(86 days)
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.
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.
The provided text is a 510(k) summary for the KSEA Neuroendoscopes and Accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific performance criteria against acceptance thresholds. Therefore, most of the requested information regarding acceptance criteria, study details, and AI-specific elements (like human-in-the-loop performance or expert consensus for ground truth) is not applicable or not present in the provided document.
Here’s a breakdown of the information that can be extracted or deduced from the text, and where gaps exist:
Acceptance Criteria and Device Performance
The concept of "acceptance criteria" for performance metrics as you've outlined (e.g., sensitivity, specificity) is not explicitly stated. This 510(k) submission relies on demonstrating substantial equivalence to existing predicate devices, meaning its safety and effectiveness are considered to be on par with devices already legally marketed. The "performance" is implicitly considered acceptable because it's equivalent to existing devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety | Substantially equivalent to predicate devices. The minor differences do not raise new issues of safety. |
| Effectiveness | Substantially equivalent to predicate devices. The minor differences have no effect on performance, function, or intended use. |
| Intended Use | Identical ("similar") to predicate devices: for use by qualified surgeons during endoscopic pituitary surgery. |
| Basic Design | Similar to predicate devices (straight shafted, rigid telescopes, Hopkins rod lens). |
| Dimensions | Similar to predicate devices. |
| Materials | Similar to predicate devices (surgical grade stainless steel). |
Study Information
The document describes a substantial equivalence determination process, not a clinical performance study with defined test sets, experts for ground truth, or adjudication methods in the way a diagnostic AI device might be.
- Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical performance study using a test set of data. The determination is based on a comparison to predicate devices and their established performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment in the context of a clinical study is not described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an endoscope, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant to this submission.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic or AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a clinical performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
- The sample size for the training set: Not applicable. This device does not involve machine learning or a training set.
- How the ground truth for the training set was established: Not applicable. There is no training set for this type of device.
In summary, the provided 510(k) pertains to a medical device (neuroendoscopes and accessories) where the regulatory pathway primarily involves demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than conducting new clinical performance studies with acceptance criteria, test sets, or AI-specific evaluations.
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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 DriveCulver 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
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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.
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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
§ 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).