The Sodem Perforator Drive is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patien's skull. The system is intended for use in neurosurgery.

Device Description

The Sodem Perforator Drive PN 3510 is made out of the combination of 2 components from the Sodem Power System. the Pneumatic motor currently used as part of the Sodem Power System and a Hudson Adapter. Sodem is not manufacturing "Cranial Perforator attachment". The technological characteristics of the Sodem Perforator Drive are similar to the pneumatic handpiece from the Sodem Power System. The safety device (disengagement of rotational movement of the "cranial perforator attachment"after relevant perforation of skull) is exclusively dependent of this attachment (not the motor). This safety device is functional so far the speed range is being respected. The speed range is indicated on the instructions for use of the manufacturer(s) of the "cranial perforator attachments" and our perforator drive motor is falling within recommended range of operation.

AI/ML Overview

This 510(k) summary (K993851) for the Sodem Perforator Drive does not describe a study to prove the device meets acceptance criteria. Instead, it focuses on claiming substantial equivalence to predicate devices. Therefore, much of the requested information about a specific study and its methodology for meeting acceptance criteria cannot be extracted.

However, based on the provided text, we can infer some "acceptance criteria" through the basis of substantial equivalence:

Inferred Acceptance Criteria from Substantial Equivalence Claim:

Criteria Feature	Description from Document
Intended Use	Identical to predicate devices (Sodem High Speed System, Sodem Power System). The Sodem Perforator Drive is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull, intended for neurosurgery.
Materials	Not in direct patient contact and similar to the Sodem Power System.
Sterility Status	Provided non-sterile, requires decontamination after use, and resterilization by the user facility, similar to predicate systems.
Pneumatic Power	Operates using compressed air or nitrogen. Power is adjustable from 0-950. The range is comparable to the predicate device, Sodem Power System.
Operational Principles	Uses the same operational principles as the cited predicate system.
Safety Device Functionality	The safety device (disengagement of rotational movement of the "cranial perforator attachment" after relevant perforation of the skull) is functional so long as the speed range is respected. The motor falls within the recommended range of operation for "cranial perforator attachments." (Note: this safety device is dependent on the attachment, not the motor itself).

Since no specific study is described in the provided text, the following information cannot be extracted:

Reported device performance: Not available as no study details are provided. The only performance metric mentioned is the power range (0-950), which is stated to be "comparable."
Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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 applicable (this is a medical device, not an AI/imaging device with readers).
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Explanation of the Document's Nature:

This document is a 510(k) summary, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). For this type of submission, extensive new clinical studies or performance testing against specific acceptance criteria with defined outcomes are often not required if substantial equivalence can be demonstrated through comparison to a predicate device already on the market. The core of this 510(k) is the claim of substantial equivalence based on shared fundamental characteristics (intended use, materials, sterility, power, operational principles) with existing predicate devices.

Summary

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DEC 27 1999

510(k) SUMMAR Y FOR SODEM PERFORATOR DRIVE

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1 APPLICANT

sodemsystems Sodem Diffusion SA 110, ch. Du Pont du Centenaire CH-1228 Geneva, Switzerland

Contact Person :	Daniel BACCINO
Tel :	+41 22 794 96 96
Fax :	+41 22 794 45 46
Manufacturing site :	sodemsystemsSodem Diffusion SA110, ch. Du Pont du Centenaire

2 DEVICE NAME

Trade Name :	Sodem Perforator Drive
Classification Name :	Pneumatic Cranial Drill Motor
Common / Usual Name :	Surgical drill

3 PREDICATE DEVICES

The Sodem Perforator Drive claims equivalence to the following systems:

. Sodem Power System ( K935567)
Sodem High Speed System ( K954717) .

CH-1228 Geneva, Switzerland

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510(k) SUMMARY FOR SODEM PERFORATOR DRIVE

4 DEVICE DESCRIPTION

The Sodem Perforator Drive PN 3510 is made out of the combination of 2 components from the Sodem Power System.

the Pneumatic motor currently used as part of the Sodem Power System and a Hudson Adapter.

Sodem is not manufacturing "Cranial Perforator attachment".

The technological characteristics of the Sodem Perforator Drive are similar to the pneumatic handpiece from the Sodem Power System.

The safety device (disengagement of rotational movement of the "cranial perforator attachment"after relevant perforation of skull) is exclusively dependent of this attachment (not the motor).

This safety device is functional so far the speed range is being respected.

The speed range is indicated on the instructions for use of the manufacturer(s) of the "cranial perforator attachments" and our perforator drive motor is falling within recommended range of operation.

5 INTENDED USE

6 BASIS FOR CLAIM OF SUBSTANTIAL EQUIVALENCE

Sodemsystems claims substantial equivalence to other Perforator Motors. This claim is based on equivalence in:

Intended use

The intended use of the Sodem Perforator Drive is identical to that of the Sodem High Speed System as cited above.

Materials

The materials of the Sodem Perforator Drive are not in direct patient contact and similar with the Sodem Power System.

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305 3

510(k) SUMMARY FOR SODEM PERFORATOR DRIVE

Sterility Status

The Sodem Perforator Drive is, like the cited predicate systems, provided non-sterile, require decontamination after use, and resterilzation by the user facility.

Pneumatic power

Systems operate using compressed air or nitrogen. Power to the Sodem Perforator Drive is adjustable from 0-950. Range is comparable for the cited predicate device, Sodem Power System.

Operational Principles

The Sodem Perforator Drive and cited predicate system use the same operational principles.

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Image /page/3/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 resembling a stylized caduceus or a bird-like figure with three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 7 1999

Mr. Daniel Baccino Ouality and Regulatory Affairs Director Sodemsystems Sodem diffusion s.a. 110, ch. du Pont-du-Centenaire CH 1228 Geneva Switzerland

K993851 Re:

Trade Name: Sodem Perforator Drive Regulatory Class: II Product Code: HBB Dated: November 9, 1999 Received: November 12, 1999

Dear Mr. Baccino:

We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Nunc et /ε,,

I. E. Dill. XIII.

James E. Dillard III 86-Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) PREMARKET NOTIFICATION For the Sodem Perforator Drive

Indications for Use Statcment

510(k) Number: K993851

Device Name: Perforator Drive

Indication for Use : The Sodem Perforator Drive is intended for use in neurosurgery.

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Over-The-Counter Use

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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).