(82 days)
The Sodem High Speed motor allows the fixation of spindles, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone (knee, ankle, hand, foot, facial and maxillary bones) for orthopedics and general plastic surgery.
Motor, attachments and cutting tools are for use in general orthopedics and general plastic 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, -
- drills, burs and cutters -
- This 510(k) doesn't deal with the skull perforator motor because we have submitted a separate 510(k) for neuro/spine applications.
The motor is to be attached to the Sodem High Speed console and is 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 text describes a 510(k) submission for the Sodem High Speed System (Electric), focusing on its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets acceptance criteria in the way typically expected for a medical device efficacy or performance study (e.g., clinical trials, algorithm performance testing). Instead, the submission argues for substantial equivalence based on comparisons of intended use, materials, sterility status, system description (console, accessories, electrical power), and speed.
Therefore, a table of acceptance criteria and reported device performance or details of a study structured around those criteria cannot be directly extracted from this document, as the document's purpose is to demonstrate equivalence rather than report on a performance study against specific acceptance metrics.
However, I can extract the information that is present according to your numbered list, acknowledging that many points will be stated as "Not applicable" or "Not provided" given the nature of a 510(k) summary for a high-speed surgical system based on equivalence.
1. A table of acceptance criteria and the reported device performance
This document does not present a table of acceptance criteria and reported device performance for a study in the context of efficacy or clinical outcomes. Instead, it compares the Sodem High Speed System (Electric) to predicate devices based on various technical and operational characteristics to establish substantial equivalence.
The "performance" is demonstrated by showing that the device's technical specifications are comparable to predicate devices. For example:
| Characteristic | Acceptance Criteria (Predicate Devices) | Reported Device Performance (Sodem High Speed System) |
|---|---|---|
| Intended Use | Orthopedics and general plastic surgery (drilling, cutting, sculpting hard tissue and bone) | Orthopedics and general plastic surgery (drilling, cutting, sculpting hard tissue and bone) |
| Patient Contact Materials | Surgical stainless steel | Surgical stainless steel |
| Sterility Status | Non-sterile (except burs/drills), steam sterilizable after reprocessing | Non-sterile (except burs/drills), steam sterilizable after reprocessing |
| Console Connection | Multiple connections for various hand pieces/motors | Two specific connections (one for High Speed Motor, one for Skull Perforator Motor) |
| Accessories | Wide variety (chuck, adapters, spindles, burs), identical or similar technical characteristics | Wide variety (spindles, burs), identical or similar technical characteristics |
| Angled Nose Piece | Linvatec: integral angling capability; Stryker: angled nose | Angled nose |
| Electrical Power Source | Electrical power source controlled by foot pedal | Electrical power source controlled by foot pedal |
| Max Drill Speed (RPM) | Linvatec E9000/Advantage: 0-80,000 rpm; Stryker TPS: 0-75,000 rpm | Adjustable from 0-80,000 rpm |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a 510(k) submission based on substantial equivalence to predicate devices, not an independent performance study with a test set of data. No data provenance or sample size for a test set is provided.
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. This document is a regulatory submission for device clearance, not a study evaluating human performance or diagnostic accuracy where expert ground truth would be established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. 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
Not applicable. This document pertains to a high-speed surgical system, not an AI-assisted diagnostic or interpretive device. No MRMC study, human reader improvement, or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as used in diagnostic or AI studies is not relevant to this 510(k) submission for a surgical instrument. The "truth" in this context is the predicate device's established safety and effectiveness.
8. The sample size for the training set
Not applicable. This document does not describe the development of an algorithm using a training set.
9. How the ground truth for the training set was established
Not applicable. This document does not describe the development of an algorithm using a training set or its associated ground truth.
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510(k) SUMMARY FOR SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDIC & GENERAL PLASTIC SURGERY)
3. PREDICATE DEVICES
The Sodem High Speed System (Electric) claims equivalence to the following systems:
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, -
- drills, burs and cutters -
- This 510(k) doesn't deal with the skull perforator motor because we have submitted a separate 510(k) for neuro/spine applications.
The motor is to be attached to the Sodem High Speed console and is 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).
20/07/01
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510(k) SUMMARY FOR SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDIC & GENERAL PLASTIC SURGERY)
5. INTENDED USE
The Sodem High Speed motor allows the fixation of spindles, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone (knee, ankle, hand, foot, facial and maxillary bones) for orthopedics and general plastic surgery.
Motor, attachments and cutting tools are for use in general orthopedics and general plastic surgery.
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 (orthopedics and general plastic surgery).
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 K94175), 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 connections 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).
20/07/01
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510(k) SUMMARY FOR SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDIC & GENERAL PLASTIC SURGERY)
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.
Some 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 mighting to ability to change burs and spindles without the need for a wrench.
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.
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.
SODEM HIGH SPEED SYSTEM (ELECTRIC) 510(K) (ORTHOPEDIC/PLASTIC SURGERY) 20/07/01
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Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
OCT 22 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carole Burnier Ouality and Regulatory Affairs Manager Sodem Systems 110, ch. du-Pont du-Centenaire CH - 1228 Geneva. Switzerland
Re: K012453
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 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,
Susan Walk, m
Image /page/4/Picture/5 description: The image shows a signature in black ink on a white background. The signature appears to be stylized and cursive, with loops and curves that are difficult to decipher as distinct letters. The overall impression is that of a quick, practiced autograph.
Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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100_ 1 Page_
KO12453 510(k) Number (if known);
SODEM HIGH SPEED SYSTEM (ELECTRIC ) Device Name:
Indications For Use:
The Sodern High Speed motor allows the fixation of spindles, which operate with drills, burs and cutters for drilling, cutting and sculpting hard tissue and bone (knee, ankle, hand, foot, facial and maxillary bones) for orthopedics and general plastic surgery.
Motor, attachments and cutting tools are for use in general orthopedics and general plastic surgery.
(PLEASE DO NOT WRITE BELOW THIS I.INE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Use
(Optional Format 1-2-96)
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(Division Sign-Off) Division of General, Restorative and Neurological Devices
³ 510(k) Number K01245
§ 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).