KSEA RIGID CULDOSCOPE AND ACCESSORIES by KARL STORZ ENDOSCOPY-AMERICA, INC.

The KSEA Rigid Culdoscope and Accessories is intended for use by qualified surgeons for viewing the organs within the peritoneal cavity, via a posterior vaginal fornix entry, using CO2 gas insufflation. This Culdoscope is not intended for trausvaginal hydrolaparoscopy (transflotation). This Culdoscope has the following diagnostic indications:

Unexplained pelvic pain (acute, chronic)
Menstrual abnormalities
Infertility and sterility
Indefinite pelvic mass
Ectopic pregnancy
Pelvic endometriosis
Polycystic ovaries
Pelvic inflammatory disease
Pain mapping
Congenital anomalies of the pelvic organs

Device Description

The KSEA Culdoscope and Accessories are manual reusable surgical devices. The KSEA Culdoscope and Accessories are composed of a Forward-Oblique 300 Telescopes, Culdoscope Sheath and a sharp obturator. The body contact portions of the KSEA Culdoscope and Accessories 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 is a 510(k) Summary for a medical device (KSEA Culdoscope and Accessories). This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) Summary like this typically does not include detailed studies with acceptance criteria and performance data in the way a clinical trial report or a performance validation study for an AI/software device would. The purpose of a 510(k) is to show equivalence, often based on comparison to existing devices and basic engineering/design specifications, rather than extensive clinical efficacy data.

Therefore, many of the requested points cannot be answered from the provided text because such information is not part of a standard 510(k) summary for this type of device (a manual, reusable surgical instrument).

Here's a breakdown of what can be inferred and what cannot:

1. A table of acceptance criteria and the reported device performance

Not Applicable / Not Provided. The document describes a manual surgical instrument. Acceptance criteria for such a device would typically relate to manufacturing specifications (e.g., material compliance, dimensions, finish, sterilization compatibility, durability), rather than performance metrics like sensitivity, specificity, or improvement in diagnostic accuracy that would be relevant for an AI/software device. No specific acceptance criteria or quantitative performance data are presented in this 510(k) summary. The summary focuses on comparing its features and intended use to predicate devices to establish substantial equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided. This 510(k) does not describe a "test set" in the context of performance validation data for an AI/software device. The submission is for a physical medical instrument.

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 / Not Provided. Ground truth establishment is not relevant for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided. Adjudication methods are not relevant for this type of device submission.

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 / Not Provided. This is a manual surgical instrument, not an AI/software device. Therefore, no MRMC study, AI assistance, or effect size is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Provided. This is a manual surgical instrument, not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Not Provided. Ground truth is not a concept applied to the approval process for this type of device as presented in this 510(k) summary.

8. The sample size for the training set

Not Applicable / Not Provided. There is no "training set" for a manual surgical instrument in this context.

9. How the ground truth for the training set was established

Not Applicable / Not Provided. Ground truth for a training set is not relevant for this type of device submission.

Summary based on the Provided Text:

The provided document is a 510(k) premarket notification for a KSEA Culdoscope and Accessories, a manual, reusable surgical device. The intent of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to provide detailed clinical performance data or studies with acceptance criteria as one would find for an AI/software device.

The "study" referenced in a 510(k) of this nature is primarily the comparison of the device's design, materials, and intended use against a predicate device. The key assertion is that "The minor differences between the Karl Storz Culdoscope and Accessories 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." This statement is the "proof" within the 510(k) framework that the device "meets" the safety and effectiveness requirements by demonstrating it's as safe and effective as a device already on the market.

Therefore, many of the questions related to AI/software performance validation are not applicable to this document or the device it describes.

Summary

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FEB 7 2000

K993804
Page 1 of 2

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) 558-1500
Contact:	Kevin KennanRegulatory Affairs Specialist
Device Identification:	Common Name:Culdoscope
	Trade Name: (optional)KSEA Culdoscope

Indication: The KSEA Rigid Culdoscope and Accessories is intended for use by qualified surgeons for viewing the organs within the peritoneal cavity, via a posterior vaginal fornix entry, using CO2 gas insufflation. This Culdoscope is not intended for trausvaginal hydrolaparoscopy (transflotation). This Culdoscope has the following diagnostic indications:

Unexplained pelvic pain (acute, chronic) ●
. Menstrual abnormalities
Infertility and sterility
. Indefinite pelvic mass
Ectopic pregnancy
. Pelvic endometriosis
� Polycystic ovaries
. Pelvic inflammatory disease
. Pain mapping
Congenital anomalies of the pelvic organs

Device Description: The KSEA Culdoscope and Accessories are manual reusable surgical devices. The KSEA Culdoscope and Accessories are composed of a Forward-Oblique 300 Telescopes, Culdoscope Sheath and a sharp obturator. The body contact portions of the KSEA Culdoscope and Accessories 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 KSEA Culdoscope and Accessories is substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Culdoscope and Accessories 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:

Kevin Kennan Senior Regulatory Affairs Specialist

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 FEB

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

Re: K993804

KSEA Rigid Culdoscope and Accessories, Series G27 Dated: November 5, 1999 Received: November 9, 1999 Requiatory Class: II 21 CFR §884.1640/Procode: 85 HEW

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 proor 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). 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 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 Compiance 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. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings or body. The logo is black and white.

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510(k) Number (if known): 993804

Device Name: Rigid Culdoscope and Accessories

Indications for Use: The KSEA Rigid Culdoscope and Accessories is intended for use by qualified surgeons for viewing the organs within the peritoneal cavity, via a posterior vaginal fornix entry, using CO2 gas insufflation. This Culdoscope is not intended for transvaginal hydrolaparoscopy (transflotation). This Culdoscope has the following diagnostic indications:

●

Unexplained pelvic pain (acute, chronic) .
Menstrual abnormalities ●
Infertility and sterility .
Indefinite pelvic mass .
Ectopic pregnancy .
Pelvic endometriosis ●
Polycystic ovaries ●
Pelvic inflammatory disease .
Pain mapping C
Congenital anomalies of the pelvic 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. K993804

Regulation Number and Section

§ 884.1640 Culdoscope and accessories.

(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. 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 preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such culdoscope accessory instruments include: 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.