The Drill Guide Attachment of the Sodem High Speed System allows to make holes in adjustable depth and operate with drills and cutters in different applications and surgeries.

This attachment is intended for use in Neurology (spine and craniotomy), General Plastic surgery (median sternotomy) and Orthopedic (revision implant surgery, extremity: hand, foot ... ) applications.

Device Description

The Drill Guide Attachment PN 3105 DG is used with different elements of the Sodem High Speed System (Pneumatic).

The Sodem High Speed System is a modular pneumatically powered high speed instrument system consisting of a hand piece, adapters and accessories/attachments (spindles, burs ... ) and especially Drill Guide Attachment used to make holes in the bone with an adjustable depth.

The Sodem High Speed System (Pneumatic) is a complete system including:

a High Speed motor, .
. a foot pedal,
dedicated hoses to connect the motor and the foot pedal, -
adapters (angled adapter)
Drill Guide Attachment PN 3105 DG (other attachments/spindles already submitted exist as angled attachments, straight attachments standard and tapered, craniotomes)
drills, burs and cutters -

The Sodem High Speed System (Pneumatic) for use in Neurology applications is the same product as the Sodem High Speed System (Pneumatic) already submitted for Neurology, Orthopedic and General plastic surgery (K954717, K954080, K955174) and currently submitted for ENT and Dental surgery. The difference is the addition of a new attachment PN 3105 DG : Drill Guide Attachment.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device, the "Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic)." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study demonstrating the device meets specific acceptance criteria through a clinical trial or performance study with detailed metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and comparative effectiveness studies is not present in this document. The 510(k) process relies on demonstrating that the new device is as safe and effective as a predicate device, primarily through comparison of intended use, technological characteristics, and materials.

Here's a breakdown of why each specific point cannot be addressed from the provided text:

A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria for the Drill Guide Attachment in the way a clinical trial would. Its performance is implicitly deemed acceptable if it is substantially equivalent to the predicate device.
Sample sized used for the test set and the data provenance: No test set or associated data provenance (country of origin, retrospective/prospective) is mentioned, as this is not a clinical study report.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no "test set" and thus no ground truth established by experts within this document. The FDA reviews the submission for substantial equivalence.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no test set or adjudication process described.
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: This device is a surgical drill attachment, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or included.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical surgical instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): No "ground truth" as typically defined in diagnostic studies is used here. The basis for acceptance is substantial equivalence to a predicate device in terms of intended use, materials, and technological characteristics.
The sample size for the training set: Not applicable, as this is not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set mentioned or required for this type of device submission.

In summary, the provided document demonstrates substantial equivalence, not performance against specific acceptance criteria through empirical study results. The "study" in this context is the FDA's review of the comparison between the new device and predicate devices.

Summary

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023066

1. COMPANY NAME AND ADDRESS

Sodemsystems Sodem Diffusion SA Applicant: 110, Ch. du Pont-du-Centenaire CH-1228 Geneva, Switzerland Carole BURNIER Contact Person: +41 22 794 96 96 Tel: +41 22 794 45 46 Fax: Sodemsystems Sodem Diffusion SA Manufacturing site: 110, Ch. du Pont-du-Centenaire CH-1228 Geneva, Switzerland

Date:

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2. DEVICE NAME

Classification Name:	Surgical instrument motors and accessories/attachmentpneumatically powered
Proprietary Name:	Drill Guide Attachment (PN 3105 DG)of the Sodem High Speed System (Pneumatic)
Common Name:	Powered Surgical Drill

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3. PREDICATE DEVICES

The Drill Guide Attachment and the Sodem High Speed System (Pneumatic) are very similar in terms of use and technological characteristics to products currently on the market (Anspach Black max / Micromax).

4. DEVICE DESCRIPTION

The Drill Guide Attachment PN 3105 DG is used with different elements of the Sodem High Speed System (Pneumatic).

The Sodem High Speed System (Pneumatic) is a complete system including:

a High Speed motor, .
. a foot pedal,
dedicated hoses to connect the motor and the foot pedal, -
adapters (angled adapter)
Drill Guide Attachment PN 3105 DG (other attachments/spindles already submitted exist as angled attachments, straight attachments standard and tapered, craniotomes)
drills, burs and cutters -

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5. INTENDED USE

The Drill Guide Attachment of the Sodem High Speed System allows to make holes in adjustable depth and operate with drills and cutters in different applications and surgeries.

6. BASIS FOR CLAIM OF SUBSTANTIAL EQUIVALENCE

The Drill Guide Attachment and the Sodem High Speed System (Pneumatic) claims substantial equivalence to other currently marketed high-speed Pneumatic power systems. This claim is based on equivalence in:

Intended use

The Sodem High Speed System (Pneumatic) including the Drill Guide Attachment and predicate Pneumatic instruments share the same clinical applications and intended used [Neurology].

Materials

Patient contact materials for all systems consist of surgical stainless steel.

Sterility Status

All systems are supplied non-sterile except drills and burs (special 510k Nº K994175 for sterile drills and burs), requiring reprocessing between surgical applications. Sterilization of all systems is accomplished using steam. All systems require decontamination after use, and resterilization by the user facility.

System Description

Motor

All cited systems are operated using a pneumatic power source controlled by a foot pedal. For all systems, users can increase or reduce speed with foot pedal.

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The nominal power output of the Sodem High Speed System is identical or substantially equivalent to the other commercially available pneumatic motors (Anspach). The drill speed of the Sodem High Speed System (Pneumatic) is adjustable from 0-85'000 rpm, the drill speed of the Anspach motors system is adjustable from 0-80'000 rpm.

Accessories

The Sodem High Speed System (Pneumatic) and predicate systems consist of various attachments (burs, spindles). All offer a wide variety of accessories including but not limited to chuck, adapters, spindles and burs. The technical characteristics of the various adapters are identical or similar. That is, adapters allow the use of hand pieces with various power system accessories.

All Systems have a specific attachment for making hole in the bone with adjustable depth. The Sodem High Speed System has this kind of attachment (PN 3105DG : Drill Guide Attachment), Anspach Micromax / Black Max Systems have two attachments called Adjustable drill guide and Controlled Depth attachment.

Based on the above comparison, SodemSystems believes that the Drill Guide Attachment of the Sodem High Speed System (Pneumatic) is substantially equivalent to the systems cited. that any differences between the Sodem High Speed System (Pneumatic) including Drill Guide Attachment and these other currently available powered systems are minor and raise no new issues of safety and effectiveness.

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Image /page/4/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the perimeter of the circle.

NOV 2 5 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sodem Systems Carole Burnier Quality and Regulatory Affairs Manager 110. ch. du Pont-du-Centenaire CH - 1228 Geneva Switzerland

Re: K023066

Trade/Device Name: Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System Regulation Number: 882.4370 Regulation Name: Powered surgical drill Regulatory Class: Class II Product Code: HBB Dated: September 10, 2002 Received: September 16, 2002

Dear Ms. Burnier:

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 set forth in the

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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. 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 (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,

iriam C. Provost

for Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) PREMARKET NOTIFICATION FOR SODEMSYSTEMS DRILL GUIDE ATTACHMENT PN 3105 DG SODEM HIGH SPEED SYSTEM (PNEUMATIC) (NEUROLOGY)

7.1 Intended Use

The Drill Guide Attachment of the Sodem High Speed System allows to make holes in adjustable depth and operate with drills and cutters in different applications and surgeries.

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

K623066

DRILL GUIDE ATTACHMENT PN 3105 DG SODEM HIGH SPEED SYSTEM (PNEUMATIC) 510(K)

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).