(235 days)
No
The summary describes a rigid endoscope for visualization and surgical assistance, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is used for visualization and surgical assistance, which are diagnostic and procedural functions rather than direct therapeutic actions.
No
The device is described as being for "viewing the ventricles of the brain" and "visualization of tumors, cysts and neurovascular compression syndromes" and for "endoscopic assisted microsurgery," indicating it is used for surgical viewing and assistance, not for diagnosing conditions.
No
The device description clearly states it is a "rigid endoscope," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description: The description clearly states the Olympus Neuroendoscope is a rigid endoscope intended for viewing and visualization within the brain and related cavities. It is used inside the body (in vivo) for surgical assistance and direct observation.
- Intended Use: The intended uses listed are all related to direct visualization and surgical procedures within the brain, not laboratory testing of samples.
Therefore, the function and intended use of this device fall under the category of a surgical or visualization device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Olympus Neuroendoscopes are intended for viewing the ventricles of the brain, for use in endoscopic assisted microsurgery for cerebral aneurysms, and shunt placement and for visualization of tumors, cysts and neurovascular compression syndromes.
Product codes
GWG
Device Description
The Olympus Neuroendoscope is a rigid endoscope indicated for intraventricular (and other intracranial CSF-containing cavities), subarachnoid and brain parenchymal environments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain, intraventricular (and other intracranial CSF-containing cavities), subarachnoid and brain parenchymal
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
OCT 0 8 2002
020507
OLYMPUS
WINTER & IB
Business address: Kuehnstr. 61 D-2204 Mailing address: Postfach 70 17 09 D-2201' Tel: +49-40-6 69 66-0 Telefax +49-40-6 68
Olympus Neuroendoscopes
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDS 1990 and 21 CFR Part 807.92
Submitter's Name, Address, Phone, Coutact Person and Summary Date A.
Olympus Winter & Ibe Manufacturer of subject device: Keuhnstr. 61 D-22045 Hamburg Germany 8010313 Registration number: Contact Person:
Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville NY 11747-3157
Telephone: (631) 844-5688
B. Device Name
Device Name: Olympus Neurocndoscopes
Common/Usual Name: Neurological endoscopes
Neurological endoscope Classification Name:
Classification: 21 CFR 882.1480 Class II
- C. Predicate Devices:
Olympus Neuroendoscopes (K971340)
Device Description D.
The Olympus Neuroendoscope is a rigid endoscope indicated for intraventricular (and other intracranial CSF-containing cavities), subarachnoid and brain parenchymal environments.
1
Intended Use of Device £.
The Olympus Neuroendoscopes are intendod for viewing the ventricles of the brain and for use in The Orympus Neurochaosopes are meeters and shunt placement and shunt placement and for ondoooopto absteted instruction of the rovascular compression syndromes.
| Item | Predicate
device, model
A7594A | Subject
device, S-
1349/1 | Subject
device, S-
1349/2 | Subject
device, S-
1349/3 | Subject
device, S-
1349/4 |
|-----------------------------|--------------------------------------|---------------------------------|---------------------------------|---------------------------------|---------------------------------|
| Telescope Diameter | Ø 4 mm | Ø 4 mm | Ø 2.7 mm | Ø 2.7 mm | Ø 2.7 mm |
| Telescope Total
Length | 218.5 mm | 218.5 mm | 225.3 mm | 225.0 mm | 233 mm |
| Telescope Working
Length | 158.1 mm | 158.1 mm | 158.1 mm | 157.7 mm | 156.7 mm |
| Lens Diameter | Ø 2.8 mm | Ø 2.8 mm | Ø 1.7 mm | Ø 1.7 mm | Ø 1.9 mm |
| Field of view | 95.8° | 95.8° | 70.8° | 68.4° | 85° |
| Direction of view | 0° | 0° | 0° | 30° | 70° |
| Best working distance | 10 mm | 10 mm | 10 mm | 10 mm | 10 mm |
| Magnification | 2.1 | 2.1 | 2.15 | 2.22 | 2.19 |
Comparison to Predicate Devices F.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laura Storms-Tyler Director Regulatory Affairs and . Quality Assurance Olympus America, Inc. 2 Corporate Center Drive Melville, New York 11747
Re: K020507
Trade/Device Name: Olympus Neuroendoscope Regulation Number: 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: July 3, 2002 Received: July 10, 2002
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Image /page/2/Picture/10 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the top half of the circle. The bottom half of the circle is blank. Inside the circle is a stylized design that resembles an abstract representation of a human form.
OCT 08 2002
OCT 0 8 2002
3
Page 2 - Ms. Storms-Tyler
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K020507
Device Name: Olympus Neuroendoscope
Indications for Use:
The Olympus Neuroendoscopes are intended for viewing the ventricles of the brain, for use in endoscopic assisted microsurgery for cerebral aneurysms, and shunt placement and for visualization of tumors, cysts and neurovascular compression syndromes.
(Please do not write below this line. Continue on another page is needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE) X Prescription Use _ the-Counter Use (Per 21 CFR 801.109) (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number -