(48 days)
Not Found
No
The summary describes a standard electrosurgical system with a generator and instruments for cutting and coagulation using RF and microwave energy. While it mentions proprietary software for controlling energy delivery, there is no indication of AI/ML being used for tasks like image analysis, decision support, or adaptive control based on complex data patterns. The performance studies are standard bench and ex-vivo/in-vivo testing, not studies typically associated with validating AI/ML algorithms.
Yes
The device is intended for "cutting of soft tissue," "coagulation (hemostasis, cauterization) of soft tissue," and "delivery and injection of solutions for endoscopic surgical procedures," which are all therapeutic actions.
No
The device is primarily used for surgical procedures involving cutting, coagulation, and delivery of solutions for endoscopic surgical procedures within the gastrointestinal tract, rather than for diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including a surgical instrument, electrosurgical generator, footswitch, and interface cable. While the generator incorporates software, the device as a whole is a system of both hardware and software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures within the gastrointestinal tract, specifically for cutting, coagulation, and injection of solutions. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details an electrosurgical system that delivers energy (radiofrequency and microwave) to tissue for cutting and coagulation. This is consistent with surgical tools, not devices used to examine specimens from the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro analysis.
IVD devices are used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on tissue within the body during a surgical procedure.
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 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 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.
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)
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.
Key results from performance testing included:
- Cut: Energy - Bench testing showed substantial equivalence with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The difference in cut energy raises no new questions regarding safety and efficacy.
- Cut: Design distal tip - Bench testing showed substantial equivalence with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The difference in the design of the distal tip raises no new questions regarding safety and efficacy.
- Coagulation: Energy - Bench testing showed substantial equivalence with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The difference in coagulation energy raises no new questions regarding safety and efficacy.
- Coagulation: Design distal tip - Bench testing showed substantial equivalence with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. The difference in the design of the distal tip raises no new questions regarding safety and efficacy.
- Shaft and distal tip materials - Bench testing showed substantial equivalence with the predicate device for the penetration and spread of thermal effects in gastrointestinal tissue. Biocompatibility: Meets all relevant requirements of ISO10993. The difference in the shaft and distal tip materials raises no new questions regarding safety and efficacy.
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/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.
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.
1
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
4
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: Energy | |
| The predicate device (Hook Knife) | |
| uses monopolar RF energy at | |
| 350 kHz while the subject device | |
| uses bipolar RF energy at 400 | |
| kHz | Bench testing: |
| 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. | |
| The difference in cut energy raises no new questions | |
| regarding safety and efficacy. |
DIFFERENCE BETWEEN SUBJECT AND PREDICATE DEVICES 7.
5
| Difference | Performance Testing |
|---|---|
| Cut: Design distal tip | |
| The predicate device (Hook Knife) | |
| has a L- shaped stainless steel | |
| distal tip while the subject device | |
| has a blade shaped gold- | |
| metallized ceramic tip with a | |
| metal hull | Bench testing: |
| 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. | |
| The difference in the design of the distal tip raises no new | |
| questions regarding safety and efficacy. | |
| Coagulation: Energy | |
| The predicate device (Gold | |
| Probe) uses bipolar RF energy at | |
| 350 kHz while the subject device | |
| uses microwave energy at 5.8 | |
| GHz | Bench testing: |
| 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. | |
| The difference in coagulation energy raises no new | |
| questions regarding safety and efficacy. | |
| Coagulation: Design distal tip | |
| The predicate device (Gold | |
| Probe) has a dome shaped gold- | |
| metallized ceramic distal tip while | |
| the subject device has a blade | |
| shaped gold-metallized ceramic | |
| tip with a metal hull | Bench testing: |
| 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. | |
| The difference in the design of the distal tip raises no new | |
| questions regarding safety and efficacy. | |
| Shaft and distal tip materials | |
| The materials used in the distal | |
| tip and shaft of the subject device | |
| are similar but not identical to the | |
| predicate devices | Bench testing: |
| Comparison with the predicate devices 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. | |
| The difference in the shaft and distal tip materials raise no | |
| new 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.