(82 days)
The Sodem High Speed motor allows the fixation of spindles and craniotomes, which opcrate with drills, burs and cutters for drilling, cutting and sculpting the cranial and spinal bones.
The Sodom High Speed System (Electric) includes a skull perforator motor, which powers a cranial perforation attachment and allows skull perforation. The System does not include the cranial perforation attachment. The safety of the skull perforation depends exclusively on the safety of the cranial perforation attachment, which is neither manufactured nor sold by Sodcm, but is available on the market from other manufacturers.
Both motors, attachments and cutting tools are for use in neurosurgery, as well craniotomy as spinal surgery.
The Sodem High Speed System (Electric) is a complete system including:
- two motors (a Skull Perforator motor and a High Speed motor), -
- a foot pedal, -
- a console allowing to connect the motors and to select their max. operating speed, -
- dedicated wires to connect the motors, the foot pedal and the console -
- attachments/spindles and craniotomes -
- drills, burs and cutters -
The motors are to be attached to the Sodem High Speed console and are operated with a foot pedal.
The Sodem High Speed System (Electric) is an electrical system developed in conformity with the norms IEC 60601 and UL 2601.
The provided document is a 510(k) premarket notification for a medical device, the Sodem High Speed System (Electric). It focuses on establishing substantial equivalence to predicate devices already on the market, rather than delineating specific acceptance criteria and detailed study results to prove device performance against those criteria.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in this document.
Here is a summary of what can be gleaned from the document regarding the device's characteristics and the basis for its clearance:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with specific numerical performance targets (e.g., accuracy, precision, speed, torque) or a comparison of the device's measured performance against such targets.
Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices. The performance characteristics of the Sodem High Speed System (Electric) are described in comparison to the predicates in terms of:
| Characteristic | Sodem High Speed System (Electric) | Predicate Devices (Stryker TPS, Linvatec E9000/Advantage) | Equivalence Justification/Performance Statement |
|---|---|---|---|
| Intended Use | Neurosurgery (cranio & spinal) | Same clinical applications and intended use (neurosurgery - spine and craniotomy) | Equivalent - "share the same clinical applications and intended used" |
| Materials | Surgical stainless steel | Patient contact materials consist of surgical stainless steel | Equivalent - "Patient contact materials for all systems consist of surgical stainless steel." |
| Sterility Status | Non-sterile (except burs/drills) | Supplied non-sterile (except burs/drills), requiring reprocessing. Sterilization by steam. | Equivalent - "All systems are supplied non-sterile...requiring reprocessing...Sterilization...using steam." |
| Console | Two specific connections | Multiple connections (e.g., Linvatec E9000 one for 14 hand pieces, Stryker TPS 3 for ~10 hand pieces) | Similar - All operated using electrical power console, allow motor selection, speed choice. Difference: Sodem has two specific connections, not interchangeable. (Considered minor difference) |
| Accessories | Chuck, adapters, spindles, burs | Wide variety of accessories: chuck, adapters, spindles, burs. Angled nose pieces (Stryker & Sodem), integral angling (Linvatec) | Similar - "All offer a wide variety of accessories..." "technical characteristics...identical or similar." "All hand pieces are designed with a terminal angle." |
| Electrical Power | Foot pedal controlled | Foot pedal controlled | Equivalent - "All cited systems are operated using an electrical power source controlled by a foot pedal." |
| Nominal Power Output | Identical or substantially equivalent | Commercially available electrical motors (Linvatec, Stryker) | Equivalent - "The nominal power output...is identical or substantially equivalent" |
| Max. Drill Speed (High Speed Motor) | Adjustable 0-80,000 rpm | Linvatec E9000/Advantage: 0-80,000 rpm; Stryker TPS: 0-75,000 rpm | Equivalent/Similar - Within comparable range of predicate devices. |
| Max. Drill Speed (Skull Perforator Motor) | Fixed 800 rpm | Linvatec: Fixed 800 rpm | Equivalent - "The skull perforator motors of Sodem and Linvatec have maximum and fixed speed of 800 rpm." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a specific "test set" or data provenance in the context of a performance study with patient data or human subjects. The basis for substantial equivalence is a comparison of technical specifications and intended use against existing cleared devices, not a clinical trial with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As noted above, there was no "test set" requiring ground truth established by experts in the context of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set was used for this type of performance 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 or therapeutic device. Therefore, MRMC studies and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth as typically understood for diagnostic or AI devices is not relevant to this submission. The "truth" for substantial equivalence lies in the established safety and efficacy of the predicate devices based on their specifications and market history.
8. The sample size for the training set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
In summary: This 510(k) submission is for a traditional medical device (a surgical drill) and relies on demonstrating substantial equivalence to predicate devices. It does not involve the type of acceptance criteria, performance studies, test/training sets, or expert evaluations that would be typical for more complex diagnostic or AI-powered devices. The "study" that proves the device meets the (implied) acceptance criteria is the comparison of its design, materials, intended use, and technical specifications with already legally marketed devices. The FDA's clearance letter confirms that this comparison was deemed sufficient to establish substantial equivalence.
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OCT 22 2001
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:
20/07/01
2. DEVICE NAME
| Classification Name: | - Motor drill electric- Drills, burs, trephines and accessories (simple powered) |
|---|---|
| Proprietary Name: | Sodem High Speed System (Electric) |
| Common Name: | Powered Surgical Drill |
3. PREDICATE DEVICES
The Sodem High Speed System (Electric) claims equivalence to the following systems:
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4. DEVICE DESCRIPTION
The Sodem High Speed System (Electric) is a complete system including:
- two motors (a Skull Perforator motor and a High Speed motor), -
- a foot pedal, -
- a console allowing to connect the motors and to select their max. operating speed, -
- dedicated wires to connect the motors, the foot pedal and the console -
- attachments/spindles and craniotomes -
- drills, burs and cutters -
The motors are to be attached to the Sodem High Speed console and are operated with a foot pedal.
The Sodem High Speed System (Electric) is an electrical system developed in conformity with the norms IEC 60601 and UL 2601.
The Sodem High Speed System (Electric) is very similar in terms of use and technological characteristics to products currently on the market (TPS from Stryker and E9000 / Advantage from Linvatec).
Also, the Sodem High Speed System (Electric) is equivalent in terms of use with the Sodem High Speed System (Pneumatic) already submitted (K954717). The skull perforator motor has the same use than the Sodem Perforator Drive also already submitted (K993851).
5. INTENDED USE
The Sodem High Speed motor allows the fixation of spindles and craniotomes, which operate with drills, burs and cutters for drilling, cutting and sculpting the cranial and spinal bones.
The Sodem High Speed System (Electric) includes a skull perforator motor, which powers a cranial perforation attachment and allows skull perforation. The System does not include the cranial perforation attachment. The safety of the skull perforation depends exclusively on the safety of the cranial perforation attachment, which is neither manufactured nor sold by Sodem, but is available on the market from other manufacturers.
Both motors, attachments and cutting tools are for use in neurosurgery, as well craniotomy as spinal surgery.
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6. BASIS FOR CLAIM OF SUBSTANTIAL EQUIVALENCE
The Sodem High Speed System (Electric) claims substantial equivalence to other currently marketed high-speed electric power systems. This claim is based on equivalence in:
Intended use
The Sodem High Speed System (Electric) and predicate electric instruments share the same clinical applications and intended used (neurosurgery [spine and craniotomy]).
Materials
Patient contact materials for all systems consist of surgical stainless steel.
Sterility Status
All systems are supplied non-sterile except burs and drills (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
Console ।
All cited systems are operated using an electrical power console. Console allows to select motors and to choose operating speed. All console provide one or more connection for several hand pieces/motors (ex E9000 of Linvatec one connection for 14 hand pieces, TPS of Stryker 3 connection for approximately 10 hand pieces). Difference between Sodem console and other currently marketed consoles is that Sodem console has two specific connection (one for High Speed Motor, and one for Skull Perforator Motor, an inversion is not possible).
Accessories
The Sodem High Speed System (Electric) 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 hand pieces are designed with a terminal angle (nose piece). The Sodem and Stryker systems have an angled nose. The Linvatec E9000 / Advantage systems have an integral angling capability from straight to 20 degrees with a twist of the collet. All systems feature to ability to change burs and spindles without the need for a wrench.
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Electrical power
All cited systems are operated using an electrical power source controlled by a foot pedal. For all systems, users can choose maximum operating speed on the console and with the foot pedal increase or reduce speed until maximum speed selected.
The nominal power output of the Sodem High Speed System is identical or substantially equivalent to the other commercially available electrical motors (Linvatec, Stryker). The maximum drill speed of the Sodem High Speed System (Electric) is adjustable with the console from 0-80'000 rpm, the drill speed of the E9000 / Advantage system of Linvatec is adjustable with the console from 0-80'000 rpm, the drill speed of the TPS of Stryker is adjustable with the console from 0-75'000 rpm. The skull perforator motors of Sodem and Linvatec have maximum and fixed speed of 800 rpm.
Based on the above comparison, SodemSystems believes that the Sodem High Speed System (Electric) is substantially equivalent to the systems cited, that any differences between the Sodem High Speed System (Electric) 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 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 a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
OCT 22 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carole Burnier Quality and Regulatory Affairs Manager Sodem Systems 110, ch. du-Pont du-Centenaire CH - 1228 Geneva, Switzerland
Re: K012457 Trade Name: Sodem Systems Regulation Number: 882.4360, 882.4310 Regulation Name: Electric Cranial Drill Motor, Powered Simple Cranial Drills, Burrs, Trephines and Accessories Regulatory Class: Class II Product Code: HBC, HBE Dated: July 27, 2001 Received: August 1, 2001
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 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.
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Page 2 - Ms. Carole Burnier
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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 nate 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 fire number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, us
Image /page/5/Picture/5 description: The image shows a black and white close-up of a handwritten letter. The letter appears to be a cursive lowercase 'h'. The letter is slightly tilted to the left.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Celia M. Witten, Ph.D., MD
Enclosure
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1 of 1 Page
| 510(k) Number (if known): | K012457 |
|---|---|
| --------------------------- | --------- |
SODEM HIGH SPEED SYSTEM (ELECTRIC ) Device Name:
Indications For Use:
The Sodem High Speed motor allows the fixation of spindles and craniotomes, which opcrate with drills, burs and cutters for drilling, cutting and sculpting the cranial and spinal bones.
The Sodom High Speed System (Electric) includes a skull perforator motor, which powers a cranial perforation attachment and allows skull perforation. The System does not include the cranial perforation attachment. The safety of the skull perforation depends exclusively on the safety of the cranial perforation attachment, which is neither manufactured nor sold by Sodcm, but is available on the market from other manufacturers.
Both motors, attachments and cutting tools are for use in neurosurgery, as well craniotomy as spinal surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prcscription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
Neurological Devices
510(k) Number 20124
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).