(48 days)
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.
The Creo Medical Electrosurgical System comprises: Speedboat RS2 surgical instrument (7-RS2-001), Electrosurgical Generator (7-EMR-050), Footswitch (2-EMR-032), Interface Cable (7-RS2-210). The Electrosurgical Generator is designed to 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 RS2 is an electrosurgical instrument for use with the Creo Medical Electrosurgical Generator only. Speedboat RS2 is for endoscopic use and provides cutting, coagulation and injection of fluids incorporated in a single device. Speedboat RS2 is for single-use only and provided sterile.
This document describes the premarket notification (510(k)) for the Creo Medical Electrosurgical System, including the Speedboat RS2 surgical accessory. This device is intended for electrosurgical procedures within the gastrointestinal tract, specifically for cutting soft tissue using radiofrequency (RF) current, coagulating soft tissue using microwave energy, and delivering/injecting solutions.
Based on the provided text, the submission relies heavily on bench testing and compliance with existing medical device standards rather than clinical studies with human participants or a detailed AI model evaluation. Therefore, many of the requested elements for an AI-based device acceptance criteria and study cannot be fully addressed.
Here's the information that can be extracted or inferred:
Acceptance Criteria and Device Performance
The document states that the system "meets all design specifications, design-risk analysis, and medical device standards." When discussing differences between the subject device and predicate devices, the "Performance Testing" column serves as an implicit acceptance criterion, with the reported device performance being "substantial equivalence with the predicate device" in relevant areas.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Cutting Performance (Energy) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Cutting Performance (Distal Tip Design) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Coagulation Performance (Energy) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Coagulation Performance (Distal Tip Design) | "Comparison with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The bench testing showed substantial equivalence with the predicate device." |
| Biocompatibility | "Meets all relevant requirements of ISO10993." (Performance data also states, "The mechanical, cut, coagulation and injection performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicate devices.") |
| Electrical Safety and EMC | "Meets... medical device standards for electrical safety and EMC (IEC 60601)." |
| Sterility | "Meets... medical device standards for... sterility (ISO 11135)." |
| Mechanical, Cut, Coagulation and Injection Performance (Overall) | "The mechanical, cut, coagulation and injection performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicate devices." (This appears to be an overarching summary of the performance.) The statement also notes: "The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered." |
Study Details for Acceptance Criteria Proof
Based on the provided document, the "study" demonstrating the device meets acceptance criteria is primarily a series of bench tests and compliance checks against established standards. The information provided does not indicate a clinical study with human patients for AI performance evaluation.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for "bench testing" explicitly. It refers to "gastrointestinal tissue" for thermal effects comparisons. It also mentions "ex-vivo and in-vivo" testing, but no specific numbers for samples or cases are provided.
- Data Provenance: The bench testing and "ex-vivo and in-vivo" tests were conducted by Creo Medical Ltd. The country of origin of the data is not explicitly stated beyond Creo Medical's location in the United Kingdom. It is considered prospective for the purpose of this submission, as it was conducted to support the 510(k).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The assessment relies on measurements of physical effects (penetration, thermal spread) and compliance with standards, rather than expert interpretation of images or other subjective data. If experts were involved in interpreting histological samples from the ex-vivo/in-vivo tests, their number and qualifications are not disclosed.
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Adjudication method for the test set:
- This information is not provided. Given the nature of bench testing and comparing physical effects, a formal adjudication method (like 2+1, 3+1 for expert review) is not typically applicable in the same way it would be for diagnostic AI.
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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 MRMC study was conducted. This device is an electrosurgical system, not a diagnostic AI system intended to assist human readers in interpreting medical images or data. The "AI" mentioned is proprietary software controlling energy delivery, not an AI for diagnostic assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The "performance" described refers to the physical effects of the electrosurgical device as controlled by its internal software. In essence, the "algorithm only" performance (referring to the control software) is what was tested through the bench and ex-vivo/in-vivo studies to ensure it produced the desired energy outputs and tissue effects. There is no separate "standalone" performance in the context of an AI diagnostic device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench testing, the "ground truth" seems to be physical measurements of parameters like penetration depth and spread of thermal effects in tissue, likely compared against established safe and effective ranges or the performance of predicate devices. For biocompatibility, electrical safety, and sterility, the ground truth is adherence to specified international standards (ISO 10993, IEC 60601, ISO 11135).
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The sample size for the training set:
- The document mentions that the Electrosurgical Generator incorporates "proprietary software developed by Creo Medical for generating and controlling the two energies delivered." This is control software, not explicitly described as a machine learning/AI model that undergoes "training" in the conventional sense. Therefore, a "training set" for such a system would not be applicable or described in this type of submission.
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How the ground truth for the training set was established:
- As there is no described training set for an AI model, this question is not applicable. The control software functionality would have been developed and validated through traditional software engineering and testing processes, likely using design specifications as the "ground truth" for its correct operation.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2017
Creo Medical Ltd. % Keith Penny Director Quality Assurance and Regulatory Affairs Creo Medical Ltd. Riverside Court, Beaufort Park Chepstow, NP16 5UH United Kingdom
Re: K171983
Trade/Device Name: Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: KNS Dated: June 29, 2017 Received: June 30, 2017
Dear Keith Penny:
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. 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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171983
Device Name
Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory
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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SECTION 5 510(k) SUMMARY
1. SUBMITTER
Creo Medical Ltd Riverside Court Beaufort Park Chepstow NP16 5UH United Kingdom Phone: +44 (0) 1291 606005 Fax: +44 (0) 1291 606015
Contact: Keith Penny Director Regulatory Affairs
Date Prepared: June 28, 2017
DEVICE 2.
| Device Name: | Creo Medical Electrosurgical System including Speedboat RS2 surgical |
|---|---|
| accessory | |
| Common Name: | Electrosurgical System |
| Classification Name: | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) |
| Regulation Number: | 21 CFR 876.4300 |
| Product Code: | KNS |
| Classification: | Class II |
3. PREDICATE DEVICES
Olympus Hook Knife, single-use electrosurgical knife K092309 K133933 Boston Scientific Injection Gold Probe, bipolar electrohemostasis catheter ERBE VIO 300 D electrosurgical generator K083452
4. SYSTEM DESCRIPTION
The Creo Medical Electrosurgical System comprises:
- Speedboat RS2 surgical instrument (7-RS2-001) ●
- Electrosurgical Generator (7-EMR-050) .
- Footswitch (2-EMR-032) .
- . Interface Cable (7-RS2-210)
The Electrosurgical Generator is designed to 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
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controlling the two energies delivered. The Electrosurgical Generator and Footswitch are nonsterile 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 RS2 is an electrosurgical instrument for use with the Creo Medical Electrosurgical Generator only. Speedboat RS2 is for endoscopic use and provides cutting, coagulation and injection of fluids incorporated in a single device. Speedboat RS2 is for single-use only and provided sterile.
5. INDICATION 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.
6. TECHNOLOGICAL CHARACTERISTCS
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.
The Speedboat RS2 surgical instrument is 2.3 m long and used through the working channel of a compatible endoscope. The distal tip comprises:
- a qold-metallized ceramic bipolar electrode assembly (Blade) for delivery of cutting and . coagulation energies
- . a stainless-steel rounded contour component (Hull) mounted to the Blade
- . 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 Speedboat RS2 incorporates a Luer-lock port for connection of a usersupplied 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.
| Difference | Performance Testing |
|---|---|
| Cut: EnergyThe predicate device (Hook Knife)uses monopolar RF energy at350 kHz while the subject deviceuses bipolar RF energy at 400kHz | 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 cut energy raises no new questionsregarding safety and efficacy. |
DIFFERENCE BETWEEN SUBJECT AND PREDICATE DEVICES 7.
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| Difference | Performance Testing |
|---|---|
| Cut: Design distal tipThe predicate device (Hook Knife)has a L- shaped stainless steeldistal tip while the subject devicehas a blade shaped gold-metallized ceramic tip with ametal 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. |
| Coagulation: EnergyThe predicate device (GoldProbe) uses bipolar RF energy at350 kHz while the subject deviceuses microwave energy at 5.8GHz | 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 deviceare similar but not identical to thepredicate devices | 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.Biocompatibility:Meets all relevant requirements of ISO10993.The difference in the shaft and distal tip materials raise nonew questions regarding safety and efficacy. |
PERFORMANCE DATA 8.
The system meets all design specifications, design-risk analysis, and medical device standards for electrical safety and EMC (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The mechanical, cut, coagulation and injection performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicate devices.
CONCLUSION 9.
The Creo Medical Electrosurgical System is substantially equivalent to the predicate devices.
§ 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).