(130 days)
The "ZMM 2000 Zeppelin Millenium Motordrill System" is a fast running (~90.000 rpm) powered surgical drill system for the rapide trepanation of bone, plastic, metal or cement with high precision. It is in particular usefull to rapidly cut bone in neurosurgical, ENT, maxillofacial and orthopedic procedures.
The ZMM 2000 Zeppelin Millenium Motordrill System consists of a small handpiece motor, a motor air tube, a foot control, a wall air tube, various nosepieces and craniotoms and burs. The system components connect to each other via a proprietary coupling system.
The provided document is a 510(k) premarket notification summary for the ZMM 2000 Zeppelin Millennium Motordrill System. It outlines the device description, intended use, and substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.
The document states under section F. "PERFORMANCE STANDARDS" that: "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Zeppelin's ZMM 2000 Zeppelin Millenium Motordrill Sytem is manufactured in accordance with ISO and German DIN Standards. Furthermore, the Zeppelin GmbH has received ISO 9001 certification."
This indicates that the device's acceptance criteria are based on compliance with manufacturing standards (ISO, DIN, ISO 9001 certification) rather than specific performance benchmarks demonstrated through a clinical or technical study designed to prove efficacy or safety metrics against predefined criteria.
Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies because this information is not present in the provided 510(k) summary. The submission focuses on demonstrating substantial equivalence to predicate devices (Zeppelin Motordrill System #K922299, Aesculap HiLan Motor System for Neurosurgery #K980686, Midas Rex, Midas Rex I, II #K950518, Komet Medical Xk -95 Perforator Motor #991625, Black Max by Anspach) rather than presenting a performance study against specific acceptance criteria.
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premarket notifica
un este GmoH submission of ZMM 2000 ZEPPELIN MILLENIUM HIGHSPEED MOTORDRILL SYSTEM
KO13091 PREMARKET NOTIFICATION [510(k)] SUMMARY
A. SUBMITTER INFORMATION:
Date of summary:
Submitted by:
09-10-01
JAN 2 5 2002
VON ZEPPELIN CHIRURGISCHE INSTRUMENTE GMBH Gististrasse 99 82049 Pullach- Germany -Tel .: +49 / 89 / 7936880 Fax: +49 / 89 / 7938545
Establishment registration no .:
8010947
Contact person:
Mr. von Zeppelin, President
B. DEVICE INFORMATION:
Trade Name Aneurysm Clips:
Trade Name Parts:
Common Name:
Class of Device:
Classification Name:
Equivalent Device:
ZMM 2000 Zeppelin Millenium Motordrill System
| ZMM-100 | Motordrill Handpiece |
|---|---|
| ZMN-SI | Nosepiece attachment small |
| ZMN-VI | Nosepiece attachment, medium |
| ZMN-BL | Nosepiece attachment, large |
| ZMN-BA | Nosepiece attachment, X-large |
| ZMN-RE | Nosepiece attachment,XX-large |
| ZMC-01 | Craniotome, small |
| ZMC-02 | Craniotome, medium |
| ZMC-03 | Craniotome, large |
| ZMW-110 | Motor Tubing |
| ZMW-121 | Wall Tubing |
Pneumatic Cranial Drill Motor
Class II
Cranial Drill Motor
Zeppelin Motordrill System (#K92229) Aesculap HiLan Motor System for Neurosurgery (#K980686) Midas Rex, Midas Rex I, II (#K950518) Komet Medical Xk -95 Perforator Motor (#991625) Black Max by Anspach
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C. DEVICE DESCRIPTION:
The ZMM 2000 Zeppelin Millenium Motordrill System consists of a small handpiece motor, a motor air tube, a foot control, a wall air tube, various nosepieces and craniotoms and burs. The system components connect to each other via a proprietary coupling system.
D. INTENDED USE OF DEVICE:
The ZMM 2000 Zeppelin Millenium Motordrill System is a fast turning (~90.000 rpm) pneumatic powered surgical drill system for the rapid trepanation and resection of bone, plastic, metal or cement with high precision. It is in particular usefull to rapidely cut bone in neurosurgical procedures.
E. TECHNOLOGICAL CHARACTERISTICS
The ZMM 2000 is a variation and very much similar to the old Zeppelin Motordrill System with 510(k) Number: #K922299 submitted in July 1992.
F. PERFORMANCE STANDARDS
No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Zeppelin's ZMM 2000 Zeppelin Millenium Motordrill Sytem is manufactured in accordance with ISO and German DIN Standards. Furthermore, the Zeppelin GmbH has received ISO 9001 certification.
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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
JAN 2 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Von Zeppelin Chirurgische Instrumente GMBH Dieter von Zeppelin President Gistlstrasse 99 82049 Pullach Germany
Re: K013091
Trade Name: ZMM 2000 Zeppelin Millennium Motordrill System Regulation Number: 882.4370 Regulation Name: Pneumatic Cranial Drill Motor Regulatory Class: II Product Code: HHB Dated: December 18, 2001 Received: January 15, 2002
Dear Mr. von Zeppelin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 set forth in the quality systems (OS) 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. Dieter von Zeppelin
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Marlu A. Mulkeren
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page / of
510(k) Number (if known): (K013091)
Device Name : ZMM 2000 Zeppelin Millenium Motordrill System
Indication For Use:
INDICATION FOR USE STATEMENT:
The "ZMM 2000 Zeppelin Millenium Motordrill System" is a fast running (~90.000 rpm) powered surgical drill system for the rapide trepanation of bone, plastic, metal or cement with high precision. It is in particular usefull to rapidly cut bone in neurosurgical, ENT, maxillofacial and orthopedic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTIMUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter USE
(Optional Format 1-2-96)
Mati A. Milker
(Division Sign-Off) (Division of General, Restorative and Neurological Devi
510(k) Number -
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).