(386 days)
The EBERLE shaver system C3 is a powered instrument system and consists of a control unit, a footswitch, a handpiece and accessories. It is designed for arthroscopy surgical procedures like shaving, burring, cutting and resecting of fibrous tissue, cartilage tissue and bone.
The EBERLE shaver system accessories are designed to use with the EBERLE shaver system for arthroscopy surgical procedures like shaving, burring, abrading, cutting, drilling and resecting of fibrous tissue, cartilage tissue and bone.
The EBERLE Shaver System C3 and shaver blades is a powered instrument system and consists of a control unit, a foot switch, handpiece(s), and accessories - associated sterile shaver blades for single use.
The control unit C3 includes three software systems. The other components of the shaver system C3 e.q. handpiece or footswitch consist only of hardware components. All software systems on the control unit are running on microcontrollers.
The Eberle Shaver Blades consists of an outer tube with a hub and a rotating inner tube with a connector. The inner and outer tube consists of stainless steel. The hub and connector consist of Polyoxymethylen (POM), the tubes consists of stainless steel. The shaver blades are provided in a sterile packaging and are intended for single use. The shaver blades are sterilized using EO sterilization with a Sterilization Assurance Level (SAL) of 10-6.
The Eberle Handpieces with switch buttons have three buttons to select the direction of rotation depending on the user assignment of functionalities to the buttons. It consists of Stainless Steel and Aluminum.
The Eberle Drill and the Saw - Handpieces also consist of Stainless Steel and Aluminum. The Drill Handpiece has two buttons to select the direction of rotation and the saw has an operator lever.
All these components are designed, constructed and intended to be operated exclusively as a system. EBERLE Shaver System C2 and C3 use the same shaver blades. The shaver blades are identical with the once already cleared under the predicated device K092977 - Eberle Shaver System Accessories. Eberle has added addition blades to provide a broader offering.
EBERLE Shaver System C2 and C3 have common handpieces and use the same kind of adapters.
While the provided document details the testing performed for the EBERLE Shaver System C3 to demonstrate substantial equivalence to its predicate devices, it does not explicitly state "acceptance criteria" in the typical quantitative sense for each test. Instead, the document describes the compliance with recognized standards and a demonstration of substantial equivalence as the desired outcome of the testing.
Therefore, for the purpose of answering your request, I will interpret "acceptance criteria" as the successful demonstration of compliance with the referenced standards and the achievement of substantial equivalence, as reported in the "Results" column of the summary table.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Interpreted) | Reported Device Performance |
|---|---|---|
| Electrical safety and Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1 and IEC 60601-1-2 standards. Demonstration of substantial equivalence to predicate device. | Evaluation and testing were performed on the subject device and demonstrated to be substantially equivalent to the predicate device. |
| Biocompatibility testing | Compliance with FDA Guidance "Use of International Standard ISO 10993, Biological evaluation of medical Devices Part 1" and ISO 10993-1, 10993-4, 10993-5, 10993-10, 10993-11. Demonstration of substantial equivalence to predicate device. | The following non clinical tests were performed on the subject or equivalent device: Cytotoxicity, Sensitization, Irritation and Acute systemic toxicity and demonstrated to be substantially equivalent to the predicate device. |
| Software Verification and Validation Testing | Compliance with FDA guidance "General Principles of Software Validation" and IEC 62304. Demonstration of substantially equivalent performance to identified predicate device. | Evaluation and testing were performed on the subject device and demonstrated substantially equivalent performance to identified predicate device. |
| Sterilization Validation | Compliance with ISO 11135, ISO 11135-1, ISO 14937, and ISO 10993-7. Sterility assurance level (SAL) of 10^-6. Residual EO |
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.