(130 days)
The EBERLE Shaver System C2 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 conducted by qualified surgeons only.
The EBERLE Shaver System is a powered surgical instrument system and consists of a control unit, a footswitch, a handpiece and associated shaver blades (autoclavereusable, sterile/ non-sterile). All these components are designed, constructed and intended to be operated exclusively as a unit.
This F510(k) summary for the EFS Eberle Feinwerktechnische Systeme GmbH & CO. KG Shaver System does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria.
This document is a 510(k) premarket notification, which largely focuses on demonstrating "substantial equivalence" to previously approved devices rather than presenting the results of a specific clinical performance study with acceptance criteria.
Here's a breakdown of why the requested information cannot be extracted from the provided text and what is mentioned:
1. Table of Acceptance Criteria and Reported Device Performance
- Not present. The document does not define specific acceptance criteria (e.g., performance metrics, thresholds) for the shaver system, nor does it report quantitative device performance data against such criteria. The focus is on qualitative statements of safety and equivalence.
Regarding a "study that proves the device meets the acceptance criteria":
The document states, "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 available for sale in the USA." This implies that testing was done, but the details of such testing (including acceptance criteria, methodology, and results) are not provided in this summary.
Here's why the other requested points (2-9) cannot be answered based on the provided text:
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2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. No information about a "test set" or specific study data is provided.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not present. This type of information is relevant for studies involving human assessment (e.g., image interpretation), which is not applicable to a surgical shaver system in the context of this 510(k) summary.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. Not applicable in this context.
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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 present. Not applicable. MRMC studies are typically for diagnostic AI devices, not surgical instruments.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not present. Not applicable, as this is not an AI/algorithm-driven device.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not present. No specific "ground truth" as typically understood in diagnostic studies is mentioned. The device's performance relies on its mechanical and functional capabilities.
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8. The sample size for the training set
- Not present. Not applicable, as this is not an AI/machine learning device that would require a training set.
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9. How the ground truth for the training set was established
- Not present. Not applicable.
Summary of what is stated in the document regarding the device's validation:
- Safety Justification: "The selection of the materials for the EBERLE Shaver System C2 and Blades 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."
- Substantial Equivalence: The primary method of demonstrating safety and effectiveness for this 510(k) submission is by showing substantial equivalence to legally marketed predicate devices (K973195, K030009, K990524, K002523).
- Performance Mention: "Biocompatibility, function, indications and designs have been developed to ensure the safety of this device..." This indicates that functional testing and design verification were performed, but the details of these tests and their specific acceptance criteria are not included in this summary.
Conclusion:
The provided 510(k) summary for the EBERLE Shaver System C2 and Shaver Blades does not contain the detailed information regarding specific acceptance criteria for a performance study or the results of such a study. The document focuses on establishing substantial equivalence to predicate devices, which is the standard pathway for 510(k) clearance for medical devices. Full details of bench testing, biocompatibility reports, and other verification and validation activities would be contained within the complete 510(k) submission, not typically in the public summary.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
EFS Eberle Feinwerktechnische Systeme GmbH & CO. KG Shaver System
SEP - 1 2006
April 17th, 2006
1. Submitter Information:
| a. Correspondent/ Distributor: | |
|---|---|
| Name: | Innovative Endoscopy Components, LLC |
| Address: | 731-733 Shotgun Road |
| Ft. 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 Systeme |
| GmbH & CO. KG | |
| Address: | Glasbronnenstrasse 6 |
| D-75449 Wurmberg | |
| GERMANY | |
| Telephone: | (+49) 07044-9611-0 |
| Fax: | (+49) 07044-9611-11 |
| E-Mail: | info@efs-eberle.de |
| Registration No: | |
| Owner/ Operator No: | |
| 2. Device Name: | |
| Classification Name: | Arthroscope and Accessories |
| Common Name: | Surgical Shaver and Accessories |
EBERLE Shaver System C2 and Shaver Blades
3. Classification
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Proprietary Name:
CFR 888.1100 Class II Classification Number: Product Code: HRX
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- Indication for use:
The EBERLE. Shaver System C2 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 conducted by qualified surgeons only.
- Indication for use:
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- Description of Device:
The EBERLE Shaver System is a powered surgical instrument system and consists of a control unit, a footswitch, a handpiece and associated shaver blades (autoclavereusable, sterile/ non-sterile).
- Description of Device:
All these components are designed, constructed and intended to be operated exclusively as a unit.
7. Description of Safety:
The selection of the materials for the EBERLE Shaver System C2 and Blades 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.
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- 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 available for sale in the USA.
- Summary:
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Image /page/2/Picture/2 description: The image shows a logo for the Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES" is arranged vertically along the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EFS Eberle Feinwerktechnische System % Innovative Endoscopy Components, LLC Mr. Florian Gruber 1112 Weston Road, PMB 227 Ft. Lauderdale, Florida 33326
SEP - 1 2006
Re: K061134
Trade/Device Name: EBERLE Shaver System C2 and Shaver Blades Regulation Number: 21 CFR 888.1100 Regulation Name: Athroscope Regulatory Class: II Product Code: HRX Dated: July 28, 2006 Received: August 1, 2006
Dear Mr. Gruber:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as sct 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.
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Page 2 – Mr. Florian Gruber
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
kn
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): (イベイト
Device Name: EBERLE Shaver System C2 and Shaver Blades Indications For Use:
The EBERLE Shaver System C2 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, cartillage tissue and bone conducted by qualified surgeons only.
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)
sion Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L061134
Page 1 of_1
§ 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.