(87 days)
Not Found
No
The description focuses on mechanical and electrical components for driving surgical blades and abraders. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
No.
The device is used for surgical procedures to remove tissue and bone, which are interventional actions rather than therapeutic in the sense of treating a disease or condition for alleviation or cure through non-invasive means. It is a surgical tool.
No
The Riwo Drive System is an surgical instrument used for removing tissue or abrading bone during arthroscopic and sinus procedures. It does not provide any diagnostic information.
No
The device description clearly outlines hardware components such as a generator, motor handle, footswitch, suction pump, and rotary blades/abraders. It also mentions testing according to hardware standards (IEC, UL).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Riwo Drive System is a surgical tool used for mechanical procedures within the body (arthroscopic procedures in joints and sinus procedures). It physically removes tissue and bone using blades and abraders.
- Lack of Biological Sample Analysis: The description does not mention the analysis of any biological samples. The device's function is purely mechanical and surgical.
Therefore, the Riwo Drive System falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Riwo Drive System is used for arthroscopic procedures in human joints. It is also used for sinus procedures in the nasal cavity.
The Riwo Drive generator with motor handle serves to drive WOLF blades or abraders.
Depending on the indication, different styles of blades are attached to the motor handle. Two basic styles are most common:
-
- Blades are for removal of soft tissue and cartilage
-
- Abraders for bones and bony structures
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The RIWO Drive Generator is build to efficiently drive and control different motor handles. The handle functions are controlled by a footswitch.
The Motor Handle is a tubular system with a motor and clamping chuck for driving rotary blades and abraders. A suction pump is connected to the built-in suction tube and the suction stream can be controlled by a valve.
The rotary blades consist of a hollow, fenestrated tube, containing a rotating two-edged cylindrical blade or an abrader that spins within the hollow tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human joints, nasal cavity (sinus)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The use of the system is reserved to surgeons with special training in the respective procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Riwo Drive Generator 2302 with Footswitch 2030.221 and with the Motor handles 8561.121 and 8562.111 were tested according to the specified standards IEC601-1, IEC601-1-2 and UL2601-1. A life-cycle test shows that the function of the motor handle can be guarantied for more than 200 steam sterilization cycles when using the fractional method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
970088
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
510(k) Summary of Safety and Effectiveness
| Date of Preparation: | December 28, 1996 |
|---|---|
| FDA establishment registration number: | 14 184 79 |
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Phone number (include area code): | (847 ) 913-1113 |
| Street address: | 353 Corporate Woods Parkway |
| FAX number (include area code): | (847 ) 913-0924 |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
Product Information:
| Trade name: | Riwo Drive Generator and Accessories |
|---|---|
| Model number: | 2302, motor handle 8561.121 and various rotary blades and abraders (see section 1: Submitted devices) |
| Common name: | Drive Generator |
| Classification name: | Instrument, surgical, orthopedic, DC-powerded motor and accessory/attachment |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 K871250 | 1 Intra-articulated arthro power system 2161 | 1 Richard Wolf M.I.C. |
| 2 | 2 Surgical Drive System EP-1 | 2 Dyonics |
| 3 | 3 Shaver System SE 5 | 3 Stryker |
| 4 | 4 Drive System Apex | 4 Linvatec |
1.0 Description
The RIWO Drive Generator is build to efficiently drive and control different motor handles. The handle functions are controlled by a footswitch.
The Motor Handle is a tubular system with a motor and clamping chuck for driving rotary blades and abraders. A suction pump is connected to the built-in suction tube and the suction stream can be controlled by a valve.
The rotary blades consist of a hollow, fenestrated tube, containing a rotating two-edged cylindrical blade or an abrader that spins within the hollow tube.
Image /page/0/Figure/10 description: The image shows the logo for Richard Wolf. The logo consists of the name "RICHARD WOLF" in bold, block letters. To the right of the name is a square containing a stylized image that resembles a wolf's head or a geometric design. The overall design is simple and modern, with a focus on the company name and a distinctive symbol.
1
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
2.0 Intended Use
The Riwo Drive System is used for arthroscopic procedures in human joints. It is also used for sinus procedures in the nasal cavity.
The Riwo Drive generator with motor handle serves to drive WOLF blades or abraders.
Depending on the indication, different styles of blades are attached to the motor handle. Two basic styles are most common:
-
- Blades are for removal of soft tissue and cartilage
-
- Abraders for bones and bony structures
The use of the system is reserved to surgeons with special training in the respective procedures.
Technological Characteristics 3.0 Riwo Drive Generator:
- Four user specified, selectable settings for the speed .
- continuous digital display of desired and actual speed .
- automatic adaptation of speed range and maximal torque (current) for three different motor . handles, display of speed range with LED
- acoustic and optical alarm for: overload of motor, incorrect cable connection or interrupted cable .
- footswitch to control motion forward, reverse, oscillation (3 changes per second), speed and speed . range by the surgeon, automatically stored.
Motor handle:
- 360° rotation of clamping chuck for various cutting position .
- variable suction control with one-hand operation ●
- . watertight housing and cable, for steam sterilization
- t lightweight design
- detachable cable .
- t BF insulation according to IEC601-1
Rotary Blades and Abraders:
- atraumatic design .
- . colored coding
- sterile, for single use .
- . various diameters and tip designs
4.0 Substantial Equivalence
The submitted devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf and 510(k) devices sold by Storz.
Image /page/1/Picture/29 description: The image shows the logo for Richard Wolf. The words "RICHARD WOLF" are stacked on top of each other, with "RICHARD" in a smaller font than "WOLF". To the right of the words is a square with rounded corners, inside of which is a stylized image that looks like the letters "A" and "H" connected together.
(Revised 3/11/97)
2
Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
Performance Data 5.0
The Riwo Drive Generator 2302 with Footswitch 2030.221 and with the Motor handles 8561.121 and 8562.111 were tested according to the specified standards IEC601-1, IEC601-1-2 and UL2601-1. A life-cycle test shows that the function of the motor handle can be guarantied for more than 200 steam sterilization cycles when using the fractional method.
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the Instruction manual.
By: Robert J. Casan
Robert L. Casarsa Quality Assurance Manager
Date: 1or 8, 97
Image /page/2/Picture/11 description: The image shows the logo for Richard Wolf. The text "RICHARD WOLF" is displayed in a bold, sans-serif font, with "RICHARD" stacked above "WOLF". To the right of the text is a square-shaped emblem containing a stylized drawing of a wolf's head. The wolf's head is drawn with simple lines and geometric shapes.