The Sodem High Speed System includes a pneumatic motor which allows the fixation of spindles, adapters and attachments, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone for different applications and surgeries.

The system is intended for use in Ear Nose and Throat (plastic reconstructive surgery) applications.

Device Description

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 ... ) used to cut hard tissue or bone.

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

a High Speed motor, -
a foot pedal,
dedicated hoses to connect the motors and the foot pedal, -
adapters (angled adapter)
attachments/spindles, (angled attachments, straight attachments standard and tapered, craniotomes)
drills, burs and cutters

AI/ML Overview

The Sodem High Speed System (Pneumatic) is a surgical instrument motor and accessories intended for use in Ear, Nose, and Throat (plastic reconstructive surgery) applications. It is designed to drill, cut, and sculpt hard tissue and bone.

Here's an analysis of its acceptance criteria and the study proving it meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are based on demonstrating substantial equivalence to predicate devices, specifically the Anspach Black Max/Micromax systems. The "reported device performance" in this context refers to the characteristics and specifications of the Sodem High Speed System Pneumatic) itself, which are compared against the predicate.

Feature/Acceptance Criteria (Predicate)	Reported Device Performance (Sodem High Speed System)
Used in ENT surgery	Yes
Pneumatic power source	Yes
Drill Function	Yes
Supplied non sterile (except burs)	Yes (except burs)
Recommended sterilization by steam	Yes
Patient contact materials: Principally surgical stainless steel	Yes (Surgical stainless steel and titanium (Ti 6-Al 4-V))
Angled nose piece	Yes
Foot pedal	Yes
Spindles multiple length	Yes
Change burs without wrench	Yes
Change spindles without wrench	Yes
Motor speed (RPM)	0-85'000 rpm
Rotation mode	Forward only

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

This submission is a 510(k) Pre-Market Notification based on substantial equivalence, not a clinical trial evaluating device performance with patient data. Therefore, there is no "test set" in the traditional sense (i.e., a set of patient cases or samples) for which data provenance or geographic origin would apply. The "test" consists of a comparison of the device's technical specifications and intended use against legally marketed predicate devices.

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

As this is a substantial equivalence submission, no external experts were used to establish ground truth for a test set in the way one would for evaluating diagnostic accuracy or clinical outcomes. The "ground truth" is established by the detailed technical specifications and intended uses of the predicate devices already cleared by the FDA. The FDA reviewers (Office of Device Evaluation, Center for Devices and Radiological Health) act as the authoritative body in determining if the comparison demonstrates substantial equivalence.

4. Adjudication method for the test set

Not applicable. There was no test set requiring expert adjudication. The determination of substantial equivalence was made by the FDA's Office of Device Evaluation.

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

Not applicable. This device is a powered surgical drill, not an AI-assisted diagnostic tool or imaging system. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

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

Not applicable. This device is a mechanical surgical instrument, not an algorithm.

7. The type of ground truth used

The "ground truth" is the technical specifications, intended use, and performance characteristics of the legally marketed predicate devices (Anspach Black Max/Micromax System and others). The applicant compared their device's attributes against these established products to demonstrate substantial equivalence.

8. The sample size for the training set

Not applicable. This is a conventional medical device, not an AI/ML-driven device that requires a training set.

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

Not applicable. No training set was used.

Summary

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K023070

1. COMPANY NAME AND ADDRESS

Applicant:	SodemsystemsSodem Diffusion SA110, Ch. du Pont-du-CentenaireCH-1228 Geneva, Switzerland
Contact Person:	Carole BURNIER
Tel:	+41 22 794 96 96
Fax:	+41 22 794 45 46
Manufacturing site:	SodemsystemsSodem Diffusion SA110, Ch. du Pont-du-CentenaireCH-1228 Geneva, Switzerland
Date:	09/10/02

2. DEVICE NAME

Classification Name:	Surgical instrument motors and accessories/attach nentpneumatically powered
Proprietary Name:	Sodem High Speed System (Pneumatic)
Common Name:	Powered Surgical Drill

3. PREDICATE DEVICES

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

SODEM HIGH SPEED SYSTEM (PNEUMATIC) INCLUDING THE DRILL GUIDE ATTACHMENT 510(K)

APPENDIX F 1/4

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4. DEVICE DESCRIPTION

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

a High Speed motor, -
a foot pedal,
dedicated hoses to connect the motors and the foot pedal, -
adapters (angled adapter)
attachments/spindles, (angled attachments, straight attachments standard and ﮮ tapered, craniotomes)
drills, burs and cutters

The Sodem High Speed System (Pneumatic) for use in ENT applications is the same product as the Sodem High Speed System (Pneumatic) already cleared for Neurology, Orthopedic and General plastic surgery (K954717, K954080, K955174).

5. INTENDED USE

The Sodem High Speed motor allows the fixation of spindles, adapters and attachments, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone for different applications and surgeries.

The system is intended for use in Ear Nose and Throat (plastic reconstructive surgery applications.

6. BASIS FOR CLAIM OF SUBSTANTIAL EQUIVALENCE

The Sodem High Speed System (Pneumatic) claims substantial equivaler ce to other currently marketed high-speed Pneumatic power systems. This device is s ibstantially equivalent to Anspach Black Max/ Micromax System (see the attached table of comparison)

SODEM HIGH SPEED SYSTEM (PNEUMATIC) INCLUDING THE DRILL GUIDE ATTACHMENT 510(K)

APPENDIX F 2/4

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: .

	SodemHigh Speed System(Pneumatic)	AnspachBlack Max/Micromax
510(k) Number	current submission	K960630 / K965080
Used in ENT surgery	Yes	Yes
Pneumatic power source	Yes	Yes
Drill Function	Yes	Yes
Supplied non sterile	Yes (except burs)	Yes
Recommended sterilization by steam	Yes	Yes
Patient contact materials:Principally surgical stainless steel	Yesand titaniumsee § 7.3	Yes
Angled nose piece	Yes	Yes
Foot pedal	Yes	Yes
Spindles multiple length	Yes	Yes
Change burs without wrench	Yes	Yes
Change spindles without wrench	Yes	Yes
Motor speed (RPM)	0-85'000 rpm	0-80'000' rpm
Rotation mode	Forward only	Forward/Reverse

Intended use

The Sodem High Speed System (Pneumatic) and predicate Pneumatic instruments share the same clinical applications and intended used (For Anspach and Linvatec: Ear, nose and throat surgery [Plastic reconstructive surgery]).

Materials

Patient contact materials for all systems consist of surgical materials and principally surgical stainless steel. We use also Titanium Ti 6-Al 4-V for specific spindles. This titanium has a common use in prosthetic implants (ISO 5832-3).

SODEM HIGH SPEED SYSTEM (PNEUMATIC) INCLUDING THE DRILL GUIDE ATTACHMENT 210(K)

APPENDIX F 3/4

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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 controlle 1 by a foot pedal. For all systems, users can increase or reduce speed with a foot pedal.

The nominal power output of the Sodem High Speed System is identical or substantially equivalent to the other commercially available pneumstic motors (Linvatec, Anspach). The drill speed of the Sodem High Speed Systern (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 consis 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 products (Sodem, Linvatec and Anspach) have an angled nose.

All systems feature to ability to change burs and spindles without a need of a wrench.

Some systems have a specific attachment for making hole in 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 Sodem High Speed System (Pneumatic) including the Drill Guide Attachment is substantially equivalent to the systems cited, that any differences between the Sodem High Speed System (Pneumatic) and these other currently available powered systems are minur and raise no new issues of safety and effectiveness.

SODEM HIGH SPEED SYSTEM (PNEUMATIC) INCLUDING THE DRILL GUIDE ATTACHMENT 210(K)

APPENDIX F 4/4

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 8 2003

Sodemsystems c/o Carole Burnier Ouality & Regulatory Affairs Manager Sodem diffusion sa 110. ch. du Pont-du-Centenaire CH - 1228 Geneva Switzerland

Re: K023070

Trade/Device Name: Sodem High Speed System (Pneumatic) Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: December 12, 2002 Received: December 12, 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 reguirements for annual registration. Iisting 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

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Page 2 - Carole Burnier

forth in the 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) 594-4692. 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,
A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Page l of

510(k) Number (if known) : K 023070

Device Name : SODEM HIGH SPEED SYSTEM (PNEUMATIC)_

Indications For Use:

The system is intended for use in Ear Nose and Throat (plastic reconstructive surgery) applications.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-The Counter Use (optional Format 1-2-96)

Anabole

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devis

510(k) Number K023070

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.