MEDICON VIPAIR HIGH SPEED SYSTEM
Device Facts
| Record ID | K042974 |
|---|---|
| Device Name | MEDICON VIPAIR HIGH SPEED SYSTEM |
| Applicant | Medicon EG |
| Product Code | HBB · Neurology |
| Decision Date | Jan 13, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4370 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Medicon VIPAIR high speed system is a pneumatically operated motor system. The VIPAIR motor system provides power to operate removable rotating surgical tools like burs, cutters and drills intended for use in neurosurgery, including craniotomy and spinal surgery; as well as general surgical applications.
Device Story
The Medicon VIPAIR is a pneumatically powered surgical drill system used in hospitals and surgical centers. It consists of a handpiece motor, foot control, air tubes, and various attachments including craniotoms, burs, drills, and cutters. The system is operated by surgeons to cut and drill bone during neurosurgical, ENT, and orthopedic procedures. The foot pedal allows the surgeon to control the motor speed (up to 100,000 RPM) and power. The device is supplied non-sterile and requires steam sterilization between uses. By providing a high-speed, ergonomic, and low-noise power source for surgical tools, the system assists surgeons in performing precise bone removal, potentially improving procedural efficiency and patient outcomes.
Clinical Evidence
Bench testing only. No clinical data provided. Equivalence is established through comparison of technical specifications, materials, and intended use with legally marketed predicate devices.
Technological Characteristics
Pneumatic motor system; surgical stainless steel (DIN ISO 7153-1) patient-contact materials; foot-pedal speed control; operating pressure 90-120 PSI; max speed 100,000 RPM; steam sterilization (DIN 58953-9); compliant with MDD 93/42 EEC and EN ISO 13485-2003.
Indications for Use
Indicated for cutting and drilling of cranial and spinal bones in neurology, ENT, and orthopedics. Intended for use by professional and qualified neurology, ENT, or orthopaedic surgeons.
Regulatory Classification
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.
Predicate Devices
- Zeppelin ZMM 200 Millenium Motordrill System (K013091)
- Zeppelin Motordrill System (K92229)
- Aesculap HiLan Motor System for Neurosurgery (K980686)
- Komet Medical Xk - 95 Perforator Motor (K991625)
- Midas Rex Legend System (K020069)
- Midas Rex, Midas Rex I, II (K950518)
- Sodem Powered Surgical Drill (K023066)
- Black Max by Anspach (K930660)
- Micromax by Anspach (K965080)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a collection of medical equipment, categorized into Implants, Instruments, Endoscopes, Laryngoscopes, and Containers. Each category displays different tools and devices used in medical procedures. The image also contains the date "JAN 1 8 2005" at the bottom. The medical equipment is displayed against a dark background.
Medicon eG Traditional 510(k) - HBB
2.
# 510(k) SUMMMARY of Safety and Effectiveness +
k042974
# SE Comparison Table
# Medicon eG
[As required by Section 807.92)]
| 2.1 | Submitter: [807.92 (a)(1)] | | |
|-----|----------------------------|-------|------------------------------------------|
| | Medicon eG | | |
| | Gänsäcker 15 | Tel. | +49 7462 2009 0 |
| | D-78532 Tuttlingen | Fax | +49 7462 2009 50 |
| | Germany | eMail | sales@medicon.de<br>marketing@medicon.de |
- Date Summary Prepared: [807.92 (a)(1)] 2.2 September 2004
{1}------------------------------------------------
- 2.3 Device Names: [807.92(a)(2)] Proprieatary MEDICON VIPAIR Pneumatic High Speed System
Common VIPAIR System
Device Motor, Drill, Pneumatic
Device Description Pneumatic cranial drill motor
Product Code HBB
Device Class Class II
- 2.4. Reason for Submission: [807.81(2)] New Device
### 2.5 Predicate Device [807.92(a)(3)]
The Medicon High Speed Systems claims equivalence to the following system:
Zeppelin ZMM 200 Millenium Motordrill System (K013091) Zeppelin Motordrill System (K92229) Aesculap HiLan Motor System for Neurosurgery (K980686) Komet Medical Xk - 95 Perforator Motor (K991625) Midas Rex Legend System (K020069) Midas Rex, Midas Rex I, II (K950518) Sodem Powered Surgical Drill (K023066) Black Max by Anspach (K930660) Micromax by Anspach (K965080)
### 2.6 Device Describtion [807,92(a)(4)]
The Medicon VIPAIR pneumatic high speed system is specially designed for cutting and drilling of cranial and spinal bones. This system combines security and precision in an ergonomic design. The latest technology allows a reduction of the noise level to a minimum. The System consists of a small handpiece motor, a motor air tube, a foot control, a wall air tube, various hand pieces, craniotoms , burs, drills and cutters. The system components connect to each other via a safety coupling mechanism.
### 2.7 Intended Use: [807.92 (a)(5)]
The Medicon VIPAIR high speed system is a pneumatically operated motor system. The VIPAIR motor system provides power to operate removable rotating surgical tools like burs, cutters and drills intended for use in neurosurgery, including craniotomy and spinal surgery; as well as general surgical applications.
{2}------------------------------------------------
#### 2.8 Environment of Use
The MEDICON VIPAIR high speed system are intended for use in healthcare facilities, including hospitals, medical clinics and surgical centers.
Within these facilities the MEDICON VIPAIR high speed system may be located in areas where sterile surgical/dental instruments are used such as operating rooms for surgery.
### Difference in Design and Technological 2.9 Characteristics when Compared to SE Devices [807.92(a)(6)]
Material: Patient contact materials for all High Speed Systems consist of surgical stainless steel
- The design is very similar between the systems. All High Design: Speed Systems consists of hand piece motor, a motor air tube, a foot control, a wall air tube, various hand pieces, craniotoms, burs, drills and cutters.
#### Industry Standards: [807.92 (d)] 2.10
No applicable industry standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the Medicon VIPAIR high speed system is manufactured accordance the MDD 93/42 EEC (please find Certificate from the notified body), the ISO and the German DIN Standards. Furthermore, the Medicon e. G. has received EN ISO 13485-2003 certification.
## Substantially Equivalent
#### Information Bearing on the Safety and Effectiveness: 2.11
[807.92 (b)(3)]
The MEDICON VIPAIR system have the same intended use as predicate pneumatic motor systems. They are made of identical material (Patient contact material). The slight differences in design and size do not adversely affect the safety and effectiveness of this device.
{3}------------------------------------------------
#### 2.12 Comparison with predicate devices (table)
The Medicon VIPAIR High Speed System (Pneumatic) including cutting tools and accessories claims substantial equivalence to other currently marketed high speed pneumatic motor systems. This claim is based on equivalence in:
### INTENDED USE
The Medicon VIPAIR High Speed System (Pneumatic) including cutting tools and accessories are used for the same clinical applications and intended use (Neurology) as the currently marketed high speed pneumatic motor systems.
| Medicon | Aesculap | Zeppelin | Komet | Midas Rex | Sodem | Anspach |
|---------|----------|----------|-------|-----------|-------|---------|
| YES | YES | YES | YES | YES | YES | YES |
### METHODS OF STERILIZATION / STERILITY STATUS
Steam Sterilization Processes (DIN 58953-9) :
134° C, 2 bar, induction time at least 5 minutes, or 121° C, 1 bar, induction time at least 15 minutes.
All systems are supplied non-sterile, requiring reprocessing between surgical applications. Sterilization of all systems is accomplished using steam (see above). All systems require decontamination after use, and resterilization by the user facility.
| Medicon | Aesculap | Zeppelin | Komet | Midas Rex | Sodem | Anspach |
|---------|----------|----------|-------|-----------|-------|---------|
| YES | YES | YES | YES | YES | YES | YES |
### MATERIAL
Patient contact materials for all systems consists of surgical stainless steel. (Stainless Steel after DIN ISO 7153-1)
| Medicon | Aesculap | Zeppelin | Komet | Midas Rex | Sodem | Anspach |
|---------|----------|----------|-------|-----------|-------|---------|
| YES | YES | YES | YES | YES | YES | YES |
### SYSTEM DESCRIPTION
### Motor
All cited systems are operated using a pneumatic power source controlled by a foot pedal. For all systems, user can increase or reduce speed with foot pedal. The nominal power output of the Medicon VIPAIR is identical or substantially equivalent to ther commercially available pneumatic motor systems. The drill speeds are adjustable from 0 up to
{4}------------------------------------------------
| Medicon | Aesculap | Zeppelin | Komet | Midas Rex | Sodem | Anspach |
|---------|----------|----------|--------|-----------|--------|------------|
| 100.000 | 90.000 | 95.000 | 95.000 | 85.000 | 80.000 | 80.000 RPM |
### Pressure
All cited systems operated using as power sources: air supply
The operating pressure is as follow:
| Medicon | Aesculap | Zeppelin | Komet | Midas Rex | Sodem | Anspach | |
|---------|----------|----------|---------|-----------|--------|---------|-----|
| 90-120 | 90-120 | ~120 | 120-150 | 20-120 | 90-120 | -120 | PSI |
### Hand pieces and Accessories
The Medicon VIPAIR system and the other commercially available pneumatic motor systems includes straight and curved hand pieces as well as craniotoms. Furthermore all offer a wide variety of accessories including burs, drills and cutters.
| Medicon | Aesculap | Zeppelin | Komet | Midas Rex | Sodem | Anspach |
|---------|----------|----------|-------|-----------|-------|---------|
| YES | YES | YES | YES | YES | YES | YES |
### Industry Standards
The Medicon VIPAIR System and the other cited systems are after the MDD 93/42 EEC (European Medical Device Directive) a Class IIA product. That means that the notify body has to examine the product and the DMF (Device Master File) before selling the product in the European Community.
CE Certificate after examination through the notify body according to the MDD 93/42 EEC
| Medicon | Aesculap | Zeppelin | Komet | Midas Rex | Sodem | Anspach |
|---------|----------|----------|-----------|-----------|-------|---------|
| YES | YES | YES | not known | YES | YES | YES |
The companies of all cited Systems are certified after DIN ISO 9001:2000 or EN ISO 13485-2003
| Medicon | Aesculap --------------------------------------------------------------------------------------------------------------------------------------------------------------------- | | | Zeppelin Komet | | Anspach |
|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-----------|-------------------------|-----|---------|
| YES | YES | YES | not known | YES | YES | YES |
Furthermore the companies fulfil the MPG (German Medical Product Law)
| Medicon | Aesculap | Zeppelin | Komet | Midas Rex | Sodem | Anspach |
|---------|----------|----------|-----------|-----------|-------|-----------|
| YES | YES | YES | not known | YES | YES | not known |
{5}------------------------------------------------
Image /page/5/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 that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2005
Mr. Joachim Schmid General Manager Medicon eG Gänsäcker 15 D-78532 Tuttlingen Germany
Re: K042974
Trade/Device Name: Medicon VIPAIR High Speed System Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic cranial drill motor Regulatory Class: II Product Code: HBB Dated: October 22, 2004 Received: November 10, 2004
Dear Mr. Schmid:
We have reviewed your Section 510(k) premarket notification of intent to market the device w C nave reviewed your becalent on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the encrease, 1976, the enactment date of the Medical Device Amendments, or to conniner or prior to may 20, 2011 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 r ou may, therefore, mans 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 rryour device is enabilional 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 r 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 or unf I vith all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the 11et 011 CFR Part 801); good manufacturing practice requirements as set Of It Furt 6077, laoeming (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{6}------------------------------------------------
Page 2 - Mr. Joachim Schmid
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
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
{7}------------------------------------------------
| 510(k) Number | K042974 |
|----------------|----------------------------------|
| Device Name | Medicon VIPAIR high speed system |
| Classification | Motor, Drill, Pneumatic |
| Product Code | 84 HBB Class II 21 CFR 882.4370 |
# INDICATIONS FOR USE
The Medicon VIPAIR high speed system is specially designed for cutting and drilling of cranial and spinal bones in the Neurology. Thanks to a wide variety of working attachments and tools, the Medicon pneumatic high speed system "VIP AIR" can be also used in the ENT and Orthopaedics.
The Medicon VIPAIR high speed system are intended for use and handling by professional and qualified Neurology , ENT or Orthopaedic surgeons.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per CFR 801 109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
**510(k) Number** K042974
