(313 days)
The KSEA Fiberscope is indicated for use to provide visualization of the pericardium and cardiac chambers during endoscopic heart surgery procedures.
The KSEA Fiberscope is a manually operated surgical device. The KSEA Fiberscope is flexible fiberoptic telescope which utilizes fiber-optic technology.
The provided document is a 510(k) summary for the KSEA Fiberscope, a medical device for visualization during endoscopic heart surgery. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics as would be found in a clinical trial report for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth is not explicitly available in this type of regulatory submission.
Here's an analysis based on the available information, noting what cannot be extracted from this document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria or quantitative performance metrics in the way a study for an AI/ML device would. For 510(k) submissions, the acceptance criteria are generally met by demonstrating that the new device has "substantially equivalent" features, design, body contact material, and general intended uses to legally marketed predicate devices, and that it does not raise new safety or effectiveness issues.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Basic Features | Substantially equivalent to predicate devices |
| Design | Substantially equivalent to predicate devices |
| Body Contact Material | Substantially equivalent to predicate devices |
| General Intended Uses | Substantially equivalent to predicate devices |
| Safety Concerns | Does not incorporate any significant change that could affect safety or effectiveness; minor differences raise no new issues of safety and effectiveness; design differences have no affect on performance, function, or intended use. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a 510(k) summary demonstrating substantial equivalence, not a study evaluating performance on a specific test set of data. It describes the device itself and its equivalence to others.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" establishment in the context of a data-driven test set is described here. The evaluation is based on comparing device specifications and intended use against predicate devices.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.
5. 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 document is for a fiberscope, a manually operated surgical device, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The ground truth for this type of submission is the regulatory knowledge and performance history of the predicate devices. The device's "truth" is its ability to visualize as intended, which is assumed to be similar to its predicates.
8. The sample size for the training set
Not applicable. This device is not an AI/ML product developed with a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML product requiring a training set with established ground truth.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in This Sammary of '910(th) Sale of the Safe Medical Devices Act (SMDA) of 1990 and accordance with and recurrent is accurate 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.Regulatory Affairs Specialist |
| Device Identification: | Common Name:Flexible FiberscopeTrade Name: (optional)Karl Storz Fiberscope |
Indication: The KSEA Fiberscope is indicated for use to provide visualization of the pericardium and cardiac chambers during endoscopic heart surgery procedures.
Device Description: The KSEA Fiberscope is a manually operated surgical device. The KSEA Fiberscope is flexible fiberoptic telescope which utilizes fiber-optic technology.
Substantial Equivalence: The KSEA Fiberscope is substantially equivalent to the predicate devices since the basic features, design, body contact material and general intended uses are the same. The KSEA Fiberscope does not incorporate any significant change that could affect safety or effectiveness. The minor differences between the KSEA Fiberscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
Kankakee
Signed:
James A. Lee, Ph.D. Regulatory Affairs Specialist
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2002
James A. Lee. Ph.D. Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe 5th Floor Culver City, CA 90230
Re: K011793
Trade Name: KSEA Fiberscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II (two) Product Code: 74 LYK Dated: January 31, 2002 Received: February 1, 2002
Dear Dr. Lee:
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, 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.
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Page 2 - James A. Lee, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toase of actived 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 or any I odetar 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 Of It Fur 0077, ideoining (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 preared 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 xitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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,
Dolotau
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Number (if known): K011793
Device Name: KSEA Fiberscope
Indications for Use: The KSEA Fiberscope is indicated for use to provide visualization of the pericardium and cardiac chambers during endoscopic heart surgery procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011793
Prescription Use
(Per 21 CFR 801.109)
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.