(185 days)
Not Found
No
The summary describes a set of manual surgical instruments and an endoscopic system focused on visualization, with no mention of AI or ML capabilities.
Yes
The device is used for the visualization and removal of herniated discs, directly treating a medical condition.
No
The device is described as an endoscopic spine system for visualization and removal of herniated discs, which are therapeutic and surgical functions, not diagnostic ones.
No
The device description explicitly lists multiple hardware components (telescope, forceps, sheath, etc.) and describes a physical scope system for visualization.
Based on the provided information, the Yeung Endoscopic Spine System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used in vitro (outside the body).
- The Yeung Endoscopic Spine System is used in vivo (inside the body) for visualization and removal of herniated discs. It is a surgical instrument used directly on the patient.
The description clearly indicates its use in a surgical procedure within the lumbar region of the body, which is the opposite of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Yeung Endoscopic Spine System is indicated for the visualization and removal of herniated discs in the lumbar region.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The set consists of a telescope, forceps, sheath, obturator, adapter, tephine, punch, scissors, dilator, cannula, and caps. It is designed to be compatible with other available systems, but with increased emphasis on superior quality imaging. The scope system is designed to allow for clear visualization of spinal anatomy and pathology through its unique multichannel flow integrated system and working channels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar region (spine)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
None
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
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: $47.913.1143 Fax: 847.913.1488
K9734QS
MAR 1 3 1008
RICHARD MEDICAL INSTRUMENTS CORP
510(k) Summary of Safety and Effectiveness
| Submitter: | |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | January 12, 1998 |
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
| Product Information: | |
|---|---|
| Trade name: | Discoscope Set |
| Model number: | |
| Common name: | Spinal Arthroscopic Set |
| Classification name: | Arthroscope and Accessories |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| K930191 | MED Microendoscopy Disectomy System | Sofamor Danek |
| K922519 | Kambin Arthroscopic Microdiscetomy System | Dyonics |
| 3 | 3 | 3 |
| 4 | 4 | 4 |
| 5 | 5 | 5 |
| 6 | 6 | 6 |
| 7 | 7 | 7 |
| 8 | 8 | 8 |
1.0 Description
The set consists of a telescope, forceps, sheath, obturator, adapter, tephine, punch, scissors, dilator, cannula, and caps. It is designed to be compatible with other available systems, but with increased emphasis on superior quality imaging. The scope system is designed to allow for clear visualization of spinal anatomy and pathology through its unique multichannel flow integrated system and working channels.
1
Intended Use 2.0
Intended Use
The Yeung Endoscopic Spine System is indicated for the visualization and removal of herniated discs in the lumbar region.
Technological Characteristics 3.0
- T echnological Characteristics
Designed to allow for clear visualization of spinal anatomy and pathology through its unique multichannel flow integrated system and working channels.
Substantial Equivalence 4.0
Substantial Equivalence
- Richard Wolf 8986.401 Operative Scope .
- Sofamor Danek MED Endoscope .
- Smith & Nephew Richards AMD VideoDiscoscope .
All devices have the same intended use.
5.0 Performance Data
None
Clinical Tests 6.0 None
7.0 Conclusions Drawn
Concellations branni the instruction manual.
By: Ret. Casana
Robert L. Casarsa Quality Assurance Manager
Date: Jan 9, 1998
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Mr. Robert L. Casarsa Manager of Quality Assurance Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re : K973405 Yeung Endoscopic Spine System Trade Name: Regulatory Class: II Product Code: HRX Dated: January 9, 1998 Received: January 13, 1998
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 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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (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 requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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.
3
Page 2 - Mr. Robert L. Casarsa
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 requlation (21 CFR Part 801 and additionally 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" (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/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
510(k) Number (if known):_ - 10(K) Nambo
Indications for Use:
Indications for Use:
Indications for USC.
The Yeung Endoscopic Spine System is indicated for the visualization and removal of hemiated discs in the lumbar region.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
luation (ODF)
(Division $ign-Off)
Division of General Botas D
Division of General Restorative Devices
510(k) Number K67340
Prescription Use
Per CFR 21 CFR 801.109
()ver-The-Counter Use_________________________________________________________________________________________________________________________________________________________