(105 days)
The ReNew XR Handpiece is indicated for cutting, grasping, dissecting, and coagulating tissue during endoscopic (inclusive of laparoscopic) surgical procedures.
The ReNew XR Handpiece is a reusable laparoscopic surgical device used, in combination with legally marketed interchangeable end effectors, such as scissors, and dissectors (all of which are outside of the scope of this submission), to cut, grasp, and dissect various tissues for use in endoscopic, including laparoscopic, surgical procedures where instruments are inserted into the body through a cannula. The ReNew XR Handpiece is pressure tested to ensure that insufflation can be retained during laparoscopic surgery. The ReNew XR Handpiece does not produce energy, but can be connected to any commercially available and legally marketed standard monopolar electrosurgical generator. In combination with such a generator, the ReNew XR Handpiece delivers monopolar electrocautery (electrical) energy to the patient, in which the current is applied through a hand-held active electrode and travels back to the electrosurgical generator through a return electrode attached to the patient, so that the patient is part of the electrical circuit. The ReNew XR Handpiece can be used with a legally-marketed third party electrosurgical high-frequency generator which complies with IEC 60601-1-1 safety and IEC 60601-1-2 electromagnetic compatibility requirements. After use in a procedure, the subject device can be reprocessed via a validated cleaning and steam sterilization procedure as described in the Instructions for Use.
The subject devices are made of six primary components including the Handle Assembly, Turning Knob, Top Cover, Cautery and Flushing Port Assembly, Inner Rod and Outer Tube Assembly.
Variations of the subject devices include varying handle length, presence of a ratcheting mechanism, and single-piece vs. modular (three piece) instruments.
The subject devices are supplied as non-sterile and intended for cleaning and sterilization by a medical facility before use.
The provided document is a 510(k) premarket notification for a medical device called the "ReNew XR Handpiece." It's a regulatory submission to the FDA (Food and Drug Administration) to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing a new device to an existing one, rather than presenting a detailed study of the new device's performance against specific acceptance criteria in the way a clinical trial might.
Therefore, the document does not directly provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, especially in the context of AI performance or clinical efficacy against predefined metrics. This is because the device is a surgical handpiece, not an AI-powered diagnostic or assistive tool, and the focus of a 510(k) is on safety and substantial equivalence, not novel clinical efficacy studies.
However, I can extract information related to performance testing and equivalence to address parts of your request where applicable, and explain why other parts are not present in this document.
Explanation of Missing Information:
- Acceptance Criteria and Reported Device Performance (Table): This document does not present specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) for an AI or diagnostic device. Instead, it focuses on demonstrating that the device is "substantially equivalent" to a predicate device through various types of engineering and biocompatibility testing. The "performance" here refers to its functional safety and similarity to an existing device, not performance on a diagnostic task.
- AI-Specific Questions (MRMC, Standalone AI performance): The ReNew XR Handpiece is an electrosurgical device, not an AI-enabled device. Therefore, questions about AI assistance, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone AI algorithms are not applicable to this submission.
- Ground Truth for Test Set & Training Set, Experts & Adjudication: These concepts are relevant for studies evaluating diagnostic or AI system performance where a "ground truth" needs to be established (e.g., presence of disease confirmed by pathology). For a surgical handpiece, the "ground truth" relates to its functional integrity, material properties, and safety, which are evaluated through different means (bench testing, material analysis, sterilization validation, biocompatibility).
Information that can be extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance
As explained above, direct acceptance criteria and performance metrics for clinical efficacy are not provided for this type of device and submission. However, the document does state that "Bench performance testing was performed as design verification testing and to establish Substantial Equivalence to the predicate device." The implicit acceptance criterion is that the device performs safely and comparably to the predicate device in the tested aspects.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Functional Safety & Equivalence to Predicate Device: | Bench Performance Testing: "The functional testing for the subject devices primarily included nonclinical (ex vivo and animal) testing, electrical safety testing, cleaning and sterilization, and biocompatibility testing. The testing establishes that subject device is Substantially Equivalent to the predicate device in fundamental technology, design, or performance. There were no new risks or safety, or effectiveness issues raised in the testing results." (Page 5) |
| * Pressure Retention | "The ReNew XR Handpiece is pressure tested to ensure that insufflation can be retained during laparoscopic surgery." (Page 4) (Result: Implied satisfactory, no new risks identified). |
| * Electrical Safety | "The ReNew XR Handpiece can be used with a legally-marketed third party electrosurgical high-frequency generator which complies with IEC 60601-1-1 safety and IEC 60601-1-2 electromagnetic compatibility requirements." (Page 4). Electrical safety testing was performed. (Result: Implied satisfactory, no new risks identified). |
| Biocompatibility: | Biocompatibility testing was conducted per ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-12, addressing cytotoxicity, intracutaneous reactivity, delayed type sensitivity, acute systemic toxicity, and pyrogenicity. "For the subject devices, biocompatibility testing successfully established that the subject devices did not raise any new risks, and that they were determined to be biologically safe." (Page 6) |
| Device Reprocessing (Cleaning & Sterilization Validation): | "After use in a procedure, the subject device can be reprocessed via a validated cleaning and steam sterilization procedure as described in the Instructions for Use." (Page 4). "The subject devices are supplied as non-sterile and intended for cleaning and sterilization by a medical facility before use." (Page 4 & 5). Cleaning and sterilization testing was performed. (Result: Implied satisfactory, no new risks identified for reprocessing). |
| Material & Design Changes Effects: | Changes: 1. Seal changed from elastomer o-ring to solid overmolded polyvinylidene fluoride bushing to improve service life. 2. Internal metal components changed to improve insulation in ratchet and hand grip areas during electrosurgery. 3. Color changed from black to grey. (Page 5). (Result: "The subject device is virtually identical to the predicate in terms of indication for use and operation, and is substantially equivalent in design, technological characteristics, materials, and labeling... no new risks or safety, or effectiveness issues raised in the testing results.") (Page 5) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set (for performance testing): Not specified in terms of distinct "test sets" or sample sizes in the way a clinical study would. The performance testing refers to "nonclinical (ex vivo and animal) testing, electrical safety testing, cleaning and sterilization, and biocompatibility testing." These are typically engineering or lab-based tests, not human subject clinical trials.
- Data Provenance: Not specified, but generally, such tests are conducted at the manufacturer's facility or contract labs in the country where the manufacturer operates (USA, in this case). The report does not indicate retrospective or prospective classification in the clinical sense, as it describes laboratory and engineering verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable. The "ground truth" for this device revolves around its physical and functional properties, not diagnostic accuracy. Testing involves engineering standards, material science, and biological safety evaluations performed by specialized labs and engineers, not clinical experts establishing diagnostic "ground truth."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are used in clinical studies where expert consensus is needed to define a "true" diagnosis for evaluating an algorithm's performance.
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
- Not applicable. This device is not an AI-powered tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established through adherence to recognized performance standards, material specifications, and regulatory requirements. For example:
- Biocompatibility: Adherence to ISO 10993 standards.
- Electrical Safety: Compliance with IEC 60601-1-1 and IEC 60601-1-2.
- Functional performance: Bench testing (e.g., pressure retention, cutting/coagulation capabilities) against engineering specifications and comparison to the predicate device's established performance.
- Sterilization: Validation according to established protocols to ensure sterility assurance levels.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
In summary, this FDA 510(k) submission demonstrates the safety and substantial equivalence of a surgical handpiece to an existing device through engineering, functional, and biocompatibility testing, rather than through clinical efficacy studies involving human readers, AI algorithms, or diagnostic performance metrics.
§ 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.