Circon's Rigid Culdoscopes and Accessories are intended for viewing pelvic organs endoscopically via a posterior vaginal fornix entry. Culdoscopy is indicated for: 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

CIRCON's Rigid Culdoscopes and Accessories are rod lens-type endoscopes which consist of imaging optics and fiber optic illumination fibers contained within a stainless steel sleeve. Light from a high intensity light source is transmitted to the scope by a fiber optic light guide that is detachably connected to a light post on the body of the scope. The light is carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the rod lens train. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an eyepiece ocular. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.

AI/ML Overview

The provided document is a 510(k) summary for the CIRCON Rigid Culdoscope and Accessories (K980972). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical trials or performance studies with detailed statistical analysis.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement.

Here's why and what the document does provide:

Acceptance Criteria and Reported Device Performance (1): This information is not present. The 510(k) process for this device relies on demonstrating that the new device is "substantially equivalent" to predicate devices already on the market prior to May 28, 1976. This typically involves comparing design, materials, intended use, and operating principles, rather than presenting new performance data against specific acceptance criteria.
Sample Size for Test Set and Data Provenance (2): Not applicable, as no performance study data is presented.
Number of Experts and Qualifications for Ground Truth (3): Not applicable, as no ground truth establishment for a test set is described.
Adjudication Method (4): Not applicable.
Multi-reader Multi-case (MRMC) Comparative Effectiveness Study (5): This is not a study type relevant to a 510(k) submission for a culdoscope in 1998, which is focused on physical and functional equivalence to existing devices. Therefore, no such study is described, nor is any effect size for human readers with or without AI assistance.
Standalone Performance Study (6): No standalone performance study (algorithm only) is mentioned, as this device is a physical medical instrument, not an AI or software-only device.
Type of Ground Truth Used (7): Not applicable, as no performance evaluations against a ground truth are described.
Sample Size for Training Set (8): Not applicable, as no machine learning model or training set is involved.
How Ground Truth for Training Set was Established (9): Not applicable.

What the document does provide in lieu of performance data:

The core of this 510(k) submission is the demonstration of substantial equivalence to predicate devices.

Name of Device: Rigid Culdoscope and Accessories
Intended Use: "CIRCON's Rigid Culdoscopes and Accessories are intended to be used for direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures. The system is introduced into the pelvic cavity through the posterior vaginal fornix."
Indications for Use: Unexplained pelvic pain, 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.
Predicate Devices: ACMI's Decker Culdoscope and Decker Operating Culdoscope, Karl Storz Endoscopy America, Inc.'s Culdoscopes, and Richard Wolf Medical Instrument Corp.'s Fiber Light Culdoscopes. All were marketed prior to May 28, 1976.
Comparison of Technical Characteristics: "CIRCON's scopes employ the same design considerations and operating principles as the legally marketed predicate devices, and each can be sterilized and reused. Any differences between these culdoscopes do not raise new questions regarding safety or effectiveness."

In summary, this document is a regulatory submission focused on demonstrating equivalence in design and intended use to pre-existing devices, rather than presenting a study proving performance against specific acceptance criteria.

Summary

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K980972

JUN 1 2 1998

510(k) Summary

#K98 0972

CIRCON Corporation 1) Submitter: 6500 Hollister Avenue Santa Barbara, CA 93117
- Dr. Ronald J. Ehmsen Contact: (805) 961-3290

March 12, 1998 Date Prepared:

1. Name of Device: Rigid Culdoscope and Accessories
  Proprietary/Trade Name: (Not yet determined)

Common/Usual Name: Culdoscope

Classification: Class II (21 CFR §884.1640)

Classification Name: Culdoscope and Accessories

3) Name of Predicate or Legally Marketed Devices:

CIRCON's Rigid Culdoscopes and Accessories are substantially equivalent to ACMI's Decker Culdoscope and Decker Operating Culdoscope, to Karl Storz Endoscopy America, Inc.'s Culdoscopes and to Richard Wolf Medical Instrument Corp.'s Fiber Light Culdoscopes. All of these devices were legally marketed for the same intended use (i.e., culdoscopy) prior to May 28, 1976.

4) Description of Device:

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K980972
P20972

510(k) Summary #K98 0972 Circon Corporation Rigid Culdoscopes & Accessories March 12, 1998 Page 2/2

ട്) Intended Use of Device:

CIRCON's Rigid Culdoscopes and Acessories are intended to be used for direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures. The system is introduced into the pelvic cavity through the posterior vaginal fornix.

Comparison of Technological Characteristics: 6)

CIRCON Rigid Culdoscopes and Accessories are substantially equivalent' to the Decker Culdoscopes and Decker Operating Culdoscopes that were first marketed by ACMI, and to the Storz and Wolf culdoscopes. CIRCON's scopes employ the same design considerations and operating principles as the legally marketed predicate devices, and each can be sterilized and reused. Any differences between these culdoscopes do not raise new questions regarding safety or effectiveness.

'The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features an eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ronald J. Ehmsen, Sc.D. Vice President, Regulatory Affairs CIRCON Corporation 6500 Hollister Avenue Santa Barbara, CA 93117-3019

JUN 1 2 1998

Re: K980972

Rigid Culdoscopes and Accessories, G27 Series (Diagnostic Use) Dated: March 12, 1998 Received: March 16, 1998 Regulatory Class: II 21 CFR 884.1640/Procode: 85 HEW

Dear Dr. Ehmsen:

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 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). 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 (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 (OS) 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 80) 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/odrh/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph.D.

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: K980972

Device Name: Rigid Culdoscopes and Accessories

Indications for Use:

Circon's Rigid Culdoscopes and Accessories are intended for viewing pelvic organs endoscopically via a posterior vaginal fornix entry. Culdoscopy is indicated for:

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 ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Robert R. Ratting /
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 1980977 510(k) Number .

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.