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.

Device Description

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.

AI/ML Overview

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 < 4 mg and ECH < 9 mg after 1 day of aeration. Package and product integrity tested in accordance with ISO11607-1. Demonstration of substantial equivalence to predicate device.	Validation was performed on the subject device and demonstrated to be substantially equivalent to the identified predicate devices. Residual EO < 4 mg and ECH < 9 mg. SAL was 10^-6. Package and product integrity tested.
Bench Tests (Functional and Usability)	Compliance with IEC 62366 - Medical Devices - Part 1: Application of Usability Engineering to Medical Devices. 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.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" sample size in terms of number of devices or cases for the performance tests. The testing appears to be conducted on the EBERLE Shaver System C3 itself, rather than on a dataset of patient information.

For the Biocompatibility testing, it mentions "the subject or equivalent device," implying samples of the device materials were used.

For the Sterilization Validation, it refers to "the EBERLE Shavers" as the subject of validation.

The data provenance is not explicitly stated as country of origin, but it is implied to be from the manufacturer's internal testing processes. The studies are retrospective in the sense that they are conducted after the device design is largely finalized, but they are not based on retrospective patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The performance testing described (electrical safety, EMC, biocompatibility, software verification, sterilization, bench tests) does not involve expert review or adjudication of medical images or patient data to establish ground truth. These are engineering and laboratory-based assessments against defined standards.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" in the context of expert review or consensus as typically seen in clinical evaluation of AI/diagnostic devices. The outcomes of the engineering and lab tests are based on direct measurement and comparison to predefined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a surgical shaver system, not an AI or diagnostic imaging device that would typically involve human readers interpreting cases.

6. Standalone Performance Study

Yes, a standalone study (i.e., algorithm only without human-in-the-loop performance) was effectively done for the software components. The "Software Verification and Validation Testing" specifically states that "Conformity of software with the user needs and intended use of the device were performed through the 'Validation' phase of the EBERLE Shaver System C3 device," implying the software was tested independently to confirm its correct function according to its requirements.

7. Type of Ground Truth Used

For the specific tests described:

Electrical safety and EMC: Ground truth is established by recognized international standards (IEC 60601-1, IEC 60601-1-2).
Biocompatibility: Ground truth is established by recognized international standards (ISO 10993 series) and FDA guidance.
Software Verification and Validation: Ground truth is established by software requirements specifications, design specifications, and relevant standards (FDA guidance, IEC 62304).
Sterilization Validation: Ground truth is established by recognized international standards (ISO 11135, ISO 14937, ISO 10993-7) for sterility assurance level, residual levels, and package integrity.
Bench Tests (Functional and Usability): Ground truth is established by the device's functional design specifications and usability engineering standards (IEC 62366).

8. Sample Size for the Training Set

Not applicable. The device is a physical surgical instrument system with software components. It does not employ machine learning or AI that would require a "training set" of data in the typical sense. The software development follows a traditional software lifecycle process (design, implement, test) rather than a machine learning training paradigm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning model. The software's "ground truth" (i.e., its correct functionality) is established through its design specifications and validation against those specifications and relevant regulatory standards.

Summary

{0}------------------------------------------------

January 15, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Eberle GmbH & Co. KG % Arne Briest Managing Director VISAMED GmbH Kastellstr. 8 Karlsruhe, 76227 Germany

Re: K193608/S002

Trade/Device Name: EBERLE Shaver System C3 and Accessories Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: December 18, 2020 Received: December 18, 2020

Dear Arne Briest:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K193608

Device Name EBERLE Shaver System C3

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995,

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "EBERLE" in all capital letters. The letters are a dark red color. The background is white.

K193608

510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part §807.92.

-SUBMISSION SPONSOR and APPLICATION CORRESPONDANT

A. SUBMISSION SPONSOR

Eberle GmbH & Co. KG

Glasbronnenstrasse 6 75449 Wurmberg www.eberle-med.de

Tel: +49 - 7044 9611 -0

Contact Person:

Mr. Udo Schniebs Product Development and Quality Management u.schniebs@eberle-med.de

B. APPLICATION CORRESPONDANT

VISAMED GmbH

Kastellstr. 8 D-76227 Karlsruhe-Germany www.visamed.com Tel +49 (0)721-476 4847

Contact Person: Arne Briest CEO arne.briest@visamed.com

II. Dated prepared: December 17, 2020

{4}------------------------------------------------

EBERLE

DEVICE IDENTIFICATION III

Proprietary Name ofDevice:	Eberle Shaver System C3
Common Name:	Surgical Shaver and Accessories
Classification Name:	Arthroscope and Accessories (21 CFR §888.1100)
Classification Panel:	Orthopedic
Regulatory Class:	II
Product Code:	HRX
510k #:	K193608

IV PREDICATE DEVICE

K061134 Eberle Shaver System C2 and Shaver Blades
K092977 Eberle Shaver System Accessories o

{5}------------------------------------------------

V. DEVICE DESCRIPTION

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.

EBERLE Shaver System C2 and C3 have common handpieces and use the same kind of adapters.

{6}------------------------------------------------

VI INDICATIONS FOR USE

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, abrading, cutting and resecting of fibrous tissue, cartilage tissue and bone.

The EBERLE Shaver System accessories are designed to be used with the EBERLE Shaver System for arthroscopy surgical procedures like shaving, burring, abrading, cutting, drilling and resecting of fibrous tissue, cartilage tissue and bone.

VII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The EBERLE Shaver System C2 and Shaver Blades and the EBERLE Shaver System accessories are the predicate devices for the EBERLE Shaver System C3 and shaver blades.

Both Eberle Shaver Systems and Shaver Blades are designed, developed and manufactured using the same general design principles and similar mechanical and electrical components.

They have the same intended use and incorporate the same basic design. Specifically, both the EBERLE Shaver System C2 and the EBERLE Shaver System C3 and shaver blades are used for arthroscopy surgical procedures like shaving, burring, abrading, cutting, drilling and resecting of fibrous tissue, cartilage tissue and bone.

Software and Hardware

The EBERLE Shaver System C3 has additional software functionalities (rotation and frequency based oscillation modus, increased max. speed of 10.000 min-1, improved rpm accuracy of +/- 5%, functionality of buttons of the footswitch and handpiece can be free assigned) when compared to the EBERLE Shaver System C2. In addition the two handpiece connectors are identical. Both connectors can used for all EBERLE handpieces.

The EBERLE Shaver System C3 utilizes a new faster processors - (model name: Atmel ATxmega256A3U). The programing languages C was utilized for both the EBERLE Shaver System C2 and EBERLE Shaver System C3.

{7}------------------------------------------------

Handpieces

The EBERLE Shaver system handpieces for the C2 and C3 system are available with stainless steel or aluminum housing. The housing design was optimized for the C3 handpieces to reduce the weight. The main benefit of the handpieces with stainless steel housing is the higher resistance against potential mechanical damage. The hand pieces with an aluminum housing are lighter. The handpieces are available with and without control buttons. The functionalities are identical. The connector cable was changed to adapt to the new connectors of the C3 control units.

The brushless DC motors used in the C2 and C3 handpieces use identical materials and are identical in design components. The handpieces for the C3 are using a new gearbox to reach higher rotational speed (rpm; 10.000 min-1).

Adapter

Eberle has added new adapter made of the same material than the previous cleared adapter under the predicated device. The new adapters are designed to adapt more closer to selected drill or wire diameter. In addition a drill chuck adapters is offered with key less fixation.

The universal handpiece can be used with the following adapters:

Drill chuck adapter, high-power, 0.7-7.4 mm ●
Drill chuck adapter, 0-3.0 mm, keyless ●
Sagittal saw adapter ●
o Wire driver adapter, 1.8-3.2mm
Drill chuck adapter 0.7-7.4 mm ●
Wire driver adapter, 0.6-1.8 mm ●

The method of operations and the design are substantial equivalent.

Footswitch

The footswitch for the C2 has four buttons. The functionalities were preassign and programed to the buttons. The oscillation mode was activated by pressing two button's at the same time. The footswitch used for the C3 has five buttons. The functionalities can be freely assigned to the buttons. The additional button can be used to activate the oscillation mode.

{8}------------------------------------------------

Conclusion

The differences in the technological characteristics of both the predicate devices and the proposed device EBERLE Shaver System C2 and shaver blades and the EBERLE Shaver System Accessories and the EBERLE Shaver System C3 and shaver blades are minor and do not raise new questions of safety and effectiveness.

Both the EBERLE Shaver System C2 and shaver blades and the EBERLE Shaver System Accessories and the EBERLE Shaver System C3 and shaver slades are designed to be used with compatible shavers from Eberle.

{9}------------------------------------------------

VIII PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Software

The software was developed, tested, and verified in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and in accordance with the following standard:

· IEC62304- Medical Device Software - Software Life Cycle Processes.

Software tests were conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 Standard (Medical Device Software - Life Cycle Process). The software was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator.

Software verification activities were performed during the "Integration & Testing" and "Verification" and "Validation" phases of software lifecycle.

Outputs generated during these phases include:

Software and Hardware Requirements Specification
Software Description ●
Architecture Design Chart ●
Software Design Specification (SDS) ●
Risk management ●
Traceability Matrix ●
Verification and Validation test plans and test reports ●
Revision Level History .
Unresolved Anomalies .

The software tests during the "Integration & Testing" and "Verification" and "Validation" phases of software lifecycle were performed according to the Software Test Plan. Verification tests were performed for each software requirement according to the Software Verification Plan.

Conformity of software with the user needs and intended use of the device were performed through the "Validation" phase of the EBERLE Shaver System C3 device.

{10}------------------------------------------------

EBERLE

Design verification testing of the EBERLE Shaver System C3 demonstrates that the device performs as intended and that the performance does not raise new questions of safety and effectiveness.

Electrical safety and electromagnetic compatibility

Electrical safety and electromagnetic compatibility (EMC) testing was conducted on the EBERLE Shaver System C3.

The device complies with recognized electrical safety standards:

IEC 60601-1 standard for electrical safety .
IEC 60601-1-2 standard for electromagnetic compatibility. .

Biocompatibility testing

The biocompatibility evaluation for EBERLE handpieces, adapters and shaver blades has been conducted in accordance with FDA Guidance Document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process" and ISO 10993-1 – "Biological evaluation of medical devices – Evaluation and testing within a risk management system". The evaluation reveals that biocompatibility requirements are met by the EBERLE handpieces, adapters and shaver blades.

Biocompatibility testing was performed in accordance with:

. ISO 10993-1 - Biological evaluation of medical devices- Evaluation and testing within a risk management system;
. ISO 10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
. ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity; and
. ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
. ISO 10993-11 - Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity.

{11}------------------------------------------------

Ethylene Oxide (Single Use Devices)

In addition, the sterilization validation on the EBERLE Shavers has been performed in accordance with:

· ISO 11135 Sterilization of health care products Ethylene Oxide -Requirements for the development, validation and routine control of a sterilization process for medical device
ISO 11135-1 Sterilization of health care products Ethylene oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices;
· ISO 14937 Sterilization of health care products General criteria for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; and
· ISO 10993-7 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals.

Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) data show that the limit of EO < 4 mq and ECH < 9 mg after 1 day of aeration (gas release) that remain on the EBERLE Shavers will not be exceeded. The sterility assurance level (SAL) was 10-6. Package and product integrity of the shaver blades were tested in accordance with ISO11607-1 - Packaging for terminally sterilized medical devices.

Cleaning and Sterilization Validation (Reusable Devices)

Eberle has performed for the handpieces and adapters (attachments) an cleaning and sterilization validation.

Performance Testing - Bench

The following performance tests were conducted:

Performance of Handpieces and Shaver Blades within Intended Use
Control of Handpiece Speed by Eberle Shaver System C3 .
Performance of Handpiece Adapter .
. Performance Test - Shelf Life of Shaver Blades

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the word "EBERLE" in a bold, red font. The letters are all capitalized and evenly spaced. The background is white, which makes the red letters stand out.

Animal studies

Data from animal studies were not required to support the safety and effectiveness of the EBERLE Shaver System C3 and Shaver Blades.

Clinical Studies

Clinical data were not required to support the safety and effectiveness of the EBERLE Shaver System C3 and shaver blades. All validation was performed based on non-clinical performance tests.

{13}------------------------------------------------

Image /page/13/Picture/1 description: The image shows the word "EBERLE" in a bold, red font. The letters are capitalized and evenly spaced. The background is white.

IX SUMMARY OF NON CLINICAL PERFORMANCE TESTING - Bench

Test	Test Method Summary	Results
Electrical safety andelectromagneticcompatibility(EMC)	Testing in compliance with theIEC 60601-1 and IEC 60601-1-2	Evaluation and testing wereperformed on the subject deviceand demonstrated to besubstantially equivalent to thepredicate device.
Biocompatibilitytesting	Testing in compliancewith FDA Guidance "Use ofInternational Standard ISO10993, Biological evaluation ofmedical Devices Part 1" andISO 10993-1	The following non clinical testswere performed on the subject orequivalent device: Cytotoxicity,Sensitization, Irritation and Acutesystemic toxicity anddemonstrated to be substantiallyequivalent to the predicatedevice.
Software VerificationandValidation Testing	Software verification testing incompliance with FDA guidance"General Principles of SoftwareValidation" and IEC 62304	Evaluation and testing wereperformed on the subject deviceand demonstrated substantiallyequivalent performancetoidentified predicate device
SterilizationValidation	The sterilization validation wasperformed according to ISO11135 and ISO 11135-1Sterilization of health careproducts - Ethylene oxide -Part 1:Requirements for thedevelopment, validation androutine control of a sterilizationprocess for medical devices;and• ISO 10993-7 - Biologicalevaluation of medical devices- Part 7: Ethylene oxidesterilization residuals.	Validation was performed on thesubject device and demonstratedto be substantially equivalent tothe identified predicate devices.
Bench Tests	The functional and usabilitytests on EBERLE ShaverSystem C3 and ShaverBlades were performedaccording to IEC 62366 -Medical Devices - Part 1:Application of UsabilityEngineering to Medical toMedical Devices.	Evaluation and testing wereperformed on the subject deviceand demonstrated substantiallyequivalent performancetoidentified predicate device.
Animal studies	Not applicable	Not applicable
Clinical Studies	Not applicable	Not applicable

{14}------------------------------------------------

X Overall CONCLUSIONS

Based on the similar intended use, the same basic technological characteristics and performance testing, the EBERLE Shaver System C3 and shaver blades is substantially equivalent to the predicate devices EBERLE Shaver System C2 and shaver blades and the EBERLE Shaver System accessories. The differences between the proposed device and the predicate device do not raise new questions of safety and effectiveness.

Regulation Number and Section

§ 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.