(127 days)
No
The 510(k) summary describes a purely mechanical and optical endoscopic system with manual surgical instruments and does not mention any AI or ML components or capabilities.
Yes
The device is intended for aiding in the search and removal of vertebral bone and nucleus material, which is a therapeutic intervention.
No
The device is intended for visualizing tissue and aiding in the search and removal of material, which are surgical and therapeutic functions, not diagnostic.
No
The device description lists multiple hardware components including instruments, a telescope, and adaptors, indicating it is a physical medical device system, not software-only.
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 for visualizing and aiding in the search and removal of tissue within the body (lumbar disc, herniated disc material, etc.). IVDs are used to examine specimens outside the body (in vitro) to provide information about a patient's health.
- Device Description: The components listed are surgical instruments and visualization tools used during a surgical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue samples, or any other biological material in a laboratory setting.
This device is a surgical endoscope system used for a minimally invasive surgical procedure.
N/A
Intended Use / Indications for Use
The Olympus Endoscopic System for Lumbar Hernia Discectomy and its ancillary equipment are intended for visualizing lumbar disc, lumbar herniated disc material and lumbar paravertebral tissue, and aiding in search and removal of vertebral bone and nucleus material.
Product codes
HRX, KOG
Device Description
The Olympus Endoscopic System for Lumbar Hernia Discectorny and Accessories consist of the following components:
- Initial Placement Instruments
- Olympus XELSPAS Series Manual Surgical Hand Instruments
- Telescope to view operative site
- Light Guide Adaptor an adaptor to be used with commercially available light systems to provide illumination
- Surgical Holder Adaptor an adaptor to be used to attach the endoscope to Olympus surgical holder device (510(k) K960068)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar disc, lumbar herniated disc material and lumbar paravertebral tissue
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sofamor Danek's MED MicroEndoscopic Discectomy System, Sofamor Danek's INCL Endoscopic System (K955471), Rigid Arthroscope (K950501), and MICRO-ENDO Instruments (K950130).
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are simple and abstract, with flowing lines suggesting hair or head coverings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top and left side of the profile graphic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
e look APR
Olympus Optical Company, Ltd. Mr. James R. Veale Vice President, Regulatory Services c/o Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K982133 Trade Name: Olympus Endoscopic Systems for Lumbar Hernia Discectomy Regulatory Class: II Product Code: HRX and KOG Dated: August 27, 1998 Received: August 28, 1998
Dear Mr. Veale:
This letter corrects our substantially equivalent letter of October 22, 1998 regarding the regulatory classification of your device, which is changed from HRZ to HRX. This device is regulated under 21 CFR 888.1100, Arthroscope and 21 CFR 876.1500, endoscope.
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 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 (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 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
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Page 2 - Mr. James R. Veale
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) 594-4595. 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,
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
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982133 510(k) Number (if known): J
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Olympus Endoscopic System for Lumbar Hernia Discectomy and its ancillary equipment are intended for visualizing lumbar disc, lumbar herniated disc material and lumbar paravertebral tissue, and aiding in search and removal of vertebral bone and nucleus material.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
boell
Division Sion-Off of General Re 1982133 510(k) Numbe
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use
Optional Format (1-2-96)
CONFIDENTIAL
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OCT 2 2 1998
510(k) Summary for Olympus Endoscopic System for Lumbar Hernia Discectomy
SPONSOR/APPLICANT NAME, ADDRESS 1.
Olympus Optical Co. Ltd. Endoscope Division 2951 Ishikawa-Cho Hachioji, Tokyo 192-8507 Japan
Contact Person: Shigeyoshi Terawaki 0426-42-5101 Telephone: Facsimile: 0426-42-9979
DATE OF SUMMARY PREPARATION: June 16, 1998
- Endoscopic System for Lumbar Hernia 2. TRADE/PROPRIETARY NAME: Discectomy and its Ancillary Equipment Endoscopic System for Lumbar Hernia COMMON/USUAL NAME: Discectomy Arthroscope and Accessories CLASSIFICATION NAME:
- IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE TO WHICH 3. EQUIVALENCE IS BEING CLAIMED:
Sofamor Danek's MED MicroEndoscopic Discectomy System, Sofamor Danek's INCL Endoscopic System (K955471), Rigid Arthroscope (K950501), and MICRO-ENDO Instruments (K950130).
4. DEVICE DESCRIPTION
The Olympus Endoscopic System for Lumbar Hernia Discectorny and Accessories consist of the following components:
- . Initial Placement Instruments
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| Instrument | Function |
|---|---|
| Guide Needle | Guide to target site |
| Dilators | Dilation of tissues |
| Mandolin | Guide of Flexible Sheath, and Dissection of tissue on lamina |
| Flexible Sheath | Delivery of Endoscope |
| Pusher | Delivery of Flexible Sheath |
| Side Sheath | Delivery of Endoscope |
- Olympus XELSPAS Series Manual Surgical Hand Instruments .
- Telescope to view operative site .
- Light Guide Adaptor an adaptor to be used with commercially . available light systems to provide illumination
- Surgical Holder Adaptor an adaptor to be used to attach the endoscope . to Olympus surgical holder device (510(k) K960068)
5. INTENDED USE
The Olympus Endoscopic System for Lumbar Hernia Discectomy is intended for visualizing lumbar disc, lumbar herniated disc material, and lumbar paravertebral tissue and for aiding in search and removal of vertebral bone and nucleus material.
ર. STATEMENT OF HOW TECHNOLOGICAL CHARACTERISTICS COMPARE TO PREDICATE
The Olympus Endoscopic System for Lumbar Hernia Discectomy is substantially equivalent to Sofamor Danek's MED MicroEndoscopic Discectomy System in technological characteristics. Both include an endoscope (arthroscope) for visualizing lumbar discs, lumbar herniated disc material, and lumbar paravertebral tissue. The proposed Olympus Endoscope is also substantially equivalent to the Olympus Endoscope described in 510(k) K951354, in optical characteristics and
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design. Both systems offer several surgical instruments for aiding in search and removal of vertebral bone and nucleus materials of manufacture of the Olympus system are all standard material used in medical products. Additionally, the materials in the proposed Olympus Endoscopic System for Lumbar Hernia Discectomy are identical to those cleared in legally marketed Olympus devices.
Additionally, the components of the Olympus Endoscopic System for Lumbar Hernia Discectomy are substantially equivalent in design and dimensions to other Olympus devices.