(247 days)
The Synergetics Disposable Spetzler-Malis Dual Irrigating Bipolar Forceps are single use product sold sterile and are intended for use in electrosurgery for coagulation and irrigation of tissue.
The Synergetics Disposable Spetzler Malis Irrigating Bipolar Forceps is a sterile single use device. It consists of dual inlet irrigating pathways that run along side of the forceps from the proximal end the distal end. This allows the surgeon to view the surgical field without obstruction allowing the fluid to irrigate through the irrigation module through the forceps.
This document is a 510(k) summary for the Synergetics Disposable Spetzler Malis Dual Irrigating Bipolar Forceps and details its substantial equivalence to a predicate device. It primarily focuses on comparing technical characteristics and non-clinical testing.
Here's an analysis based on your requested information, acknowledging that this type of regulatory submission often doesn't contain detailed study breakdowns in the same way a clinical trial publication would:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable table format for various performance metrics with corresponding numerical results. Instead, it relies on demonstrating substantial equivalence to a predicate device through comparison of technical characteristics and non-clinical testing.
The implicit acceptance criteria are that the new device performs comparably to the predicate device and meets relevant safety standards.
| Criteria (from "Comparison of Technical Characteristics") | Predicate Device Performance (K080187) | Synergetics Device Performance |
|---|---|---|
| Intended Use | Sterile single use, for use in electrosurgery for coagulation and irrigation of tissue. | Sterile single use, for use in electrosurgery for coagulation and irrigation of tissue. |
| For Use With | Electrosurgical generators, irrigation modules and irrigation tubing. | Electrosurgical generators, irrigation modules and irrigation tubing. |
| Forceps Design | Bayonet Style | Bayonet Style |
| Patient Contact Material | Stainless Steel base, with Nylon insulation. | Biocompatible Silver plated Aluminum base with PVDF insulation. (Note: This is a difference, but the summary implies it raises no new issues.) |
| Electrical Safety Testing | IEC 60601-2-2 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2 |
| Latex Free | Yes | Yes |
| Luer connector for connection to irrigation tubing | Yes | Yes |
| Delivery line for fluid to distal end of forceps | Yes | Yes |
| Single Use | Yes | Yes |
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) |
| Packaging | Tyvek Pouch | Rigid PETG Tray, Tyvek lid (Note: This is a difference, but validated to ISO 11607-1:2006). |
| Summary of Non-clinical Testing | Performance comparable to predicate device in bench testing and comparative performance testing. Meets IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. |
The "study" to prove the device meets these (mostly implicit) acceptance criteria is a sum of:
- Bench testing: Performed to compare the new device's performance to the predicate device.
- Comparative performance testing: Against the predicate device.
- Electrical safety testing: Conducted according to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
- Risk Management: Implemented in compliance with ISO 14971.
- Sterilization Validation: In accordance with AAMI/ISO 11135.
- Packaging Validation: In accordance with ISO 11607-1:2006.
The conclusion from these tests is that "The non-clinical testing indicates the device performance is substantially equivalent to the predicate and the slight differences raise no new issues of safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a quantitative sample size (e.g., number of units tested) for the bench or comparative performance testing. Typically, regulatory submissions for devices like this demonstrate equivalence through a sufficient number of tests to establish reliability and consistent performance rather than large clinical trial-style sample sizes for a 'test set.'
- Data Provenance: The studies are non-clinical (bench testing) and were conducted by Synergetics, Inc. (the applicant). The country of origin for the data is implicitly the United States, where the company is based. The data is prospective in the sense that the tests were specifically performed to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is a non-clinical device summary. "Ground truth" in the context of expert consensus or pathology is typically associated with diagnostic or prognostic devices, not electrosurgical tools where performance is assessed through engineering and safety standards. The "truth" here is established by adherence to technical specifications and validated performance against a known device.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is non-clinical testing against technical standards and a predicate device, not involving human interpretation or adjudication in the sense of a clinical or image-based study.
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 an electrosurgical tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study with human readers and AI assistance is entirely outside the scope of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware electrosurgical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the device's performance is based on:
- Engineering specifications and design attributes: For technical characteristics like design, materials, and connectors.
- International Standards: Compliance with IEC 60601 series for electrical safety and ISO standards for packaging and sterilization.
- Predicate Device Performance: The functional performance of the new device is considered "true" or acceptable if it is comparable to the legally marketed predicate device (K080187) during bench and comparative testing.
8. The Sample Size for the Training Set
Not applicable. There is no AI component or machine learning model for which a "training set" would be used.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
§ 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.