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.

Device Description

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.

AI/ML Overview

The provided document is a 510(k) Summary for the Medicon VIPAIR Pneumatic High Speed System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving performance against those specific criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study details, human reader studies, and training data is not present.

However, I can extract information related to the comparison with predicate devices, which serves as a form of "acceptance criteria" in the context of 510(k) submissions, as the device must be shown to be substantially equivalent.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission, "acceptance criteria" are typically defined by demonstrating substantial equivalence to existing legally marketed predicate devices. The performance is assessed by comparing key characteristics.

Characteristic / "Acceptance Criteria"	Medicon VIPAIR System Performance / Comparison
Intended Use	YES (Used for same clinical applications as predicates in Neurology, ENT, Orthopaedics)
Methods of Sterilization / Sterility Status	YES (Steam Sterilization (DIN 58953-9); non-sterile upon delivery, requiring user reprocessing)
Material (Patient Contact)	YES (Surgical stainless steel, as per DIN ISO 7153-1)
Motor (Operation)	YES (Pneumatic power source, foot pedal control for speed)
Motor (Speed - RPM)	100,000 RPM (Comparable to predicates ranging from 80,000 to 95,000 RPM)
Pressure (Operating PSI)	90-120 PSI (Comparable to predicates ranging from ~20 to 150 PSI)
Handpieces and Accessories	YES (Includes straight and curved handpieces, craniotoms, burs, drills, and cutters, similar to predicates)
Industry Standards (MDD 93/42 EEC)	YES (Class IIA product, CE Certificate)
Company Certification (ISO 9001:2000 or EN ISO 13485-2003)	YES
German Medical Product Law (MPG)	YES

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

Not applicable (N/A): This document describes a 510(k) submission focused on substantial equivalence to predicate devices, not a clinical study with a "test set" in the traditional sense of evaluating a novel algorithm or diagnostic performance. Instead, it relies on comparative analysis of technical specifications and intended use against existing devices. There is no mention of a "test set" or data provenance (country of origin, retrospective/prospective).

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

Not applicable (N/A): As explained above, there is no "test set" or "ground truth" to be established by experts in the context of this 510(k) submission. The evaluation is based on comparing device specifications and regulatory compliance.

4. Adjudication method for the test set:

Not applicable (N/A): No test set or expert adjudication is described.

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, not done: This is a pneumatic surgical drill system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and not described.

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

No, not done: This is medical hardware (a pneumatic drill system), not a standalone algorithm.

7. The type of ground truth used:

Not applicable (N/A): No "ground truth" as typically defined in diagnostic studies (e.g., pathology, outcomes data, expert consensus) is used here. The "truth" for this 510(k) submission is the existence and regulatory status of predicate devices with similar characteristics and the device's conformance to established industry standards and its own specifications.

8. The sample size for the training set:

Not applicable (N/A): This document does not describe the development or evaluation of an algorithm or AI model, so there is no training set.

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

Not applicable (N/A): As there is no training set, this information is not relevant or provided.

In summary: The provided document is a regulatory submission for a pneumatic surgical drill, demonstrating substantial equivalence to existing devices. It is not a study evaluating acceptance criteria for a novel diagnostic or AI-powered medical device. Therefore, many of the requested details about studies, sample sizes, ground truth establishment, and expert involvement are not pertinent to this specific document or type of device.

Summary

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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

510(k) SUMMMARY of Safety and Effectiveness +

K042974

SE Comparison Table

Medicon eG

[As required by Section 807.92)]

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 marketing@medicon.de

Date Summary Prepared: [807.92 (a)(1)] 2.2 September 2004

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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)]

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.

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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.

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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

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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

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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.

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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

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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 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)

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

Regulation Number and Section

§ 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).