CIRCON's USA Series™ Laparoscopes are intended for use by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs, and canals during endoscopic and laparoscopic surgical procedures. These include, but are not limited to, laparoscopic procedures used in general surgical procedures, cholecystectomy, colon resection or therapeutic thoracoscopy.

Device Description

CIRCON's USA Series™ Laparoscopes are substantially equivalent to the other currently marketed laparoscopes which are referenced above. CIRCON's USA Series™ Laparoscopes and their predicate devices are all telescopes that incorporate fiber optics and optical lenses within a rigid shaft and are connected to a light source. Several models of CIRCON's USA Series™ Laparoscopes and predicate devices also incorporate a working channel within the diameter of the rigid shaft that allows for the introduction and manipulation of accessory instrumentation for use during the procedure.

AI/ML Overview

Here's a breakdown of the information you requested based on the provided text, though it's important to note that this document is a 510(k) summary, which often relies on comparison to predicate devices rather than extensive new clinical trials to establish acceptance criteria and performance.

Key Observation: The document does not describe a study to prove acceptance criteria in the way a clinical trial for a novel AI device would. Instead, it asserts substantial equivalence to existing predicate devices. This means the acceptance criteria are implicitly met by demonstrating that the new device has "the same general intended use" and "technological characteristics" as previously cleared devices. Therefore, the "study" referred to here is essentially the comparison and justification of equivalence to the predicate devices, rather than a performance study with a test set.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Substantial Equivalence)	Reported Device Performance
Intended Use: Device provides access, illumination, and visualization of body cavities, hollow organs, and canals during endoscopic and laparoscopic surgical procedures, including (but not limited to) laparoscopic cholecystectomy, colon resection, and therapeutic thoracoscopy. (Same as predicate devices)	CIRCON's USA Series™ Laparoscopes have the same general intended use as the previously cleared predicate devices.
Technological Characteristics: Device is a telescope incorporating fiber optics and optical lenses within a rigid shaft, connected to a camera system. May include a working channel for accessory instrumentation. (Same as predicate devices)	CIRCON's USA Series™ Laparoscopes are substantially equivalent to predicate devices; they are all telescopes that incorporate fiber optics and optical lenses within a rigid shaft and are connected to a camera system. Several models also incorporate a working channel.
Biocompatibility: Made of medical-grade, biocompatible materials with the same body contact, contact duration, and intended use as predicate devices.	All CIRCON USA Series™ Laparoscopes are made of medical grade biocompatible materials of the same type as used in other biocompatible predicate laparoscopes.
Safety and Effectiveness: Raises no new issues of safety or effectiveness. (Implied by substantial equivalence)	CIRCON's USA Series™ Laparoscopes raise no new issues of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size Used for Test Set: Not applicable. The document does not describe a performance study with a distinct test set in the conventional sense for evaluating performance metrics. The "test" is an assertion of equivalence to predicate devices, not a quantitative measure against a sample.
Data Provenance: Not applicable. There is no mention of specific data derived from a test set, country of origin, or whether it was retrospective or prospective. The justification is based on the characteristics of the device itself and its similarity to existing marketed devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No experts were used to establish ground truth for a test set, as no performance study on a test set (e.g., patient cases) is described. The "ground truth" for substantial equivalence is the FDA's existing clearance of the predicate devices and the manufacturer's assertion that the new device is functionally identical and made of similar materials.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring ground truth establishment or adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. This type of study (comparing human readers with and without AI assistance) is not mentioned and is not relevant for a traditional medical device like a laparoscope (which is an instrument, not an AI diagnostic tool).
Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable. This concept pertains to AI algorithms. The device described (CIRCON's USA Series™ Laparoscopes) is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the identified predicate devices, as determined by the FDA's prior clearances. The submission asserts that the new device shares sufficient characteristics and intended use with these predicates that it can be considered equally safe and effective.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no mention of a "training set" as this device is not an AI/machine learning algorithm that requires training.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

Summary

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JAN 1 8 2002

510(k) SUMMARY

CIRCON's USA Series™ Laparoscopes

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

CIRCON Corporation 6500 Hollister Avenue Santa Barbara, CA 93117

Phone: (805) 961-3290 Facsimile: (805) 968-7385

Mr. Wayne B. Sterner Contact Person: Corporate Director Regulatory Affairs

9-20-01 Date Prepared:

Name of Device and Name/Address of Sponsor

CIRCON's USA Series™ Laparoscopes with various Tradenames

CIRCON Corporation 6500 Hollister Avenue Santa Barbara, CA 93117

Common or Usual Name

Laparoscopes

Classification Name

Laparoscope, General and Plastic Surgery

Predicate Devices

Richard Wolf's Operating Laparoscopes (K991718); Smith and Nephew Dyonics 2.7 mm Microlaparoscope (K982149); Karl Storz's MVM 3.3 mm Microendoscope (K972504); Surgical Image Laboratories, Inc.'s Model LL100, 103, and 104 Laparoscopes (K955845); and Surgical Image Laboratories, Inc.'s 3.5 mm Laparoscope (K001594);

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Intended Use

CIRCON's USA Series™ Laparoscopes have the same general intended use as the previously s Oblicate devices. The USA Series™ Laparoscopes are use as the proviously crowned physicians to provide access, illumination and mended for use by qualified physical pryans, and canals during endoscopic and visualization or body carrites, nonon organs, dass, dass not limited to, laparoscopic laparoscopic surgical procedures, cholecystectomy, colon resection, and therapeutic thoracoscopy.

Technological Characteristics and Substantial Equivalence

CIRCON's USA Series™ Laparoscopes are substantially equivalent to the other currently marketed laparoscopes which are referenced above. CIRCON's the other carrences and their predicate devices are all telescopes that incorporate fiber optics and optical lenses within a rigid shaft and are connected to morporate fiber optios and veral models of CIRCON's USA Series™ Laparoscopes and predicate devices also incorporate a working channel within the diameter of the and production as 1200s throughput of accessory instrumentation for use during Itgia share that anow b vironging in Thus, CIRCON's USA Series™ Laparoscopes raise no new issues of safety or effectiveness.

Biocompatibility

All CIRCON USA Series™ Laparoscopes are made of medical grade biocompatible materials and are of the same type of material as used in other blocompatible fracticate laparoscopes that have the same body contact, contact duration, and intended use and indications.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2002

ACMI Circon Corporation Mr. Wayne B. Sterner Corporate Director Regulatory Affairs 6500 Hollister Avenue Santa Barbara, California 93117-3019

Re: K013165

Trade Name: USA Series Laparoscopes Regulation Number: 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: January 4, 2002 Received: January 7, 2002

Dear Mr. Sterner:

We have reviewed your Section 510(k) premarket 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) 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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 comply with all 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Wayne Sterner

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 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 vours.

Sincerely yours,

Mark N Mulkeren

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ Ho43 U43 U66

CIRCON's USA Series™ Laparoscopes Device Name:

Indications for Use:

(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) X

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

A. Muli N. Millerson

Division Sign-Off) (Division Sign of General, Restorative and Neurological Devices

510(k) Number -

\\DC - 66763/1 - #1380464 v2

Regulation Number and Section

§ 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.