(183 days)
Kirwan battery-powered cautery units are intended for general surgical use to cauterize small blood vessels in order to help reduce blood loss and keep the site clear of excess blood.
Kirwan battery-powered cautery units are intended for general surgical use to cauterize small blood vessels in order to help reduce blood loss and keep the site clear of excess blood.
This 510(k) submission (K062659) for Kirwan Disposable Battery-Powered Cautery relies on a different approach to demonstrate substantial equivalence than clinical studies with explicit acceptance criteria. Instead, it leverages the device's adherence to existing standards and its analogous nature to legally marketed predicate devices.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study to Prove Performance |
|---|---|---|---|
| Safety | Compliance with ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing) | Device found to comply with applicable sections of ISO 10993-1. | Not explicitly described as a discrete "study" in the provided text. Likely involved testing and documentation demonstrating conformity to the standard's requirements for biocompatibility. |
| Safety | Hazard analysis determined low-to-moderate hazard level. | For the 41-61XX Disposable Battery-Powered Cautery, hazard conditions range in the low-to-moderate level and are deemed acceptable. | Hazard analysis conducted, but details of methodology and specific results are not provided. |
| Sterilization | Compliance with ISO 11137 (Sterilization of health care products - Requirements for validation and routine control - radiation sterilization) | Device found to comply with applicable sections of ISO 11137. | Not explicitly described as a discrete "study." Likely involved validation and routine control procedures in accordance with the standard for radiation sterilization. |
| Effectiveness (Technological Equivalence) | Does not contain any new technological risks or characteristics compared to legally marketed predicate devices. | "These cautery units do not contain any new technological risks or characteristics when compared to the legally marketed devices offered here as predicates." Also, "They are manufactured according to prevailing standards and represent a technology that has existed in clinical settings for over 25-years." | This is a declarative statement based on a comparison of the device's design and operating principles to its predicates. No specific study is detailed for this comparison beyond the general statement of technological equivalence. |
| Performance (Substantial Equivalence) | Substantially equivalent in intended use, technological safety and effectiveness, and performance to predicate devices. | The 41-61XX Disposable Battery-Powered Cautery devices are substantially equivalent in intended use, technological safety and effectiveness and performance to the listed predicates: AAXXX Series Bovie/Aaron Cautery units, E844XXXX Series Medtronic/Solan Cautery units, and 23X Series Bovie Medical Corp., Perfectemp Cautery units. | This is the overarching conclusion of the 510(k) submission, supported by the compliance with standards and the lack of new technological risks or characteristics as assessed by the manufacturer and accepted by the FDA. No specific performance study (e.g., in vivo or in vitro efficacy trials) is described. |
Study Details (as applicable to this type of submission):
Given the nature of this 510(k) for a well-established device technology, the "study" demonstrating adherence to acceptance criteria is not a traditional clinical trial or performance study with a test set of data, but rather a demonstration of compliance with recognized standards and a comparison to predicate devices.
-
Sample size used for the test set and the data provenance: Not applicable in the context of a traditional performance study. The "test set" here refers to the device itself being evaluated against standards and predicates. The data provenance would be internal manufacturing and testing records in compliance with ISO standards.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for device safety and sterilization is established by adherence to recognized international standards (ISO). For technological equivalence, the manufacturer's engineering and regulatory teams would assess the device against predicate designs.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Device compliance with standards and technological equivalence is typically a direct assessment, not an adjudicated review of clinical data.
-
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 a surgical instrument, not an AI-powered diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a manual surgical device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Safety and Sterilization: Ground truth is established by international standards (ISO 10993-1 for biological evaluation, ISO 11137 for sterilization) and internal hazard analysis.
- Technological Equivalence/Performance: Ground truth for this aspect is based on the characteristics of legally marketed predicate devices (AAXXX Series, E844XXXX Series, 23X Series Cautery units) and the determination that the new device does not introduce new technological risks.
-
The sample size for the training set: Not applicable. This is not a machine learning or AI device that would require a "training set."
-
How the ground truth for the training set was established: Not applicable.
§ 886.4115 Thermal cautery unit.
(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.