(51 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 for ear, nose and throat surgery.
Motor, attachments and cutting tools are for use in ear, nose and throat 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, -
- ー. attachments/spindles,
- drills, burs and cutters -
- A separate 510(k) Premarket Notification has been submitted for neurolspine surgery, so on this 510(k) submission, we will cover only the High Speed Motor and its use in ear, nose and throat surgery.
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).
The provided text is a 510(k) Summary for the Sodem High Speed System (Electric) and a subsequent FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria, efficacy studies, or specific performance metrics demonstrating that the device meets acceptance criteria.
The FDA clearance is based on the device being "substantially equivalent" to predicate devices already on the market (TPS from Stryker and E9000/Advantage from Linvatec). This means the manufacturer argued that their new device is as safe and effective as the existing devices, primarily by comparing their intended use, materials, sterility, system description (console, accessories), and electrical power characteristics.
Therefore, I cannot provide the requested information. The document explicitly states:
- No acceptance criteria are listed.
- No studies proving the device meets acceptance criteria are described.
- No sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance data, or ground truth details are present.
The crucial comparison points for substantial equivalence are highlighted in section 6 and confirm similarities in:
- Intended use: Both Sodem and predicate devices are for ear, nose, and throat surgery for drilling, cutting, and sculpting hard tissue and bone.
- Materials: All patient contact materials are surgical stainless steel.
- Sterility Status: All are supplied non-sterile (except specific drills/burs with their own 510k) and require steam sterilization after use.
- System Description (Console, Accessories, Electrical Power):
- Consoles connect motors and select speed, with similar functionalities.
- Accessories like chucks, adapters, spindles, and burs are comparable.
- The nominal power output is "identical or substantially equivalent."
- The maximum drill speed is within a similar range (Sodem: 0-80,000 rpm; Linvatec: 0-80,000 rpm; Stryker: 0-75,000 rpm).
The manufacturer's conclusion is 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."
In summary, the provided text does not contain the information requested regarding acceptance criteria and performance study details because the clearance was based on substantial equivalence, not on specific performance data against predefined acceptance criteria for a new clinical efficacy claim.
§ 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.