(267 days)
Not Found
No
The description focuses on the electrosurgical generator's software for generating and controlling energy, but there is no mention of AI or ML capabilities for analysis, decision-making, or adaptive control based on data.
Yes
The device is described as an "electrosurgical system" intended for "cutting" and "coagulation" of soft tissue, as well as "delivery and injection of solutions for endoscopic surgical procedures." These actions directly influence the body's function (e.g., stopping bleeding, removing tissue) to treat medical conditions, fitting the definition of a therapeutic device.
No
The device is described as an electrosurgical system intended for cutting, coagulation (hemostasis, cauterization), and fluid delivery for endoscopic surgical procedures. These are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including an Electrosurgical Generator, Footswitch, Interface Cable, and Speedboat instruments. While the generator incorporates proprietary software, the system is fundamentally a hardware-based electrosurgical system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "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." This describes a surgical intervention and treatment device, not a device used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description details an electrosurgical system with instruments designed for direct interaction with tissue within the body (cutting, coagulation, injection).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, calibrators, or controls, which are typical components and uses of IVD devices.
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KNS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
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)
Performance testing via bench tests for:
- 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.
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
§ 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).
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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"
1
(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).
2
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
3
Indications for Use
510(k) Number (if known) K230328
Device Name Speedboat Flush SB1 Instrument
Indications for Use (Describe)
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.
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)
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.
INDICATIONS FOR USE STATEMENT
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.
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Image /page/6/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.
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 function | |
| The subject device incorporates a fluid lumen | |
| while the predicate incorporates an extendable | |
| and retractable needle for fluid injection. | The subject device was tested to be able to |
| produce a jet (constant stream) of saline from | |
| the device tip at minimum pressure which has | |
| been determined to be equivalent to the use of | |
| a needle for the intended device operation. | |
| Shaft diameter | |
| outer shaft diameter is 2.35 mm compared to | |
| 3.2 mm for predicate Speedboat RS2. It is to be | |
| compatible with an endoscope of minimum | |
| working channel 2.8 mm instead of minimum | |
| 3.7 mm. | The subject device performances were |
| evaluated via the bench tests listed below and | |
| has been determined to be substantially | |
| equivalent to the predicate device. | |
| Distal tip dimensions | |
| The antenna of the subject device is slightly | |
| longer and thinner compared to the predicate | |
| device. However, the shape of the antenna and | |
| distance between the electrode has not | |
| changed. | The subject device lifetime cut and coagulation |
| performance was evaluated and demonstrated | |
| to be substantially equivalent to the predicate | |
| device. | |
| Handle design | |
| The handle of the subject device has had an | |
| overall redesign compared to the predicate | |
| device. As the device does not incorporate a | |
| needle, the slider to actuate the needle has | |
| been removed. | The function of the handle has not changed |
| and incorporate the same connections for RF | |
| and microwave energy output (QMA | |
| connector) and for fluid injection (luer lock | |
| connector). | |
| The handle was evaluated via the bench tests | |
| listed below and has been determined to be | |
| substantially equivalent to the predicate | |
| device. |
The system meets all design specifications, risk mitigation requirements and applicable medical device standard requirements.
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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.