provenance

Not specified in the document. The document describes various bench tests (e.g., Lifetime Cut & coagulation, Fluid injection, Hot tissue damage) but does not provide details on the number of samples tested for each or the specific "data provenance" as one would expect for clinical data. These are likely performed in a lab setting rather than with human or animal data for this type of submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not specified. For bench testing of physical device characteristics, human expert "ground truth" setting in the context of interpretation (like radiology) is not relevant. The "ground truth" is typically defined by engineering specifications, physical measurements, and performance benchmarks.

4. Adjudication method for the test set

Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or subjective assessments. This document describes bench testing, where outcomes are typically objective measurements against engineering specifications.

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

Not applicable. This device is an electrosurgical instrument, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not conducted.

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

Not applicable. This is a physical electrosurgical device; it does not have a standalone "algorithm-only" performance that would be evaluated in this manner. Software verification and validation were conducted for the generator's control software, which is part of the integrated system.

7. The type of ground truth used

For the bench tests, the "ground truth" would be engineering specifications, physical and electrical standards, and predetermined performance benchmarks established during device design and validated against the predicate device. For biocompatibility, the ground truth is established by the relevant ISO standards and FDA guidance.

8. The sample size for the training set

Not applicable. This document describes a medical device, not an AI model requiring a training set.

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

Not applicable. As above, this is not an AI model. For the software verification and validation, the "ground truth" would be the software requirements specifications and expected functional behavior.

Summary

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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.

October 31, 2023

Creo Medical Ltd Diane Davis Regulatory Specialist Unit 2 Beaufort Park, Beaufort Part Way Chepstow, Monmouthshire NP16 5UH United Kingdom

Re: K230328

Trade/Device Name: Speedboat Flush SB1 Instrument Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: KNS Dated: September 29, 2023 Received: September 29, 2023

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 (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.

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"

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(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 (QS) 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 OS 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.

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 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).

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Sincerely,

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. 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) K230328

Device Name Speedboat Flush SB1 Instrument

Indications for Use (Describe)

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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Image /page/4/Picture/1 description: The image shows the Creo Medical logo. The logo consists of two blue squares, each with a white triangle cut out of the top left corner. The squares are positioned next to each other, forming a larger square shape. To the right of the squares is the text "CREO MEDICAL" in a sans-serif font, with "CREO" on top of "MEDICAL".

510(k) Summary

Speedboat Flush SB1 Instrument

SUBMITTER INFORMATION

Company Name:	Creo Medical Ltd.
Company Address:	Unit 2 Beaufort Park, Beaufort Park Way, Chepstow NP16 5UH, UK

CONTACT

Name:	Diane Davis
Telephone:	+44 7899 306000
Email:	diane.davis@creomedical.com
Date Prepared:	February 6th, 2023

DEVICE IDENTIFICATION

Trade Name:	Speedboat Flush SB1 Instrument
Common Name:	Electrosurgical system with surgical instrument
Classification Name:	Endoscopic electrosurgical unit and accessories
Regulation Number:	21 CFR 876.4300
Product Code:	KNS
Regulatory Class:	Class II

PREDICATE DEVICE INFORMATION

K171983 Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory

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Image /page/5/Picture/0 description: The image shows the logo for Creo Medical. The logo consists of two blue geometric shapes on the left, resembling stylized origami or folded paper. To the right of the shapes, the words "CREO MEDICAL" are written in a simple, sans-serif font, also in blue.

K230328 Page 2 of 6

SYSTEM DESCRIPTION

The Creo Medical Electrosurgical System with Speedboat surgical instrument comprises:

Electrosurgical Generator (7-EMR-050)
. Footswitch (2-EMR-032)
. Interface Cable Procedure Pack (cable with sterile sheath) (7-RS2-210)
Speedboat RS2 instrument (7-RS2-001)
. Speedboat RS2 8 Fr instrument (7-RS2-003)
. Speedboat SB1 instrument (7-RS2-001)

Speedboat SB1 instrument is a line addition to the system, designed to be used in endoscopes with a minimum working channel of 2.8 mm.

INDICATIONS FOR USE STATEMENT

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K230328 Page 3 of 6

TECHNOLOGICAL AND PERFORMANCE CHARACTERISTICS

The Electrosurgical Generator comprises two distinct energy sources for the independent generation of bipolar radiofrequency (RF) current at 400 kHz and microwave 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.

Speedboat SB1 instrument is 2.3 m long and used through the working channel of a compatible endoscope. The distal tip comprises:

. a gold-metallized ceramic bipolar electrode assembly (Antenna) for delivery of cutting and coagulation energies;
. a stainless-steel rounded contour component (Hull) mounted to the Antenna;
. a fluid lumen for delivery and injection of fluids.

The proximal handle of Speedboat SB1 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 microwave frequencies.

The subject and predicate devices use the same electrosurgical generator, footswitch, and interface cable. They are composed of the same technological components with the same principles of operation which are:

. Cutting of mucosa, sub-mucosa, muscle using bipolar RF energy,
. Thermal coagulation (cauterization) of mucosa and/or sub-mucosa, muscle, vascular and arterial structures using microwave energy,
. Injection of a fluid into the sub-mucosa using the fluid injection function located at the distal tip of the device.

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Image /page/7/Picture/0 description: The image shows the logo for Creo Medical. The logo consists of a blue geometric shape on the left and the words "CREO MEDICAL" on the right. The geometric shape is made up of two triangles that are joined together. The words "CREO MEDICAL" are written in a sans-serif font, with "CREO" on top of "MEDICAL".

COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following technological differences between the subject and predicate device were compared:

Difference	Equivalence assessment
Fluid injection functionThe subject device incorporates a fluid lumenwhile the predicate incorporates an extendableand retractable needle for fluid injection.	The subject device was tested to be able toproduce a jet (constant stream) of saline fromthe device tip at minimum pressure which hasbeen determined to be equivalent to the use ofa needle for the intended device operation.
Shaft diameterouter shaft diameter is 2.35 mm compared to3.2 mm for predicate Speedboat RS2. It is to becompatible with an endoscope of minimumworking channel 2.8 mm instead of minimum3.7 mm.	The subject device performances wereevaluated via the bench tests listed below andhas been determined to be substantiallyequivalent to the predicate device.
Distal tip dimensionsThe antenna of the subject device is slightlylonger and thinner compared to the predicatedevice. However, the shape of the antenna anddistance between the electrode has notchanged.	The subject device lifetime cut and coagulationperformance was evaluated and demonstratedto be substantially equivalent to the predicatedevice.
Handle designThe handle of the subject device has had anoverall redesign compared to the predicatedevice. As the device does not incorporate aneedle, the slider to actuate the needle hasbeen removed.	The function of the handle has not changedand incorporate the same connections for RFand microwave energy output (QMAconnector) and for fluid injection (luer lockconnector).The handle was evaluated via the bench testslisted below and has been determined to besubstantially equivalent to the predicatedevice.

The system meets all design specifications, risk mitigation requirements and applicable medical device standard requirements.

K230328

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Image /page/8/Picture/0 description: The image shows the logo for Creo Medical. The logo consists of a blue geometric shape on the left and the words "CREO MEDICAL" in blue on the right. The geometric shape is made up of two triangles that are arranged to form a square.

PERFORMANCE DATA

Sterilization and Shelf-life

As per ISO 11135:2014 and AAMI TIR28:2016 standard evaluation, Speedboat SB1 sterility assurance level is 106.

The shelf-life for the Speedboat SB1 instrument is 1 year (12 months).

Biocompatibility

The biocompatibility evaluation of Speedboat SB1 was conducted in accordance with ISO 10993-1:2009 and the FDA guidance document, Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process: Guidance for Industry and Food and Drug Administration Staff," issued by the FDA on June 16, 2016.

When used as intended, Speedboat SB1 Instrument is categorized as an externally communicating device in limited contact (≤ 24 hours) with tissue. Following Speedboat SB1 categorization as per Attachment A of the FDA guidance and Table A.1 Annex A of ISO 10993-1, the relevant biological endpoints are:

Physical and/or chemical information
Cytotoxicity
Sensitization
Irritation or intracutaneous reactivity
Material-mediated pyrogenicity
Acute systemic toxicity
Hemocompatibility via hemolysis

the biological risk assessment performed provide evidence that Speedboat SB1 meets all required biological endpoints.

Electrical Safety, Microwave Safety and Electromagnetic Compatibility

Electrical safety and EMC tests were conducted on the Creo Medical Electrosurgical System with Speedboat Instrument. The system complies with FDA-recognized versions of IEC 60601-1, IEC 60601-2-2 and IEC 60601-2-6 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

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Image /page/9/Picture/0 description: The image shows the logo for Creo Medical. The logo consists of a blue geometric shape on the left and the words "CREO MEDICAL" in blue on the right. The geometric shape is made up of two triangles that are joined together.

Performance testing via bench tests

The following bench tests were performed:

Lifetime Cut & coagulation;
Connection latch and retention;
. Minimum bend radius;
Connector rotation; ●
Fluid injection;
Device rotation;
. Device & injection fluid temperature;
. Endoscope insertion and withdrawals;
Vector Network Analysis (VNA);
Hot tissue damage;
Cutting speed and thermal margin; ●
. Distal tip shear force;
Components and sub-assemblies strength.

All bench tests passed the acceptance criteria and indicated that Speedboat SB1 is substantially equivalent to the predicate device.

CONCLUSION

Based on the indications for use, technological characteristics, performance results, and comparison to the predicate, the Speedboat Flush SB1 has been shown to be substantially equivalent to the predicate device identified in this submission and does not present any new issues of safety or effectiveness.

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).