(153 days)
The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation on nonresectable liver tumors.
The Emprint™ Ablation System is not intended for use in cardiac procedures
The Emprint™ Ablation System with Thermosphere™ Technology, Covidien's microwave ablation system, was released for commercial distribution in the United States in April 2014.
The 510(k) Cleared Emprint™ Ablation System consists of the following components:
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- Emprint™ Ablation Generator (2450 MHz)
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- Emprint™ Percutaneous Antenna (sterile, single use)
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- Emprint™ Ablation Reusable Cable
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- Emprint™ Ablation Pump
The system also includes the following optional equipment/accessories:
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- Emprint™ Ablation Cart (with Isolation Transformer)
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- Ablation Footswitch
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- Remote Temperature Probe (sterile, single use)
The current Emprint™ Ablation System utilizes a 2450 MHz 100W generator (CAGEN1) to deliver power to a dedicated single microwave ablation antenna. The optional cart, Emprint™ Ablation Cart is intended to be used with the Emprint™ Ablation Generator.
The new system component, Emprint™ HP Ablation Generator (CAGENHP) [subject device] is similar to the device, Emprint™ Ablation Generator (CAGEN1) [predicate device] as described in K193232 with two exceptions. The new system component, Emprint™ HP Ablation Generator (CAGENHP), will extend the power setting range from 5 to 100W (Emprint™ Ablation Generator - CAGEN1) to 5 to 150W. The increased power will allow clinicians to create larger ablation zones when ablating soft tissue lesions, compared to use of the system with the existing 100-watt microwave generator (CAGEN1). Further the Emprint™ HP Ablation Generator (CAGENHP) is composed of analog and digital circuits with software whereas the predicate Emprint™ Ablation Generator (CAGEN1), is composed of analog and digital circuits with no software or firmware. The Emprint™ HP Generator will be compatible with all current Emprint™ ablation system components and accessories except the cart. The new optional Emprint™ HP Cart (CARTHP) has been added to the system and is compatible with the Emprint™ HP Ablation Generator (CAGENHP).
The optional cart holds the Emprint™ HP Generator (CAGENHP) and the Emprint™ Ablation Pump (CAPUMP1) securely in one location. The optional footswitch can be placed on the cart's lower shelf. There are hooks on both sides of the cart which are meant to hold either the normal saline bag during a procedure, or to loop (and store) the reusable cable over while not in use.
Emprint™ HP Ablation Cart (CARTHP) is similar to the previously cleared (K193232) Emprint™ Ablation Cart (CART1), which holds the Emprint™ Generator (CAGEN1) and the Emprint™ Ablation Pump (CAPUMP1) securely in one location.
The provided document is a 510(k) summary for the Covidien Emprint™ Ablation System with Thermosphere™ Technology. It describes a submission for new components, specifically the Emprint™ HP Ablation Generator (CAGENHP) and its optional accessory, the Emprint™ HP Ablation Cart (CARTHP).
This document does not describe an AI medical device or a study proving its performance against acceptance criteria for an AI or imaging-based diagnostic device. Instead, it focuses on demonstrating substantial equivalence of a microwave ablation system (a physical medical device used for soft tissue coagulation) to a predicate device.
Therefore, many of the questions asked in the prompt, such as those related to AI-specific performance criteria (e.g., sample size for training/test sets, expert consensus, MRMC studies, effect size of AI assistance), are not applicable to the content of this document.
However, I can extract information relevant to the device's acceptance criteria and the studies performed to prove its substantial equivalence as described in the document.
Analysis of Device Acceptance Criteria and Performance (Based on the provided non-AI device document):
Since the document describes a microwave ablation system and not an AI/imaging diagnostic device, the acceptance criteria and supporting studies are focused on the safety and effectiveness of the physical device and its new components, primarily demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal "acceptance criteria" table in the way one might for an AI device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the various tests and verification activities conducted to demonstrate the new components are safe and effective and do not alter the system's fundamental performance compared to the predicate.
| Implied Acceptance Criterion / Test Objective | Reported Device Performance / Outcome (Conclusion) |
|---|---|
| Bench Verification Testing: | |
| 1. System meets all design requirements. | Demonstrated. |
| 2. Ablation performance design requirements met; equivalent ablation zone dimensions at identical power settings (HP Generator vs. Predicate Generator). | Demonstrated that the ablations zone dimensions created with the Emprint™ HP Ablation Generator (subject) and Emprint™ Ablation Generator (predicate) are equivalent for identical power settings. |
| 3. Compatibility with previously approved Emprint™ Ablation System accessories (except cart). | Verified as compatible. (Note: New HP Cart is compatible with HP Generator). |
| 4. Meets IEC 60601-1-2:2014 EMC regulatory requirements. | Met. |
| 5. Meets IEC 60601-1:2005 and IEC 60601-2-6:2016 safety requirements. | Met. |
| 6. Performs as specified within storage and use conditions. | Verified. |
| 7. Usability of Emprint™ HP Ablation Generator. | Verified. |
| 8. Packaging protects generator and cart during simulated transportation. | Verified. |
| Animal Testing (In Vivo Porcine Model): | |
| Equivalent performance in terms of ablation zone creation relative to predicate control device. | Demonstrated equivalent performance and procedural safety of the Emprint™ Ablation System with CAGENHP generator in an in vivo porcine model undergoing soft tissue ablation procedures. |
| Overall Substantial Equivalence: | |
| Differences (extended power range, software control) do not impact safety and effectiveness. | Performance data demonstrate that these differences do not impact the safety and effectiveness of the device. (Implies all tests support this). |
| Addition of optional accessory (HP Ablation Cart) has no impact on safety and effectiveness. | Verification and validation activities conducted have shown that the addition of the optional accessory, Emprint™ HP Ablation Cart, has no impact on the safety and effectiveness of the Emprint™ Ablation System. (Implies all tests support this). |
The following points are not applicable as the document describes a physical medical device, not an AI/imaging diagnostic device. I'll explicitly state "Not Applicable" or "Not Provided/Relevant" for these.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly specified for discrete tests. For the animal study, it mentions "an in vivo porcine model" but doesn't give a specific number of animals. For bench testing, typical engineering verification involves numerous tests without a "sample size" in the clinical trial sense.
- Data Provenance (Country of origin, retrospective/prospective): Not specified. The animal study is stated as "GLP-compliant pivotal study," suggesting a prospective, controlled experimental design, but location is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. This is not an AI/diagnostic device where human expert "ground truth" for image interpretation would be established. The ground truth for this device is based on physical measurements (e.g., ablation zone dimensions), engineering specifications, and safety standards.
4. Adjudication Method for the Test Set:
- Not Applicable. No human interpretation for "ground truth" to be adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is not a diagnostic device involving human readers.
- Effect size of human readers improve with AI vs. without AI assistance: Not Applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device, not an algorithm.
7. The Type of Ground Truth Used:
- For the ablation performance, the "ground truth" appears to be physical measurements of ablation zone dimensions (compared directly between the subject and predicate devices under identical power settings) and compliance with engineering design requirements, international safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-6), and preclinical (animal) study results demonstrating equivalent therapeutic effect and safety.
8. The Sample Size for the Training Set:
- Not Applicable. This is not an AI device trained on a dataset.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.