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510(k) Data Aggregation
(48 days)
The intended use of the HydroCision ArthroJet System with Cautery is to resect damaged tissue, remove extraneous matter, and control bleeding in surgical applications of articular body cavities.
The HydroCision ArthroJet System with Cautery is a surgical device which provides cutting, tissue removal, and electrocauterization in the same tool. The HydroCision ArthroJet System with Cautery uses the same system as the FDA approved HydroCision ArthroJet System (K982266) with the addition of a bipolar cauterization function at the distal tip of the handpiece. The ArthroJet System with Cautery is compatible with standard RF generators which provide bipolar energy output (with a voltage of less than or equal to 1.000 volts p-p). The ArthroJet System with Cautery operates in a saline or Ringer's Lactate environment. The bipolar cables used in the ArthroJet System with Cautery are available in two types, reusable and single use.
The HydroCision ArthroJet System with Cautery is a surgical device designed for cutting, tissue removal, and electrocauterization in articular body cavities. The 510(k) summary indicates that its substantial equivalence to predicate devices, rather than comprehensive performance studies with acceptance criteria, was the primary basis for its clearance.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a study. Instead, it relies on demonstrating substantial equivalence to existing legally marketed devices and compliance with voluntary standards.
| Acceptance Criteria (Not explicitly stated, inferred from 510(k) process) | Reported Device Performance (as per document) |
|---|---|
| Safety and Effectiveness (Inferred) | "substantially equivalent in intended use and/or function to the following predicate devices: the HydroCision ArthroJet System (K982266) and the Valleylab Electrosurgical Pencil (K861112)/Valleylab Electrode (K791638), and the Kirwan Suction Coagulator (K965421)." "It is also substantially equivalent to the ArthroCare Electrosurgery System (K961323)..." |
| Functionality (Cutting and Tissue Removal) | "provides the same functions as the first predicate device, the HydroCision ArthroJet System (K982266)." "Both are used in arthroscopy to cut and remove tissues." |
| Functionality (Electrocauterization) | "provides the additional electrocautery function using bipolar energy to cauterize small vessels." "The electrocautery function and its intended use is the same as that provided by the Valleylab Electrosurgical Pencil (K861112)/Electrode (K791638) and the Kirwan Suction Coagulator (K965421)." |
| Compliance with Standards | "complies with the following voluntary standards: ANSI/AAMI HF18-1993, IEC 60601-2" |
| Compatibility | "compatible with standard RF generators which provide bipolar energy output (with a voltage of less than or equal to 1.000 volts p-p)." |
| Environmental Operation | "overates in a saline or Ringer's Lactate environment." |
| Protection from Electrical Hazards | "The hand piece and electrical connections are protected from the possibility of shorting should spillage of conductive fluid onto the unit occur." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not report any specific test set sample sizes or data provenance from a clinical study for the HydroCision ArthroJet System with Cautery. The clearance is based on substantial equivalence to predicate devices, which implies that the safety and effectiveness of the existing predicate devices provide the basis, rather than new clinical data from this specific device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe a clinical study involving a test set and adjudication.
5. 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
This information is not applicable. The device is a surgical tool, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study and AI assistance are irrelevant to its clearance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a surgical tool, not an algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically used in AI/diagnostic device studies (e.g., pathology, outcomes data) is not directly applicable in this 510(k) submission. The "ground truth" for demonstrating substantial equivalence is the established safety and effectiveness of the predicate devices. The device's performance is gauged against the functionalities and characteristics of these predicates.
8. The Sample Size for the Training Set
This information is not applicable as the document does not describe a training set for an algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the document does not describe a training set.
In summary, the 510(k) clearance for the HydroCision ArthroJet System with Cautery was primarily based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices, rather than conducting new clinical trials with detailed performance data, acceptance criteria, or ground truth establishment as would be seen for new diagnostic or AI-driven systems. The focus was on comparing the new device's intended use, technological characteristics, and safety profiles to those of the predicates, along with compliance with relevant voluntary standards.
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