(53 days)
This instrument is indicated for use to view the larynx, bronchi, and trachea, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the K.SEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided text is a 510(k) Summary of Safety and Effectiveness for the KSEA DCI Endoscope. This document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Key takeaway: This is not a study proving device performance against acceptance criteria in the way one would describe an AI/ML device study.
Instead, this document asserts substantial equivalence based on the device's design, materials, and intended use being similar to existing, legally marketed devices. It does not contain information about "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics for an AI/ML algorithm.
Therefore, I cannot extract the requested information as it is not present in the provided text. The questions asked are typically relevant for demonstrating the performance of novel AI-driven medical devices, which this endoscope is not.
To directly answer your request based on the provided text, many fields will be "Not Applicable" or "Not Provided," as the document focuses on regulatory equivalence rather than performance metrics from a controlled study.
Here's how I would answer if I were forced to interpret the spirit of your questions within the context of a 510(k) for a non-AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Implied by Substantial Equivalence and Device Description) |
|---|---|
| Intended Use: To view larynx, bronchi, trachea, and perform diagnostic/therapeutic procedures with accessories. | The KSEA DCI Endoscope is "designed to be used by qualified surgeons and physicians to view the larynx, bronchi, and trachea, and, using additional accessories, to perform various diagnostic and therapeutic procedures." This matches the predicate. |
| Design & Features: Utilizes rod lens technology, rigid, panoramic telescope. | The KSEA DCI Endoscope "is comprised of a rigid, panoramic telescope which utilizes rod lens technology." This matches the predicate. |
| Materials: Body contact portions composed of surgical grade stainless steel. | The KSEA DCI Endoscope's "body contact portions... are composed of surgical grade stainless steel, which is commonly used in medical devices... and has a long history of biocompatibility for human use." This matches the predicate. |
| Safety & Effectiveness: Raises no new issues of safety and effectiveness compared to predicate devices. | "The minor differences between the KSEA DCI Endoscope 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." |
| Biocompatibility: Materials are biocompatible for human use. | "[Surgical grade stainless steel] has a long history of biocompatibility for human use." |
| Substantial Equivalence: Basic features, design, and intended uses are the same as predicate devices. | "The KSEA DCI Endoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a traditional medical device (endoscope), not a machine learning algorithm that requires a "test set" in the sense of a dataset for performance evaluation. Substantial equivalence is based on comparison to existing device designs and materials, not clinical performance data from a specific "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. See above. "Ground truth" in this context refers to regulatory assessment by the FDA, based on engineering, materials science, and clinical equivalence, rather than expert annotation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See above.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implicit "Ground Truth": Regulatory standards and the characteristics of legally marketed predicate devices. The "ground truth" for substantial equivalence is that the device's design, materials, and intended use align with established devices and accepted medical practices/safety standards.
8. The sample size for the training set
- Not Applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. This is not a machine learning device.
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2 9 1999 JAN
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510(k) SUMMARY OF SAFETY AND EFFECTIVENE
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) 558-1500 |
|---|---|
| Contact: | Kevin KennanRegulatory Affairs Specialist |
| Device Identification: | Common Name:Endoscope |
| Trade Name: (optional)Karl Storz DCI Endoscope |
Indication: The KSEA DCI Endoscope is designed to be used by qualified surgeons and physicians to view the larynx, bronchi, and trachea, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Device Description: The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the K.SEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Substantial Equivalence: The KSEA DCI Endoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA DCI Endoscope 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.
Signed:
A:
Kevin Kennan
Senior Regulatory Affairs Specialist
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 1999
Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America 600 Corporate Pointe Culver City, CA 90230-7600
Re:
K984369 DCI Endoscope Dated: December 2, 1998 Received: December 7, 1998 Regulatory class: II 21 CFR 874.4760/Procode: 77 EOB
Dear Mr. Kennan:
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 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). 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 requirements, 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 Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. 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/dsma/dsmamain.html".
Sincerely yours,
Capt. Daniel G. Schultz, M.D.
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K984369
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Device Name: DCI Endoscope
Indications for Use: This instrument is indicated for use to view the larynx, bronchi, and trachea, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seym
ivision Sign-Off) (Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number
Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.