(29 days)
The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors.
The Emprint Ablation System is not intended for use in cardiac procedures.
Covidien has modified the Emprint™ Ablation System's Percutaneous Antenna (Catalog Numbers: CA15L1, CA20L1 and CA30L1). The modified ablation antenna is identical to the device described in K133821, with two exceptions. The antenna's tissue contacting cooling jacket is manufactured from a new, biocompatible material that significantly increases the antenna's stiffness. Additionally, an adhesive has been added at the antenna shaft's proximal joint to strengthen the seal. By making the antenna stiffer, the cooling jacket material change is expected to enhance the antenna's usability; it does not affect the Emprint Ablation System's essential function, performance or underlying principles of operation.
Like its predicate, the modified antenna (Catalog Numbers CA15L2, CA20L2 CA30L2) is provided sterile (EO) and is intended for use with the Emprint Ablation System in health care facilities.
The provided text describes a 510(k) submission for a modified medical device, the Emprint™ Ablation System's Percutaneous Antenna. The modification involves a change in the cooling jacket material to increase stiffness and an improved adhesive seal. This submission focuses on demonstrating that the modified device is substantially equivalent to its predicate.
However, the document does not contain the kind of detailed information typically found in a study proving a device meets specific acceptance criteria in terms of diagnostic performance or clinical outcomes, as would be relevant for an AI/ML-driven diagnostic device. Instead, it focuses on verifying that the modification does not negatively impact the device's original performance and safety.
Given the context of the document (a 510(k) summary for a physical medical device modification), I will adapt the request to what information is available about the performance criteria and the study conducted to demonstrate equivalence for this specific type of device.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance (Adapted to a Physical Medical Device Modification)
The "acceptance criteria" here are implicitly related to maintaining the performance characteristics and safety of the predicate device despite the modification. The "reported device performance" refers to the verification that these characteristics are maintained or improved without introducing new risks.
| Acceptance Criteria (Implied for Device Modification) | Reported Device Performance |
|---|---|
| Mechanical Robustness: The modified antenna must maintain or improve its resistance to mechanical stresses. | Verification testing demonstrated the modified antenna's continued robustness to mechanical stresses. |
| Printed Depth Markings Integrity: The new cooling jacket material should not affect the clarity or accuracy of the antenna's printed depth markings. | Verification testing confirmed that the antenna's printed depth markings were not affected by the underlying cooling jacket material change. |
| Stiffness: The modified antenna's shaft must demonstrate increased stiffness as intended by the material change. | Verification testing quantified the stiffness of the antenna's shaft relative to the 510(k) cleared device, indicating an increase. |
| Essential Function (Thermal Ablations): The modification must not impact the system's ability to perform thermal ablations in soft tissue correctly and safely. | Verification testing confirmed that the change did not impact the system's essential function – the performance of thermal ablations in soft tissue. |
| Biocompatibility: The new materials must be biocompatible and not introduce new biological risks. | Biocompatibility testing of the new fiberglass material and the modified cooling jacket subassembly was conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. The modified cooling jacket subassembly also underwent a full chemical characterization. (Presumably, these tests showed acceptable biocompatibility). |
| Stability/Performance Over Time: The modification should not negatively affect the antenna's performance or integrity over its shelf life or intended use time. | Product stability testing evaluated the effect of the cooling-jacket material change on the antenna's performance over time. The testing included mechanical stress testing, cytotoxicity testing, and performance testing. (Presumably, these tests showed acceptable stability and performance retention). |
| Usability & Safety (User Interaction): The altered stiffness should not introduce new use-related risks or negatively impact usability, and should meet usability requirements. | Representative end users participated in a simulated-use validation study. Objective and subjective test results confirmed that (1) essential and safety-critical tasks were performed with the stiffer antenna in a safe and effective manner, (2) the modified device met usability requirements and, (3) there were no new, use-related risks, associated with the change. |
Here's the additional information requested, based on the provided document:
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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 verification testing," "product stability testing," "biocompatibility testing," or "validation testing." For the validation study, it mentions "Representative end users participated," but not the number of users.
- Data Provenance: The studies were conducted by Covidien LLC as part of their 510(k) submission to the FDA. The location of the testing is not explicitly stated, but it would presumably be internal to Covidien or conducted by contract research organizations on their behalf. This is a prospective set of tests and analyses designed specifically for this regulatory submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and its modification. The "ground truth" here isn't a diagnostic label established by medical experts, but rather the objective physical and functional properties of the device and its safety characteristics. The "experts" involved would be engineers and scientists performing the verification and validation tests, and possibly human factors specialists for the usability study, but their number and specific qualifications beyond being "representative end users" are not detailed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This concept is not applicable here. Adjudication methods like "2+1" or "3+1" are used to resolve disagreements among multiple human readers on diagnostic labels. The studies described are physical and functional performance tests for a medical device modification, not diagnostic reads.
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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, an MRMC comparative effectiveness study was not done. This device is a physical ablation system, not an AI-driven diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm-only) performance study was not done. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on established engineering principles, material science standards, biocompatibility regulations (ISO 10993 series), and functional performance specifications of the predicate device. For example:
- Mechanical Integrity: Ground truth is defined by engineering specifications (e.g., force required to cause deformation, tear strength).
- Biocompatibility: Ground truth is defined by regulatory standards (e.g., ISO 10993) and the absence of adverse biological reactions.
- Functional Performance: Ground truth is the ability to generate the same type, size, and shape of thermal ablations as the predicate device, as measured in test media.
- Usability: Ground truth is the successful completion of tasks by users and the absence of new use-related hazards.
- The "ground truth" for this device's performance is based on established engineering principles, material science standards, biocompatibility regulations (ISO 10993 series), and functional performance specifications of the predicate device. For example:
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The sample size for the training set:
- There is no "training set" in the context of this device. Training sets are typically used for machine learning algorithms.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device submission.
§ 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.