(86 days)
Not Found
Not Found
No
The description focuses on the physical components and intended use of a rigid endoscope and accessories, with no mention of AI or ML capabilities.
No.
The device is described as an endoscope and accessories for viewing and managing the surgical site, not for directly treating a disease or condition.
No
Explanation: The device is described as an endoscope intended for viewing and surgical procedures (pituitary surgery) and removal of fluids/debris, not for diagnosing medical conditions. It aids in surgical procedures by providing visualization, but does not provide a diagnosis.
No
The device description explicitly states it is a rigid telescope with accessory instruments made of surgical grade stainless steel, indicating it is a hardware device.
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 devices are for use by qualified surgeons during endoscopic pituitary surgery for viewing, protection, irrigation, and suction. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details rigid telescopes and accessory instruments made of surgical grade stainless steel. These are surgical tools used directly on or within the patient's body.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health status. The provided information does not mention any such function or interaction with patient specimens outside the body.
Therefore, the KSEA Neuroendoscopes and Accessories are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The KSEA Neuroendoscopes and Accessories are intended for use by qualified surgeons during endoscopic pituitary surgery.
The Neuroendoscope Set is intended for use by qualified surgeons in endoscopic pituitary surgery.
The Neuroendoscopes is intended for viewing the sella and pituitary gland in endoscopic pituitary surgery.
The Sheath is intended to be used to protect the Neuroendoscope and provides irrigation during the endoscopic procedures.
The KSEA Suction Tube is intended to remove blood, fluid, excised tissue, and debris from the operation site.
Product codes (comma separated list FDA assigned to the subject device)
GWG
Device Description
The KSEA Neuroendoscopes are straight shafted, rigid telescopes that utilize Hopkins rod lens. The accessory instruments include the irrigation sheaths, suction tubes, etc. The body contact materials are surgical grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pituitary gland; sella
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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): 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.
Not Found
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
§ 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
Image /page/0/Picture/0 description: The image shows a grainy background with the date "JUN 2 6 2002" printed in black ink. The date is centered horizontally and appears to be stamped or printed onto the surface. The background has a speckled texture, with varying shades of gray and white creating a mottled effect.
Ko21050 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 338-8100 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | James A. Lee, Ph.D.
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Endoscopic Instruments |
| | Trade Name: (optional)
KSEA Neuroendoscopes and Accessories |
Indication: The KSEA Neuroendoscopes and Accessories are intended for use by qualified surgeons during endoscopic pituitary surgery.
Device Description: The KSEA Neuroendoscopes are straight shafted, rigid telescopes that utilize Hopkins rod lens. The accessory instruments include the irrigation sheaths, suction tubes, etc. The body contact materials are surgical grade stainless steel.
Substantial Equivalence: The KSEA Neuroendoscopes and Accessories are substantially equivalent to the predicate devices since the basic design, dimensions. stainless steel, and intended use are similar. The minor differences between the KSEA Neuroendoscopes Set and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
James A. Lee, Ph.D. Senior Regulatory Affairs Specialist
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, with flowing lines above them, possibly representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2002
James A. Lee, Ph.D. Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Drive Culver City, California 90230
Re: K021050
Trade Name: Neuroendoscopes and Accessories Regulation Number: 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: March 29, 2002 Received: April 1, 2002
Dear Dr. Lee:
We have reviewed your Section 510(k) premarket 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) 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, 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 (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.
2
Page 2 - Dr. James A. Lee
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,
Ha
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
3
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510(k) Number (if known): Not yet assigned.
K02/050
Device Name: Neuroendoscopes and Accessories
Indications for Use: The Neuroendoscope Set is intended for use by qualified surgeons in endoscopic pituitary surgery.
TheNeuroendoscopes is intended for viewing the sella and pituitary gland in endoscopic pituitary surgery.
The Sheath is intended to be used to protect the Neuroendoscope and provides irrigation during the endoscopic procedures.
The KSEA Suction Tube is intended to remove blood, fluid, excised tissue, and debris from the operation site.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X OR Over-The-Counter Use: __
(Per 21 CFR 801.109) do
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K021050