The KSEA DCI Endoscope is indicated for use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Specific Indications for Use

unexplained pelvic pain (acute, chronic)
infertility work-up
tubal sterilization
unexplained primary or secondary amenorthea
diagnosis and/or treatment of ectopic pregnancy
evaluation, diagnosis and/or treatment of small pelvic tumors, including myomata
evaluation of congenital anomalies of the pelvic organs
retrieval of foreign bodies
determination of the presence and extent of pelvic endometriosis
determination of the presence and extent of pelvic inflammatory disease
laparoscopic assisted vaginal hysterectomy
visualization, diagnosis and/or treatment of perforate abdominal organs

Device Description

The KSEA DCI Endoscope is comprised of a rigid, panoramic tolescope which utilizes rod lens technology. The body contact portions of the KSEA 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.

AI/ML Overview

The provided text does not contain information about acceptance criteria, device performance, or details of a study that proves the device meets specific criteria for the Karl Storz Direct Coupled Interface (DCI) Endoscope.

Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a device already legally marketed. It typically does not involve independent studies with specific performance metrics against acceptance criteria in the same way a Premarket Approval (PMA) application would.

Therefore, I cannot fulfill the request for the following sections as the information is not present in the provided text:

A table of acceptance criteria and the reported device performance: Not available. The document states "minor differences...raise no new issues of safety and effectiveness" because "these design differences have no affect on the performance, function or intended use of the devices," implying that performance is considered equivalent to the predicate without specifying new performance metrics.
Sample sizes used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
Adjudication method: Not applicable as no test set or ground truth 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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an endoscope, not an algorithm.
The type of ground truth used: Not applicable as no ground truth is described.
The sample size for the training set: Not applicable as no training set is described.
How the ground truth for the training set was established: Not applicable as no training set is described.

Summary of what is available from the text:

Device Name: Karl Storz Direct Coupled Interface (DCI) Endoscope
Intended Use/Indications for Use: For use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures. Specific indications include unexplained pelvic pain, infertility work-up, tubal sterilization, amenorrhea, ectopic pregnancy, small pelvic tumors (myomata), congenital anomalies, foreign body retrieval, pelvic endometriosis, pelvic inflammatory disease, laparoscopic assisted vaginal hysterectomy, and visualization/diagnosis/treatment of perforate abdominal organs.
Regulatory Pathway: 510(k) Premarket Notification, asserting substantial equivalence to predicate devices.
Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Summary

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Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be alphanumeric. The characters are 'K990004'. The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly overlapping or connected.

5100% 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) 558-1500
Contact:	Kevin KennanRegulatory Affairs Specialist
Device Identification:	Common Name:Endoscope
	Trade Name: (optional)Karl Storz Direct Coupled Interface (DCI) Endoscope

Indication: The KSEA DCI Endoscope is indicated for use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Specific Indications for Use

unexplained pelvic pain (acute, chronic) ●
infertility work-up ●
. tubal sterilization
unexplained primary or secondary amenorthea
. diagnosis and/or treatment of ectopic pregnancy
. evaluation, diagnosis and/or treatment of small pelvic tumors, including m vomata
evaluation of congenital anomalies of the pelvic organs �
retrieval of foreign bodies .
determination of the presence and extent of pelvic endometriosis .
. determination of the presence and extent of pelvic inflammatory disease
. laparoscopic assisted vaginal hysterectomy
. visualization, diagnosis and/or treatment of perforate abdominal organs

Device Description: The KSEA DCI Endoscope is comprised of a rigid, panoramic tolescope which utilizes rod lens technology. The body contact portions of the KSEA 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.

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Substantial Equivalence: The KSIEA 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:

Kevin Kennan
Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the symbol.

Public Health Service

APR 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K990004

Karl Storz Direct Coupled Interface (DCI) Endoscope (for Gynecologic Laparoscopy) Dated: September 23, 1998 Received: January 4, 1999 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET

Mr. Kevin A. Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230-7600

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 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,

APT 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): K990004

Device Name: Karl Storz Direct Coupled Interface (DCI) Endoscope

Indications for Use: This instrument is indicated for use during gynecologic laparoscopic surgical procedures, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Specific Indications for Use

unexplained pelvic pain (acute, chronic) .
infertility work-up .
. tubal sterilization
unexplained primary or secondary amenorthea t
diagnosis and/or treatment of ectopic pregnancy .
evaluation, diagnosis and/or treatment of small pelvic turnors, including . myomata
evaluation of congenital anomalies of the pelvic organs .
retrieval of foreign bodies .
determination of the presence and extent of pelvic endometriosis ●
determination of the presence and extent of pelvic inflammatory disease ●
laparoscopic assisted vaginal hysterectomy ●
visualization, diagnosis and/or treatment of perforate abdominal organs .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ✓ OR Over-The-Counter Use: __
(Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number. K990004

Regulation Number and Section

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.