(156 days)
Not Found
No
The summary describes a standard electrosurgical generator and accessory for cutting and coagulation using RF and MW energy. It mentions proprietary software for generating and controlling the energies but does not include any terms or descriptions indicative of AI or ML capabilities, such as image processing, data analysis for diagnosis, or adaptive algorithms based on learned patterns. The performance studies are standard bench and in-vivo testing, not studies related to AI/ML model performance.
Yes.
Justification: The device is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation of soft tissue, and is also indicated for use in endoscopic injection therapy and electrohemostasis of actual or potential bleeding sites in the gastrointestinal tract, which are all therapeutic actions.
No
The device uses radiofrequency and microwave energy for cutting and coagulation of tissue, and for endoscopic injection therapy and electrohemostasis. It is not designed to diagnose conditions.
No
The device description explicitly lists hardware components: HS1 hemostasis surgical accessory, Electrosurgical Generator, Footswitch, and Interface Cable. While the generator incorporates software, the system is not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for providing electrosurgical energy for cutting and coagulation of soft tissue and for endoscopic injection therapy and electrohemostasis of bleeding sites in the gastrointestinal tract. These are all procedures performed in vivo (within a living organism).
- Device Description: The description details a system for delivering energy and fluids directly to tissue within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are typically used to test samples to detect diseases, conditions, or to monitor health.
The device is a therapeutic and procedural device used directly on the patient's tissue.
N/A
Intended Use / Indications for Use
The Creo Electrosurgical Generator is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, and is for use only with compatible Creo Medical instruments and accessories.
The HS1 Hemostasis Accessory is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:
- · Peptic Ulcers
- · Dieulafoy Lesions
- · Mallory-Weiss Tears
- · Bleeding Polyp Stalks
- · Arteriovenous Malformations (AVMs)
- · Angiomata
The HS1 also has irrigation capability. Any other use is not recommended.
Product codes (comma separated list FDA assigned to the subject device)
KNS
Device Description
The Creo Medical Electrosurgical System with HS1 hemostasis accessory comprises of the following:
- . HS1 hemostasis surgical accessory
- . Electrosurgical Generator
- Footswitch
- Interface Cable
The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave (MW) energy for the purpose of cutting and coagulating tissue. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cut: the other pedal activates the MW energy output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.
The Interface Cable connects electrosurgical instruments to the Electrosurgical Generator and is for single-use and is supplied with a sterile sheath that is fitted over its distal end during connection to the surgical accessory.
HS1 is an electrosurgical hemostasis accessory for use with the Creo Medical Electrosurgical Generator only. HS1 is for endoscopic use and provides coagulation and injection of fluids incorporated in a single device. HS1 is for single-use only and provided sterile.
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
Prescription Use
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)
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.
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.
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 FDA guidance and ISO 10993. The difference in the shaft and distal tip materials raise no new questions regarding safety and efficacy.
Bench Testing:
Performance testing of injection flowrate.
Performance testing of the insertion and retraction durability the needle can extend and retract throughout lifetime use.
The needle continues to perform to specification in a worst-case endoscope position.
Performance testing of the needle point sharpness throughout the lifetime use of the device.
Performance testing needle to hypotube and ferrule tensile strength.
All bench testing showed an acceptable level of performance.
Biocompatibility:
Meets all relevant requirements of FDA guidance and ISO 10993.
The difference in the needle configuration and materials raise no new questions regarding safety and efficacy.
The system meets all design specifications, design-risk analysis, and medical device standards for electrical safety and FDA recognized versions of EMC (IEC 60601), electrical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The mechanical, coagulation and injection performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicate devices.
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).
0
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 in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
March 19, 2020
Creo Medical Ltd. % Leif Geoghegan Senior Design and Development Engineer Phil Triolo and Associates LC Creo House, Unit 2, Beaufort Park Way Chepstow, NP16 5 UH United Kingdom
Re: K192905
Trade/Device Name: Creo Electrosurgical System with HS1 Hemostasis Accessory Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit And Accessories Regulatory Class: Class II Product Code: KNS Dated: February 18, 2020 Received: February 19, 2020
Dear Leif Geoghegan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Shani P. Haugen, Ph.D. Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192905
Device Name
Creo Electrosurgical System with HS1 Hemostasis Accessory
Indications for Use (Describe)
The Creo Electrosurgical Generator is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, and is for use only with compatible Creo Medical instruments and accessories.
The HS1 Hemostasis Accessory is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:
- · Peptic Ulcers
- · Dieulafoy Lesions
- · Mallory-Weiss Tears
- · Bleeding Polyp Stalks
- · Arteriovenous Malformations (AVMs)
- · Angiomata
The HS1 also has irrigation capability. Any other use is not recommended.
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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3
Creo Electrosurgical System with HS1 Hemostasis
Accessory
Page 1
510(k) Summary
Date Prepared: October 11, 2019
1.GENERAL
| 510(k) Sponsor: | Creo Medical Ltd
Creo House, Unit 2, Beaufort Park Way
Chepstow
NP16 5UH
United Kingdom |
| ----------------- | ----------------------------------------------------------------------------------------------------- |
|---|
Contact Person: Leif Geoghegan Senior Design and Development Engineer Phone: +44 (0) 1291 606005 Fax: +44 (0) 1291 606015
- Prepared By: Phil Triolo and Associates, LC
2.DEVICE
| Trade/Device Name: | Creo Electrosurgical System with HS1 Hemostasis Accessory |
|---|---|
| Common Name: | Electrosurgical System |
| Classification Name: | Endoscopic electrosurgical unit and accessories / |
| Electrosurgical cutting and coagulation device and accessories | |
| Regulation number: | 21 CFR 876.4300 |
| Product Code: | KNS |
3.PREDICATE DEVICES
Boston Scientific Injection Gold Probe, bipolar electrohemostasis catheter (K133933) ERBE VIO 300 D electrosurgical generator (K083452) Creo Electrosurgical System including Speedboat RS2 surgical accessory (RS2) (K171983)
4.ASSOCIATED FDA DOCUMENT NUMBER
Q182299
4
The Creo Medical Electrosurgical System with HS1 hemostasis accessory comprises of the following:
- . HS1 hemostasis surgical accessory
- . Electrosurgical Generator
- Footswitch
- Interface Cable
The Electrosurgical Generator is designed to deliver bipolar radiofrequency (RF) energy and microwave (MW) energy for the purpose of cutting and coagulating tissue. The Electrosurgical Generator output is actuated via a two-pedal Footswitch. One pedal activates the bipolar RF energy output for cut: the other pedal activates the MW energy output for coagulation. The Electrosurgical Generator incorporates proprietary software developed by Creo Medical for generating and controlling the two energies delivered. The Electrosurgical Generator and Footswitch are non-sterile and reusable.
The Interface Cable connects electrosurgical instruments to the Electrosurgical Generator and is for single-use and is supplied with a sterile sheath that is fitted over its distal end during connection to the surgical accessory.
HS1 is an electrosurgical hemostasis accessory for use with the Creo Medical Electrosurgical Generator only. HS1 is for endoscopic use and provides coagulation and injection of fluids incorporated in a single device. HS1 is for single-use only and provided sterile.
6.INDICATIONS FOR USE
The Creo Electrosurgical Generator is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, and is for use only with compatible Creo Medical instruments and accessories.
The HS1 Hemostasis Accessory is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:
- · Peptic Ulcers
- · Dieulafoy Lesions
- · Mallory-Weiss Tears
- · Bleeding Polyp Stalks
- · Arteriovenous Malformations (AVMs)
- · Angiomata
The HS1 also has irrigation capability. Any other use is not recommended.
5
7.TCHNOLOGICAL CHARACTERISTICS
The Electrosurgical Generator comprises two distinct energy sources for the independent generation of bipolar RF current at 400 kHz and MW current at 5.8 GHz. Both energy sources are delivered through the same output coaxial connector. These generator outputs are controlled in terms of voltage, power, current, duty cycle, and duration by means of widely used and long-established design and engineering techniques. Via these controls and system design, only one energy source can be delivered to the output coaxial connector at any one time.
The HS1 surgical accessory is 1.75m long and used through the working channel of a compatible endoscope. The distal tip of the device comprised of:
- . Stainless-steel bipolar electrodes that are separated by a PEEK dielectric for delivering coagulation energies.
- . A parylene coating for provided a lubricious 'non-stick' coating
- An extendable and retractable needle for delivery and injection of fluids that is useroperated by a slider control located on the proximal handle of the instrument
The proximal handle of the HS1 incorporates a Luer-lock port for connection of a user-supplied syringe containing injection solution and a coaxial connector for connection to the Interface Cable.
The Interface Cable has push-fit latching connectors on each end designed to deliver energy at both RF and MW frequencies.
| Difference | Performance Testing |
|---|---|
| Coagulation: Energy | |
| The predicate device (Gold | |
| Probe) uses bipolar RF energy at | |
| 350 kHz while the subject device | |
| uses MW 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 | 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. |
8.DIFFERENCES BETWEEN SUBJECT AND PREDICATE DEVICES
6
Creo Electrosurgical System with HS1 Hemostasis Accessory
| Difference | Performance Testing |
|---|---|
| are similar but not identical to the | |
| predicate devices | Biocompatibility: |
| Meets all relevant requirements of FDA guidance and ISO |
The difference in the shaft and distal tip materials raise no
new questions regarding safety and efficacy. |
| Needle and Injection
configuration and materials
The materials used in the needle
and the internal lumen of the
predicate device are similar but
not identical to the predicate
devices (Gold probe) | Bench Testing:
Performance testing of injection flowrate.
Performance testing of the insertion and retraction durability
the needle can extend and retract throughout lifetime use.
The needle continues to perform to specification in a worst-
case endoscope position.
Performance testing of the needle point sharpness
throughout the lifetime use of the device.
Performance testing needle to hypotube and ferrule tensile
strength.
All bench testing showed an acceptable level of
performance.
Biocompatibility:
Meets all relevant requirements of FDA guidance and ISO
10993.
The difference in the needle configuration and materials
raise no new questions regarding safety and efficacy. |
9.PERFORMANCE DATA
The system meets all design specifications, design-risk analysis, and medical device standards for electrical safety and FDA recognized versions of EMC (IEC 60601), electrical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The mechanical, coagulation and injection performance in ex-vivo and in-vivo meets the design specification and shows substantial equivalence to the predicate devices.
10.CONCLUSION
The Creo Medical Electrosurgical System with HS1 surgical accessories is substantially equivalent to the Boston Scientific Injection Gold Probe, bipolar electrohemostasis catheter (K133933) and the ERBE VIO 300 D electrosurgical generator (K083452).