(86 days)
Not Found
No
The description focuses on mechanical components (motor, blades, suction, irrigation) and control via a footswitch. There is no mention of AI/ML terms, image processing, or data-driven decision making.
Yes
The device is used "for therapy with endoscopic accessories" to remove pathological tissue and perform other surgical procedures, which are considered therapeutic actions.
No
The device is described as being used for the "removal of pathological tissue during endoscopic interventions" and "therapy with endoscopic accessories," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines hardware components such as a generator, motor handles, suction/irrigation adapters, and a footswitch. It is a system that includes physical hardware for driving rotary blades and abraders.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions." This is a surgical procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a surgical tool with a motor, handle, and suction/irrigation capabilities. This aligns with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information. The device's function is purely mechanical tissue removal.
- Anatomical Site: The listed anatomical sites (arthroscopy, thoracic, sinus, spine) are all surgical intervention sites.
- Intended User: The intended user is a "surgeon," which is consistent with a surgical device.
In vitro diagnostics are tests performed on samples taken from the body to diagnose diseases or conditions. This device is used for surgical treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The RIWO Drive with small motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions.
Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation.
Indications and Fields of Application:
For therapy with endoscopic accessories:
- · in arthroscopy, e.g. for meniscus resection, removal of soft tissue, as well as intra-articular severing or abrasion of osseous tissue, e.g. ACL or shoulder procedures.
- thoracic surgery, e.g. for removing hematomas .
- sinus surgery (ENT), e.g. for removing polyps or cysts.In cases, bone structures are . removed or trimmed.
- spine surgery (arthroscopic micro disectomy (AMD), spinal endoscopsy) e.g. removal of . pathological tissue.
Product codes (comma separated list FDA assigned to the subject device)
77 EQL, 79 GEY
Device Description
The RIWO Drive Generator is designed to efficiently drive and control different motor handles. The handle functions are controlled by a footswitch.
The motor handle is a tubular system. The modular system consists of:
- motor unit
- · motor housing
- · suction adapter (8563.111) And/Or suction /irrigation adapter (8563.311)
The suction and irrigation stream are controlled by slide valves. The motor handle is connected to the RIWO Drive 2302 by a removable cable.
RIWO Drive Generator
- four speed settings, user selected .
- continuous digital display of selected and true speed .
- automatic adaptation of speed range and maximum torque (current) for three different . motor handles, display of speed range with LED
- . acoustic and optical alarm for, 1) motor overload, 2) incorrect cable connection or interrupted cable
- footswitch, operated by surgeon, to control motion forward, reverse, oscillation (3 changes . per second), speed and speed range automatically stored.
Motor Handle
.
- 360° rotation of clamping chuck for various cutting positions (8561.121 and 8562.111) .
- modular construction (8563.111/.311) .
- variable irrigation control with one-hand operation (8563.331) .
- watertight housing and motor unit, for steam sterilization .
- . lightweight design
- . detachable cable
- . BF insulation according to IEC601-1
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arthroscopy (e.g. meniscus, soft tissue, ACL, shoulder), Thoracic (e.g. hematomas), Sinus (ENT - e.g. polyps, cysts, bone structures), Spine (arthroscopic micro disectomy (AMD), spinal endoscopy - e.g. pathological tissue)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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 with the motor handles were tested according to the standards IEC601-1 and UL2601-1.
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.
K970088, K972584, K973499, K953370
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
§ 874.4750 Laryngostroboscope.
(a)
Identification. A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. The light and microphone that amplifies acoustic signals from the glottic area may or may not contact the patient.(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 the limitations in § 874.9.
0
3/17/99
E
1984521
| 510(k) Summary of Safety and Effectiveness | | RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | Date of Preparation:
December 18, 1998 |
| Division name (if applicable): | N.A. | FDA establishment registration number:
14 184 79 |
| Street address: | 353 Corporate Woods Parkway | Phone number (include area code):
(847) 913-1113 |
| City: | Vernon Hills | FAX number (include area code):
(847) 913-0924 |
| State/Province: | Illinois | ZIP / Postal Code:
60061 |
| Country: | USA | |
| Contact name: | Mr. Robert L. Casarsa | |
| Contact title: | Quality Assurance Manager | |
| Product Information: | | |
| Trade name: | RIWO Drive System 2302 with small motor handles | Model number:
2302, 8563.111, 8563.351, 8563.351 / .451 / .551 |
| Common name: | Drive Generator, Motor Handles | Classification name:
ENT electric surgical drill |
| Information on devices to which substantial equivalence is claimed: | | |
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
| 1 K970088 | 1 RIWO Drive Generator with Footswitch, Motor handles and single use rotary blades and abraders | 1 Richard Wolf |
| 2 K972584 | 2 Hummer ENT micro debrdier | 2 Stryker |
| 3 K973499 | 3 XPS Straightshot Microresector | 3 Xomed |
| 4 K953370 | 4 Karl Storz Paranasal Sinus Shaver | 4 Karl Storz |
1.0 Description
The RIWO Drive Generator is designed to efficiently drive and control different motor handles. The handle functions are controlled by a footswitch.
The motor handle is a tubular system. The modular system consists of:
- motor unit
- · motor housing
- · suction adapter (8563.111) And/Or suction /irrigation adapter (8563.311)
The suction and irrigation stream are controlled by slide valves. The motor handle is connected to the RIWO Drive 2302 by a removable cable.
Image /page/0/Picture/11 description: The image contains the word "ប្រជាជាតិ", which translates to "nation" or "people" in Khmer. The text appears to be written in Khmer script. The image quality is poor, making it difficult to discern any other details.
1
2.0 Intended Use
The RIWO Drive with motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions.
Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation.
Technological Characteristics 3.0
RIWO Drive Generator
- four speed settings, user selected .
- continuous digital display of selected and true speed .
- automatic adaptation of speed range and maximum torque (current) for three different . motor handles, display of speed range with LED
- . acoustic and optical alarm for, 1) motor overload, 2) incorrect cable connection or interrupted cable
- footswitch, operated by surgeon, to control motion forward, reverse, oscillation (3 changes . per second), speed and speed range automatically stored.
Motor Handle
.
- 360° rotation of clamping chuck for various cutting positions (8561.121 and 8562.111) .
- modular construction (8563.111/.311) .
- variable irrigation control with one-hand operation (8563.331) .
- watertight housing and motor unit, for steam sterilization .
- . lightweight design
- . detachable cable
- . BF insulation according to IEC601-1
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf and sold by Stryker, Xomed, or Karl Storz.
5.0 Performance Data
The RIWO Drive Generator with the motor handles were tested according to the standards IEC601-1 and UL2601-1.
2
6.0 Clinical Tests
Clinical tests performed were not performed.
7.0 Conclusions Drawn
These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual.
By: Robert L. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Dec 17, 98
3
Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 1999
Robert L. Casarsa Manager of Quality Assurance Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL, 60061
Re:
K984521 RIWO Drive Small Motor Handle Dated: December 18, 1999 Received: December 21, 1999 Regulatory class: II 21 CFR 874.4250/Procode: 77 EQL 21 CFR 878.4820/Procode: 79 GEY
Dear Mr. Casarsa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 vour device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
ag 4521 510(k) Number (if known):
Device Name: ___Small Motor Handles for RIWO Drive System 2302
Intended Use:
The RIWO Drive with small motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions.
Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation.
Indications and Fields of Application:
For therapy with endoscopic accessories:
- · in arthroscopy, e.g. for meniscus resection, removal of soft tissue, as well as intra-articular severing or abrasion of osseous tissue, e.g. ACL or shoulder procedures.
- thoracic surgery, e.g. for removing hematomas .
- sinus surgery (ENT), e.g. for removing polyps or cysts.In cases, bone structures are . removed or trimmed.
- spine surgery (arthroscopic micro disectomy (AMD), spinal endoscopsy) e.g. removal of . pathological tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
David C. Syverson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number
Prescription Use
Per 21 CFR 801.109
ર - I
Over-The Counter_