(156 days)
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.
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.
This submission describes the Creo Electrosurgical System with HS1 Hemostasis Accessory. The device is intended to provide radiofrequency (RF) electrosurgical energy for cutting and microwave energy (MW) for coagulation (hemostasis, cauterization) of soft tissue, primarily for endoscopic electrohemostasis in the gastrointestinal tract.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail format typical for AI/ML device submissions. Instead, it details performance testing to demonstrate substantial equivalence to predicate devices. The performance aspects tested are related to the device's functional characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Coagulation Energy Equivalence (penetration and spread of thermal effects) | Bench testing showed substantial equivalence with the predicate device (Boston Scientific Injection Gold Probe) regarding the penetration and spread of thermal effects in gastrointestinal tissue, despite using different energy types (MW vs. bipolar RF). |
| Distal Tip Design Equivalence (penetration and spread of thermal effects) | Bench testing showed substantial equivalence with the predicate device concerning the penetration and spread of thermal effects in gastrointestinal tissue, despite differences in distal tip design (blade vs. dome-shaped). |
| Shaft and Distal Tip Materials Biocompatibility | Meets all relevant requirements of FDA guidance and ISO 10993 (biocompatibility). Bench testing showed substantial equivalence with the predicate devices regarding penetration and spread of thermal effects. |
| Needle and Injection Performance (flowrate, durability, sharpness, tensile strength) | Bench testing showed acceptable levels of performance for injection flowrate, insertion and retraction durability (throughout lifetime use and in worst-case endoscope positions), needle point sharpness (throughout lifetime use), and needle to hypotube and ferrule tensile strength. |
| Needle and Injection Materials Biocompatibility | Meets all relevant requirements of FDA guidance and ISO 10993 (biocompatibility). |
| General Design Specifications & Standards Compliance | 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). |
| Mechanical, Coagulation, and Injection Performance (in ex-vivo/in-vivo) | Meets the design specification and shows substantial equivalence to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each type of bench, ex-vivo, or in-vivo test.
- Data Provenance: The studies include "bench testing," "ex-vivo," and "in-vivo" tests. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though in-vivo studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a electrosurgical device, "ground truth" might refer to histological analysis of tissue effects or clinical outcomes. The document does not mention the use of experts for establishing ground truth or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method, such as 2+1 or 3+1, which is typically relevant for studies involving human interpretation or subjective assessments. For objective performance metrics like thermal spread or mechanical durability, such methods are not usually applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is an electrosurgical system, not an AI-assisted diagnostic or interpretive tool that would typically involve human readers. Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the device incorporates "proprietary software developed by Creo Medical for generating and controlling the two energies delivered," the submission focuses on the performance of the integrated electrosurgical system (hardware + software). There is no mention of a standalone algorithm performance study independent of the physical device or a human operator. The system itself is the "standalone" entity whose performance is being evaluated.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for evaluation involved:
- Physical Measurements/Observations: For bench testing of coagulation (penetration and spread of thermal effects), injection flowrate, durability, sharpness, and tensile strength.
- Standard Compliance: Adherence to electrical safety (IEC 60601), EMC (IEC 60601), biocompatibility (ISO 10993), and sterility (ISO 11135) standards.
- Clinical/Biological Equivalence: Demonstrated through ex-vivo and in-vivo tests (though specific metrics for "ground truth" here are not detailed, they would likely involve histological analysis or observable clinical effects in tissue).
8. The Sample Size for the Training Set
This information is not applicable/not provided in the context of this device submission. This is a medical device (electrosurgical system), not an AI/ML diagnostic or predictive algorithm that typically undergoes a training phase with a distinct training set of data. The "proprietary software" controls energy delivery but isn't described as a machine learning model trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a specific "training set" for an AI/ML algorithm in this submission, this information is not applicable. The "ground truth" for the device's design and engineering would have been established through established physics, electrical engineering principles, surgical practice, and regulatory standards.
§ 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).