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510(k) Data Aggregation
(183 days)
Single Use Irrigation bipolar cable
The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or The Malis irrigation module 1000.
The device is single use and is used to connect an irrigation bipolar forceps to electrosurgical generator and irrigation module for coagulation and delivering saline to the tip of forceps simultaneously. The socket connector of the cable is to fit Codman irrigating bipolar forceps. The fixed 2-pin plug is connected to any compatible generators or the flying lead connectors are connected to Malis bipolar coagulators or any compatible generators. The tubing set of the cable can be used with the Malis CMC-II irrigation module or the Malis irrigation module 1000.
This document is a 510(k) premarket notification from the FDA for a medical device called "Single Use Irrigation Bipolar Cable." It focuses on demonstrating the device's substantial equivalence to a predicate device, not on proving new clinical effectiveness or diagnostic accuracy. Therefore, the typical "acceptance criteria" and study details you're asking about for AI/diagnostic devices (e.g., sensitivity, specificity, reader studies, ground truth establishment, sample sizes for training/test sets) are not present or applicable in this type of submission.
This document details the engineering and material equivalence of the proposed device to a legally marketed predicate device. The "performance testing" here refers to non-clinical tests to verify safety, electrical performance, sterility, and shelf life, not clinical diagnostic accuracy or AI performance.
Here's how to address your request based on the provided document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria here are focused on demonstrating substantial equivalence to the predicate device and meeting international safety standards. There isn't a table of quantitative performance metrics in the way you'd expect for a diagnostic or AI device.
| Acceptance Criteria Category | Reported Device Performance (Summary from the text) |
|---|---|
| Indications for Use | Substantially equivalent to predicate: "The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or the Malis irrigation module 1000." |
| Regulation, Product Code, Use | Same as predicate: 21 CFR 878.4400, GEI, Prescription use. |
| Energy Delivery/Technology | Same as predicate: High frequency electrical current/energy, for monopolar electrosurgery. |
| Design | Same as predicate: Combined of Irrigation tubing with bipolar cable. |
| Material of Components | Mostly same as predicate (e.g., Copper wire/PVC insulation for cable, PVC for tubing, PC for Luer lock, ABS for puncture utensil, PP for pinch clamp). |
| Difference noted: Protector for luer and puncture utensil: Proposed device uses ABS, Predicate uses LDPE/PP. Comment: "Similar, provide the same function." | |
| Rated Accessory Voltage | 500Vp. Predicate listed as 500Vp-p. Comment: "Both meets IEC safety requirements." |
| Sterility | EO sterile (same as predicate). Validation and Verification testing performed in accordance with ISO 11135:2014. |
| Shelf Life | 3 years (same as predicate). Supported by packaging integrity and accelerated aging tests. |
| Electrical Safety and EMC | Comply with IEC60601-1, IEC60601-1-2, IEC60601-2-2. (Predicate listed as Comply with AAMI HF-18). Comment: "Same." |
| Biocompatibility | Comply with ISO10993. (Same as predicate). Comment: "Meet biocompatibility requirements so it does not raise any safety issue for [user/patient - cut off text]." |
| Packaging Integrity | Tests completed to support proposed shelf life (ISO 11607-1:2019). |
| Accelerated Aging | Tests completed to support proposed shelf life (ASTM F1980-16). |
2. Sample sizes used for the test set and the data provenance
For this type of device, the "test set" would refer to samples of the device itself undergoing engineering and biocompatibility testing. The document doesn't specify sample sizes for these non-clinical tests (e.g., how many cables were tested for dielectric strength or sterility).
- Data Provenance: Not applicable in the context of clinical data for AI/diagnostic devices. The data here comes from internal laboratory testing and compliance with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. "Ground truth" in this context would implicitly be the established performance parameters of the predicate device and the requirements of the relevant IEC/ISO standards. There are no clinical "experts" establishing ground truth in the sense of image interpretation or diagnosis for this specific submission.
4. Adjudication method for the test set
Not applicable. There's no human interpretation or adjudication in the context of device performance testing for substantial equivalence for this electrosurgical accessory.
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 is not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used
The "ground truth" for this submission is:
- The performance specifications and characteristics of the predicate device (Codman Integrated Irrigation Tubing and Bipolar Cord Set with 510(k) number K052449).
- The requirements outlined in relevant international standards (e.g., IEC 60601-1, IEC60601-2-2, IEC60601-1-2, ISO10993-1, ASTM F1980-16, ISO 11607-1:2019) for electrical safety, biocompatibility, sterility, and packaging.
8. The sample size for the training set
Not applicable. There is no training set as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
Not applicable.
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