(130 days)
Not Found
No
The summary describes a standard powered surgical instrument system for arthroscopy and does not mention any AI or ML components or functionalities.
No
The device is described as a powered surgical instrument system for procedures like shaving and cutting tissue, which are surgical interventions, not therapeutic treatments.
No
The device is a powered surgical instrument system for arthroscopy procedures, designed for cutting and resecting tissues, not for diagnosing conditions.
No
The device description explicitly lists hardware components (control unit, footswitch, handpiece, shaver blades) and describes it as a "powered instrument system" and "powered surgical instrument system," indicating it is not software-only.
Based on the provided information, the EBERLE Shaver System C2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "arthroscopy surgical procedures like shaving, burring, abrading, cutting and resecting of fibrous tissue, cartilage tissue and bone". This describes a surgical instrument used on the patient's body during a procedure.
- Device Description: The description confirms it's a "powered surgical instrument system".
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The EBERLE Shaver System C2 does not perform this function.
Therefore, the EBERLE Shaver System C2 is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / 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, cartilage tissue and bone conducted by qualified surgeons only.
Product codes
HRX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K973195, K030009, K990524, K002523
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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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:
-
- 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.
-
- 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:
2
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.
3
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
4
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
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