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 conducted by qualified surgeons only.

Device Description

The Eberle Shaver System Accessories are manufactured by EFS Eberle Feinwerktechnische Systeme GmbH & CO. KG in Germany. They are developed for surgical use in the field of arthroscopy and should only be used by trained personnel in designated institutions.

The Eberle Single Use 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 POM, the tubes consists of stainless steel. The Blades are provided in a sterile packaging and are intended for single use (not autoclave- reusable).

The Eberle Hand Piece with Switch has three buttons to select the direction of rotation. It consists of Stainless Steel and Aluminum.

The Eberle Drill- and the Saw- Hand Piece also consist of Stainless Steel and Aluminum. The Drill has two buttons to select the direction of rotation and the Saw hast a operator lever.

All these components are designed, constructed and intended to be operated exclusively as a unit with the Eberle Shaver System C2.

AI/ML Overview

The provided document is a 510(k) Summary of Safety and Effectiveness for the EFS Eberle Feinwerktechnische Systeme GmbH & CO. KG Shaver System Accessories. This summary focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.

Therefore, many of the requested elements for a study that proves the device meets acceptance criteria are not directly applicable or available in this document. The document primarily attests to safety and substantial equivalence based on material selection, design, and adherence to various electrical, sterilization, and biocompatibility standards.

Here's an analysis based on the information provided and what is typically expected for a 510(k) submission of this nature:

1. Table of acceptance criteria and the reported device performance

The document does not present a table of specific performance acceptance criteria in terms of clinical or technical metrics for the shaver system accessories and their corresponding tested performance. Instead, it refers to compliance with various safety and material standards.

Acceptance Criteria (Implied by Standards)	Reported Device Performance (Implied by Compliance)
Safety & Electrical:
EMC according to IEC 60601-1-2	Compliant (for not life supporting group 1, class B equipment)
Electrical safety according to EN 60601-1 / IEC 601-1	Compliant
Biocompatibility:
Appropriate levels of biocompatibility	Materials selected through demonstrated appropriate levels of biocompatibility; similar/identical to predicate devices.
Sterilization & Packaging:
DIN EN 12011:1998 (Instrumentation with non-active surgical implants)	Compliant
RKI/BfArM Hygiene requirements (processing medical products)	Compliant
DIN EN 556-1 (Sterilization of medical devices)	Compliant
DIN EN ISO 17664 (Sterilization of medical devices)	Compliant
DIN EN ISO 11138-3 (Sterilization of health care products)	Compliant
DIN EN ISO 11737 (Sterilization of medical devices)	Compliant
EN ISO 11607 (Packaging for terminally sterilized medical devices)	Compliant
Functional Equivalence:
To perform arthroscopy surgical procedures (shaving, burring, abrading, cutting, drilling, resecting)	Designed to use with EBERLE Shaver System for these procedures; function ensured through development.

2. Sample size used for the test set and the data provenance

The document refers to compliance with standards, implying that testing was conducted as required by those standards. However, it does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for any specific performance tests of the device in a clinical or simulated clinical setting. This type of detail is generally not included in a 510(k) Summary for non-complex, predicate-based devices like surgical accessories.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set in the context of device performance, especially for AI or diagnostic devices. The acceptance is based on compliance with engineering and safety standards, and functional equivalence to predicate devices, verified through bench testing and material conformity, not expert evaluation of output.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. No adjudication method would be detailed for a submission of this type.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those incorporating AI, to assess the impact of the AI on human performance. The EBERLE Shaver System Accessories are surgical tools, not diagnostic aids.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. There is no AI algorithm being evaluated for standalone performance described in this document.

7. The type of ground truth used

The "ground truth" for this device's acceptance is primarily:

Compliance with established engineering, electrical safety, biocompatibility, and sterilization standards. These standards define the "truth" for safety and materials.
Functional equivalence to legally marketed predicate devices. The predicate devices serve as the "ground truth" for acceptable design and performance profile in the intended use.
Material properties and design specifications for the components.

8. The sample size for the training set

This information is not applicable. This is not an AI or machine learning device, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

EFS Eberle Feinwerktechnische Systeme GmbH & CO. KG Shaver System Accessories

K092977

September 14th, 2009

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1. Submitter Information:

SEP 2 9 2010

a. Correspondent/ Distributor:

Name:	Innovative Endoscopy Components, LLC
Address:	731-733 Shotgun RoadFt. Lauderdale, FL 33326
Telephone:	(954) 217-8780
Fax:	(954) 217-8781
E-Mail:	info@endoscopy.md

Registration No: . 1064152 Owner/ Operator No: 9026517

b. Manufacturer:

Name:	EFS Eberle Feinwerktechnische SystemeGmbH & CO. KG
Address:	Glasbronnenstrasse 6D-75449 WurmbergGERMANY
Telephone:	(+49) 07044-9611-0
Fax:	(+49) 07044-9611-11
E-Mail:	info@efs-eberle.de

Registration No: 3005820796 Owner/ Operator No: 9086231

1. Device Name:

Classification Name:	Arthroscope and Accessories
Common Name:	Surgical Shaver and Accessories
Proprietary Name:	EBERLE Shaver System Accessories

1. Classification
  Classification Number: CFR 888.1100 Class II Product Code: HRX

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4. Indication for use:

5. Description of Device:

The Eberle Hand Piece with Switch has three buttons to select the direction of rotation. It consists of Stainless Steel and Aluminum.

The Eberle Drill- and the Saw- Hand Piece also consist of Stainless Steel and Aluminum. The Drill has two buttons to select the direction of rotation and the Saw hast a operator lever.

All these components are designed, constructed and intended to be operated exclusively as a unit with the Eberle Shaver System C2.

6. Substantial Equivalence:

K061134, Eberle Shaver System C2 and Shaver Blades K032117, Stryker Total Performance System Shaver K030009, KSEA Powershaver System S2 K990524, Linvatec E9000 System K002523, Linvatec Advantage Drive System K072706, Linvatec Handpiece System K080617, Richard Wolf Power Driver ART1

2/3

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1. Description of Safety:
- EMC according IEC 60601-1-2 for not life supporting group 1, class B . equipment
- Electrical safety according EN 60601-1 / IEC 601-1 .
- . DIN EN 12011:1998 Instrumentation to be used in association with non-active surgical implants - General requirements
- . Recommendation of the Commission for Hospital Hygiene and Infection Prevention of the Robert Koch Institute (RKI) and the Federal Institution for Drugs ad Medical Devices (BfArM. Hygiene requirements in processing medical products. Federal Health Publication 44 (2001). 1115-1126
- DIN EN 556-1 Sterilization of medical devices .
- DIN EN ISO 17664 Sterilization of medical devices ●
- DIN EN ISO 11138-3 Sterilization of health care products .
- DIN EN ISO 11737 Sterilization of medical devices ●
- EN ISO 11607 Packaging for terminally sterilized medical devices .

The selection of the materials for the EBERLE Shaver System Accessories has been determined through demonstrated appropriate levels of biocompatibility. The materials are similar or identical to those used for predicate devices as well as other brands legally sold in the United States.

1. Summary:
  Biocompatibility, function, indications and designs have been developed to ensure the safety of this device and it is substantially equivalent to commercially approved shaver systems and accessories available for sale in the USA.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

EFS Eberle Feinwerktechnische Systeme % Innovative Endoscopy Components, LLC Mr. Gerald Goigitzer Managing Director 731-733 Shotgun Road Ft. Lauderdale, Florida 33326

2 9 2010 SEP

Re: K092977

Trade/Device Name: EBERLE Shaver System Accessories Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 20, 2010 Received: September 22, 2010

Dear Mr. Goigitzer:

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. 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.

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Page 2 - Mr. Gerald Goigitzer

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
For

Mark N. Melkerson Director Division of Surgical. Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K092977

SEP 2 9 2010

Device Name: EBERLE Shaver System Accessories Indications For Use:

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 conducted by qualified surgeons only.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nidkep Daden for mxm

Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K092177 Page 1 of 1

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.